刍议美国罗格列酮的风险评估与减低计划

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (12): 714-718.

刍议美国罗格列酮的风险评估与减低计划

许荣芹,许美婷,杨悦^*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2013-03-05 修回日期:2016-03-09 出版日期:2013-12-08 发布日期:2016-03-09
通讯作者: 杨悦,女,教授,博士生导师,药事管理与药品政策。 E-mail：yyue315@126.com
作者简介:许荣芹,女,在读硕士,药品安全性监测。

Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America

XU Rong-qin, XU Mei-ting ,YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-03-05 Revised:2016-03-09 Online:2013-12-08 Published:2016-03-09

摘要/Abstract

摘要： 目的分析美国对罗格列酮的上市后风险管理,以期为我国上市后药品风险管理提供参考和借鉴。方法通过检索FDA和CFDA网站以及相关文献,收集并整理分析罗格列酮相关信息,详细回顾了FDA对罗格列酮采取的风险评估与减低计划（REMS）,同时分析了我国对罗格列酮的上市后监管,并对中美风险干预措施进行比较。结果与结论 美国罗格列酮的 REMS是罗格列酮上市后风险管理的一项重要举措,严格限制了罗格列酮的使用,对我国上市后药品风险管理具有指导意义。

关键词: 罗格列酮, 风险评估与减低计划, 风险效益

Abstract: Objective To analyze post -marketing risk management of rosiglitazone in America, in order to provide references for risk management of post -marketing drugs in China. Methods By searching medical literature from the FDA and CFDA website, and collecting rosiglitazone related information, it introduced the risk evaluation and mitigation strategy(REMS) on rosiglitazone in America. It analyzed post -marketing supervision of rosiglitazone in China and compared the risk intervention measures of China with America's. Results and Conclusion The American rosiglitazone REMS is an important measure in post-marketing supervision and it strictly limited the use of rosiglitazone. It has significant meaning to guide our drugs post-marketing risk management.

Key words: rosiglitazone, risk evaluation and mitigation strategy, risk benefit

中图分类号:

R951

许荣芹,许美婷,杨悦. 刍议美国罗格列酮的风险评估与减低计划[J]. 中国药物警戒, 2013, 10(12): 714-718.

XU Rong-qin, XU Mei-ting ,YANG Yue. Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America [J]. Chinese Journal of Pharmacovigilance, 2013, 10(12): 714-718.

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