乌普萨拉监测中心VigiBase数据库研究

doi:10.19803/j.1672-8629.2020.10.06

中国药物警戒 ›› 2020, Vol. 17 ›› Issue (10): 676-680.
DOI: 10.19803/j.1672-8629.2020.10.06

乌普萨拉监测中心VigiBase数据库研究

张威, 卫付茜, 杨悦^*

沈阳药科大学工商管理学院,沈阳药科大学国际食品药品政策与法律研究中心,辽宁沈阳 110016

收稿日期:2020-10-14 修回日期:2020-10-14 出版日期:2020-10-15 发布日期:2020-10-13
通讯作者: ^*杨悦,女,博士,教授·博导,药事法规与药品政策研究。E-mail：yyue315@vip.126.com
作者简介:张威,男,在读硕士,药事管理。

Study of VigiBase Database of Uppsala Monitoring Centre

ZHANG Wei, WEI Fuqian, YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University / International Food & Drug Policy and Law Research Centre of Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China

Received:2020-10-14 Revised:2020-10-14 Online:2020-10-15 Published:2020-10-13

摘要/Abstract

摘要： 目的研究乌普萨拉监测中心（UMC）VigiBase数据库的结构、工具和功能,为完善我国药品不良反应数据库提供参考。方法采用文献研究法并查阅VigiBase数据库,系统学习并分析该数据库的结构和功能。结果 VigiBase数据库是全球最大的个例安全性报告数据库。UMC利用VigiGrade评估ICSRs质量,VigiMatch检测重复报告,VigiRank检测药品安全信号,并向各成员国提供VigiLyze、VigiFlow、VigiAccess等工具,用于管理ICSRs和检索VigiBase数据库。结论我国不良反应数据库中报告质量评估、安全信号检测等方面,仍需改进和完善。

关键词: WHO国际药物监测计划, 乌普萨拉监测中心, 数据库, VigiBase

Abstract: Objective To study the structure, tools and functions of VigiBase, a database managed by the Uppsala Monitoring Centre (UMC), and to provide reference for improving the database of adverse drug reactions (ADRs) in China. Methods The structure and functions of VigiBase were analyzed by consulting literature and searching VigiBase. Results VigiBase was the largest database of individual case safety reports (ICSRs) in the world. UMC evaluated the quality of ICSRs via VigiGrade, inspected the duplicate reports via VigiMatch, detected drug safety signals via VigiRank, and also provided VigiLyze, VigiFlow, VigiAccess and other tools for member states to manage ICSRs and retrieve data from VigiBase. Conclusion The assessment of report quality and drug safety signal detection need to be improved in China.

Key words: WHO programme for international drug monitoring, Uppsala Monitoring Centre, database, vigivase database

中图分类号:

R951

张威, 卫付茜, 杨悦. 乌普萨拉监测中心VigiBase数据库研究[J]. 中国药物警戒, 2020, 17(10): 676-680.

ZHANG Wei, WEI Fuqian, YANG Yue. Study of VigiBase Database of Uppsala Monitoring Centre[J]. Chinese Journal of Pharmacovigilance, 2020, 17(10): 676-680.

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乌普萨拉监测中心VigiBase数据库研究

Study of VigiBase Database of Uppsala Monitoring Centre

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