活血类中药注射剂不良反应流行病学特点探究.docVIP

活血类中药注射剂不良反应流行病学特点探究 　　摘要：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。 关键词：活血类中药注射剂；药物不良反应；药物流行病学 DOI：10.3969/j.issn.1005-5304.2013.07.010 中图分类号：R2-05；R969.3 文献标识码：A 文章编号：1005-5304（2013）07-0024-03 Epidemiological Characteristics of Adverse Reaction Induced by Chinese Activating Blood Herbal Injection WU Jia-rui1， MA Li-biao1，2， ZHANG Bing1， ZHANG Xiao-meng1 （1.Beijing University of Chinese Medicine， Beijing 100102， China；2.The First Affiliated Hospital of Tsinghua University， Beijing 100016， China） Abstract：Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese activating blood herbal injection. Methods Domestic medicinal periodicals issued during 1972-2011 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. Key words：Chinese activating blood herbal injection；drug adverse reaction；drug epidemiology 中药注射剂系指饮片经提取、纯化后，制成的供注入人体的溶液、乳状液及供临用前配制成溶液的粉末或浓溶液的无菌制剂。自20