已上市中成药说明书安全信息修订实践与思考  

Current Progress and Considerations in Updating the Safety Information in Labels of Chinese Traditional Patent Medicines

作　　者：朱兰 邵波 朱彦[2] 戴洁 钟诗琦 ZHU Lan;SHAO Bo;ZHU Yan;DAI Jie;ZHONG Shiqi(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China;Institute of Information on Traditional Chinese Medicine,CACMS,Beijing 100700,China;Shaanxi Center for ADR Monitoring,Xi’an Shaanxi 710065,China;Center for Drug Reevaluation,Guiyang Guizhou 550081,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100076 [2]中国中医科学院中医药信息研究所,北京100700 [3]陕西省药品不良反应监测中心,陕西西安710065 [4]贵州省药品评价中心,贵州贵阳550081

出　　处：《中国药物警戒》2025年第2期188-192,共5页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82174534);中央级公益性科研院所基本科研业务费专项资金资助:中医药语义信息标准化探索研究(ZZ13-YQ-126)。

摘　　要：目的总结已上市中成药说明书安全信息修订相关工作经验。方法梳理已上市中成药说明书【不良反应】【禁忌】【注意事项】和“警示语”修订相关指导原则及要求,结合实际工作提出针对性建议。结果由于历史原因,部分已上市中成药说明书存在安全信息缺失的情形,应该及时予以修订,使医务人员、患者及时全面了解药品安全信息,从而指导临床安全合理用药。结论说明书修订是药品风险管理措施之一,解决了说明书安全信息缺失的问题后,仍然需要持续开展不良反应监测、上市后研究与评价发现药品风险,通过修订说明书等措施控制药品风险。Objective To review Current status of updating safety information in labels of Chinese traditional patent medicines.Methods To analyze the guidelines and requirements for the updating of information on adverse reactions,contraindications,precautions and warnings information in the labels of Chinese traditional patent medicines,and to make suggestions based on working experience.Results For some historical reasons,safety information is missing from some Chinese traditional patent medicine labels and should be added to provide guidance to healthcare professionals and patients on the use of medicines.Conclusion Revision of labeling and updating of safety information is one of the risk management measures,after solving the problem of missing safety information,there is still a need for continuous monitoring of adverse reactions,post-marketing research to identify drug risks,and to control the risks by revising labels and other measures.

关 键 词：中药 说明书 安全性信息 药品不良反应 禁忌 注意事项 

分 类 号：R956.13[医药卫生—药学] R994.11