我院2003-2012年338例中药不良反应报告分析

目的:了解中药不良反应(ADR)发生的原因及特点,为临床合理用药提供参考。方法:对338例ADR报告从患者情况、药品分类、剂型、ADR发生时间、严重ADR、ADR累及器官和/或系统等多个方面进行分析。结果:我院中药ADR大多发生于中老年及女性患者,剂型以中药注射剂为主,近10年ADR数量有波动,ADR主要累及皮肤及其附件损害。结论:中药ADR不容忽视,中成药上市前研究和上市后的ADR汇总同样重要,应完善ADR报表的填报,进一步保障临床安全、合理用药。

Analysis of 338 Cases of ADR Induced by TCM in Our Hospital during 2003--2012

OBJECTIVE： To know the causes and characteristics of adverse drug reactions （ADR） induced by TCM, and to provide reference for clinical rational drug use. METHODS ： 338 TCM-induced ADR cases were analyzed statistically in respects of patients＇ character, drug classification, dosage forms, occurrence time, serious ADR, organs or systems involved in ADR. RE- SULTS： Most of ADR appeared in senile patients and female patients. TCM injections caused the largest number of ADR. During the past 10 years, the number of ADR was fluctuations. The incidence of the lesion of skin and its appendants were higher than oth- er systems. CONCLUSIONS ： Great importance should be attached to TCM-induced ADR, Chinese patent medicine research before listing and post-marketed drug ADR both play an important role. Better ADR monitoring and reporting could guarantee the safe and rational drug use.