文章摘要
王胜锋,詹思延.大数据时代的药品安全主动监测:对照选择的挑战与机遇[J].中华流行病学杂志,2016,37(7):909-916
大数据时代的药品安全主动监测:对照选择的挑战与机遇
Active surveillance of adverse drug reaction in the era of big data: challenge and opportunity for control selection
收稿日期:2016-03-01  出版日期:2016-07-15
DOI:10.3760/cma.j.issn.0254-6450.2016.07.001
中文关键词: 主动监测  电子医疗数据  对照选择
英文关键词: Active surveillance  Electronic medical records  Control selection
基金项目:国家自然科学基金(81502884,81473067)
作者单位E-mail
王胜锋 100191 北京大学公共卫生学院流行病与卫生统计学系  
詹思延 100191 北京大学公共卫生学院流行病与卫生统计学系 siyan-zhan@bjmu.edu.cn 
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中文摘要:
      电子医疗数据已成为大数据时代开展药品安全主动监测的重要资源。基于此确认药品与不良事件是否存在关联,要回归传统的流行病学研究设计,选取恰当的对照进行对比。本文主要阐述不同对照选取的原理、适用情形,介绍、评价并比较各种对照选取的思路与参数,引入对照选择批量化实现的进展性成果,以期为我国利用电子医疗数据开展上市后药品安全性监测提供方法学参考。
英文摘要:
      Electronic healthcare databases have become an important source for active surveillance of drug safety in the era of big data. The traditional epidemiology research designs are needed to confirm the association between drug use and adverse events based on these datasets, and the selection of the comparative control is essential to each design. This article aims to explain the principle and application of each type of control selection, introduce the methods and parameters for method comparison, and describe the latest achievements in the batch processing of control selection, which would provide important methodological reference for the use of electronic healthcare databases to conduct post-marketing drug safety surveillance in China.
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