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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。
Objective To analyze the regularity and characteristics of adverse reactions (ADR) after using traditional Chinese medicine injections. Methods A retrospective study was conducted on 334 cases of adverse drug reactions reported in the Dongguan area. The patient’s sex, age, grade of adverse reactions, medication status, ADR involving the system-organ were analyzed. Results Among the 464 patients with ADR, 39.7% were young adults aged 19 to 39 years, and 18.8% and 15.1% were children aged ≥60 years old. The adverse reactions involved 7 types of herbal injections and 47 varieties, of which the incidence of blood circulation was found. The highest rate was 34.9%; the incidence of new and serious adverse reactions was high, at 39.6%; the adverse effects of systemic-organ involvement of the skin and its accessories were most common, accounting for 39.2%. Conclusions The adverse reactions of traditional Chinese medicine injections can occur in all age groups, the majority of drug species involved, and the damage caused by skin and its attachments are the most common.