46例中药注射剂致药品不良反应报告

Reports on 46 Cases of Adverse Drug Reaction Induced by Traditional Chinese Medicine Injection

目的:了解上海中医药大学附属市中医医院(以下简称"我院")肿瘤科中药注射液致药品不良反应(adverse drug reaction,ADR)发生情况,探讨问题与对策,为中药注射剂的合理应用提供参考。方法:收集2014年1月—2016年6月我院肿瘤科上报的中药注射剂致ADR报告46例,对患者的性别与年龄、ADR累及器官和(或)系统、引发ADR的中药注射剂及ADR的转归等进行分析,并分析药品说明书中的"不良反应"与临床所发现的ADR的差异。结果:46例ADR报告中,女性患者均略多于男性;60~75岁患者居多。ADR主要累及皮肤及其附件,其次为消化系统。肿瘤科目前应用的18种中药注射剂的药品说明书中所描述的"不良反应"详略不一;华蟾素注射液引发的ADR病例数最多,其次为复方苦参注射液、消癌平注射液。所有ADR经停药、治疗及对症处理后均治愈或好转。结论:中药注射剂致ADR不可忽视,药品说明书有待补充、规范,应加强药物的规范化管理,加强用药监测,促进合理用药。

OBJECTIVE： To investigate the adverse drug reaction（ ADR） induced by traditional Chinese medicine（ TCM） injection in Oncology department from Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine（ hereinafter referred to as＂our hospital＂）,and to discuss the problems and countermeasures,so as to provide reference for the rational application of TCM injection. METHODS： 46 cases of ADR reports reported from Oncology department of our hospital from Jan. 2014 to Jun. 2016 were collected,statistical analysis was conducted on patients＇ age and gender,ADR involved organs and（ or） systems,ADR-inducing TCM injections and prognosis,and differences of ADR were fund through analyzing ＂adverse reactions＂in dispensatory and the clinic. RESULTS： Of the 46 ADR cases,there were more females than males; patients aged 60-75 years old took the lead. ADR mainly involved skin and its accessories,followed by digestive system. In terms of the 18 kinds of TCM injections used in Oncology department,the description of ＂adverse reactions ＂ in dispensatory was slightly different. The number of ADR cases induced by cinobufagin injection took the lead,followed by compound Kushen injection and Xiaoaiping injection. After drug withdraw,treatment and symptomatic treatment,all of the ADR cases were improve or cured. CONCLUSIONS： ADR induced by TCM injections can not be ignored,and the dispensatory needs to be replenished and normalized. It is necessary to strengthen the standardized management and monitoring of drugs,so as to promote the rational drug application.