124例中药不良反应/不良事件的分析

Analysis of 124 cases of traditional Chinese medicine adverse drug reactions/adverse events

目的探讨中药药物不良反应/不良事件(ADR/AE)的发生情况及发生原因。方法用回顾性分析方法对上报的124例中药的ADR报告,用Excel软件对患者性别、年龄、出现ADR/AE的药品种类、给药途径、ADR/AE累及的系统-器官等主要指标进行统计分析。结果中药的ADR可以发生在任何年龄段,因果关系评价中可能居多,涉及ADR的药品剂型以注射剂居首位,给药途径以静脉滴注为主,主要的ADR累及系统-器官及其临床表现为皮肤及其附件损害。结论应加强中药的ADR监测,重视中药临床应用的合理性及安全性。

Objective To explore the occurrence and causes of adverse drug reactions/adverse events（ ADR/AE） in traditional Chinese medicine. Methods The retrospective analysis method was used to the reported 124 cases of adverse drug reactions caused by common Chinese patent medicine,the main indexes such as patients＇ gender,age,appear drug varieties,dosage of ADR/AE way,ADR/AE involving system-organs was statistically analyzed by using of Excel software. Results The ADR induced by traditional Chinese medicines appeared at different age groups, possibly taking a big proportion in the causal relation appraisal. Injections took the lead among all the traditional Chinese drugs involved in ADR and intravenous drip infusion was the major route of administration. The chief ADR involved systems/organs and manifested by lesions of skin and the appendants. Conclusion It is necessary to strengthen the monitoring of adverse drug reactions of traditional Chinese medicine,and attach importance to the rationality and safety of TCM clinical application.