复旦大学附属金山医院中成药药品不良反应分析

Analysis of Chinese Patent Drug-induced Adverse Drug Reactions in Jinshan Hospital Affiliated to Fudan University

目的:调查复旦大学附属金山医院(以下简称"我院")中成药不良反应发生率、临床特点及引起不良反应的原因。方法:对2006—2014年我院上报的中成药所致不良反应情况及相关影响因素进行分析。结果:上报发生中成药所致不良反应的155例病例中,女性96例,男性59例;60岁以上老人45例,15岁以下儿童4例,其他年龄段109例。不良反应以过敏反应最多,用药途径主要以口服给药为主,且大多为首次发生的不良反应。结论:尽管中成药安全性相对较高,但其不良反应不容忽视,临床应用时应注意规范、谨慎使用注射剂型,注意口服给药的合理性,加强对医护人员中成药不良反应的教育,保障公众安全、合理用药。

OBJECTIVE ：To investigate the prevalence, clinical features and the influential factor of the adverse drug reactions （ADRs） induced by Chinese patent drug in Jinshan Hospital Affiliated to Fudan University （hereinafter referred to as ＂our hospital＂ ）. METHODS ： The prevalence and the influencing factors of the ADRs induced by Chinese patent drugs between 2006 and and 2014 in our hospital were statistically analyzed and classified. RESULTS： Among the 155 ADR cases reported, 96 were females and 59 males, with 45 aged above 60 years, 4 aged below 4 years, leaving 109 cases the other age groups. The anaphylaxis induced by Chinese patent drugs showed the highest proportion in our hospital; the ADRs were more often induced via oral administration, and the ADRs in most cases were initial onset type; allergic reaction was the major ADR type. CONCLUSIONS： Although the Chinese patent drug enjoys good safety, yet the ADR induced by the Chinese patent drug can not be ignored and the injection dosage forms of the Chinese patent drug should be used standardly with caution and its oral dosage forms should also be used rationally as well. It is important to tighten education on the ADRs induced by Chinese patent drug to ensure safety and rationality in medication.