June 01, 2011 [Clipping News]
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1．携帯通話で脳腫瘍リスク増大も ＷＨＯ専門組織が見解
2．行政の裁量権逸脱を認定、「不当検査」との国の主張も棄却
3．C. difficile感染の再発：fidaxomicinの登場
4．軽症バセドウ病、セレン投与で進行抑制、QOL改善
5．加齢黄斑変性症に対するラニビズマブvs. bevacizumab：CATT
6．ベバシズマブ＋エルロチニブ、非小細胞肺癌患者の生存期間延長せず
7．小児の睡眠不足、過体重のリスクと関連、FLAME試験
8．卒中後の体重免荷トレッドミル歩行訓練、自宅運動と効果に有意差なし
9．転移性前立腺癌へのabiraterone、生存期間を延長
10．脳卒中へのterutroban、アスピリンに非劣性示せず、PERFORM試験
11．細菌性髄膜炎へのセフトリアキソン、投与期間5日と10日で効果は同等
12．New push aims to find cure for Aids virus
13．Killer bacteria claims victims in Germany, Sweden
14．Cell Phones May Cause Brain Cancer, WHO Experts Say
15．Studies Refute Virus' Link to Chronic Fatigue Syndrome
16．Corticosteroids May Speed Pneumonia Recovery in Some
17．In Diabetics, Good Scores on Bone Tests May Not Rule Out Risk
18．Study Suggests Special MRI Might Help Diagnose Autism
19．プレスリリース
1) IARC classifies Radiofrequency Electromagnetic Fields as possibly carcinogenic to humans.
2) 心血管のステント留置治療を、明瞭な画像でスムーズに
3) 外科用止血材製品「吸収性局所止血材TDM-621」製造販売承認申請についてのお知らせ
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1．携帯通話で脳腫瘍リスク増大も ＷＨＯ専門組織が見解
日本経済新聞社2011年6月1日
世界保健機関（ＷＨＯ）の専門組織の国際がん研究機関（ＩＡＲＣ）は31日、「携帯電話の電磁波が脳腫瘍を発症するリスクを増大させる可能性がある」とする調査結果を発表した。ＩＡＲＣはこれまでの調査では電磁波とがん発症について「因果関係は確認できない」との見解を示していたが、その可能性を初めて認めた。
14カ国、31人の専門家から成る研究グループが24～31日に会合を開き、調査結果をまとめた。
全体として発症のリスクがどの程度増えるという数値は出していない。ただ、携帯電話を１日平均30分で10年以上使用した場合、脳腫瘍のリスクが40％増えるという調査結果も一部にはあるという。ＩＡＲＣは「携帯を頻繁かつ長期間使用する人に対する追加的な調査が必要」と指摘した。
発症リスクを減らす対策として、頭部に携帯を近づけずに通話できるヘッドセットの使用のほか、通話ではなく携帯メールに切り替えることを勧めた。
ロイター通信によると、米国の携帯電話の業界団体である移動体通信・インターネット協会（ＣＴＩＡ）は「ＩＡＲＣの分析は携帯電話ががんを引き起こすことを意味しない」と反発。「新たな研究は何も行われていないのに、判断が変更された」と批判した。
2．行政の裁量権逸脱を認定、「不当検査」との国の主張も棄却
保険医取消訴訟、東京高裁が行政処分に違法判決
日経メディカル2011年6月1日
東京高等裁判所は5月31日、山梨県の小児科医・溝部達子氏が無診察処方や不当検査などで保険医と保険医療機関の登録を取り消された行政処分について、違法と判断した2010年3月末の甲府地方裁判所の一審判決を支持し、国の控訴を棄却した。福島、神戸の医療機関が取消処分を不服として提訴したケースが過去にあったが、いずれも地裁では医療機関側の訴えが認められたものの、高裁では敗訴していた。二審で医師の訴えが認められたのは今回が初めてとなる。今後、国が上告するかどうかは未定。
溝部氏が山梨社会保険事務局の指導・監査の結果、保険医の登録を取り消されたのは05年11月。タミフルの予防投与や、保険診療上必要な限度を越えたインフルエンザウイルス抗原迅速診断検査の実施などが不正・不当の保険請求とされた。これに対して溝部氏は、不正・不当請求を一部認めながら、「違反内容に比べて処分が重すぎる」とし、国を相手取って処分取り消しを求める訴訟を提起していた。
一審では、不正・不当とされた41万円余りの請求内容の大半を容認しつつも、同氏の行為は患者のためで悪質性は高いとまでいえないと判断。取消処分は社会通念上著しく妥当性を欠くとし、社会保険事務局の裁量権の範囲を逸脱したものとして違法と判じた（関連記事：2010.8.26「保険医取消に違法判決の背景」）。
これに対して今回の二審では、「保険医療機関の指定および保険医の登録の各取消処分は事実上、医療機関の廃止および医師としての活動の停止を意味する極めて重大な不利益処分である」とし、「処分を検討する際は、処分理由とした行為の動機など諸事情を考慮しなければならない」と指摘。その上で、溝部氏の行為は悪質性が高いとまでいえないと判断し、国の取消処分に関する主張を退けた。
さらに、「1シーズンにインフルエンザに罹患するのは多くても2回である」として、インフルエンザウイルス抗原迅速診断検査を3回実施して保険請求した溝部氏の行為を不当検査とした国の主張に対して高裁は、「十分な根拠を有するものとは認めがたい」として棄却。1シーズン中に数回インフルエンザウイルスに感染する患者も相当数発生していると推測されることなどを理由に挙げた。このほか、国が無診察処方とした複数の事例についても、診療録の記載内容などから「受診した事実がなかったと認めることができない」と判断。不正・不当請求額も、一審の「41万円余り」より少ない「約37万円」とした。
判決後の記者会見で溝部氏は、「高裁の誠意と勇気に敬意を表したい。全国の医師は、行政にいつ保険医を取り消されるか分からない恐怖を抱いている。今回の判決で、暗黒時代が長く続く保険行政に夜明けの光が差してきた」とコメントした。代理人弁護士の石川善一氏は、「高裁は不正・不当請求とされたケース個々を丁寧に審理してくれた」と判決を評価。一方で、依然として指導・監査の基準が明確になっておらず改善が必要であると訴えた。
3．C. difficile感染の再発：fidaxomicinの登場
【原題】Recurrent C. difficile Infection: Enter Fidaxomicin
日経メディカル2011年6月1日
Fidaxomicin significantly lowered recurrence rate in patients infected with non-NAP1/BI/027 strains.
Recurrence of Clostridium difficile infection (CDI) is common, whether metronidazole or vancomycin is used as initial therapy. Fidaxomicin, a macrocyclic antibiotic that is not yet FDA approved, has no crossresistance with other antibiotics and is more active than vancomycin in vitro against clinical C. difficile isolates. In this randomized manufacturer-sponsored phase III trial, 629 adults with CDI received oral fidaxomicin or vancomycin for 10 days.
The rate of clinical cure (resolution of diarrhea; no need for additional CDI therapy as of posttreatment day 2) with fidaxomycin was noninferior to that with vancomycin ― 88% and 86%, respectively. The rate of CDI recurrence during the 4-week period after treatment was significantly lower with fidaxomicin than with vancomycin (15% vs. 25%). Fidaxomicin did not lower the recurrence rate in patients who were infected with the hypervirulent NAP1/BI/027 strains, but it did so in patients infected with other strains. Rates of adverse events were similar between treatment arms.
COMMENT
On the basis of the findings from this investigation, an editorialist wrote that fidaxomicin appeared to be “an important advance.” I hope that this is the case ― new, more-effective treatments for CDI are needed badly.
― Larry M. Baddour, MD, Journal Watch Infectious Diseases
Louie TJ et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011 Feb 3; 364:422.
DuPont HL. The search for effective treatment of Clostridium difficile infection. N Engl J Med 2011 Feb 3; 364:473.
4．軽症バセドウ病、セレン投与で進行抑制、QOL改善
CareNet2011年6月1日
日本ではバセドウ病と称されるグレーブス病眼症（GO）の軽症患者に対する治療として、健康栄養素セレンの投与が、QOL改善、眼症減少、GO進行抑制に寄与することが報告された。欧州グレーブス病眼症グループ（EUGOGO）を代表してイタリア・ピサ大学内分泌・代謝学部門のClaudio Marcocci氏らが、同グループに参加する4ヵ国6施設の患者を対象に二重盲検無作為化プラセボ対照試験を行った結果による。軽症GO患者には症状が悪化するまで積極的な治療を行わないが、QOLの低下が問題視されていた。Marcocci氏らはGOの発症機序から、抗酸化作用を有するセレンと、抗炎症作用や種々の免疫調整作用を有するペントキシフィリンの可能性に着目。ペントキシフィリンが小規模パイロット試験でGO患者にベネフィットがあることが示唆されたことを踏まえ、本検討を行った。NEJM誌2011年5月19日号掲載報告より。
セレン、ペントキシフィリン、プラセボで二重盲検無作為化試験
試験は2005年1月～2009年1月、イタリアとドイツ各2施設、スイスとギリシャ各1施設の計6施設で、軽症GO患者159例を対象に行われた。
被験者は無作為に、セレン投与群（セレンサプリメント、100μgを1日2回、54例）、ペントキシフィリン投与群（Trental、600mgを1日2回、48例）、プラセボ投与群（1日2回、50例）に割り付けられ6ヵ月間にわたる経口投与を受け、投与を中止した後6ヵ月間追跡された。
主要アウトカムは、6ヵ月時点での、治療割り付けを知らされていない眼科医による眼の全般的評価と、患者によるGO特異的QOL質問票による評価とした。またCAS（Clinical Activity Score）と複視スコアを副次的アウトカムとした。
セレン群、プラセボとの比較でQOL改善、眼症減少、GO進行抑制
6ヵ月時点の評価でプラセボと比較して、セレン投与群は、QOLが改善（P＜0.001）、眼症状がより少なく（P＝0.01）、GO進行の抑制（P＝0.01）が認められた。一方、ペントキシフィリン投与群ではいずれも認められなかった。
CASは3群とも低下が認められたが、セレン投与群での変化（平均3.5）が有意に大きかった。ペントキシフィリン投与群とプラセボ群の低下は有意差が認められなかった（平均3.0）。
これらの結果は、12ヵ月時点の探索的評価においても確認された。
なお、プラセボ群2例とペントキシフィリン投与群1例の患者で、病態悪化による免疫抑制療法が必要となった。有害事象は、セレン投与群ではそれとわかる事象が認められなかったが、ペントキシフィリン投与群では高頻度の胃腸症状が認められた。
http://www.ncbi.nlm.nih.gov/pubmed/21591944
5．加齢黄斑変性症に対するラニビズマブvs. bevacizumab：CATT
CareNet2011年6月1日
滲出型加齢黄斑変性症（AMD）に対する、血管内皮増殖因子（VEGF）阻害薬のラニビズマブ（商品名：ルセンティス）とbevacizumabの有効性および安全性について検討した、多施設共同単盲検非劣性無作為化試験「CATT」の結果が発表された。ラニビズマブは臨床試験により滲出型AMDに対する有効性が認められる承認薬である。一方、bevacizumab（商品名：アバスチン、抗悪性腫瘍薬としてのみ承認）はAMDに対しては未承認で大規模臨床試験データもないが、ラニビズマブ同様VEGFをターゲットとすること、また投与コストがラニビズマブよりも安価であること（1回投与につきラニビズマブ約2,000ドル、bevacizumab約50ドル）から、ラニビズマブのFDA承認待ちの間に眼科医たちが適応外使用を始め、米国ではAMD治療薬として最も一般的に用いられるようになっているという。NEJM誌2011年5月19日号（オンライン版2011年4月28日号）掲載報告より。
ラニビズマブとbevacizumabは同等
CATT（Comparison of Age-Related Macular Degeneration Treatments Trials）は、ラニビズマブとbevacizumabの有効性および安全性を評価すること、また「必要に応じて投与」が「月1回投与」と比べて長期的視力を損なうかどうかの検討を目的に行われた。2008年2月から2009年12月の間に米国内44のクリニックから登録された患者1,208例（50歳以上、未治療の滲出型AMDを片眼以上有する、電子視力検査による視力が20/25～20/320）を対象とした。
被験者は無作為に、ラニビズマブかbevacizumabを硝子体内注射される群に、また月1回投与か月1回の評価で必要に応じて投与する群に割り付けられた。
主要アウトカムは、1年時点の視力変化の平均とした。非劣性の範囲は、視力表5文字とした。
結果、1年時点の視力変化の平均は、月1回投与bevacizumab群8.0文字増、同ラニビズマブ群8.5文字増で、両群は同等であることが認められた。
必要に応じて投与bevacizumab群（5.9文字増）、同ラニビズマブ群（6.8文字増）も同等であることが認められた。
また、ラニビズマブは投与法が異なっても（月1回投与か必要に応じて投与）、同等であることが認められたが、bevacizumab群については確証が得られなかった。
中心窩網膜厚減少の平均は、月1回投与ラニビズマブ群196μmで、他の群（必要に応じて投与ラニビズマブ群168μm、月1回投与bevacizumab群164μm、必要に応じて投与bevacizumab群152μm）より大きかった（分散分析によるP＝0.03）。
入院リスク、bevacizumab群がラニビズマブ群の1.29倍だがさらなる検証が必要
死亡、心筋梗塞、脳卒中の発生率は、bevacizumab群とラニビズマブ群で同程度であった（P＞0.20）。
一方で、重篤な全身有害事象（主に入院）リスクが、ラニビズマブ群よりもbevacizumab群でより高かった［発生率：bevacizumab群24.1％、ラニビズマブ群19.0％、リスク比：1.29（95％信頼区間：1.01～1.66）］。それらの多発したイベントは、先行研究のがんトライアルではみられなかった疾患カテゴリーにまで多岐にわたっていた。
以上を踏まえCATT研究グループは、「1年時点で、ラニビズマブとbevacizumabの視力に対する効果は、投与スケジュールが同じ場合、同等であった。ラニビズマブの視力に対する効果は、月1回の評価で必要に応じて投与する群と月1回投与群で同等だった」と結論。重篤な有害事象発生率の差異については、偶然である可能性、病歴や多変量モデルに基線の健康状態が含まれなかったことなどが考えられ、より多くの症例数による「さらなる検討が必要」と結論している。
http://www.ncbi.nlm.nih.gov/pubmed/21526923
6．ベバシズマブ＋エルロチニブ、非小細胞肺癌患者の生存期間延長せず
文献：Herbst RS et al.Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial.Lancet 2011;377:1846-1854.
標準化学療法無効の再発性または難治性非小細胞肺癌（NSCLC）におけるベバシズマブ＋エルロチニブの有効性および安全性を、二重盲検プラセボ対照無作為化第3相試験で検討。患者の全生存期間の中央値は、エルロチニブ＋プラセボ群（317人）で9.2カ月、ベバシズマブ＋エルロチニブ群（319人）で9.3カ月と同等だった。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60545-X/abstract
7．小児の睡眠不足、過体重のリスクと関連、FLAME試験
文献：Carter PJ et al.Longitudinal analysis of sleep in relation to BMI and body fat in children: the FLAME study.BMJ 2011; 342:d2712.
小児244人を追跡調査し、睡眠と体格指数（BMI）および体脂肪との関係を縦断的研究で検討。複数の交絡因子の調整後、3-5歳時で睡眠が1時間増えるごとにBMIの0.48減少と関連し、また7歳時での過体重（BMIが85パーセンタイル以上）リスクの0.39低下と関連した。BMIの変化は除脂肪量指数ではなく体脂肪量指数によるものだった。
http://www.bmj.com/content/342/bmj.d2712.abstract
8．卒中後の体重免荷トレッドミル歩行訓練、自宅運動と効果に有意差なし
文献：Duncan PW et al.Body-Weight–Supported Treadmill Rehabilitation after Stroke.NEJM 2011; 364:2026-2036.
卒中後2カ月の歩行障害患者408人を対象に、体重免荷トレッドミル歩行訓練の有効性および適切な実施時期（発作後2カ月または6カ月）を無作為化試験で検討。発作1年後、理学療法士管理下の自宅運動群との比較で、早期・後期歩行訓練群とも歩行機能の回復に有意差は見られず、浮動性めまいの発生率上昇を認めた（P＝0.008）。
http://www.nejm.org/doi/full/10.1056/NEJMoa1010790
9．転移性前立腺癌へのabiraterone、生存期間を延長
文献：de Bono JS et al.Abiraterone and Increased Survival in Metastatic Prostate Cancer.NEJM 2011; 364:1995-2005.
化学療法歴のある転移性去勢抵抗性前立腺癌患者1195人を対象に、abiraterone acetateの延命効果を無作為化プラセボ対照試験で検討。介入群では対照群に比べ全生存期間（14.8カ月対10.9カ月）、PSA増悪までの期間（10.2カ月対6.6カ月）、無増悪生存期間（5.6カ月対3.6カ月）が延長された。
http://www.nejm.org/doi/full/10.1056/NEJMoa1014618
10．脳卒中へのterutroban、アスピリンに非劣性示せず、PERFORM試験
文献：Bousser MG et al.Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial.The Lancet, Early Online Publication, 25 May 2011.
虚血性脳卒中または一過性脳虚血発作歴のある患者1万9120人を対象に、terutrobanの再発予防効果を無作為化二重盲検試験でアスピリンと比較。主要複合評価項目（虚血性脳卒中、心筋梗塞、その他の血管死）や有害事象の発現率に有意な群間差はなかった。著者らは、依然としてアスピリンが標準的な再発予防薬と結論している。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60600-4/abstract
11．細菌性髄膜炎へのセフトリアキソン、投与期間5日と10日で効果は同等
文献：Molyneux E et al.5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study.Lancet 2011;Volume 377:1837-1845.
肺炎球菌、インフルエンザ菌b型、髄膜炎菌を起炎菌とする生後2カ月-12歳の化膿性髄膜炎患児1004人を対象に、5日間投与と10日間投与の非経口セフトリアキソンの治療効果を、二重盲検無作為化プラセボ対照同等性試験で比較。5日間投与群496人中2人に再発が見られたが、両群とも細菌学的失敗は認められず、副作用は軽微だった。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60580-1/abstract
12．New push aims to find cure for Aids virus
BBC News2011年6月1日
More investment is needed to find a cure for HIV, the new head of the International Aids Society has said.
Bertrand Audoin admits this might take as long as 25 years, but he says a cure is the only way to keep ahead of the HIV epidemic in the long term during tough financial times.
Sunday sees the 30th anniversary of the first medical reports of a new illness.
Some experts have warned that talk of a cure could lead to false hopes, and developing a vaccine would be better.
Mr Audoin said: "It is the right moment - from the scientific and financial point of view - to invest more time and money in researching a cure.
"There is already some basic science in this area. We know that some people who are on HIV treatment can contain the virus in a way which makes them unable to infect other people.
"So we think further work could help us develop a functional cure, which would allow the virus to remain latent in the body, without people feeling sick or needing treatment. That's the goal."
Fast epidemic
Mr Audoin ran a French Aids organisation called Sidaction, before heading the IAS - an organisation of 18,000 health professionals and activists.
He said: "At the moment, for every one person beginning treatment in badly affected countries in Africa, two people get infected with HIV in that time.
"So treatment with anti-retroviral drugs isn't the only solution in the long run.
"It could take 25 years before we find a cure - and the hardest part will be convincing donor governments and other funding organisations to put money into research.
"But if we don't invest in the science, the epidemic will go faster than our work on it - and the financial situation will make it more difficult to put people on treatment."
False hopes
The IAS has convened a working group of international researchers to develop a strategy that might lead to a cure. It is due to deliver a draft report at the end of the year.
The group is co-chaired by Professor Francoise Barre-Sinoussi, who won the Nobel Prize in 2008 for discovering HIV.
A virologist at University College London, Professor Robin Weiss, said: "Much as I would love to see one, the word 'cure' can lead to false hopes.
"I don't believe you can cure HIV infection, but you can keep the amount of virus down.
"I would prefer to see a vaccine so we can stop people being infected in the first place. But we're still years away from having one for HIV."
Next week, heads of governments will attend a high-level UN meeting on Aids in New York. Negotiations have already begun to look at the wording of a final declaration.
Mr Audoin said: "Some of us are fighting for very simple words to be put in the declaration - for example, mentioning condoms - but we are not sure if that will happen.
"There is a trend in some governments to think that we've done enough on HIV, or that everything has failed. We need to keep developing our programmes."
http://www.bbc.co.uk/news/health-13605224
13．Killer bacteria claims victims in Germany, Sweden
Reuters News2011年5月31日
A killer bacteria linked to contaminated cucumbers claimed a 15th victim in Germany on Tuesday and its first fatality abroad when a Swedish woman who had been traveling in Germany died, authorities said.
One of the largest E.coli outbreaks of its kind, it has also made more than 1,000 people ill in Germany as well as people from Spain, Sweden, Britain, Denmark, France and the Netherlands who had recently been in Germany.
It has also caused diplomatic tension between Germany and countries such as Spain, France and Russia. The source of the virulent strain of the bacteria is unknown, authorities said. Most of the deaths have been in northern Germany.
The E. coli pathogen has been identified on cucumbers imported from Spain, but it is not clear if they were contaminated there, during transport, or possibly in Germany.
"The situation is tense but it can be dealt with," said Health Minister Daniel Bahr at a news conference late on Monday. He said he expected the number of cases to continue rising.
The German government has identified the disease as hemolytic-uremic syndrome (HUS), a serious complication of a type of E. coli known as Shiga toxin-producing E. coli (STEC).
Russia has banned vegetable imports from Germany and Spain and said it may expand the ban to all European Union member states, head of Russia's Federal Consumer Protection Agency Gennady Onishchenko was quoted by corporate-owned Interfax news agency as saying.
"If the situation does not change, we will ban all the European vegetable products," he said.
Spanish farmers are losing around 200 million euros ($286 million) per week in lost sales because of it, a farmers association said on Tuesday.
German authorities have warned consumers to avoid eating cucumbers, lettuces and tomatoes.
GROWING TENSION
Spain said on Monday there was no proof that cucumbers from its growers had caused the outbreak of E.coli in Germany and that it would be demanding to know why its farmers had been blamed.
Spanish media reported Germany, Denmark, Czech Republic, Luxembourg, Hungary, Sweden, Belgium and Russia are blocking entry of Spanish cucumbers.
In a further sign of growing tension in Europe, French Health Minister Xavier Bertrand demanded in a TV interview on Tuesday greater transparency from Spain and Germany over the mysterious outbreak after three people in France became ill.
"At first the German authorities were categorical," he said. "Today there are more and more questions arising. I want to know the origin (of the contamination)," Bertrand told France 2 television. "We need completely transparent information from the German authorities, and from the Spanish authorities as well.
Hungary's news agency MTI cited Spain's Minister for Environment and Rural Affairs Rosa Aguilar as saying on Tuesday ahead of an informal meeting of EU farm ministers in eastern Hungary that the bacteria which had killed several people had not been identified in Spain before.
"From the Spanish side there will be two important topics at today's discussion: on the one hand we wish to make it clear that Spanish products are safe and of good quality -- on the other hand we advocate a common solution," the minister said.
In Brussels, the European Commission said: "The Commission notes that the outbreak is limited geographically to an area surrounding the city of Hamburg.
"Also, efforts to pinpoint all possible sources of contamination are well under way and have already yielded preliminary results. It would, therefore, consider any ban on any product as disproportionate."
In the Netherlands, a Dutch horticulture group said exports of cucumbers to Germany, the most important market, had all but halted and it Dutch farmers were losing millions of euros.
The European Center for Disease Prevention and Control (ECDC) said in a risk assessment that the HUS/STEC outbreak is one the largest in the world of its kind.
HUS affects the blood, kidneys and, in severe cases, the nervous system and can be particularly serious for children and the elderly. In an average year, around 60 cases of HUS are reported in Germany, the government said.
http://www.reuters.com/article/2011/05/31/us-germany-ecoli-idUSTRE74S12V20110531
14．Cell Phones May Cause Brain Cancer, WHO Experts Say
World Health Organization now classifies the devices as 'possibly carcinogenic to humans'
HealthDay News2011年5月31日
Cell phones may cause brain cancer, a panel of experts reporting to the World Health Organization (WHO) announced Tuesday.
After reviewing dozens of studies that explored a possible link between cancer and the ubiquitous hand-held phones, the experts classified cell phones as "possibly carcinogenic to humans" and placed them in the same category as the pesticide DDT and gasoline engine exhaust.
The panel determined that an increased risk for glioma, a malignant form of brain cancer, appears associated with wireless phone use.
Globally, it's estimated that 5 billion cell phones are in use. "The number of users is large and growing, particularly among young adults and children," the International Agency for Research on Cancer said in a news release issued Tuesday.
The IARC made the announcement in Lyons, France, based on the work of 31 scientists from 14 countries. It will present its findings to the WHO, which may then issue its recommendations on safe cell phone use.
Experts said children are especially vulnerable.
"Children's skulls and scalps are thinner. So the radiation can penetrate deeper into the brain of children and young adults. Their cells are dividing at a faster rate, so the impact of radiation can be much larger," Dr. Keith Black, chairman of neurology at Cedars-Sinai Medical Center in Los Angeles, told CNN.
Until Tuesday's announcement, the WHO had said that cell phones were safe to use.
The international experts behind Tuesday's announcement met for eight days to review exposure data, studies of cancer in humans and in experimental animals, and other relevant data, looking for associations between cancer and the type of electromagnetic radiation found in cell phones, televisions and microwaves.
Dr. Christopher Wild, director of the International Agency for Research on Cancer, said this new paper is important "first and foremost just because of the large number of users worldwide that have access now to this technology."
Also, the scientists found notable gaps in the existing research, he said, which "suggest interesting areas of future research that will improve the evidence base which we have in order to make decisions about the usage of mobile phones in the future."
Responding to Tuesday's announcement, John Walls, vice president of public affairs for CTIA-The Wireless Association, a trade group representing the wireless industry said: "Today, an International Agency for Research on Cancer (IARC) working group in Lyon, France categorized radiofrequency fields from cellphones as 'possibly' carcinogenic based on 'limited evidence.' IARC conducts numerous reviews and in the past has given the same score to, for example, pickled vegetables and coffee. This IARC classification does not mean cell phones cause cancer. Under IARC rules, limited evidence from statistical studies can be found even though bias and other data flaws may be the basis for the results.
"The IARC working group did not conduct any new research, but rather reviewed published studies," Walls added in a news release. "Based on previous assessments of the scientific evidence, the Federal Communications Commission has concluded that '[t]heres no scientific evidence that proves that wireless phone usage can lead to cancer.' The Food and Drug Administration has also stated that '[t]he weight of scientific evidence has not linked cell phones with any health problems.'"
There has been conflicting research in recent years on the health hazards posed by cell phones. As recently as February, British researchers reported that cell phones do not increase the risk of brain cancer.
Their analysis of data on newly diagnosed cases of brain cancer in England between 1998 and 2007 -- when cell phone use was climbing -- revealed no statistically significant change in the incidence of brain cancers in men or women, said the University of Manchester researchers.
There was a very small increase (0.6 more cases per 100,000 people) in the incidence of cancers of the brain's temporal lobe. That works out to 31 extra cases per year in England's population of nearly 52 million people, the researchers said.
But the study authors also noted that cancers of the brain's parietal lobe, cerebrum and cerebellum in English men fell slightly during the study period.
That study was released online in the journal Bioelectromagnetics.
Dr. Otis Brawley, chief medical officer for the American Cancer Society, said the WHO's classification of cell phones "means that there could be some risk, but that the evidence is not strong enough to be considered causal, and needs to be investigated further. The bottom line is the evidence is enough to warrant concern, but it is not conclusive."
Dr. Nagy Elsayyad, an assistant professor in the Department of Radiation Oncology at the University of Miami Sylvester Cancer Center, agreed, saying scientists don't know much more about cell phone safety than they did before the WHO statement. "They [WHO] indicate it is a possible, not a probable source," he said. "But they still cannot come out with a positive conclusion."
Elsayyad advises using an ear piece or speaker when talking on a cell phone.
"If you hold the phone away from your brain that ought to decrease the risk tremendously," he said.
More information
To learn more about brain cancer, visit the U.S. National Library of Medicine.
SOURCES: Nagy Elsayyad, M.D., assistant professor, Department of Radiation Oncology, University of Miami Sylvester Cancer Center and Miller School of Medicine; Otis Brawley, M.D., chief medical officer for the American Cancer Society; World Health Organization, news release, May 31, 2011; CTIA-The Wireless Association, news release, May 31, 2011; CNN
http://consumer.healthday.com/Article.asp?AID=653428
15．Studies Refute Virus' Link to Chronic Fatigue Syndrome
Contamination of human samples in the lab led to errors in influential 2009 study, scientists say
HealthDay News2011年5月31日
A virus identified two years ago as a possible cause of chronic fatigue syndrome now turns out not to be the culprit, new research says.
Experts say it's a major setback in the effort to understand and treat this mysterious and debilitating disease.
The authors of a new study published May 31 in Science find that the so-called XMRV viral pathogen spotted in human samples in the prior study (published by the same journal in 2009) likely got there as a result of "genetic recombination." That can occur in the laboratory when DNA from different viruses mix.
In this case, two mouse viruses combined and the product of that union then contaminated the human specimens via "reagent" compounds used in the lab, the new research shows.
This probable contamination of the samples with XMRV in the lab "means that this virus has no proven association" with chronic fatigue syndrome, said Stuart LeGrice, head of the lab that oversees all XMRV research at the U.S. National Cancer Institute, which conducted the new study.
"I believe the evidence is incontrovertible," he added. "It doesn't rule out the possibility that there's another retrovirus [involved] but, as of right now, we're close to 100 percent certain that this eliminates the virus as a causative agent of either condition."
The study was accompanied by a rare "Expression of Concern" from the editors of Science. While they did not call for an outright retraction of the original paper, the editors pointedly questioned the study's validity.
According to the Wall Street Journal, the editors of Science have asked the authors of the 2009 paper to voluntarily retract their paper. The authors have responded that any retraction would be "premature," the newspaper reported.
This sequence of events began two years ago, with the publication of a finding that about two-thirds of patients with chronic fatigue syndrome sampled were infected with XMRV, which stands for xenotropic murine leukemia virus-related virus. These viruses can cause cancer and other problems in mice and they can infect human cells in the laboratory.
At the time, the finding raised hopes that there might finally be a concrete cause for chronic fatigue syndrome and perhaps, down the line, treatments for the disease.
The illness affects an estimated 1 percent of people worldwide and, as its name implies, involves crippling fatigue as well as aching joints, headaches and various other symptoms.
Unfortunately, subsequent studies by other researchers failed to replicate the findings.
The authors of the new study looked at blood samples from 61 people with chronic fatigue syndrome. The samples came from the same source that had supplied samples for the 2009 study. Forty-three of the samples had earlier been diagnosed as positive for XMRV.
However, this time around the researchers avoided using any lab products derived from mice. This time, they found no evidence at all of XMRV in any of the 61 samples.
"We're learning a very important lesson that even some commonly used reagents [compounds used in scientific experiments] contain trace amounts of contaminating mouse DNA," said LeGrice, who is head of the Center of Excellence in HIV AIDS/Cancer Virology at the National Cancer Institute. "But, using diagnostic technologies that are ultra-sensitive, we can easily pick out the contaminating material. The contaminants somehow got into the samples [but] we have to be absolutely clear that this virus was never in humans."
A second study in the same issue of the journal had similar problems trying to replicate earlier research linking XMRV with prostate cancer tumors, for much the same reasons. That study was led by Jay Levy of the University of California, San Francisco.
A statement from the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America said that "these studies add to the mounting number of publications that challenge the reliability of the initial report."
The U.S. National Institutes of Health is sponsoring additional studies on XMRV and chronic fatigue syndrome.
"We will support the outcome of those studies, whichever way they lead," the CFIDS statement said.
More information
There's more on chronic fatigue syndrome at the U.S. Centers for Disease Control and Prevention.
SOURCES: Stuart LeGrice, Ph.D., head, Center of Excellence in HIV AIDS/Cancer Virology, U.S. National Cancer Institute; statement, CFIDS Association of America; May 31, 2011, Science
http://consumer.healthday.com/Article.asp?AID=653433
16．Corticosteroids May Speed Pneumonia Recovery in Some
Adding dexamethasone to antibiotic regimen helps treat community-acquired pneumonia, study says
HealthDay News2011年5月31日
Patients with an inflammatory lung condition known as community-acquired pneumonia appear to recover faster when treated with corticosteroids in addition to the standard regimen of antibiotics, Dutch researchers say.
Those treated with a combination of corticosteroids and antibiotics also required a shorter hospital stay than patients treated with antibiotics alone, the study authors found.
The observations stem from what is believed to be the largest study to date focused on the potential of corticosteroids for the treatment of community-acquired pneumonia, or CAP.
Dr. Sabine Meijvis, from the St. Antonius Hospital in Nieuwegein, the Netherlands, and colleagues reported their findings in the May 31 online edition of The Lancet.
Meijvis and her team noted that, currently, CAP is typically treated with antibiotics following an early diagnosis.
To explore whether corticosteroids might reduce the risk for complications and fatalities, the team focused on just over 300 Dutch CAP patients. Half of the patients were placed on a standard antibiotic protocol coupled with 5 milligrams a day of the corticosteroid dexamethasone. The other half were given antibiotics plus a placebo (an inactive treatment).
After four days, the research team found that those given the corticosteroid experienced less lung inflammation, and recovered more quickly than those who were just given antibiotics.
The corticosteroid group also required one less day of hospitalization than the antibiotic group (6.5 days versus 7.5 days). In addition, by the end of one month, the corticosteroid group had experienced better "social functioning" relative to the antibiotic group, the investigators found.
"Serious adverse events were rare" among the corticosteroid group, the study team noted in a journal news release, while at the same time cautioning that "the benefits of corticosteroids should be weighed against the potential disadvantages of these drugs, such as superinfections and gastric disturbances."
Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said the findings were in line with what he might expect.
"It doesn't surprise me because corticosteroids are used as nuclear anti-inflammatories," he said, noting they might suppress an otherwise lingering fever within 24 hours. "And they would mask a lot of symptoms and make a patient feel generally better whether they're asthmatics or have some inflammatory disease."
"But the downside," he cautioned, "is that we know that corticosteroids are immune-suppressive. And so the possibility exists that when you use them, you could be prolonging the actual recovery time even as you are masking the symptoms, although this study doesn't say that."
This is a potential danger for otherwise healthy people and especially so for those who have high blood pressure or diabetes, he said. "So any medication is a double-edged sword," he added. "And the use of corticosteroids in this case has to be weighed against possible complications."
More information
For more on pneumonia, visit the U.S. National Library of Medicine.
SOURCE: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City, and Northshore-LIJ Health System; The Lancet, news release, May 31, 2011
http://consumer.healthday.com/Article.asp?AID=653424
17．In Diabetics, Good Scores on Bone Tests May Not Rule Out Risk
People with normal bone density may be as prone to fracture as those with osteoporosis, study finds
HealthDay News2011年5月31日
Although many older diabetics have good bone density scores, they are as prone to fractures as people with osteoporosis, a new study finds.
For people over 65, doctors usually recommend a bone density test to look for signs of bone loss and osteoporosis, but whether those tests are of use in older people with type 2 diabetes has been a question, according to the researchers.
"People with type 2 diabetes have a strange combination," said the study's lead researcher, Ann V. Schwartz, an associate adjunct professor in the epidemiology and biostatistics department at the University of California, San Francisco. "They have a higher fracture risk and they have a higher bone density."
However, she said, "we found that these tests work to predict fracture," though the interpretation of the results needs to be different.
To assess the value of bone density tests in predicting the risk for fractures among diabetics, the researchers looked at two tests of bone strength: bone mineral density, which produces what's called a T score, and the World Health Organization's fracture risk algorithm, called a FRAX score.
"A T score of minus 2.5 or lower is generally considered osteoporotic and at high risk of fracture," Schwartz said. "But if you have someone with type 2 diabetes who has a T score of minus 2, they have about the same fracture risk as a non-diabetic with a T score of minus 2.5," she said.
Doctors should use bone density to screen older adults with type 2 diabetes, Schwartz said, "but they have to realize that the threshold they use to indicate high risk has to be raised."
The report was published in the June 1 issue of the Journal of the American Medical Association.
For the study, Schwartz's team collected data on 9,449 women and 7,436 men who took part in one of three studies, the Study of Osteoporotic Fractures, the Osteoporotic Fractures in Men Study or the Health, Aging and Body Composition study. All participants were in their 70s when their study began.
During almost 13 years of follow-up, 84 hip fractures and 262 other fractures were recorded among the 770 women with diabetes. Among 1,199 men with diabetes, 32 had hip fractures and 133 had other fractures during about eight years of follow-up, the investigators found.
The researchers noted that, among diabetics, fractures were more likely to occur even when bone density tests indicated that there was only a small risk for fracture.
"For a given T score and age, those adults with DM [diabetes mellitus] had a higher risk of fracture than those without DM, consistent with previous studies," they wrote. "Participants with DM also experienced higher fracture rates at a given FRAX score than participants without DM."
Because of this, according to the researchers, doctors should consider people with type 2 diabetes at risk for fractures even when bone density tests indicate that they don't have osteoporosis and, therefore, have a lower risk for fractures.
In addition, Schwartz said that she would start treating diabetic patients for osteoporosis if they had T scores of minus 2.
She noted that standard treatments for osteoporosis have not been studied in diabetics but that they appear to work. "In general, the treatments seem to be as effective in diabetics as in non-diabetics," she said.
Commenting on the study, Dr. Robert R. Recker, president of the National Osteoporosis Foundation, said that "a lot of people with diabetes will be at risk for fracture, and many of them don't have low bone mass."
But he noted that the reasons that someone with diabetes has a fracture risk may not be the same as for a person without diabetes. "So the same treatments may not be appropriate -- and therein lies the rub," Recker said.
He does, however, recommend calcium and vitamin D.
The real problem, he said, is that little is known about why the risk for fracture is elevated among type 2 diabetics.
"Basically, we don't know anything about it," Recker said. "There may be something going on that interferes with bone cell function -- and it's not outrageous to think that because diabetes interferes with just about all cell function all over the body."
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more on diabetes.
SOURCES: Ann V. Schwartz, Ph.D., M.P.H., associate adjunct professor, department of epidemiology and biostatistics, University of California, San Francisco; Robert R. Recker, M.D., president, National Osteoporosis Foundation; June 1, 2011, Journal of the American Medical Association
http://consumer.healthday.com/Article.asp?AID=653419
18．Study Suggests Special MRI Might Help Diagnose Autism
Scans found less responsiveness in language areas of brain, researchers report
HealthDay News2011年5月31日
At the moment, a diagnosis of autism is based on subjective evaluations, but a new way of using MRI might be an objective way of spotting the disorder, Columbia University researchers report.
Autism is a spectrum disorder that includes repetitive behaviors and impairments in language, communication and social skills. It is estimated that the condition affects one in 110 children in the United States, according to the U.S. Centers for Disease Control and Prevention.
"There is a serious unmet need in the autism world, where diagnosis is currently done by subjective reports, and after the child has missed many developmental milestones," said lead researcher Joy Hirsch, a professor of functional neuroradiology, neuroscience and psychology, and director of the Functional MRI Laboratory at Columbia University Medical Center in New York City.
"It is now possible to develop an objective imaging diagnostic," she said. Indeed, the researchers found a difference between autistic brains and typical brains in the level of responsiveness in language areas, Hirsch noted.
"What we can measure are signals in the brain, in a specific language area, that are depressed in autistic children and normal in typical children," she said.
Although this study was done with school-aged children and teens, the same test can be done with children as young as 18 months, Hirsch noted. "We know this technique can be used on young children," she said.
The report was released in the May 31 online edition of Radiology, in advance of publication in the August print issue.
For the study, 12 children with autism and 15 children without the condition underwent functional MRI (fMRI) exams. Both groups of children ranged in age from 4 to 17 years.
While the children were undergoing the fMRI, the researchers played recordings of their parents talking to them and watched for brain activity in areas of the brain responsible for hearing and understanding language.
The researchers found no differences in the activity in the hearing area of the brain between the two groups. However, in the language comprehension area, there was significantly more activity among typical children than among children with autism, Hirsch's group noted.
To further test this screening approach, another group of 27 autistic children, aged 5 to 17, underwent fMRI and the researchers were able to identify 26 of them as autistic.
Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York in Lake Success, said that "although the investigators did indeed find significant differences on neuroimaging between controls and autistic children, the clinical utility from a diagnostic standpoint is unclear."
There are important limitations to the study, Adesman said.
For one, this study was done in school-aged children, many of whom were actually teenagers, so it is impossible to know if these differences in neuroimaging would also be found in younger patients, Adesman pointed out.
"It is during the toddler/preschool years that autism typically presents and needs to be diagnosed," he explained.
"The other major limitation of this study is that the investigators did not look at whether these brain differences are specific to children with autism, or if they would also be seen, for example, in children with language delays who are not autistic," Adesman said.
Hirsch noted the study is preliminary and, as such, has some limitations. For one, it is not known whether this technique can identify autism across the entire spectrum of the disorder.
"There are questions about how this varies across the severity of autism. Also, can we distinguish autism from other forms of developmental delay?" she asked. "These are things that aren't known."
Further work is needed to refine the test, Hirsch added. "This is not the diagnostic that you can package and send to all community health centers in the United States. This is an announcement that this can be done," she said.
This test costs no more than a standard MRI, which runs around $1,500, Hirsch noted.
Another expert, Dr. Robert F. Lopez-Alberola, chief of pediatric neurology at the University of Miami Miller School of Medicine, said that "it's nice to have an objective measure, but it doesn't really do much."
Ultimately, he said, "the diagnosis of autism is a clinical diagnosis. I see this as having more implications for research into the pathophysiology of autism."
However, if this test could be done in really young children, it might help identify autism so that treatment can begin early, Lopez-Alberola suggested. "We know the earlier we begin interventions, the greater the likelihood of better outcome," he said.
"Although this technique holds promise for identifying infants at risk for autism, it still needs to be determined whether the atypical patterns of brain activation are specific to autism," said Geraldine Dawson, chief science officer for Autism Speaks.
"It is possible that children who have delayed language but not autism would also show the same pattern. Regardless, this research is promising as a method for identifying young children at risk for autism," Dawson said.
More information
For more on autism, visit the U.S. National Institute of Neurological Disorders and Stroke.
SOURCES: Joy Hirsch, Ph.D., professor, functional neuroradiology, neuroscience and psychology, and director, Functional MRI Laboratory, Columbia University Medical Center, New York City; Andrew Adesman, M.D., chief, developmental and behavioral pediatrics, Steven and Alexandra Cohen Children's Medical Center of New York, Lake Success, N.Y.; Robert F. Lopez-Alberola, M.D., associate professor, medicine, and chief, pediatric neurology, University of Miami Miller School of Medicine; Geraldine Dawson, Ph.D., chief science officer, Autism Speaks; May 31, 2011, Radiology, online
http://consumer.healthday.com/Article.asp?AID=653349
19．プレスリリース
1) IARC classifies Radiofrequency Electromagnetic Fields as possibly carcinogenic to humans.
http://www.iarc.fr/en/media-centre/pr/2011/pdfs/pr208_E.pdf
2) 心血管のステント留置治療を、明瞭な画像でスムーズに
http://www.shimadzu.co.jp/news/press/miq5fd0000000s4e.html
3) 外科用止血材製品「吸収性局所止血材TDM-621」製造販売承認申請についてのお知らせ
http://www.fuso-pharm.co.jp/cnt/news_topics/pdf/2011_05_31.pdf
1．携帯通話で脳腫瘍リスク増大も ＷＨＯ専門組織が見解
2．行政の裁量権逸脱を認定、「不当検査」との国の主張も棄却
3．C. difficile感染の再発：fidaxomicinの登場
4．軽症バセドウ病、セレン投与で進行抑制、QOL改善
5．加齢黄斑変性症に対するラニビズマブvs. bevacizumab：CATT
6．ベバシズマブ＋エルロチニブ、非小細胞肺癌患者の生存期間延長せず
7．小児の睡眠不足、過体重のリスクと関連、FLAME試験
8．卒中後の体重免荷トレッドミル歩行訓練、自宅運動と効果に有意差なし
9．転移性前立腺癌へのabiraterone、生存期間を延長
10．脳卒中へのterutroban、アスピリンに非劣性示せず、PERFORM試験
11．細菌性髄膜炎へのセフトリアキソン、投与期間5日と10日で効果は同等
12．New push aims to find cure for Aids virus
13．Killer bacteria claims victims in Germany, Sweden
14．Cell Phones May Cause Brain Cancer, WHO Experts Say
15．Studies Refute Virus' Link to Chronic Fatigue Syndrome
16．Corticosteroids May Speed Pneumonia Recovery in Some
17．In Diabetics, Good Scores on Bone Tests May Not Rule Out Risk
18．Study Suggests Special MRI Might Help Diagnose Autism
19．プレスリリース
1) IARC classifies Radiofrequency Electromagnetic Fields as possibly carcinogenic to humans.
2) 心血管のステント留置治療を、明瞭な画像でスムーズに
3) 外科用止血材製品「吸収性局所止血材TDM-621」製造販売承認申請についてのお知らせ
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1．携帯通話で脳腫瘍リスク増大も ＷＨＯ専門組織が見解
日本経済新聞社2011年6月1日
世界保健機関（ＷＨＯ）の専門組織の国際がん研究機関（ＩＡＲＣ）は31日、「携帯電話の電磁波が脳腫瘍を発症するリスクを増大させる可能性がある」とする調査結果を発表した。ＩＡＲＣはこれまでの調査では電磁波とがん発症について「因果関係は確認できない」との見解を示していたが、その可能性を初めて認めた。
14カ国、31人の専門家から成る研究グループが24～31日に会合を開き、調査結果をまとめた。
全体として発症のリスクがどの程度増えるという数値は出していない。ただ、携帯電話を１日平均30分で10年以上使用した場合、脳腫瘍のリスクが40％増えるという調査結果も一部にはあるという。ＩＡＲＣは「携帯を頻繁かつ長期間使用する人に対する追加的な調査が必要」と指摘した。
発症リスクを減らす対策として、頭部に携帯を近づけずに通話できるヘッドセットの使用のほか、通話ではなく携帯メールに切り替えることを勧めた。
ロイター通信によると、米国の携帯電話の業界団体である移動体通信・インターネット協会（ＣＴＩＡ）は「ＩＡＲＣの分析は携帯電話ががんを引き起こすことを意味しない」と反発。「新たな研究は何も行われていないのに、判断が変更された」と批判した。
2．行政の裁量権逸脱を認定、「不当検査」との国の主張も棄却
保険医取消訴訟、東京高裁が行政処分に違法判決
日経メディカル2011年6月1日
東京高等裁判所は5月31日、山梨県の小児科医・溝部達子氏が無診察処方や不当検査などで保険医と保険医療機関の登録を取り消された行政処分について、違法と判断した2010年3月末の甲府地方裁判所の一審判決を支持し、国の控訴を棄却した。福島、神戸の医療機関が取消処分を不服として提訴したケースが過去にあったが、いずれも地裁では医療機関側の訴えが認められたものの、高裁では敗訴していた。二審で医師の訴えが認められたのは今回が初めてとなる。今後、国が上告するかどうかは未定。
溝部氏が山梨社会保険事務局の指導・監査の結果、保険医の登録を取り消されたのは05年11月。タミフルの予防投与や、保険診療上必要な限度を越えたインフルエンザウイルス抗原迅速診断検査の実施などが不正・不当の保険請求とされた。これに対して溝部氏は、不正・不当請求を一部認めながら、「違反内容に比べて処分が重すぎる」とし、国を相手取って処分取り消しを求める訴訟を提起していた。
一審では、不正・不当とされた41万円余りの請求内容の大半を容認しつつも、同氏の行為は患者のためで悪質性は高いとまでいえないと判断。取消処分は社会通念上著しく妥当性を欠くとし、社会保険事務局の裁量権の範囲を逸脱したものとして違法と判じた（関連記事：2010.8.26「保険医取消に違法判決の背景」）。
これに対して今回の二審では、「保険医療機関の指定および保険医の登録の各取消処分は事実上、医療機関の廃止および医師としての活動の停止を意味する極めて重大な不利益処分である」とし、「処分を検討する際は、処分理由とした行為の動機など諸事情を考慮しなければならない」と指摘。その上で、溝部氏の行為は悪質性が高いとまでいえないと判断し、国の取消処分に関する主張を退けた。
さらに、「1シーズンにインフルエンザに罹患するのは多くても2回である」として、インフルエンザウイルス抗原迅速診断検査を3回実施して保険請求した溝部氏の行為を不当検査とした国の主張に対して高裁は、「十分な根拠を有するものとは認めがたい」として棄却。1シーズン中に数回インフルエンザウイルスに感染する患者も相当数発生していると推測されることなどを理由に挙げた。このほか、国が無診察処方とした複数の事例についても、診療録の記載内容などから「受診した事実がなかったと認めることができない」と判断。不正・不当請求額も、一審の「41万円余り」より少ない「約37万円」とした。
判決後の記者会見で溝部氏は、「高裁の誠意と勇気に敬意を表したい。全国の医師は、行政にいつ保険医を取り消されるか分からない恐怖を抱いている。今回の判決で、暗黒時代が長く続く保険行政に夜明けの光が差してきた」とコメントした。代理人弁護士の石川善一氏は、「高裁は不正・不当請求とされたケース個々を丁寧に審理してくれた」と判決を評価。一方で、依然として指導・監査の基準が明確になっておらず改善が必要であると訴えた。
3．C. difficile感染の再発：fidaxomicinの登場
【原題】Recurrent C. difficile Infection: Enter Fidaxomicin
日経メディカル2011年6月1日
Fidaxomicin significantly lowered recurrence rate in patients infected with non-NAP1/BI/027 strains.
Recurrence of Clostridium difficile infection (CDI) is common, whether metronidazole or vancomycin is used as initial therapy. Fidaxomicin, a macrocyclic antibiotic that is not yet FDA approved, has no crossresistance with other antibiotics and is more active than vancomycin in vitro against clinical C. difficile isolates. In this randomized manufacturer-sponsored phase III trial, 629 adults with CDI received oral fidaxomicin or vancomycin for 10 days.
The rate of clinical cure (resolution of diarrhea; no need for additional CDI therapy as of posttreatment day 2) with fidaxomycin was noninferior to that with vancomycin ― 88% and 86%, respectively. The rate of CDI recurrence during the 4-week period after treatment was significantly lower with fidaxomicin than with vancomycin (15% vs. 25%). Fidaxomicin did not lower the recurrence rate in patients who were infected with the hypervirulent NAP1/BI/027 strains, but it did so in patients infected with other strains. Rates of adverse events were similar between treatment arms.
COMMENT
On the basis of the findings from this investigation, an editorialist wrote that fidaxomicin appeared to be “an important advance.” I hope that this is the case ― new, more-effective treatments for CDI are needed badly.
― Larry M. Baddour, MD, Journal Watch Infectious Diseases
Louie TJ et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med 2011 Feb 3; 364:422.
DuPont HL. The search for effective treatment of Clostridium difficile infection. N Engl J Med 2011 Feb 3; 364:473.
4．軽症バセドウ病、セレン投与で進行抑制、QOL改善
CareNet2011年6月1日
日本ではバセドウ病と称されるグレーブス病眼症（GO）の軽症患者に対する治療として、健康栄養素セレンの投与が、QOL改善、眼症減少、GO進行抑制に寄与することが報告された。欧州グレーブス病眼症グループ（EUGOGO）を代表してイタリア・ピサ大学内分泌・代謝学部門のClaudio Marcocci氏らが、同グループに参加する4ヵ国6施設の患者を対象に二重盲検無作為化プラセボ対照試験を行った結果による。軽症GO患者には症状が悪化するまで積極的な治療を行わないが、QOLの低下が問題視されていた。Marcocci氏らはGOの発症機序から、抗酸化作用を有するセレンと、抗炎症作用や種々の免疫調整作用を有するペントキシフィリンの可能性に着目。ペントキシフィリンが小規模パイロット試験でGO患者にベネフィットがあることが示唆されたことを踏まえ、本検討を行った。NEJM誌2011年5月19日号掲載報告より。
セレン、ペントキシフィリン、プラセボで二重盲検無作為化試験
試験は2005年1月～2009年1月、イタリアとドイツ各2施設、スイスとギリシャ各1施設の計6施設で、軽症GO患者159例を対象に行われた。
被験者は無作為に、セレン投与群（セレンサプリメント、100μgを1日2回、54例）、ペントキシフィリン投与群（Trental、600mgを1日2回、48例）、プラセボ投与群（1日2回、50例）に割り付けられ6ヵ月間にわたる経口投与を受け、投与を中止した後6ヵ月間追跡された。
主要アウトカムは、6ヵ月時点での、治療割り付けを知らされていない眼科医による眼の全般的評価と、患者によるGO特異的QOL質問票による評価とした。またCAS（Clinical Activity Score）と複視スコアを副次的アウトカムとした。
セレン群、プラセボとの比較でQOL改善、眼症減少、GO進行抑制
6ヵ月時点の評価でプラセボと比較して、セレン投与群は、QOLが改善（P＜0.001）、眼症状がより少なく（P＝0.01）、GO進行の抑制（P＝0.01）が認められた。一方、ペントキシフィリン投与群ではいずれも認められなかった。
CASは3群とも低下が認められたが、セレン投与群での変化（平均3.5）が有意に大きかった。ペントキシフィリン投与群とプラセボ群の低下は有意差が認められなかった（平均3.0）。
これらの結果は、12ヵ月時点の探索的評価においても確認された。
なお、プラセボ群2例とペントキシフィリン投与群1例の患者で、病態悪化による免疫抑制療法が必要となった。有害事象は、セレン投与群ではそれとわかる事象が認められなかったが、ペントキシフィリン投与群では高頻度の胃腸症状が認められた。
http://www.ncbi.nlm.nih.gov/pubmed/21591944
5．加齢黄斑変性症に対するラニビズマブvs. bevacizumab：CATT
CareNet2011年6月1日
滲出型加齢黄斑変性症（AMD）に対する、血管内皮増殖因子（VEGF）阻害薬のラニビズマブ（商品名：ルセンティス）とbevacizumabの有効性および安全性について検討した、多施設共同単盲検非劣性無作為化試験「CATT」の結果が発表された。ラニビズマブは臨床試験により滲出型AMDに対する有効性が認められる承認薬である。一方、bevacizumab（商品名：アバスチン、抗悪性腫瘍薬としてのみ承認）はAMDに対しては未承認で大規模臨床試験データもないが、ラニビズマブ同様VEGFをターゲットとすること、また投与コストがラニビズマブよりも安価であること（1回投与につきラニビズマブ約2,000ドル、bevacizumab約50ドル）から、ラニビズマブのFDA承認待ちの間に眼科医たちが適応外使用を始め、米国ではAMD治療薬として最も一般的に用いられるようになっているという。NEJM誌2011年5月19日号（オンライン版2011年4月28日号）掲載報告より。
ラニビズマブとbevacizumabは同等
CATT（Comparison of Age-Related Macular Degeneration Treatments Trials）は、ラニビズマブとbevacizumabの有効性および安全性を評価すること、また「必要に応じて投与」が「月1回投与」と比べて長期的視力を損なうかどうかの検討を目的に行われた。2008年2月から2009年12月の間に米国内44のクリニックから登録された患者1,208例（50歳以上、未治療の滲出型AMDを片眼以上有する、電子視力検査による視力が20/25～20/320）を対象とした。
被験者は無作為に、ラニビズマブかbevacizumabを硝子体内注射される群に、また月1回投与か月1回の評価で必要に応じて投与する群に割り付けられた。
主要アウトカムは、1年時点の視力変化の平均とした。非劣性の範囲は、視力表5文字とした。
結果、1年時点の視力変化の平均は、月1回投与bevacizumab群8.0文字増、同ラニビズマブ群8.5文字増で、両群は同等であることが認められた。
必要に応じて投与bevacizumab群（5.9文字増）、同ラニビズマブ群（6.8文字増）も同等であることが認められた。
また、ラニビズマブは投与法が異なっても（月1回投与か必要に応じて投与）、同等であることが認められたが、bevacizumab群については確証が得られなかった。
中心窩網膜厚減少の平均は、月1回投与ラニビズマブ群196μmで、他の群（必要に応じて投与ラニビズマブ群168μm、月1回投与bevacizumab群164μm、必要に応じて投与bevacizumab群152μm）より大きかった（分散分析によるP＝0.03）。
入院リスク、bevacizumab群がラニビズマブ群の1.29倍だがさらなる検証が必要
死亡、心筋梗塞、脳卒中の発生率は、bevacizumab群とラニビズマブ群で同程度であった（P＞0.20）。
一方で、重篤な全身有害事象（主に入院）リスクが、ラニビズマブ群よりもbevacizumab群でより高かった［発生率：bevacizumab群24.1％、ラニビズマブ群19.0％、リスク比：1.29（95％信頼区間：1.01～1.66）］。それらの多発したイベントは、先行研究のがんトライアルではみられなかった疾患カテゴリーにまで多岐にわたっていた。
以上を踏まえCATT研究グループは、「1年時点で、ラニビズマブとbevacizumabの視力に対する効果は、投与スケジュールが同じ場合、同等であった。ラニビズマブの視力に対する効果は、月1回の評価で必要に応じて投与する群と月1回投与群で同等だった」と結論。重篤な有害事象発生率の差異については、偶然である可能性、病歴や多変量モデルに基線の健康状態が含まれなかったことなどが考えられ、より多くの症例数による「さらなる検討が必要」と結論している。
http://www.ncbi.nlm.nih.gov/pubmed/21526923
6．ベバシズマブ＋エルロチニブ、非小細胞肺癌患者の生存期間延長せず
文献：Herbst RS et al.Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial.Lancet 2011;377:1846-1854.
標準化学療法無効の再発性または難治性非小細胞肺癌（NSCLC）におけるベバシズマブ＋エルロチニブの有効性および安全性を、二重盲検プラセボ対照無作為化第3相試験で検討。患者の全生存期間の中央値は、エルロチニブ＋プラセボ群（317人）で9.2カ月、ベバシズマブ＋エルロチニブ群（319人）で9.3カ月と同等だった。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60545-X/abstract
7．小児の睡眠不足、過体重のリスクと関連、FLAME試験
文献：Carter PJ et al.Longitudinal analysis of sleep in relation to BMI and body fat in children: the FLAME study.BMJ 2011; 342:d2712.
小児244人を追跡調査し、睡眠と体格指数（BMI）および体脂肪との関係を縦断的研究で検討。複数の交絡因子の調整後、3-5歳時で睡眠が1時間増えるごとにBMIの0.48減少と関連し、また7歳時での過体重（BMIが85パーセンタイル以上）リスクの0.39低下と関連した。BMIの変化は除脂肪量指数ではなく体脂肪量指数によるものだった。
http://www.bmj.com/content/342/bmj.d2712.abstract
8．卒中後の体重免荷トレッドミル歩行訓練、自宅運動と効果に有意差なし
文献：Duncan PW et al.Body-Weight–Supported Treadmill Rehabilitation after Stroke.NEJM 2011; 364:2026-2036.
卒中後2カ月の歩行障害患者408人を対象に、体重免荷トレッドミル歩行訓練の有効性および適切な実施時期（発作後2カ月または6カ月）を無作為化試験で検討。発作1年後、理学療法士管理下の自宅運動群との比較で、早期・後期歩行訓練群とも歩行機能の回復に有意差は見られず、浮動性めまいの発生率上昇を認めた（P＝0.008）。
http://www.nejm.org/doi/full/10.1056/NEJMoa1010790
9．転移性前立腺癌へのabiraterone、生存期間を延長
文献：de Bono JS et al.Abiraterone and Increased Survival in Metastatic Prostate Cancer.NEJM 2011; 364:1995-2005.
化学療法歴のある転移性去勢抵抗性前立腺癌患者1195人を対象に、abiraterone acetateの延命効果を無作為化プラセボ対照試験で検討。介入群では対照群に比べ全生存期間（14.8カ月対10.9カ月）、PSA増悪までの期間（10.2カ月対6.6カ月）、無増悪生存期間（5.6カ月対3.6カ月）が延長された。
http://www.nejm.org/doi/full/10.1056/NEJMoa1014618
10．脳卒中へのterutroban、アスピリンに非劣性示せず、PERFORM試験
文献：Bousser MG et al.Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial.The Lancet, Early Online Publication, 25 May 2011.
虚血性脳卒中または一過性脳虚血発作歴のある患者1万9120人を対象に、terutrobanの再発予防効果を無作為化二重盲検試験でアスピリンと比較。主要複合評価項目（虚血性脳卒中、心筋梗塞、その他の血管死）や有害事象の発現率に有意な群間差はなかった。著者らは、依然としてアスピリンが標準的な再発予防薬と結論している。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60600-4/abstract
11．細菌性髄膜炎へのセフトリアキソン、投与期間5日と10日で効果は同等
文献：Molyneux E et al.5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study.Lancet 2011;Volume 377:1837-1845.
肺炎球菌、インフルエンザ菌b型、髄膜炎菌を起炎菌とする生後2カ月-12歳の化膿性髄膜炎患児1004人を対象に、5日間投与と10日間投与の非経口セフトリアキソンの治療効果を、二重盲検無作為化プラセボ対照同等性試験で比較。5日間投与群496人中2人に再発が見られたが、両群とも細菌学的失敗は認められず、副作用は軽微だった。
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60580-1/abstract
12．New push aims to find cure for Aids virus
BBC News2011年6月1日
More investment is needed to find a cure for HIV, the new head of the International Aids Society has said.
Bertrand Audoin admits this might take as long as 25 years, but he says a cure is the only way to keep ahead of the HIV epidemic in the long term during tough financial times.
Sunday sees the 30th anniversary of the first medical reports of a new illness.
Some experts have warned that talk of a cure could lead to false hopes, and developing a vaccine would be better.
Mr Audoin said: "It is the right moment - from the scientific and financial point of view - to invest more time and money in researching a cure.
"There is already some basic science in this area. We know that some people who are on HIV treatment can contain the virus in a way which makes them unable to infect other people.
"So we think further work could help us develop a functional cure, which would allow the virus to remain latent in the body, without people feeling sick or needing treatment. That's the goal."
Fast epidemic
Mr Audoin ran a French Aids organisation called Sidaction, before heading the IAS - an organisation of 18,000 health professionals and activists.
He said: "At the moment, for every one person beginning treatment in badly affected countries in Africa, two people get infected with HIV in that time.
"So treatment with anti-retroviral drugs isn't the only solution in the long run.
"It could take 25 years before we find a cure - and the hardest part will be convincing donor governments and other funding organisations to put money into research.
"But if we don't invest in the science, the epidemic will go faster than our work on it - and the financial situation will make it more difficult to put people on treatment."
False hopes
The IAS has convened a working group of international researchers to develop a strategy that might lead to a cure. It is due to deliver a draft report at the end of the year.
The group is co-chaired by Professor Francoise Barre-Sinoussi, who won the Nobel Prize in 2008 for discovering HIV.
A virologist at University College London, Professor Robin Weiss, said: "Much as I would love to see one, the word 'cure' can lead to false hopes.
"I don't believe you can cure HIV infection, but you can keep the amount of virus down.
"I would prefer to see a vaccine so we can stop people being infected in the first place. But we're still years away from having one for HIV."
Next week, heads of governments will attend a high-level UN meeting on Aids in New York. Negotiations have already begun to look at the wording of a final declaration.
Mr Audoin said: "Some of us are fighting for very simple words to be put in the declaration - for example, mentioning condoms - but we are not sure if that will happen.
"There is a trend in some governments to think that we've done enough on HIV, or that everything has failed. We need to keep developing our programmes."
http://www.bbc.co.uk/news/health-13605224
13．Killer bacteria claims victims in Germany, Sweden
Reuters News2011年5月31日
A killer bacteria linked to contaminated cucumbers claimed a 15th victim in Germany on Tuesday and its first fatality abroad when a Swedish woman who had been traveling in Germany died, authorities said.
One of the largest E.coli outbreaks of its kind, it has also made more than 1,000 people ill in Germany as well as people from Spain, Sweden, Britain, Denmark, France and the Netherlands who had recently been in Germany.
It has also caused diplomatic tension between Germany and countries such as Spain, France and Russia. The source of the virulent strain of the bacteria is unknown, authorities said. Most of the deaths have been in northern Germany.
The E. coli pathogen has been identified on cucumbers imported from Spain, but it is not clear if they were contaminated there, during transport, or possibly in Germany.
"The situation is tense but it can be dealt with," said Health Minister Daniel Bahr at a news conference late on Monday. He said he expected the number of cases to continue rising.
The German government has identified the disease as hemolytic-uremic syndrome (HUS), a serious complication of a type of E. coli known as Shiga toxin-producing E. coli (STEC).
Russia has banned vegetable imports from Germany and Spain and said it may expand the ban to all European Union member states, head of Russia's Federal Consumer Protection Agency Gennady Onishchenko was quoted by corporate-owned Interfax news agency as saying.
"If the situation does not change, we will ban all the European vegetable products," he said.
Spanish farmers are losing around 200 million euros ($286 million) per week in lost sales because of it, a farmers association said on Tuesday.
German authorities have warned consumers to avoid eating cucumbers, lettuces and tomatoes.
GROWING TENSION
Spain said on Monday there was no proof that cucumbers from its growers had caused the outbreak of E.coli in Germany and that it would be demanding to know why its farmers had been blamed.
Spanish media reported Germany, Denmark, Czech Republic, Luxembourg, Hungary, Sweden, Belgium and Russia are blocking entry of Spanish cucumbers.
In a further sign of growing tension in Europe, French Health Minister Xavier Bertrand demanded in a TV interview on Tuesday greater transparency from Spain and Germany over the mysterious outbreak after three people in France became ill.
"At first the German authorities were categorical," he said. "Today there are more and more questions arising. I want to know the origin (of the contamination)," Bertrand told France 2 television. "We need completely transparent information from the German authorities, and from the Spanish authorities as well.
Hungary's news agency MTI cited Spain's Minister for Environment and Rural Affairs Rosa Aguilar as saying on Tuesday ahead of an informal meeting of EU farm ministers in eastern Hungary that the bacteria which had killed several people had not been identified in Spain before.
"From the Spanish side there will be two important topics at today's discussion: on the one hand we wish to make it clear that Spanish products are safe and of good quality -- on the other hand we advocate a common solution," the minister said.
In Brussels, the European Commission said: "The Commission notes that the outbreak is limited geographically to an area surrounding the city of Hamburg.
"Also, efforts to pinpoint all possible sources of contamination are well under way and have already yielded preliminary results. It would, therefore, consider any ban on any product as disproportionate."
In the Netherlands, a Dutch horticulture group said exports of cucumbers to Germany, the most important market, had all but halted and it Dutch farmers were losing millions of euros.
The European Center for Disease Prevention and Control (ECDC) said in a risk assessment that the HUS/STEC outbreak is one the largest in the world of its kind.
HUS affects the blood, kidneys and, in severe cases, the nervous system and can be particularly serious for children and the elderly. In an average year, around 60 cases of HUS are reported in Germany, the government said.
http://www.reuters.com/article/2011/05/31/us-germany-ecoli-idUSTRE74S12V20110531
14．Cell Phones May Cause Brain Cancer, WHO Experts Say
World Health Organization now classifies the devices as 'possibly carcinogenic to humans'
HealthDay News2011年5月31日
Cell phones may cause brain cancer, a panel of experts reporting to the World Health Organization (WHO) announced Tuesday.
After reviewing dozens of studies that explored a possible link between cancer and the ubiquitous hand-held phones, the experts classified cell phones as "possibly carcinogenic to humans" and placed them in the same category as the pesticide DDT and gasoline engine exhaust.
The panel determined that an increased risk for glioma, a malignant form of brain cancer, appears associated with wireless phone use.
Globally, it's estimated that 5 billion cell phones are in use. "The number of users is large and growing, particularly among young adults and children," the International Agency for Research on Cancer said in a news release issued Tuesday.
The IARC made the announcement in Lyons, France, based on the work of 31 scientists from 14 countries. It will present its findings to the WHO, which may then issue its recommendations on safe cell phone use.
Experts said children are especially vulnerable.
"Children's skulls and scalps are thinner. So the radiation can penetrate deeper into the brain of children and young adults. Their cells are dividing at a faster rate, so the impact of radiation can be much larger," Dr. Keith Black, chairman of neurology at Cedars-Sinai Medical Center in Los Angeles, told CNN.
Until Tuesday's announcement, the WHO had said that cell phones were safe to use.
The international experts behind Tuesday's announcement met for eight days to review exposure data, studies of cancer in humans and in experimental animals, and other relevant data, looking for associations between cancer and the type of electromagnetic radiation found in cell phones, televisions and microwaves.
Dr. Christopher Wild, director of the International Agency for Research on Cancer, said this new paper is important "first and foremost just because of the large number of users worldwide that have access now to this technology."
Also, the scientists found notable gaps in the existing research, he said, which "suggest interesting areas of future research that will improve the evidence base which we have in order to make decisions about the usage of mobile phones in the future."
Responding to Tuesday's announcement, John Walls, vice president of public affairs for CTIA-The Wireless Association, a trade group representing the wireless industry said: "Today, an International Agency for Research on Cancer (IARC) working group in Lyon, France categorized radiofrequency fields from cellphones as 'possibly' carcinogenic based on 'limited evidence.' IARC conducts numerous reviews and in the past has given the same score to, for example, pickled vegetables and coffee. This IARC classification does not mean cell phones cause cancer. Under IARC rules, limited evidence from statistical studies can be found even though bias and other data flaws may be the basis for the results.
"The IARC working group did not conduct any new research, but rather reviewed published studies," Walls added in a news release. "Based on previous assessments of the scientific evidence, the Federal Communications Commission has concluded that '[t]heres no scientific evidence that proves that wireless phone usage can lead to cancer.' The Food and Drug Administration has also stated that '[t]he weight of scientific evidence has not linked cell phones with any health problems.'"
There has been conflicting research in recent years on the health hazards posed by cell phones. As recently as February, British researchers reported that cell phones do not increase the risk of brain cancer.
Their analysis of data on newly diagnosed cases of brain cancer in England between 1998 and 2007 -- when cell phone use was climbing -- revealed no statistically significant change in the incidence of brain cancers in men or women, said the University of Manchester researchers.
There was a very small increase (0.6 more cases per 100,000 people) in the incidence of cancers of the brain's temporal lobe. That works out to 31 extra cases per year in England's population of nearly 52 million people, the researchers said.
But the study authors also noted that cancers of the brain's parietal lobe, cerebrum and cerebellum in English men fell slightly during the study period.
That study was released online in the journal Bioelectromagnetics.
Dr. Otis Brawley, chief medical officer for the American Cancer Society, said the WHO's classification of cell phones "means that there could be some risk, but that the evidence is not strong enough to be considered causal, and needs to be investigated further. The bottom line is the evidence is enough to warrant concern, but it is not conclusive."
Dr. Nagy Elsayyad, an assistant professor in the Department of Radiation Oncology at the University of Miami Sylvester Cancer Center, agreed, saying scientists don't know much more about cell phone safety than they did before the WHO statement. "They [WHO] indicate it is a possible, not a probable source," he said. "But they still cannot come out with a positive conclusion."
Elsayyad advises using an ear piece or speaker when talking on a cell phone.
"If you hold the phone away from your brain that ought to decrease the risk tremendously," he said.
More information
To learn more about brain cancer, visit the U.S. National Library of Medicine.
SOURCES: Nagy Elsayyad, M.D., assistant professor, Department of Radiation Oncology, University of Miami Sylvester Cancer Center and Miller School of Medicine; Otis Brawley, M.D., chief medical officer for the American Cancer Society; World Health Organization, news release, May 31, 2011; CTIA-The Wireless Association, news release, May 31, 2011; CNN
http://consumer.healthday.com/Article.asp?AID=653428
15．Studies Refute Virus' Link to Chronic Fatigue Syndrome
Contamination of human samples in the lab led to errors in influential 2009 study, scientists say
HealthDay News2011年5月31日
A virus identified two years ago as a possible cause of chronic fatigue syndrome now turns out not to be the culprit, new research says.
Experts say it's a major setback in the effort to understand and treat this mysterious and debilitating disease.
The authors of a new study published May 31 in Science find that the so-called XMRV viral pathogen spotted in human samples in the prior study (published by the same journal in 2009) likely got there as a result of "genetic recombination." That can occur in the laboratory when DNA from different viruses mix.
In this case, two mouse viruses combined and the product of that union then contaminated the human specimens via "reagent" compounds used in the lab, the new research shows.
This probable contamination of the samples with XMRV in the lab "means that this virus has no proven association" with chronic fatigue syndrome, said Stuart LeGrice, head of the lab that oversees all XMRV research at the U.S. National Cancer Institute, which conducted the new study.
"I believe the evidence is incontrovertible," he added. "It doesn't rule out the possibility that there's another retrovirus [involved] but, as of right now, we're close to 100 percent certain that this eliminates the virus as a causative agent of either condition."
The study was accompanied by a rare "Expression of Concern" from the editors of Science. While they did not call for an outright retraction of the original paper, the editors pointedly questioned the study's validity.
According to the Wall Street Journal, the editors of Science have asked the authors of the 2009 paper to voluntarily retract their paper. The authors have responded that any retraction would be "premature," the newspaper reported.
This sequence of events began two years ago, with the publication of a finding that about two-thirds of patients with chronic fatigue syndrome sampled were infected with XMRV, which stands for xenotropic murine leukemia virus-related virus. These viruses can cause cancer and other problems in mice and they can infect human cells in the laboratory.
At the time, the finding raised hopes that there might finally be a concrete cause for chronic fatigue syndrome and perhaps, down the line, treatments for the disease.
The illness affects an estimated 1 percent of people worldwide and, as its name implies, involves crippling fatigue as well as aching joints, headaches and various other symptoms.
Unfortunately, subsequent studies by other researchers failed to replicate the findings.
The authors of the new study looked at blood samples from 61 people with chronic fatigue syndrome. The samples came from the same source that had supplied samples for the 2009 study. Forty-three of the samples had earlier been diagnosed as positive for XMRV.
However, this time around the researchers avoided using any lab products derived from mice. This time, they found no evidence at all of XMRV in any of the 61 samples.
"We're learning a very important lesson that even some commonly used reagents [compounds used in scientific experiments] contain trace amounts of contaminating mouse DNA," said LeGrice, who is head of the Center of Excellence in HIV AIDS/Cancer Virology at the National Cancer Institute. "But, using diagnostic technologies that are ultra-sensitive, we can easily pick out the contaminating material. The contaminants somehow got into the samples [but] we have to be absolutely clear that this virus was never in humans."
A second study in the same issue of the journal had similar problems trying to replicate earlier research linking XMRV with prostate cancer tumors, for much the same reasons. That study was led by Jay Levy of the University of California, San Francisco.
A statement from the Chronic Fatigue and Immune Dysfunction Syndrome (CFIDS) Association of America said that "these studies add to the mounting number of publications that challenge the reliability of the initial report."
The U.S. National Institutes of Health is sponsoring additional studies on XMRV and chronic fatigue syndrome.
"We will support the outcome of those studies, whichever way they lead," the CFIDS statement said.
More information
There's more on chronic fatigue syndrome at the U.S. Centers for Disease Control and Prevention.
SOURCES: Stuart LeGrice, Ph.D., head, Center of Excellence in HIV AIDS/Cancer Virology, U.S. National Cancer Institute; statement, CFIDS Association of America; May 31, 2011, Science
http://consumer.healthday.com/Article.asp?AID=653433
16．Corticosteroids May Speed Pneumonia Recovery in Some
Adding dexamethasone to antibiotic regimen helps treat community-acquired pneumonia, study says
HealthDay News2011年5月31日
Patients with an inflammatory lung condition known as community-acquired pneumonia appear to recover faster when treated with corticosteroids in addition to the standard regimen of antibiotics, Dutch researchers say.
Those treated with a combination of corticosteroids and antibiotics also required a shorter hospital stay than patients treated with antibiotics alone, the study authors found.
The observations stem from what is believed to be the largest study to date focused on the potential of corticosteroids for the treatment of community-acquired pneumonia, or CAP.
Dr. Sabine Meijvis, from the St. Antonius Hospital in Nieuwegein, the Netherlands, and colleagues reported their findings in the May 31 online edition of The Lancet.
Meijvis and her team noted that, currently, CAP is typically treated with antibiotics following an early diagnosis.
To explore whether corticosteroids might reduce the risk for complications and fatalities, the team focused on just over 300 Dutch CAP patients. Half of the patients were placed on a standard antibiotic protocol coupled with 5 milligrams a day of the corticosteroid dexamethasone. The other half were given antibiotics plus a placebo (an inactive treatment).
After four days, the research team found that those given the corticosteroid experienced less lung inflammation, and recovered more quickly than those who were just given antibiotics.
The corticosteroid group also required one less day of hospitalization than the antibiotic group (6.5 days versus 7.5 days). In addition, by the end of one month, the corticosteroid group had experienced better "social functioning" relative to the antibiotic group, the investigators found.
"Serious adverse events were rare" among the corticosteroid group, the study team noted in a journal news release, while at the same time cautioning that "the benefits of corticosteroids should be weighed against the potential disadvantages of these drugs, such as superinfections and gastric disturbances."
Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said the findings were in line with what he might expect.
"It doesn't surprise me because corticosteroids are used as nuclear anti-inflammatories," he said, noting they might suppress an otherwise lingering fever within 24 hours. "And they would mask a lot of symptoms and make a patient feel generally better whether they're asthmatics or have some inflammatory disease."
"But the downside," he cautioned, "is that we know that corticosteroids are immune-suppressive. And so the possibility exists that when you use them, you could be prolonging the actual recovery time even as you are masking the symptoms, although this study doesn't say that."
This is a potential danger for otherwise healthy people and especially so for those who have high blood pressure or diabetes, he said. "So any medication is a double-edged sword," he added. "And the use of corticosteroids in this case has to be weighed against possible complications."
More information
For more on pneumonia, visit the U.S. National Library of Medicine.
SOURCE: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City, and Northshore-LIJ Health System; The Lancet, news release, May 31, 2011
http://consumer.healthday.com/Article.asp?AID=653424
17．In Diabetics, Good Scores on Bone Tests May Not Rule Out Risk
People with normal bone density may be as prone to fracture as those with osteoporosis, study finds
HealthDay News2011年5月31日
Although many older diabetics have good bone density scores, they are as prone to fractures as people with osteoporosis, a new study finds.
For people over 65, doctors usually recommend a bone density test to look for signs of bone loss and osteoporosis, but whether those tests are of use in older people with type 2 diabetes has been a question, according to the researchers.
"People with type 2 diabetes have a strange combination," said the study's lead researcher, Ann V. Schwartz, an associate adjunct professor in the epidemiology and biostatistics department at the University of California, San Francisco. "They have a higher fracture risk and they have a higher bone density."
However, she said, "we found that these tests work to predict fracture," though the interpretation of the results needs to be different.
To assess the value of bone density tests in predicting the risk for fractures among diabetics, the researchers looked at two tests of bone strength: bone mineral density, which produces what's called a T score, and the World Health Organization's fracture risk algorithm, called a FRAX score.
"A T score of minus 2.5 or lower is generally considered osteoporotic and at high risk of fracture," Schwartz said. "But if you have someone with type 2 diabetes who has a T score of minus 2, they have about the same fracture risk as a non-diabetic with a T score of minus 2.5," she said.
Doctors should use bone density to screen older adults with type 2 diabetes, Schwartz said, "but they have to realize that the threshold they use to indicate high risk has to be raised."
The report was published in the June 1 issue of the Journal of the American Medical Association.
For the study, Schwartz's team collected data on 9,449 women and 7,436 men who took part in one of three studies, the Study of Osteoporotic Fractures, the Osteoporotic Fractures in Men Study or the Health, Aging and Body Composition study. All participants were in their 70s when their study began.
During almost 13 years of follow-up, 84 hip fractures and 262 other fractures were recorded among the 770 women with diabetes. Among 1,199 men with diabetes, 32 had hip fractures and 133 had other fractures during about eight years of follow-up, the investigators found.
The researchers noted that, among diabetics, fractures were more likely to occur even when bone density tests indicated that there was only a small risk for fracture.
"For a given T score and age, those adults with DM [diabetes mellitus] had a higher risk of fracture than those without DM, consistent with previous studies," they wrote. "Participants with DM also experienced higher fracture rates at a given FRAX score than participants without DM."
Because of this, according to the researchers, doctors should consider people with type 2 diabetes at risk for fractures even when bone density tests indicate that they don't have osteoporosis and, therefore, have a lower risk for fractures.
In addition, Schwartz said that she would start treating diabetic patients for osteoporosis if they had T scores of minus 2.
She noted that standard treatments for osteoporosis have not been studied in diabetics but that they appear to work. "In general, the treatments seem to be as effective in diabetics as in non-diabetics," she said.
Commenting on the study, Dr. Robert R. Recker, president of the National Osteoporosis Foundation, said that "a lot of people with diabetes will be at risk for fracture, and many of them don't have low bone mass."
But he noted that the reasons that someone with diabetes has a fracture risk may not be the same as for a person without diabetes. "So the same treatments may not be appropriate -- and therein lies the rub," Recker said.
He does, however, recommend calcium and vitamin D.
The real problem, he said, is that little is known about why the risk for fracture is elevated among type 2 diabetics.
"Basically, we don't know anything about it," Recker said. "There may be something going on that interferes with bone cell function -- and it's not outrageous to think that because diabetes interferes with just about all cell function all over the body."
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more on diabetes.
SOURCES: Ann V. Schwartz, Ph.D., M.P.H., associate adjunct professor, department of epidemiology and biostatistics, University of California, San Francisco; Robert R. Recker, M.D., president, National Osteoporosis Foundation; June 1, 2011, Journal of the American Medical Association
http://consumer.healthday.com/Article.asp?AID=653419
18．Study Suggests Special MRI Might Help Diagnose Autism
Scans found less responsiveness in language areas of brain, researchers report
HealthDay News2011年5月31日
At the moment, a diagnosis of autism is based on subjective evaluations, but a new way of using MRI might be an objective way of spotting the disorder, Columbia University researchers report.
Autism is a spectrum disorder that includes repetitive behaviors and impairments in language, communication and social skills. It is estimated that the condition affects one in 110 children in the United States, according to the U.S. Centers for Disease Control and Prevention.
"There is a serious unmet need in the autism world, where diagnosis is currently done by subjective reports, and after the child has missed many developmental milestones," said lead researcher Joy Hirsch, a professor of functional neuroradiology, neuroscience and psychology, and director of the Functional MRI Laboratory at Columbia University Medical Center in New York City.
"It is now possible to develop an objective imaging diagnostic," she said. Indeed, the researchers found a difference between autistic brains and typical brains in the level of responsiveness in language areas, Hirsch noted.
"What we can measure are signals in the brain, in a specific language area, that are depressed in autistic children and normal in typical children," she said.
Although this study was done with school-aged children and teens, the same test can be done with children as young as 18 months, Hirsch noted. "We know this technique can be used on young children," she said.
The report was released in the May 31 online edition of Radiology, in advance of publication in the August print issue.
For the study, 12 children with autism and 15 children without the condition underwent functional MRI (fMRI) exams. Both groups of children ranged in age from 4 to 17 years.
While the children were undergoing the fMRI, the researchers played recordings of their parents talking to them and watched for brain activity in areas of the brain responsible for hearing and understanding language.
The researchers found no differences in the activity in the hearing area of the brain between the two groups. However, in the language comprehension area, there was significantly more activity among typical children than among children with autism, Hirsch's group noted.
To further test this screening approach, another group of 27 autistic children, aged 5 to 17, underwent fMRI and the researchers were able to identify 26 of them as autistic.
Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at the Steven and Alexandra Cohen Children's Medical Center of New York in Lake Success, said that "although the investigators did indeed find significant differences on neuroimaging between controls and autistic children, the clinical utility from a diagnostic standpoint is unclear."
There are important limitations to the study, Adesman said.
For one, this study was done in school-aged children, many of whom were actually teenagers, so it is impossible to know if these differences in neuroimaging would also be found in younger patients, Adesman pointed out.
"It is during the toddler/preschool years that autism typically presents and needs to be diagnosed," he explained.
"The other major limitation of this study is that the investigators did not look at whether these brain differences are specific to children with autism, or if they would also be seen, for example, in children with language delays who are not autistic," Adesman said.
Hirsch noted the study is preliminary and, as such, has some limitations. For one, it is not known whether this technique can identify autism across the entire spectrum of the disorder.
"There are questions about how this varies across the severity of autism. Also, can we distinguish autism from other forms of developmental delay?" she asked. "These are things that aren't known."
Further work is needed to refine the test, Hirsch added. "This is not the diagnostic that you can package and send to all community health centers in the United States. This is an announcement that this can be done," she said.
This test costs no more than a standard MRI, which runs around $1,500, Hirsch noted.
Another expert, Dr. Robert F. Lopez-Alberola, chief of pediatric neurology at the University of Miami Miller School of Medicine, said that "it's nice to have an objective measure, but it doesn't really do much."
Ultimately, he said, "the diagnosis of autism is a clinical diagnosis. I see this as having more implications for research into the pathophysiology of autism."
However, if this test could be done in really young children, it might help identify autism so that treatment can begin early, Lopez-Alberola suggested. "We know the earlier we begin interventions, the greater the likelihood of better outcome," he said.
"Although this technique holds promise for identifying infants at risk for autism, it still needs to be determined whether the atypical patterns of brain activation are specific to autism," said Geraldine Dawson, chief science officer for Autism Speaks.
"It is possible that children who have delayed language but not autism would also show the same pattern. Regardless, this research is promising as a method for identifying young children at risk for autism," Dawson said.
More information
For more on autism, visit the U.S. National Institute of Neurological Disorders and Stroke.
SOURCES: Joy Hirsch, Ph.D., professor, functional neuroradiology, neuroscience and psychology, and director, Functional MRI Laboratory, Columbia University Medical Center, New York City; Andrew Adesman, M.D., chief, developmental and behavioral pediatrics, Steven and Alexandra Cohen Children's Medical Center of New York, Lake Success, N.Y.; Robert F. Lopez-Alberola, M.D., associate professor, medicine, and chief, pediatric neurology, University of Miami Miller School of Medicine; Geraldine Dawson, Ph.D., chief science officer, Autism Speaks; May 31, 2011, Radiology, online
http://consumer.healthday.com/Article.asp?AID=653349
19．プレスリリース
1) IARC classifies Radiofrequency Electromagnetic Fields as possibly carcinogenic to humans.
http://www.iarc.fr/en/media-centre/pr/2011/pdfs/pr208_E.pdf
2) 心血管のステント留置治療を、明瞭な画像でスムーズに
http://www.shimadzu.co.jp/news/press/miq5fd0000000s4e.html
3) 外科用止血材製品「吸収性局所止血材TDM-621」製造販売承認申請についてのお知らせ
http://www.fuso-pharm.co.jp/cnt/news_topics/pdf/2011_05_31.pdf
