利用《药品不良反应信息通报》分析我国药品不良反应监测现状  

A retrospective analysis based on Adverse Drug Reaction Information Bulletin to explore the current situation of adverse drug reaction monitoring in China

作　　者：祝晓雨[1] 张伟光 赵志刚[1] ZHU Xiao-yu1 , ZHANG Wei-guang2, ZHAO Zhi-gang 1(1. Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University,Beijing 100050, China ;2. Department of Pharmacy, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China)

机构地区：[1]首都医科大学附属北京天坛医院药学部,北京100050 [2]首都医科大学附属北京朝阳医院西院药事办,北京100043

出　　处：《临床药物治疗杂志》2018年第9期34-38,共5页Clinical Medication Journal

摘　　要：目的:利用官方发布信息,分析我国药品不良反应监测现状,探索未来重点监测药品类型。方法:对2001年11月以来国家药品不良反应监测中心发布的76期《药品不良反应信息通报》的内容进行整理,提取涉及的药品名称、分类、发布次数、累及的器官或系统、主要不良反应表现以及引发原因,利用Excel进行分类统计分析。结果:截至2018年6月16日,官方共发布的76期《药品不良反应信息通报》中,共涵盖13大类102种药品,其中化学药品76种,占74.51%;中药及中成药26种,占25.49%。二次通报的药品有15种,其中2/3为抗感染药物。所有通报的ADR/ADE累及器官中,皮肤相关的最多,生殖系统和营养代谢相关的最少。结论:我国的药品不良反应通报信息已经成为我国药物警戒的重要环节,起到至关重要的作用。但仍需要更多的关注与完善。Objective： To analyze the status of adverse drug reaction （ADR） monitoring in China and explore the key drug types for future monitoring by using the inforrnation released by the government. Methods： The contents of 76 issues of Adverse Drug Reaction Information Bulletin issued by the National Center for Adverse Drug Reaction Monitoring since November 2001 were sorted out. The names, classifications, times of publication, organs or systems involved, inanifestatious of major adverse drug reactions and causes of adverse drug reactions were extracted and classified by Excel to be analyzed Results： Up to June 16th 2018, the 76 issues covered 13 categories and 102 kinds of drugs, of which 76 kinds of chemicals accounted for 74, 51%, 26 kinds of traditional Chinese Medicine and proprietary Chinese Medicine accounted for 25.49%. Of the 15 re-notified drugs, two-thirds were anti-infective. Of all reported ADR/adverse drug event （ADE） involvement organs, skin was the most related, and reproductive system and nutritional metabolism were the least related. Conclusion： ADR notification in China has become an important part of drug vigilance and plays a vital role. However more attention and improvement are needed.

关 键 词：药品不良反应 药品不良反应信息通报 合理用药 药品不良反应监测 药物警戒 

分 类 号：R969.3[医药卫生—药理学]