参麦注射液ADR数据库建立及流行病学特点研究

Establishment of Database and Study on Epidemiological Characteristics of ADR Caused by Shenmai Injection

目的:探讨参麦注射液不良反应(ADR)的流行病学特点。方法:检索1990～2010年中文医药学期刊,收集参麦注射液ADR详细病案145例,应用ACCESS软件建立病案数据库,并依托数据库平台,对病案的流行病学资料进行统计、分析。结果:病案中,中老年患者比例最高(87.6%);男性55例(37.9%),女性90例(62.1%);原发疾病中,心血管疾病比例最高(62.1%);ADR以过敏性反应为主(38.0%),多发生在首次给药30min内(64.8%)。结论:建立参麦注射液ADR病案数据库,有助于更好地储存、分析病案信息,为临床参麦注射液ADR的预防和治疗提供参考。

OBJECTIVE：To investigate the epidemiological characteristics of adverse reaction（ADR） caused by Shenmai injection.METHODS：By retrieving from Chinese medical periodicals issued in 1990 to 2010,145 cases of ADR induced by Shenmai injection were collected to establish database using ACCESS.Based on established database,the epidemiological information was analyzed statistically.RESULTS：The incidence of ADR was the highest in the middle-aged and old sufferers（87.6%）,and was 37.9% in the male（n=55） and 62.1% in the female（n=90）.Of primary diseases cases,cardiovascular disease took up 62.1%.The incidence of allergic reaction took up 38.0% in ADR cases and ADRs usually occurred within 30 min after first injection（64.8%）.CONCLUSION：The establishment of ADR database is beneficial to the storage and analysis of ADR information and provided reference for the prevention and therapy of ADR caused by Shenmai injection.