药品不良反应数据库信号检测及其发现  

Signal Detection for Adverse Drug Reaction Database

作　　者：李明[1] 王越[1] 孙骏[1] 张鸣雨[2] 徐厚明[1] 陆叶[1] 张苏琳[1] 

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210002 [2]南京医科大学,江苏南京210029

出　　处：《中国药物警戒》2008年第2期83-85,92,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的对2005年江苏省药品不良反应自愿报告数据库进行信号检测。方法采用成比例报告比值法,以PRR-1.96SE>1;至少有3例以上的报告作为判断标准,并借助计算机信息系统,对2005年江苏省自愿呈报数据库进行定量分析。结果共有937个药品-不良反应组合结果符合信号检测标准,在信号强度排列前100位的组合中有20种未在说明书中出现。结论通过对药品不良反应数据库的定量信号检测,提示新的药品不良反应信号,为进一步的研究提供依据。Objective The Signal for Adverse Drug Reaction（ADR）spontaneous reporting database of Jiangsu Province in 2005 is detected. Methods The database of Jiangsu Center for ADR Monitoring was inves-tigated with the proportional reporting ratios. The signal criterion is PRR-1.96SE〉1 and there were at least 3 related reports about them. Results 937 Drug-ADR combinations accord with the signal detection criterion.There are 20 Drug-ADR combinations not indicated in the instruction in the first 100 of signal intensity arrangement. Conclusion New ADR signals were detected in our database, which provide data for further study.

关 键 词：药品不良反应 信号检测 自愿报告系统 

分 类 号：R954[医药卫生—药学]