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.

参考文献

[1] Jacques Caron, Michaël Rochoy, Louise Gaboriau, et al.The History of Ppharmacovigilance[J].Therapie, 2016(71):129-134.
[2] Peng LL, Wang D, Shen L, et al.Development and Origin of Pharmacovigilance[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2016, 13(7): 410-413.
[3] Uppsala Monitoring Centre. The story of UMC and the WHO Programme[EB/OL].(2018-10-11)[2020-01-27].https://www. who-umc.org/global-pharmacovigilance/who-programme/the- story-of-umc-and-the-who-programme/.
[4] Overview of the development of the WHO International Drug Monitoring Cooperation Program[J]. Adverse Drug Reactions Journal(药物不良反应杂志), 1999(1): 47-48.
[5] Uppsala Monitoring Centre. VigiMethods[EB/OL].(2017-01-10) [2020-01-27].https://www.who-umc.org/vigibase/vigilyze/ vigimethods/.
[6] Uppsala Monitoring Centre. Better Signal Detection with VigiRank [EB/OL].(2018-04-18)[2020-01-27].https://www.who-umc.org/ media/164251/uppsalareports78web.pdf.
[7] Philip Michael Tregunno, Dorthe Bech Fink, Cristina Fernandez- Fernandez, et al.Performance of Probabilistic Method to Detect Duplicate Individual Case Safety Reports[J]. Drug Safety, 2014, 37(4):249-258.
[8] Uppsala Monitoring Centre. WHO Drug Global[EB/OL].(2019-08- 30)[2020-01-27].https://www.who-umc.org/whodrug/whodrug- portfolio/whodrug-global/%E5%85%B3%E4%BA%8Ewhodrug- global/.
[9] Uppsala Monitoring Centre. Being a member of the WHO Programme for International Drug Monitoring[EB/OL].(2020-01-16)[2020- 01-27].https://www.who-umc.org/media/1434/being-a-member.pdf.
[10] Uppsala Monitoring Centre. Individual Case Safety Reports and VigiBase- the vital importance of quality[EB/OL].(2012-03) [2020-01-27].https://www.who-umc.org/media/163807/vigibase- the-vital-importance-of-quality-2017.pdf.
[11] Uppsala Monitoring Centre. WHODrug Global Chinese[EB/OL]. (2019-10-10)[2020-01-27].https://www.who-umc.org/whodrug/ whodrug-portfolio/whodrug-global/%E5%85%B3%E4%BA%- 8Ewhodrug-global/%E5%85%B3%E4%BA%8Ewhodrug-global- chinese/.
[12] Tomas Bergvall, G. Niklas Norén, Marie Lindquist. VigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues[J]. Drug Safety, 2014, 37(1):65-77.
[13] Shi W T.Identification and Elimination of Duplicate Reports in Signal Detection of Adverse Drug Reaction[D]. The Second Military Medical University, 2018.
[14] Uppsala Monitoring Centre.VigiLyze[EB/OL][2020-01-27].https:// www.who-umc.org/VigiBase/VigiLyze/.
[15] Kristina Johansson, Sten Olsson, Björn Hellman, et al.An Analysis of Vigimed, a Global E-Mail System for the Exchange of Pharmacovigilance Information[J]. Drug Safety, 2007, 30(10): 883-889.
[16] Caster Ola, Sandberg Lovisa, Bergvall Toma, et al.VigiRank for statistical signal detection in pharmacovigilance: First results from prospective real-world use[J].Pharmacoepidemiology and Ddrug Ssafety, 2017, 26(8):1006-1010.
[17] Uppsala Monitoring Centre. What is a signal?[EB/OL].(2019- 06-12)[2020-01-27].https://www.who-umc.org/research-scientific- development/signal-detection/what-is-a-signal/.
[18] Wei J.Research on Drug Safety Monitoring System[D]. Shenyang Pharmaceutical University, 2011.
[19] Liu W, Li XL, Cheng G, et al.Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2014, 11(9): 561-563, 566.
[20] Hou YF, Liu CL, Song HB, et al.Optimized Signal Detection Model in Adverse Drug Reaction Monitoring System[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2016, 13(7): 408-409, 421.

乌普萨拉监测中心VigiBase数据库研究

Study of VigiBase Database of Uppsala Monitoring Centre

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

参考文献

相关文章 15

编辑推荐

Metrics

[1]	李嘉昕, 刘慧敏, 钱文秀, 马宁, 宋丽丽, 李遇伯. 基于中药系统毒理学数据库的中药致肾毒性及药物规律研究[J]. 中国药物警戒, 2024, 21(2): 173-180.
[2]	张斗胜, 王晨, 许明哲. 基于计算模型结合数据库技术快速评价注射用左奥硝唑及其主要杂质的潜在神经毒性[J]. 中国药物警戒, 2022, 19(7): 712-716.
[3]	陈超, 赵云飞, 王长之, 龚立雄, 刘伟. 乌普萨拉监测中心vigiRank预测模型研究[J]. 中国药物警戒, 2022, 19(3): 270-274.
[4]	黄丽婷, 汤在祥, 白璐, 时贯宏, 江翊国. 基于FAERS数据库的苯二氮窧类药物的不良反应分析[J]. 中国药物警戒, 2022, 19(11): 1223-1227.
[5]	郑轶, 郭晓晶, 许金芳, 郭志坚, 迟立杰, 陈晨鑫, 梁际洲, 韦连慧, 陈枭, 叶小飞, 贺佳. 运用信息成分方法分析伊布替尼的不良反应[J]. 中国药物警戒, 2022, 19(11): 1228-1232.
[6]	汪祺, 闫明, 马双成, 文海若. 基于定量构效关系的何首乌毒性单体成分预测[J]. 中国药物警戒, 2021, 18(4): 352-355.
[7]	迟立杰, 陈晨鑫, 郑轶, 韦连慧, 陈枭, 郭志坚, 郭晓晶, 贺佳, 叶小飞. 国外主要自发呈报系统数据库分析及应用[J]. 中国药物警戒, 2021, 18(12): 1144-1147.
[8]	樊蓉, 董铎. 世界卫生组织药品安全监测工作概况及思考[J]. 中国药物警戒, 2021, 18(1): 43-46.
[9]	胡方圆, 叶小飞, 翟映红, 许金芳, 郭晓晶, 郭志坚, 庄永龙, 贺佳. 免疫抑制剂Cemiplimab的药物毒性：基于FARES数据库的真实世界研究[J]. 中国药物警戒, 2020, 17(8): 480-486.
[10]	杨书彬, 裴晨晨, 师伟, 王信, 李娜, 曹广尚, 张海鸣, 聂颖兰, 孙健. 桂枝茯苓组方的网络药理学研究[J]. 中国药物警戒, 2020, 17(4): 214-220.
[11]	沈卓捷, 许金芳, 叶小飞, 贾哲宇, 梁际洲, 王蒙, 郭晓晶. 基于医疗保险数据库的药物警戒研究现状[J]. 中国药物警戒, 2019, 16(3): 129-133.
[12]	万帮喜, 余丽娜, 徐菊萍. 基于ICH E2B（R3）指南理解个例安全性报告数据质量[J]. 中国药物警戒, 2019, 16(10): 597-601.
[13]	王涛, 王丹, 范燕, 董铎. 欧盟药物警戒数据库功能升级与思考[J]. 中国药物警戒, 2018, 15(7): 411-413.
[14]	武楠, 杨悦. 欧盟药物警戒数据库建设对我国的启示[J]. 中国药物警戒, 2018, 15(4): 230-233.
[15]	林鸿波, 刘翠丽, 沈鹏, 李海龙, 赵厚宇, 詹思延. 基于鄞州区域医疗数据的利巴韦林临床使用的分析[J]. 中国药物警戒, 2018, 15(2): 73-77.