現在地 HOME > 掲示板
> 戦争２３ > 907.html
★阿修羅♪
|
現在地 HOME > 掲示板
> 戦争２３ > 907.html
★阿修羅♪
|
|
●湾岸戦争のときもワクチンその他の未承認薬を特例で出征兵士に用い、
そのせいなのか米軍の出征兵士の５人中２人は「湾岸戦争症候群」で
現在苦しんでいるとのこと。 しかも復員軍人省も国防総省も
つれない態度……。事実上の“棄民”でというわけです。
●またも炭疽菌や天然痘の実験的なワクチンばかりでなく、神経ガス拮抗剤
のような副作用の強い化学薬物の人間モルモットにされるアメリカ兵たち。
仮に戦争が起きなくとも、現地でこうした予防薬が投与されればもうおしまい。
こんどはどんな「症候群」が帰還兵士を襲うのでしょうか……。
■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■
http://medwave.nikkeibp.co.jp/regist/medi_auth.jsp?id=1/mdps/230401
2003.2.10 FDA、ソマン被爆に臭化ピリドスチグミンの事前投与を動物データのみで承認
米国食品医薬品局（FDA）は２月５日、強いコリンエステラーゼ阻害物質であるソマンへの被爆対策として、臭化ピリドスチグミンの事前投与を、米国軍人の闘争用として承認した。FDAでは2002年６月30日から、通称「animal efficacy rule」と呼ばれる規則により、ヒトを対象にした治験が倫理的理由などから難しい際には動物実験データを元に承認を行うことを認めているが、今回の承認は、同規則を適用した初めての例という。
主にサルとギニピグを対象に行った研究結果では、ソマンへの被爆前に臭化ピリドスチグミンを投与し、被爆後にアトロピンとプラリドキシムを投与することで、生存率が増加したという。
FDAはまた、臭化ピリドスチグミンは、1955年から重症筋無力症の治療薬として承認されているため、そのデータを元に安全性を評価したという。詳しくは、FDAによる、ニュース・リリースまで。
（當麻 あづさ、医療ジャーナリスト）
■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■
【FDAのニュース・リリース】
http://medwave.nikkeibp.co.jp/regist/medi_auth.jsp?id=1/mdps/230401
●●FDA News
FOR IMMEDIATE RELEASE
PO3-08
February 5, 2003 Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
--------------------------------------------------------------------------------
FDA APPROVES PYRIDOSTIGMINE BROMIDE AS PRETREATMENT AGAINST NERVE GAS
The Food and Drug Administration (FDA) today announced approval of pyridostigmine bromide to increase survival after exposure to Soman "nerve gas" poisoning. The product is approved for combat use by United States military personnel.
Pyridostigmine bromide is the first drug approved under a recently issued FDA rule (frequently referred to as the "animal efficacy rule") that allows use of animal data for evidence of the drug's effectiveness for certain conditions when the drug cannot be ethically or feasibly tested in humans.
The "animal efficacy rule," which became effective on June 30, 2002, is an important component of FDA's efforts to make medical countermeasures available to treat or prevent the effects of biological and chemical agents.
FDA Commissioner Mark B. McClellan, M.D., Ph.D., said, "Today's action will help protect American troops and others from nerve agent attacks."
The "animal efficacy rule" enabled FDA to approve pyridostigmine bromide to increase survival from Soman poisoning despite the impossibility of ethically conducting human studies on the effectiveness of the drug.
The nerve agent Soman causes loss of muscle control and death from respiratory failure. Evidence of the effectiveness of pyridostigmine bromide as a pretreatment for exposure to Soman was obtained primarily from studies in monkeys and guinea pigs. This evidence shows that administration of the drug before exposure to Soman, together with atropine and pralidoxime given after exposure, increases survival. FDA believes that, based on the animal evidence of effectiveness, pyridostigmine bromide is likely to benefit humans exposed to Soman.
The agency's safety assessment is based on long-term use of pyridostigmine bromide, first approved by FDA in 1955, to treat a neuromuscular disease called myasthenia gravis. The Department of the Army has submitted data from multiple controlled trials and uncontrolled clinical experience demonstrating pyridostigmine bromide is well-tolerated at the doses intended for military use. The dose used for myasthenia gravis is higher than the dose used for pretreatment to protect against Soman.
To use this potentially lifesaving drug correctly, military personnel must carefully follow instructions and use the drug only under specific circumstances. For example, if U.S. troops faced the threat of exposure to Soman, they would be given instructions to take pyridostigmine bromide every 8 hours prior to the anticipated exposure. Soldiers will be warned that the drug is not effective and should not be taken at the time of, or after exposure to Soman.
The troops are to use the drug in conjunction with other protective measures, including chemical protective masks and battle dress garments. Furthermore, effectiveness depends on the rapid use of the antidotes atropine and pralidoxime and discontinuation of pyridostigmine bromide at the first indication of nerve gas exposure. The Department of Defense plans to provide all military personnel with extensive training, prior to deployment, on the proper use of pyridostigmine bromide, as well as other methods used in the prevention and treatment of nerve agent poisoning.
A leaflet that explains the drug's use, benefits, and side effects will be provided to military personnel when the drug is distributed. The leaflet advises that pyridostigmine bromide should not be used by persons who have a history of bowel or bladder obstruction, or sensitivity to certain medicines used during surgery (like physostigmine). Side effects that may occur include stomach cramps, diarrhea, nausea, frequent urination, headaches, dizziness, shortness of breath, worsening of peptic ulcer, blurred vision, and watery eyes.
The approved dose of pyridostigmine bromide for Soman pretreatment is one 30-mg. tablet every 8 hours. The leaflet states that pyridostigmine should be started at least several hours before exposure to Soman and emphasizes that it must be discontinued upon exposure to nerve gas, at which point the antidotes atropine and pralidoxime are given.
During the Gulf War, FDA had allowed distribution of pyridostigmine bromide under its Investigational New Drug provisions because pretreatment with this drug had the potential to help save lives if nerve agents were used.
Today's action provides FDA approval for the product.
####
More Information
http://www.fda.gov/cder/drug/infopage/Pyridostigmine_Bromide/default.htm
■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■■
題名には必ず「阿修羅さんへ」と記述してください。