我国基本药物不良反应报告与监测情况浅析  

Current Adverse Drug Reaction Reporting and Monitoring of Essential Medicines in China

作　　者：于洪礼 逄瑜 邵波 肖爱丽 于冬梅 YU Hongli;PANG Yu;SHAO Bo;XIAO Aili;YU Dongmei(Center for Drug Reevaluation,NMPA,Beijing 100022,China;Center for Food Evaluation,State Administration for Market Regulation,Beijing 100070,China)

机构地区：[1]国家药品监督管理局药品评价中心,北京100045 [2]国家市场监督管理总局食品审评中心,北京100070

出　　处：《中国药物警戒》2021年第8期766-768,775,共4页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2015年度(2015ZX09501004-001-001)。

摘　　要：目的分析近年来我国基本药物不良反应报告与监测情况,为临床安全用药提供参考。方法收集我国2015年~2019年国家药品监督管理部门发布的《国家药品不良反应监测年度报告》,汇总分析国家基本药物不良反应/事件(ADR/ADE)报告情况。结果近年来国家基本药物ADR/ADE报告总体数量呈递增趋势,与我国药品总体报告变化趋势保持一致。结论在国家基本药物制度完善的同时,应关注国家基本药物相关ADR,促进临床安全使用。Objective To analyze the levels of reporting and monitoring of adverse drug reactions of essential medicines in recent years in China so as to provide reference for clinical safe use.Methods The Annual Reports on National ADR Monitoring issued by the National Medical Products Administration between 2015 and 2019 were collected while those on ADR/ADE involving national essential medicines were summarized and analyzed.Results From 2015 to 2019,reports of ADR/ADE caused by essential medicines in China kept increasing,which was consistent with the overall trend of reports in China.Conclusion With the improvement of regulations on essential medicines in China,ADR related to essential medicines deserve attention in order to promote the safe clinical use.

关 键 词：基本药物 国家药品不良反应监测年度报告 药品不良反应/事件 

分 类 号：R994.11[医药卫生—毒理学]