FDA妊娠期用药登记研究指南与案例分析  

Pregnancy exposure registries: US FDA guidance and case studies

作　　者：竟永华[1] 郭剑非[1] 李行[1] 

机构地区：[1]美国辛辛那提大学药学院,美国辛辛那提45267

出　　处：《中国药物警戒》2006年第2期72-75,80,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的介绍FDA妊娠期用药登记研究的概念和方法,并讨论了妊娠期用药登记研究的实例。方法利用文献资料采取综述的方法,详细介绍了美国妊娠期用药登记研究指南的主要内容。结果作为药品上市后安全监控的一种方法,妊娠期用药登记研究越来越广泛地用于研究药品对胎儿的致畸性和描述妊娠期用药的边际收益和风险。严格按照科学原则合理设计的妊娠期用药登记研究能够提供可靠、丰富的信息,为药品在妊娠期安全使用的科学管理提供依据。结论美国妊娠期用药登记研究指南在指导研究者如何进行妊娠期用药登记研究方面具有重要的意义,对我国妊娠期用药安全研究具有借鉴作用。Objective Drug safety for women during pregnancy is an important issue in public health. Method Because little is known about the teratogenic potential of a drug in humans before new drug approval,the drug post-marketing surveillance for women during pregnancy is a critical consideration to detect drug-induced fetal effects.Result The existing passive mechanism of spontaneous reporting of adverse drug effects is inadequate to detect or measure drug-induced fetal risks and effects.Therefore,post-marketing pregnancy exposure registries have been increasingly used to proactively monitor for major fetal effects and to measure margins of safety associated with drug exposure during pregnancy.It is only through the use of rigorous methodology and procedures that data from pregnancy exposure registries will withstand scientific scrutiny.Gonclusion In this article we reviewed the US FDA published guidance on Establishing Pregnancy Exposure Registries and suggested Chinese pharmaceutical industry could improve its research in monitoring drug exposures during pregnancy.

关 键 词：妊娠期用药登记 药品安全 药物警戒 

分 类 号：R969.3[医药卫生—药理学] R95[医药卫生—药学]