基于中国医院电子病历数据的药品安全性评价模式探索

中国药物警戒 ›› 2019, Vol. 16 ›› Issue (3): 134-138.

• 药物警戒中多数据源的利用专栏 • 上一篇下一篇

基于中国医院电子病历数据的药品安全性评价模式探索

王雯¹, 谭婧¹, 于川¹, 刘艳梅¹, 吴桂芝², 熊玮仪², 董铎², 孙鑫^1,*

1 四川大学华西医院中国循证医学中心和CREAT团队,四川成都 610041;
2 国家药品监督管理局药品评价中心,北京 100021

收稿日期:2018-11-28 修回日期:2020-06-28 出版日期:2019-03-20 发布日期:2019-04-17
通讯作者: 孙鑫,男,博士,研究员·博导,循征医学。E-mail：sunx79@hotmail.com
作者简介:王雯,女,博士,助理研究员,循征医学。
基金资助:
国家重点研发计划（2017YFC1700406）：“证-病-方”冠心病中医防治的一体化评价模式及关键技术研究; 国家科技重大专项（2017ZX09304023）：新型生物技术药物和生物治疗临床评价技术示范平台-符合国际规范伦理与方法学平台; 中央组织部国家“青年千人计划”项目（D1024002）

Explore on Safety Evaluation Mode Based on Electronic Medical Records in China

WANG Wen¹, TAN Jing¹, YU Chuan, WU Guizhi², XIONG Weiyi², DONG Duo², SUN Xin^1,*

1 Chinese Evidence-based Medicine Center and CREAT Group, West China Hospital, Sichuan University, Sichuan Chengdu 610041, China;
2 Center for Drug Reevaluation, NMPA, Beijing 100021, China

Received:2018-11-28 Revised:2020-06-28 Online:2019-03-20 Published:2019-04-17

摘要/Abstract

摘要： 医院电子病历数据可为药品安全性评价提供重要数据资源,日益受到广泛关注。但在我国的实际环境下,如何基于医院电子病历记录（EMR）开展药品安全性评价仍缺乏清晰的技术框架和模式。本文基于已有的实证研究,探讨了基于我国EMR开展上市后药品安全性评价的可行性及研究模式,以期为研究者及监管部门正确生产和解读基于EMR的药物安全性研究证据提供参考。

关键词: 医院电子病历记录, 药品安全性评价, 真实世界研究

Abstract: Electronic medical records (EMRs) may represent an important data source for drug safety evaluation, and have received wide attention. However, the framework and approaches to use EMRs for drug safety evaluation have not been well established in Chinese setting. On the basis of empirical studies, we explored framework and methods for drug safety evaluation by using EMRs. Hopefully, this paper may offer a general guidance for rigorous production and appropriate use of real-world drug safety evidences based on the data from EMRs.

Key words: electronic medical records, drug safety evaluation, real world study

中图分类号:

R994.11

王雯, 谭婧, 于川, 刘艳梅, 吴桂芝, 熊玮仪, 董铎, 孙鑫. 基于中国医院电子病历数据的药品安全性评价模式探索[J]. 中国药物警戒, 2019, 16(3): 134-138.

WANG Wen, TAN Jing, YU Chuan, WU Guizhi, XIONG Weiyi, DONG Duo, SUN Xin. Explore on Safety Evaluation Mode Based on Electronic Medical Records in China[J]. Chinese Journal of Pharmacovigilance, 2019, 16(3): 134-138.

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基于中国医院电子病历数据的药品安全性评价模式探索

Explore on Safety Evaluation Mode Based on Electronic Medical Records in China

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