中国药品不良反应信息通报15年回顾分析

摘 要 目的：对2001～2015年发布的药品不良反应（ADR）信息通报进行汇总分析，以期为中国药物警戒的发展提供借鉴。方法：对69期信息通报中被通报的药物和不良反应情况进行统计分析。结果：通报发布的期数和药品种类呈上升趋势，对不同品种的不同类型ADR，国家采用多种灵活的管理措施来控制药品风险。通报的西药中，抗微生物药物所占比例最大。69期中被通报的中药有26种，其中中药注射剂不良反应尤其受到关注。此外，全球药品的最新安全性信息通报也为我国药品的临床使用风险控制提供了有益的补充。所有通报的ADR中，以皮肤及其附件的不良反应最多，严重ADR以过敏性休克居多。结论：我国的ADR通报工作在指导医药生产、使用单位对于药品风险的认识和管控中的作用已经凸显。如能在ADR通报的基础上，加强高风险品种的主动监测，同时完善现有的法律法规，针对中国的情况制定药品风险管理指南，将会进一步促进我国药物警戒工作的发展。

A Retrospective Analysis on Adverse Drug Reaction Information Bulletin in China for 15 Years

ABSTRACT Objective:Adverse drug reaction (ADR) information bulletin was an effective means of pharmacovigilance. It had so far been 15 years since China began to implement this system in 2001. To provide guidance for the development of Chinese pharmacovigilance, this study was conducted. Methods:A total of 69 issues of the bulletin during 15 years period were analyzed statistically. Results:The numbers of issues and drug varieties continued to increase, while for the different varieties of different types of ADR, the government has adopted more flexible measures to control drug risk. In terms of western medicine submitted, the anti microbial drugs had the largest proportions. 26 kinds of traditional Chinese medicine (TCM) were submitted, of which ADR of TCM injection were of particular interest. In addition, the latest information bulletin of global drug safety provided a useful complement effect for risk control of drugs using clinically. ADR regarding the skin and its annexes prevailed most from all ADR submitted, and anaphylactic shock was the most serious kind. Conclusion:Chinese ADR information bulletin had achieved some success in guiding drug manufacturing and management area. On the basis of ADR information bulletin, if we could strengthen the active surveillance of high risk species, improve the current laws and regulations, and establish the drug risk management guidelines combining Chinese conditions, it would further promote the development of our pharmacovigilance work.