国外主要自发呈报系统数据库分析及应用  

Applications of International Spontaneous Reporting System Databases

作　　者：迟立杰 陈晨鑫 郑轶 韦连慧 陈枭 郭志坚 郭晓晶 贺佳[1] 叶小飞[1] CHI Lijie;CHEN Chenxin;ZHENG Yi;WEI Lianhui;CHEN Xiao;GUO Zhijian;GUO Xiaojing;HE Jia;YE Xiaofei(Department of Health Statistics,Faculty of Health Service,Naval Medical University,Shanghai 200433,China;Department of Health Service,Hainan Hospital of PLA General Hospital,Sanya Hainan 572000,China)

机构地区：[1]海军军医大学卫勤系卫生统计学教研室,上海200433 [2]解放军总医院海南医院卫勤部,海南三亚572000

出　　处：《中国药物警戒》2021年第12期1144-1147,共4页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82073671);上海市自然科学基金资助项目(18ZR1449500);上海市第四轮公共卫生三年行动计划重点学科建设项目循证公共卫生与卫生经济学(15GWZK0901);上海市卫计委优秀青年医学人才培养计划(2018YQ47);上海市公共卫生学科带头人(GWV-10.2-XD22);上海市公共卫生优青计划(GWV-10.2-YQ33)。

摘　　要：目的介绍目前国外主要药品不良反应自发呈报系统世界卫生组织个案安全性病例报告数据库(VigiBase)、美国食品药品监督管理局不良事件报告系统(FAERS)、欧洲药品管理局不良反应数据库(EudraVigilance)应用现状。方法查阅国外主要自发呈报系统数据库相关网站,系统检索中外有关利用自发呈报系统文章并进行综述。从数据库的数据格式、利用数据库的权限、数据质量控制等方面对自发呈报系统数据库进行介绍,并对数据库的应用现状举例分析。结果国外自发呈报系统数据库数据可公开下载或在一定条件下获取,目前研究者利用国外自发呈报系统数据库已开展较多研究。结论自发呈报系统数据库对开展上市后安全性监测有较大价值,我国自发呈报系统数据库在数据共享方面可借鉴国外做法。Objective To outline the current applications of main international spontaneous reporting systems of ADR,including Vigibase,FAERS and EudraVigilance.Methods The websites of major foreign spontaneous reporting systems were searched and articles about the use of spontaneous reporting systems were retrieved.The data format of these databases,accessibility to them,data quality control and the applications of the databases were illustrated with examples.Results The databases of foreign spontaneous reporting systems can be downloaded publicly or obtained under certain conditions.A number of research programs have been conducted based on spontaneous reporting systems.Conclusion The spontaneous reporting system is of great value for post-marketing safety monitoring and China’s spontaneous reporting system database can learn from foreign practices in data sharing.

关 键 词：药品不良反应 自发呈报系统 数据库 国外 

分 类 号：R971.1[医药卫生—药品]