活血类中药注射剂不良反应流行病学特点研究

Epidemiological Characteristics of Adverse Reaction Induced by Chinese Activating Blood Herbal Injection

目的探讨活血类中药注射剂不良反应发生的流行病学的特点。方法通过检索文献,收集活血类中药注射剂不良反应个案,建立病案数据库,应用统计学方法对其不良反应特点进行分析。结果共收集566个不良反应案例,涉及16个中药注射剂品种,其中复方丹参注射液病案数量最多(139例);男性患者293例(51.77%),女性患者273例(48.23%),平均年龄为(55.01±16.07)岁;循环系统损害最多,206例(23.22%);不良反应多发生在开始给药后30 min内,357例(64.79%);原发疾病多为心脑血管疾病,384例(67.84%)。结论活血类中药注射剂药物不良反应好发于中老年人,多累及循环系统。

Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese activating blood herbal injection.Methods Domestic medicinal periodicals issued during 19722011 were searched,and 566 adverse drug reaction（ADR） cases were analyzed by database establishment and statistic method.Results Totally 566 ADR cases involving 16 different kinds of traditional Chinese medicine injection were collected,and 139 cases were related to Fufang Danshen Injection.The incidence of ADR was 51.77%（293 cases） in the male and 48.23%（273 cases） in the female.Average age of patients was（55.01±16.07） years old.The incidence of circulation system damage（206 cases,23.22%） dominated in ADRs.The number of ADR which occurred within half an hour was 357 cases（64.79%） and the original disease most were cardiovascular and cerebrovascular diseases（384 cases,67.84%）.Conclusion ADR induced by Chinese activating blood herbal injection are commonly seen in middle-aged and elderly people,and often involved circulation system.