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[摘要]
2007年5月,《新英格兰医学杂志》网站刊登研究报告说文迪雅可能大幅增加心脏病风险,导致死亡率增加的事实引起世界关注。欧盟药品管理局(EMEA)发布信息,建议暂停文迪雅及其复方制剂的上市许可。美国FDA决定严格限制文迪雅的使用,仅用于那些其他药品不能控制血糖的2型糖尿病患者。SFDA密切关注EMEA和FDA对罗格列酮及其复方制剂采取的新的监管措施,其措施反应了维护药物安全性的科学监管与保护公众利益的一致性。针对药物监管部门的这些决定,可以说是标志着糖尿病治疗的一个新时代的开始,以控制血糖水平的标准批准这类糖尿病治疗药物上市的时代已经结束。
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[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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