中国药物警戒 ›› 2010, Vol. 7 ›› Issue (11): 667-669.

• 管理及工作研究 • 上一篇    下一篇

自发呈报系统中已知ADR报告对信号检出的影响

李宏力1, 程能能2*,李熠2, 杜文民3   

  1. 1.陕西能源职业技术学院,陕西西安710613；
    2.复旦大学药学院药理学教研室,上海201203；
    3.上海市药品不良反应监测中心,上海200040
  • 收稿日期:2010-08-31 修回日期:2016-03-09 出版日期:2010-11-08 发布日期:2016-03-09
  • 通讯作者: 程能能,男,教授,博士生导师,药品不良反应监测及机理研究。 E-mail:nncheng@fudan.edu.cn
  • 作者简介:李宏力,女,副教授,药品不良反应监测及机理研究。

The Effect of Eliminated Known Adverse Drug Reaction Database of Spontaneous Reporting System for Signal Detection

LI Hong-li1, CHENG Neng-neng2*, LI Yi2 ,DU Wen-min3   

  1. 1.Shaanxi energy technology institute, Shaanxi Xi’ an 710613, China;
    2.Department of Pharmacology, School of Pharmacy, Fudan University Shanghai, Shanghai 200032 China;
    3.Shanghai Center for Drug Adverse Reaction Monitoring, Shanghai 200040, China
  • Received:2010-08-31 Revised:2016-03-09 Online:2010-11-08 Published:2016-03-09

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摘要： 目的 针对自发呈报系统中已知ADR 报告对信号检测的影响进行定量研究并提出优化策略。方法 使用综合标准法（MHRA）利用上海市药物不良反应监测中心2007~2009 年的60 996 份报告进行新策略验证。结果 排除目标药物-非目标事件中的已知ADR 报告后较不排除已知ADR 的原始MHRA 法分别多检出164、183、200 个信号,检出率增幅达到48.9%,发现新严重信号分别为17、11、14 个,其中严重信号刺五加注射液- 肝功能异常至今未见相关文献报道。结论 排除非目标药物-目标事件中的已知ADR 法可提高检出率且操作简便易行。

关键词: 自发呈报系统, 数据挖掘, MHRA法, 信号检测

Abstract: Objective To study the quantitative effect and optimized strategy of eliminate known ADR database of spontaneous reporting system for signal detection. Methods Analyze 60 996 ADR reports of 2007 ~2009 from Shanghai Center for adverse Drug Reaction Monitoring by MHRA. Results The detected single number of eliminate known ADR reports of drug of interest all other reactions of 2007 ~2009 could added 164、183、200 and detected rate was raised 48.9% compare with not eliminate known ADR. And found new important ADR signals 17、11、14 respectively. Eliminate known ADR of reactions of interest-all other drugs and eliminate all known ADR simultaneously could added number of ADR signal, but they could made important signals lost. Such as acanthopanax injection bring about liver damage have not been reported up to now in other literatures. Conclusion The strategy of eliminate known ADR database of drug of interest all other reactions can improve the efficiency of ADR signal detection and it is easy to operate.

Key words: spontaneous reporting system, date mining, MHRA, signal detection

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