我国药品不良反应/事件报告表数据特征分析  

Data Characteristics Analysis of Adverse Drug Reaction/Event Report Form in China

作　　者：李明[1] 赵起[1] 孙骏[1] 金少鸿[2] 

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210007 [2]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2010年第6期347-349,共3页Chinese Journal of Pharmacovigilance

基　　金：十一五国家科技支撑计划项目"安全用药监测研究与预警技术系统的研究及应用"(2006BAI14B03)

摘　　要：目的对我国药品不良反应/事件报告表数据特征进行分析,从数据角度对我国建立信号检测及预警系统提出建议。方法收集美国、澳大利亚、加拿大的药品不良反应/事件报告表并与我国的报告表进行对比,再对我国报告表的关键数据项进行描述性分析。结果我国的药品不良反应/事件报告表数据项能够全面反映药品不良反应/事件;报告表数据项的设计固有缺陷导致部分数据需要排除和修正;报表数据项可组成多种信号检测指标。结论必须建立信号检测和预警系统的有效数据库;报表数据信息丰富,可设计多种检测和预警功能。Objective To analyze the data characteristics of adverse drug reaction/event report form in China,and give some suggestions in building signal detection and early-warning systems from the perspective of data. Methods Collecting the adverse drug reaction/event report form of United States,Australia and Canada,and comparing with China＇s,then descriptive analyzing the critical data item of report form in China. Results The data item of adverse drug reaction/event report form can fully reflect the adverse drug reactions/events in China; Part of the data need ruling out and amending because of the inherent drawbacks of the design of the data item of the report form＇; The report form＇ data item can constitute many kinds of signal detection indicators. Conclusions Must build up an effective database of signal detection and early-warning systems; The data of the report form＇ are rich of information,can design many kinds of detection and early-warning functions.

关 键 词：药品不良反应/事件 报告表 数据特征 分析 

分 类 号：R954[医药卫生—药学]