中国药物警戒 ›› 2016, Vol. 13 ›› Issue (11): 676-677.

• 法规与管理研究 • 上一篇    下一篇

药品不良反应重复病例发现及处理策略探讨

侯永芳1, 刘巍1, 吴桂芝1, 叶小飞2*, *   

  1. 1.国家食品药品监督管理总局药品评价中心,北京 100045;
    2.第二军医大学卫生统计学教研室,上海 200433
  • 收稿日期:2016-12-05 修回日期:2016-12-05 出版日期:2016-11-20 发布日期:2016-12-05
  • 作者简介:侯永芳,男,高级工程师,硕士,药品不良反应监测。

Finding and Excluding Strategies for Duplicated Cases in National Adverse Drug Reaction Database

HOU Yong-fang1, LIU Wei1, WU Gui-zhi1, YE Xiao-fei2, *   

  1. 1.Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    2.Department of Health Statistics, Second Military Medical University, Shanghai 200433, China
  • Received:2016-12-05 Revised:2016-12-05 Online:2016-11-20 Published:2016-12-05
  • Contact: 叶小飞,男,讲师,药物流行病学。E-mail: yexiaofei@smmu.edu.cn

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摘要： 目的 研究国家药品不良反应病例报告数据库（NADRDB）中的重复病例报告发现及剔除策略。方法 基于NADRDB 中2014年数据采用变量匹配法、基于字符比较方式鉴别重复病例,对重复病例进行分类汇总。结果 2014年数据中发现3 914组重复病例,可去除重复病例3 996例（占比0.3%）。结论 鉴别和剔除药品不良反应病例报告数据库中的重复病例具有可行性。

关键词: 药品不良反应, 重复病例, 发现, 鉴别

Abstract: Objective To study the finding and excluding strategies for duplicated cases in National ADR Database (NADRDB). Methods Using variable matching method to find duplicated cases in NADRDB (only 2014 data), and classify and analyze duplicated cases. Results 3 914 sets of duplicated cases were found. 3 966 duplicated cases, accounting for 0.3% of research data. Conclusion Duplicated cases in NADRDB can be found and excluded.

Key words: adverse drug reaction, duplicated cases, finding, excluding

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