基于模拟数据库的药品不良反应信号检测方法比较

Comparison of Adverse Drug Reaction Signal Detection Methods Based on Simulation Database

目的通过蒙特卡罗模拟评价各种药品不良反应信号检测方法。方法参考国内外自发呈报系统相关资料,建立自发呈报系统模型,模型中考虑影响上报报告数的几个因素如药物上市时间、药物暴露人群大小(用药人数)、不良事件的背景发生率、不良事件的严重程度以及报告概率(或漏报系数)。在模拟数据库的基础上进行各方法的比较。结果SPRT和MHRA法灵敏度低,RR和Chi-square法特异度低,其他方法具有可比性。结论通过建立模拟数据库的方式对信号检测方法的比较具有一定的促进作用。

Objective To examine the concordance of various adverse drug reaction signal detection measures by Monte Carlo simulation. Methods We constructed spontaneous reporting system model based on some SRS references considering several factors, such as frequency of exposure, time to market, the background incidence of adverse events, the severity of ADR as well as of reporting probability （ or underreporting coefficient）. The model involving 60 kinds of drugs and 40 kinds of adverse events was constructed to compare various signal detection methods based on simulation database by SAS software. Results SPRT and MHRA have low sensitivity, RR and Chi-square with low specificity, and other methods are comparable. Conclusion Monte Carlo simulation provided the foundation for the comparison of signal detection methods.