甲巯咪唑片安全性风险的分析及思考  

Analysis and Consideration on Safety Risk of Thiamazole Tablets

作　　者：李岚[1] 夏东胜[1] 田春华[1] 彭丽丽[1] 高云娟 LI Lan;XIA Dongsheng;TIAN Chunhua;PENG Lili;GAO Yunjuan(Center for Drug Reevaluation,CFDA,Beijing 100022,China;Nanchong Center of Adverse Drug Reaction Monitoring,Sichuan Nanchong 637000,China)

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100022 [2]南充市药品不良反应监测中心,四川南充637000

出　　处：《中国药物警戒》2018年第7期393-397,共5页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项项目(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究

摘　　要：目的分析甲巯咪唑片的安全性风险,为临床合理用药提供参考。方法对世界卫生组织药品不良反应监测数据库、我国药品不良反应监测数据库,及国外文献数据库中的甲巯咪唑片的不良反应报告,国内和原研企业药品说明书及国内风险控制措施等相关资料进行整理与分析。结果应关注甲巯咪唑致粒细胞缺乏症、肝损害等严重不良反应,并定期监测血常规和肝功能。结论药品上市许可持有人应履行主体责任,及时主动地更新药品说明书安全性资料,保障公众用药安全。Objective To analyze the safety risk of thiamazole tablets in China,so as to provide reference for clinical rational drug use.Methods The individual adverse drug reaction cases in Vigibase,China adverse drug reaction database,the literatures in foreign bibliographic databases,the domestic and original drug instruction and the domestic risk management measures were analyzed.Results The risk of agranulocytosis and liver damage of thiamazole should be concerned.It is important to monitor blood test and hepatic functions regularly.Conclusion The marketing authorization holder should carry out main responsibility and amend the safety information of drug instruction constantly to guarantee the public drug safety.

关 键 词：甲巯咪唑 粒细胞缺乏症 肝损害 药品说明书 

分 类 号：R994.11[医药卫生—毒理学]