自发呈报系统中已知ADR报告对信号检出的影响

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

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60996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。

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.