2012年至2014年注射用中成药引发不良反应调查分析

Survey of Adverse Drug Reaction Induced by Chinese Herb Injection from 2012 to 2014

目的:调查分析注射用中成药引发不良反应的临床特点及影响因素,为中成药的合理使用提供参考。方法:统计2012年1月至2014年6月2042例采用注射用中成药治疗的患者中不良反应(ADR)发生率,分析ADR的临床特点,采用巢式病例对照设计分析ADR发生的危险因素。结果:2042例患者中有53例发生ADR,发生率为2.60%;不同中成药ADR发生率比较差异无统计学意义(P>0.05);ADR患者以≤7岁的患儿为主,占33.96%;多发生于输液后1d内,占73.59%;累及器官以消化系统损害及皮肤损害为主,分别占30.19%、26.42%;Logistic回归分析显示滴速过快(OR=0.83,P<0.05)、溶媒使用不当(OR=0.52,P<0.05)是ADR发生的独立危险因素,注射前未冲管(OR=0.28,P<0.05)是ADR发生的保护性因素。结论:不同种类的注射用中成药均可引发ADR,临床应加大重视,合理调整注射滴速及选择适宜溶媒,注射前严格冲管,确保用药安全。

Objective：To investigate clinical characteristics and influencing factors of adverse drug re-actions induced by Chinese herb injections, to provide a reference for the rational use of chinese herb. Meth-od：Counted ADR incidence of 2042 patients treated with Chinese herb injections during Jan. 2012 to Jun. 201, and analyzed clinical features of ADR, applied nested case-control design and analysed risk factors for ADR. Result：53 cases occurred ADR, the rate was 2.60%;ADR induced by different Chinese herb was not not statistically significant （P〈0.05）;ADR patients less than year-old children, accounting for 33.96 %;occurred in the post-infusion 1 day, accounting for 73.59%;involving organ damage and skin damage to the digestive system, accounting for 30.19%, 26.42% respectively;Logistic regression analysis showed that drip too fast （ OR = 0.83, P 〈0.05 ） , solvent misuse （ OR = 0.52, P 〈0.05） were independent risk factors for ADR occurred, before the injection without red tube （ OR = 0.28, P 〈0.05） were protective factors ADR occurred. Conclusion：Different types of injectable medicine can lead to ADR, It should pay attention to a reasonable adjustment and selection of suitable solvent injection drip, before the injection of strict red tube, ensure drug safety.