5277例中药不良反应分析

Analysis on 5277 cases of adverse drug reactions of traditional Chinese medicine

目的了解中药不良反应发生情况。方法通过对2006-2008年上海市药品不良反应监测中心收集的5 277例中药不良反应应用统计分析和PRR值计算,进行中药不良反应情况分析。结果中药发生的不良反应主要为皮肤附件损害、过敏性反应和消化系统损害;严重不良反应为2.8%;应用PRR值检测到药物不良反应信号91个,值得进一步研究。结论中药不良反应一般较为轻微,有意义的不良反应较少。PRR值计算简单,可用于不良反应信号检测。

AIM To analyze adverse drug reactions （ADRs） of traditional Chinese medicine（TCM）. METHODS Using EXCEL and SPSS sofewares we analyzed 5 277 ADR cases from Shanghai Center for Adverse Drug Reactions Monitoring during the period from 2006 to 2008. Furthermore, we calculated pmpoaional reporting ratios （PRRs） for ev- ery kind of drug and ADRs. RESULTS ADRs of TCM mainly included skin appendix damage, allergic reaction and gastrointestinal hurt.The rate of serious ADRs was 2.8% .The method of PRRs identified 91 signals which were required further evaluation. CONCLUSION Most ADRs of TCM are mild, while significant ADRs are less. The value of PPRs is conveniently calculated for monitoring the signal of ADRs.