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药品不良反应数据库信号检测及其发现
引用本文:李明,王越,孙骏,张鸣雨,徐厚明,陆叶,张苏琳.药品不良反应数据库信号检测及其发现[J].中国药物警戒,2008,5(2):83-86.
作者姓名:李明  王越  孙骏  张鸣雨  徐厚明  陆叶  张苏琳
作者单位: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
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。

关 键 词:药品不良反应  信号检测  自愿报告系统
文章编号:1672-8629(2008)02-0083-03
修稿时间:2007年12月25

Signal Detection for Adverse Drug Reaction Database
LI Ming,WANG Yue,SUN Jun,ZHANG Ming-yu,XU Hou-ming,LU Ye,ZHANG Su-lin.Signal Detection for Adverse Drug Reaction Database[J].Chinese JOurnal of Pharmacovigilance,2008,5(2):83-86.
Authors:LI Ming  WANG Yue  SUN Jun  ZHANG Ming-yu  XU Hou-ming  LU Ye  ZHANG Su-lin
Institution:LI Ming,WANG Yue,SUN Jun,ZHANG Ming-yu,XU Hou-ming,LU Ye,ZHANG Su-lin (1 Jiangsu Center For ADR Monitoring,Jiangsu Nanjing 210002,China; 2 Nanjing Medical University,Jiangsu Nanjing 210029,China)
Abstract: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.
Keywords:adverse drug reaction  signal detection  spontaneous reporting system
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