中药注射剂不良反应报告和信号检测分析

Analysis of ADRs of Traditional Chinese Medicine Injection and Signal Detection

目的探讨中药注射剂不良反应的特点及规律,尝试一种信号检测方法,为建立有效的中药注射剂不良反应预警机制提供参考。方法对2004～2006年上半年收到的所有中药注射剂不良反应报告作一般性分析和信号检测分析。结果2004～2006年上半年收到的中药注射剂不良反应报告共2853例,涉及97个中药注射剂品种;通过PRR信号检测分析得出Drug-ADR组合共有102对,涉及42种中药注射剂,包含国家中心通报的7个品种。结论对中药注射剂不良反应的安全性问题应引起重视;PRR信号检出方法可以作为有效的工具,为建立有效的中药注射剂不良反应预警机制发挥作用。

Objective To study ADRs characteristic and regularity of traditional chinese medicine （TCM） injection, attempt a method of signal detection and provide reference for precaution of TCM injection. Methods TCM injection ADRs reports were analyzed by described and signal detection from 2004 to the first half year of 2006.Results 97 TCM injections were involved in all 2 853 ADRs reports; 102 drug-ADR combinations were detected by PRR signal analysis, covered 42 TCM injections, including seven TCM injections had been reported by national center. Conclusion More attention should be paid on ADRs of TCM injection and the signal detection of PRR can contribution to ADRs precaution as an effective tool.