中美两国2009~2020年不同人群ADR/ADE报告分析及对中国药物警戒工作的启示

Analysis of Adverse Drug Reactions or Adverse Drug Events of Different Populations in China and the United States from 2009 to 2020 and Implications for Pharmacovigilance in China

目的:比较中美两国2009~2020年不同人群药品不良反应(ADR)/事件(ADE)报告情况,探讨产生差异的原因,为中国开展药物警戒工作提供参考。方法:提取中国国家药品不良反应监测中心12年间发布的《药品不良反应监测年度报告》和美国食品药品管理局药品不良事件报告系统数据库中的相关数据,从年度报告数据变化、每百万人口平均报告数、报告来源、不同性别及年龄组占比等方面进行比较,分析变化趋势及导致差异的原因。结果:2009~2020年,中国和美国ADR/ADE累计报告数量分别达14985478和16959905份,年报告数目和每百万人口平均报告数均呈上升趋势。2020年,中国年度报告数量增长率为10.7%,高于美国的1.2%,但每百万人口平均报告数仍远低于美国。中国严重ADR/ADE报告占比各年份均低于美国,2020年两国严重ADR/ADE报告占比分别为10.0%和53.6%。结论:与美国相比,中国在每百万人口平均报告数、报告涵盖范围等方面仍存在一定差距。建议提高公众对ADR的认知,推动报告数据公开透明,不断完善中国监测体系建设;同时在新冠肺炎疫情冲击下,更应促进各机构信息共享,共筑药物警戒体系。

Objective:To compare the adverse drug reactions(ADRs)or adverse drug events(ADEs)of differ⁃ent populations between China and the United States from 2009 to 2020,and to explore the possible reasons,so as to pro⁃vide suggestions for pharmacovigilance in China.Methods:The data in the annual reports on ADR monitoring issued by Na⁃tional Center for ADR Monitoring and FDA Adverse Event Reporting System database were compared from the annual repor⁃ted data changes,average reports per million population,reported sources,proportions of different sex and age groups and other aspects,and the changing trend and reasons were analyzed.Results:From 2009 to 2020,the cumulative number of ADR/ADE reports in China and the United States reached 14985478 and 16959905,respectively,and the numbers of annual reports and average reports per million population were on the rise in both countries.In 2020,China’s annual report growth rate was higher than that of the United States,with growth rates of 10.7%and 1.2%respectively,but the average number of reports per million population was still much lower than in the United States.The proportion of serious reports in China had always been lower than that in the United States,which was 10.0%and 53.6%respectively in 2020.Conclu⁃sion:There is still a gap in the average reports per million population and the coverage of reports in China,compared with the United States.It is suggested that China should improve the public’s awareness of ADR,promote transparency in reporting data,and constantly improve the construction of China’s surveillance system.At the same time,under the impact of the COVID⁃19,we should promote information sharing among agencies and jointly build pharmacovigilance system.