刍议美国罗格列酮的风险评估与减低计划

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。

Discussion of Risk Evaluation and Mitigation Strategy of Rosiglitazone in America

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.