中国药物警戒 ›› 2012, Vol. 9 ›› Issue (9): 539-541.

• 药械安全性研究 • 上一篇    下一篇

信号检测在药品不良反应监测系统中的应用

侯永芳1, 2, 王玲2, 郭秀花1*, 杜晓曦2*   

  1. 1首都医科大学公共卫生与家庭医学学院,北京 100069；
    2国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2012-06-07 出版日期:2012-09-10 发布日期:2015-08-07
  • 通讯作者: 郭秀花,女,教授,博士生导师,流行病与卫生统计学。E-mail:guoxiuh@ccme.edu.cn
  • 作者简介:侯永芳,男,工程师,硕士在读,药品不良反应监测。

Signal Detection in the Software for Adverse Drug Reaction Monitoring

HOU Yong-fang1, 2, WANG Ling2, GUO Xiu-hua1*, DU Xiao-xi2*   

  1. 1 School of Public Health and Family Medicine of Capital Medical University, Beijing 100045, China;
    2 Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2012-06-07 Online:2012-09-10 Published:2015-08-07

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摘要： 信号检测是一种能筛选大量数据的、系统的、自动化的、操作性较强的方法,可充分挖掘和利用各类药物安全性数据库,比传统评价方法更快捷、更精确地鉴别潜在的安全性问题。国家药品不良反应监测系统中采用了信号检测方法来挖掘药品不良反应数据库,辅助发现药品安全性信号。通过解释信号检测原理、方法,介绍信号检测方法在不良反应监测中的实施及应用,以期为有关人员理解和运用信号检测方法及工具提供参考。

关键词: 药品不良反应, 信号检测, 应用

Abstract: Signal detection is an automatic and systematic method to mine various types of drug safety database. Potential safety problems can be found early and accurately by the method. National center for ADR monitoring system has applied signal detection methods to discover the drug safety signal in ADR database in China. By explaining how the currently used algorithms work, introducing how the signal detection is applied in the software for adverse drug reaction monitoring, provide technique support for understanding and mastering signal detection methods and tools.

Key words: adverse drug reaction, signal detection, practice