国内外医院药品不良反应监测研究进展

Monitoring and assessment of hospital adverse drug reactions in domestic and foreign countries

文章采用文献综述的方法分析了国内外药品不良反应(ADR)及其监测体系存在的一些关键问题。认为,大多文献仅限于对ADR患者性别、年龄、给药途径、不良反应史以及发生ADR药物的类别等基本情况的分析,ADR主要发生于抗感染药物。当前ADR监测系统主要存在支持数据库不完善,报告数据不规范,检索功能薄弱,缺乏数据挖掘分析能力等问题。建议,在采取可靠的办法保证数据来源的准确性和完整性的基础上,建立以病例报告数据库和基础数据为基础的ADR监测系统和统计分析系统;设立监测控制区域,建立以药物警戒和警戒信号为基础的预警体系,及时发现区域外预警信息,做到实时控制ADR发生。

This paper gives analysis of key problems in the ADR and its surveillance system.It is concluded that most of the ADR cases are due to anti-infectious drugs based on the analysis of gender,age,route,ADR history and ADR category.Many problems of surveillance system exist including the incomplete data and index function,non-standard report data,insufficient ability of data analysis.And lastly,this paper suggests constructing ADR surveillance system and statistical analysis system based on correct and complete data,locating monitoring control area,establishing precaution system with pharmacovigilance and alarm signals in order to find out abnormal information and control ADR incidence timely.