对FDA要求修改非甾体抗炎药说明书的思考  

Opinion to FDA request of modification in NSAIDs labelling

作　　者：董怡[1] 

机构地区：[1]中国协和医科大学北京协和医院,北京100029

出　　处：《中国药物警戒》2005年第3期156-157,154,共3页Chinese Journal of Pharmacovigilance

摘　　要：为保证患者的安全,美国FDA发布使用COX-2抑制剂及非甾体抗炎药(NSAID)的声明,要求修改所有NSAID(包括COX-2抑制剂)的说明书,增加该类药物可增加心血管及胃肠道事件风险的黑框警告。这个声明基于3个长期服用COX-2抑制剂的随机对照双盲试验(RCT)出现了远期心血管事件。COX-2抑制剂以外的NSAID从未做过长期心血管安全性随机对照双盲试验,然而一些药物流行病的回顾性分析中出现了心血管事件增多的提示。监测药物上市后不良反应是保证病人用药安全性的主要手段。通过近期对NSAID不良反应的讨论,目的是提高医药人员对不良反应监测重要性的认识并积极参与不良反应监测工作。For the safety of patients FDA of United States announced a crucial issue about the modification of the labelling of all products of NSAIDs including COX-2 inhibitor,to add a black box warning which contains that all NSAIDs may have the risks of CV( cardiovascular) events and GI (serious gastrointestinal)events. This was based on 3 long term randomize control clinical trials of two COX-2 inhibitors(Rofecoxib and Celecoxib),which showed, unexpectly,that CV events occurred more than 1 1/2 years later. So far, no similar trial has been done in other NSAIDs.However,some observational studies suggested CV events did occur and with a significant difference compared with the control.All these strongly suggested postmarketing surveillance is the principle way of discovering drug safety.Recently,discussions about the ADR of NSAIDs met the purpose of keeping awareness on drug safety by postmarketing surveillance and emphasizing on the importance of postmarketing surveillance system which is meant to be utilized by the medical personers.

关 键 词：非甾体抗炎药 COX-2抑制剂 心血管事件 

分 类 号：R971.1[医药卫生—药品]