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 .
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