204例注射用灯盏花素的不良反应分析

目的：对注射用灯盏花素的不良反应（ADR）报告进行分析，为该药的临床合理应用提供有价值的依据。方法：采用回顾性研究方法，对2012年1月-2014年12月期间湖北省药品不良反应监测中心数据库中收集的204例注射用灯盏花素不良反应报告进行统计，分析ADR患者的性别与年龄分布，原发疾病和过敏史，用药方法和剂量，ADR发生的时间分布，性质、因果关系及转归，累及系统和器官等。结果：注射用灯盏花素所致ADR在各年龄组段均有分布；患者原发疾病多为心脑血管病；用药剂量和方法对不良反应的发生影响较大；不良反应发生时间多在用药2 h内且绝大多数没有造成严重后果；所致ADR以过敏反应为主，且累及多个系统和器官。结论：严格遵照药品说明书用药并加强用药监护能够有效减少和避免注射用灯盏花素不良反应地发生。

Analysis of 204 cases of adverse drug reactions caused by breviscapine injection

OBJECTIVE To analyze the adverse drug reactions (ADR) reports of breviscapine injection, providing valuable basis for clinical rational drug use. METHODS In the retrospective study, 204 cases of ADR reports of breviscapine injection, from January 2012 to December 2014, were collected from the database of the ADR monitoring center in Hubei Province. Data were then analyzed according to patients' sex and age, primary disease and allergies, dose and method of administration, occurrence time, causality evaluation, organs/systems involved and clinical manifestations. RESULTS In this study, breviscapine injection caused ADRs are seen in all age groups. Primary diseases for many patients are cardio-cerebral vascular diseases. Dosage and method are significant impact on the occurence of adverse reactions. Most ADR occurred in patients within 2 h following administration of breviscapine injection, and almost no serious consequences were observed. The symptoms of anaphylaxis involving multiple systems and organs were the most commonly reported in the ADR. CONCLUSION More attention should be paid to drug instructions and drug monitoring, in order to reduce and avoid the ADR of breviscapine injection.