摘要
以国家药品不良反应监测中心发布的第12期《药品不良反应信息通报》通报品种(硫普罗宁注射剂和胸腺肽注射剂)为主线,采用文献调研、系统分析的方法,对两品种以过敏性休克为主的安全性问题的认识过程予以了阐述。结合上述两品种在不同时期的具体监管举措,重点从文献分析的角度,对两品种被通报的缘起及实施相关风险管理措施起到的积极效应进行了解读。
Tiopronin and Thymopeptides injections in the 12nd Information Bulletin of Adverse Drug Reaction are as the clue, the article does to discuss the issued drugs process by pyramidally on the safety issue, especially the anaphylactic shock of Tiopronin and Thymopeptides injections. Combining with the characteristics of the specific regulatory measures in different stages, based on the articles published in public, this article analyses the causes issued in the Information Bulletin and positive effects from the risk managements.
出处
《中国药物警戒》
2009年第11期654-657,共4页
Chinese Journal of Pharmacovigilance
关键词
硫普罗宁注射剂
胸腺肽注射剂
不良反应
信息通报
风险管理
Tiopronin injection
Thymopeptides injection
adverse reaction
information bulletin
risk management
