中文摘要：

目的了解三级甲等综合医院中成药不良反应的特点。方法回顾性分析2014—2015年某三级甲等综合医院364例中成药不良反应的相关资料。结果 364例中成药不良反应中男女比为1.15∶1,多发生于50岁以上者（59.6%）,多为一般不良反应（75.0%）,转归较好,多由注射剂导致（82.1%）。引发不良反应例次最高的药物种类为理血剂（57.7%）,其次为补益剂和清热剂。中成药不良反应最常累及器官为皮肤及其附件（36.0%）,其次为胃肠系统和神经系统。结论三级甲等综合医院中成药不良反应具有一定特点,应加强不良反应监测和综合治理,提高中成药用药安全。

英文摘要：

Objective To investigate the characteristics of adverse reactions of Chinese patent medicine in a triple A general hospital. Methods The relevant data of 364 cases of adverse reaction caused by Chinese patent medicine in a triple A general hospital from 2014 to 2015 were analyzed retrospectively. Results The ratio of male to female was 1.15 ： 1 in 364 cases of adverse reaction of Chinese patent medicine. Most of the adverse reactions （59.6 %） occurred in the age of 50 years or older. The vast majority （75.0 %） of adverse reactions are not serious adverse reactions. 82. 1% of the adverse reactions were caused by injections, and had a relatively good prognosis. The vast majority of adverse reactions were caused by blood-regulating formula （57.7 %）, tonic formulae and heat- clearing prescription. The adverse reactions of Chinese patent medicine often involved the skin and its appendages （36.0%）, followed by gastrointestinal system and nervous system. Conclusion The adverse reaction caused by Chinese patent medicine in a triple A general hospital has certain characteristics. The monitoring and comprehen- sive treatment of the adverse reactions caused by Chinese patent medicine should be strengthened, in order to im- prove the safety of the use of Chinese patent medicine..