中药注射剂464例不良反应报告分析

Analysis of 464 adverse reactions of traditional Chinese medicine injections

目的分析使用中药注射剂后出现不良反应(ADR)的规律及特点。方法采用回顾性研究方法,对东莞地区464例中药注射剂不良反应报告,按病人性别、年龄、不良反应级别、用药情况、ADR累及系统-器官等进行汇总分析。结果464例ADR中19～39岁青壮年占39.7%,≥60岁老年人占18.8%和≤6岁婴幼儿占15.1%;不良反应涉及中药注射剂7类,47个品种,其中活血类发生率最高,占34.9%;新的、严重的不良反应发生率偏高,为39.6%;不良反应累及的系统-器官以皮肤及其附件的损害为最多见,占39.2%。结论中药注射剂不良反应可发生在各个年龄段、涉及药物品种居多、以皮肤及其附件的损害为最多见。

AIM To analyse the characteristic specificities of adverse drug reactions { ADR） after traditional Chinese medicine injection. METHODS Four hundred and sixty-four ADR reports collected in Dongguan District including patient＇s age, gender, grades and types of adverse reactions; medicine usage, and their clinical manifestation etc were statistically analyzed in the method of retrospective study. RESULTS Among these ADR patients, 19-39 years old was 39.7%, over 60 years old 18.8% and in less 6 years old 15.1%; involving seven injection types of 47 kinds with the highest incidence of 34.9% for activating blood flow types, 39.6% for the novel severely ones and 39.2% for systemic organs especially presenting on skin and the accessories. CONCLUSION ADR of traditional Chinese medicine injections occurred each ages stage, involved many drug kinds and damage the skin and the accessories frequently.