[關(guān)鍵詞]
[摘要]
2007年5月,《新英格蘭醫(yī)學(xué)雜志》網(wǎng)站刊登研究報告說文迪雅可能大幅增加心臟病風(fēng)險,導(dǎo)致死亡率增加的事實引起世界關(guān)注。歐盟藥品管理局(EMEA)發(fā)布信息,建議暫停文迪雅及其復(fù)方制劑的上市許可。美國FDA決定嚴(yán)格限制文迪雅的使用,僅用于那些其他藥品不能控制血糖的2型糖尿病患者。SFDA密切關(guān)注EMEA和FDA對羅格列酮及其復(fù)方制劑采取的新的監(jiān)管措施,其措施反應(yīng)了維護(hù)藥物安全性的科學(xué)監(jiān)管與保護(hù)公眾利益的一致性。針對藥物監(jiān)管部門的這些決定,可以說是標(biāo)志著糖尿病治療的一個新時代的開始,以控制血糖水平的標(biāo)準(zhǔn)批準(zhǔn)這類糖尿病治療藥物上市的時代已經(jīng)結(jié)束。
[Key word]
[Abstract]
In May 2007, New England Journal of Medicine web site published study to report that Avandia (Rosiglitazone ) may significantly increase the risk of heart disease, leading to increased mortality caused by the fact that world attention. European Medicines Agency (EMEA) released information, recommend the suspension of Avandia and its compound preparation of the marketing authorization. FDA of USA decided to severely restrict the use of Avandia, only for those other drugs can not control blood sugar in type 2 diabetic patients. SFDA of China paid closely attention to the EMEA and the FDA on Avandia and its compound preparations to take the new regulatory measures. The measure reflects the maintenance of scientific monitoring of drug safety and protection of the public's interests. These decisions of drug regulatory administration can be said to mark the beginning of a new era for the treatment of diabetes, and the listing of these is over using the standard to control blood sugar levels to approve diabetes treatment drugs.
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