中国药物警戒 ›› 2012, Vol. 9 ›› Issue (12): 745-747.

• 药械安全性研究 • 上一篇    下一篇

药品不良事件聚集性信号预警系统的建立和运行

冯红云, 侯永芳, 吴桂芝, 程刚*   

  1. 国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2012-07-13 出版日期:2012-12-10 发布日期:2015-08-07
  • 通讯作者: 程刚,男,硕士,药品不良反应监测。E-mail:chenggang@cdr.gov.cn
  • 作者简介:冯红云,女,博士,药品不良反应监测。

The Establishing and Running of Pre-warning System on Adverse Event Cluster Signals

FENG Hong-yun, HOU Yong-fang, WU Gui-zhi, CHENG Gang*   

  1. Center for Drug Reevaluation, Beijing 100045, China
  • Received:2012-07-13 Online:2012-12-10 Published:2015-08-07

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摘要： 为了及时发现药品不良事件聚集性信号,国家药品不良反应监测系统建立了药品不良事件聚集性信号的预警系统,并已投入正常使用。本文就预警系统的整体工作思路及预警规则的制定、初设预警系统运行后出现主要问题以及相应的调整进行了介绍,并对几次重大历史药害事件进行了人工预警,验证了预警规则的灵敏度和准确性。

关键词: 药品不良事件聚集性信号, 药品不良反应, 预警

Abstract: To discovery the adverse event cluster signals earlier, a pre-warning system was established and running in national adverse drug reaction monitoring system. Related processes, including background, pre-warning regulations, all problems during pre-warning system running and adjustments were introduced. In order to test the sensitivity and accuracy of pre-warning regulations, the three important historical drug hazards were pre-warned by hand.

Key words: adverse event cluster signals, adverse drug reaction, pre-warning