作者：Eurona Earl Tilley 齣處：WebMD醫學新聞 　　February 17 2009 — 美國食品藥物管理局(FDA)以及國際嚴重副作用聯閤會(SAEC)於上週發錶藥物副作用 有些藥物的皮膚相關副作用可能是因為基因因素 - 趣味新聞網

發表日期 2009-03-05T08:37:33+08:00

     本帖最後由 goodcat1111 於 2009-3-21 17:44 編輯

作者：Eurona Earl Tilley
齣處：WebMD醫學新聞

February 17, 2009 — 美國食品藥物管理局(FDA)以及國際嚴重副作用聯閤會(SAEC)於上週發錶藥物副作用的基因因素初步資料。

SAEC發起人、Arthur Holden主席在新聞稿中錶示，我們很榮幸能提供這些重要資料給研究界，可以改善藥物研發的生産力，以及開始研發那些預期有藥物相關嚴重副作用之病患的有效生物標記。我們相信，以基因圖研究嚴重副作用的基因基礎，將會是本技術最具産值的初步運用。

第一批發布的資料包括藥物引起的嚴重皮膚紅疹，如史蒂文-強生癥候群(Stevens-Johnson syndrome)和中毒性錶皮壞死癥(toxic epidermal necrolysis)的基因關聯，這些反應的特徵通常是起水泡和脫皮；不過，如果未加治療，可能會緻命。幸運的是，透過新資料，研究者現在或許可以辨識哪些病患有發生這些反應的高風險。

FDA藥物評估與研究中心主任Janet Woodcock醫師認為，SAEC在促進藥物安全資料上佔有一席之地，將可以研發更多個人化藥物。她在新聞稿中錶示，SAEC完成關鍵途徑的主要目標，提供有關藥物副作用的公開基因資料給研究界。

SAEC是包括藥廠、Wellcome Trust以及學術機構的非營利閤作組織。SAEC確認個彆病患對藥物的反應不同；因此，其任務在辨識與確認基因變化，以預測藥物相關嚴重副作用的風險。

新資料的樣本由GlaxoSmithKline藥廠所提供，由SAEC匯整分析之後發布。這些樣本包括嚴重皮膚紅疹案例與對照組。

根據FDA指齣，將於今年內發錶此項閤作的初步研究結果。接受資料使用同意規範的研究者可以免費獲得資料，有關藥物副作用基因基礎的一般使用者調查與結果。

Certain Skin-Related Adverse Drug Events May Have Genetic Basis

By Eurona Earl Tilley
Medscape Medical News

February 17, 2009 — The Food and Drug Administration (FDA) in conjunction with the International Serious Adverse Events Consortium (SAEC) released initial data last week on the genetic basis of adverse drug events.

"We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events," Arthur Holden, founder and chairman of the SAEC, said in a news release. "We continue to believe the application of genomics to research the genetic basis of serious adverse events will prove to be one the most productive early applications of this technology."

The first set of data released includes the genetic associations for drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. These reactions are often characterized by blistering and peeling; however, if left untreated, they can be fatal. Fortunately, through the use of the new data, researchers may now be able to identify which individuals are at risk of developing these reactions.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research commented that the work of the SAEC is playing a significant role in promoting open sharing of drug safety data, which will allow for a more personalized approach to medicine. "The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events," she said in a news release.

The SAEC is a nonprofit partnership that includes pharmaceutical companies, the Wellcome Trust, and academic institutions. The SAEC recognizes that individual patients respond differently to medicines; thus, its mission is to identify and validate genetic variants that are needed to predict the risk of drug-related serious adverse events.

The new data set was derived after the SAEC pooled and analyzed donated samples from GlaxoSmithKline. These samples were from initial serious skin rash cases and matched controls.

"The consortium will publish its initial research results later this year," according to the FDA. "Researchers who enter in to a data use agreement can obtain free access to the data to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events."

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