报告率比例法在中药注射剂不良反应/事件信号提取中的应用

Use of Proportional Reporting Ratios for Signals Detection from Adverse Drug Reaction/Event of Traditional Chinese Medicine Injection

目的运用报告率比例法(PRR)研究中药注射剂不良反应的特点及规律,以期为发现中药注射剂不良反应的警戒信号提供参考。方法对国家药品不良反应监测中心数据库的33750例中药注射剂不良反应/事件报告作信号检测分析,信号产生的最低阈值:PRR值≥2、卡方值≥4,且至少有3例以上的相关报告。结果33750例报告中,药品-不良反应(Drug-ADR)组合共有21对,涉及16种中药注射剂。结论报告率比例法可以作为有效的工具,为发现中药注射剂不良反应的警戒信号提供参考。

Objective To study ADR characteristic and regularity of traditional chinese medicine（TCM） injection, attempt a method of signal detection and provide reference for precaution of TCM injection. Methods 33 750 TCM injection ADR reports were collected by center for drug reevaluation. The minimum criterion for signal is PRR at least 2, chi-squared at least 4, There were at least 3 related reports about them. Results 21 drug-ADR combinations were detected by PRR signal analysis, covered 16 TCM injections. Conclusion The PRR method can serve as an effective tool for the discovery of adverse reactions warning signal for reference.