76例中药注射剂致不良反应

76 Cases of Adverse Drug Reaction of Traditional Chinese Medicine Injections

目的:了解常州市第一人民医院(以下简称"我院")2011—2014年中药注射剂致药品不良反应(adverse drug reaction,ADR)情况,为临床合理用药提供参考。方法:通过国家ADR监测系统,调取2011—2014年我院呈报的有关中药注射剂的ADR信息并进行分析,统计ADR占比,总结ADR的发生特点。结果:2011—2014年我院中药注射剂引发的ADR共76例,涉及10个品种,其中舒血宁注射剂引发的ADR例数最多(21例,占27.6%),其次是参麦注射剂(19例,占25.0%)和生脉注射剂(11例,占14.5%)。ADR报告中男性31例,女性45例,平均年龄(51.8±19.8)岁,42例发生在用药后1 d内,中药注射剂引发的ADR累及多个器官和(或)系统。结论:中药注射剂在临床上使用日益广泛,ADR数量也随之增加,需加强对中药注射剂规范使用的监管以及ADR的监测,降低其ADR发生率,促进临床安全、合理用药。

OBJECTIVE： To investigate the incidence of adverse drug reaction（ ADR） of traditional Chinese medicine injections in the First People＇s Hospital of Changzhou（ hereinafter referred to as＂our hospital＂） during 2012-2014,so as to provide reference for the rational drug use in clinic. METHODS： The information of ADRs about the TCM injections uploaded to National Adverse Drug Monitoring System during 2011-2014 by our hospital were analyzed,the percentage was counted,and the characteristics of ADRs were summarized. RESULTS： There were 76 cases of ADR reports about TCM injections during 2012-2014,including 10 categories,among which the case number of Shuxuening injection was the highest（ 21 cases,27. 6%）,followed by Shenmai injection（ 19 cases,25. 0%） and Shengmai injection（ 11 cases,14. 5%）. The ADR reports included 31 males and 45 females,whose ages were between（ 51. 8 ± 19. 8） years old,and 42 cases were occurred within 1 day after administration. ADRs induced byTCM injections involved multiple organs and（ or） systems. CONCLUSIONS： TCM injections were widely used in clinic,and ADRs induced by TCM injections were in an increased trend. It is necessary to strengthen the supervision of TCM injections standardization and monitoring of ADR,so as to reduce the incidence of ADR and promote the safety and rational medication in clinic.