摘要
药品上市后再评价是药品风险管理与安全评估的重要内容,《国家药品不良反应监测报告》(2010版)明确指出,中药注射剂已经成为我国药品安全风险主要集中区域之一。文章从药物和临床两个角度,初步分析当前存在的与中药注射剂上市后再评价相关的问题,并初步从药品说明书推荐、药物利用研究及药品不良反应/事件监测3个方面,探讨中药注射剂临床使用合理性与安全性再评价体系构建思路,为后续开展中药注射剂药品风险管理与安全评估,丰富与完善临床药学/中药学研究内容和学科建设提供思路和方法。
The clinical rationality and safety of the traditional Chinese medicine injections(TCMIs),is an important content of drug risk management and safety evaluation.As shown in the Monitoring Report of China's National Adverse Drug Reaction/Event(ADR/ADE)(2010 Edition),TCMIs has been one of the main risk factors for drug safety in China.It was analyzed in this article about the current problems concerned with TCMIs in two aspects of drug and clinic.Meanwhile,according to drug information leaflets,drug utilization research(DUR),and ADR/ADE monitoring,discussion was made to construct a reevaluation system for the clinical rationality and safety of TCMIs.It may provide some ideas and methods for risk management and safety evaluation on TCMIs,and enrich contents and disciplines of the clinical pharmacy/Chinese pharmacy.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2017年第4期1411-1414,共4页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家自然科学基金青年科学基金项目(No.81302887)
山东省中医药管理局科技发展计划项目(No.2013-104
No.2015-128
No.2015-134)
山东省药学会临床药学奥赛康中青年科研项目(No.Sdapask-2013-07)
山东省医务职工科技创新项目(No.鲁医工字[2014]32号
No.鲁医工字[2015]33号
No.鲁医工字[2016]35号)~~
关键词
中药注射剂
药品说明书
药物利用研究
药品不良反应/事件
合理性
安全性
再评价体系
Traditional Chinese medicine injections(TCMIs)
Drug information leaflets
Drug utilization research(DUR)
Adverse drug reaction/event(ADR/ADE)
Rationality
Safety
Reevaluation system
