上海市药品不良反应自发呈报数据库定量信号检测系统的建立  

Establishment of quantitative signal detection system on adverse drug reaction spontaneous reporting database of Shanghai

作　　者：魏志军[1] 程能能[1] 何乐[1] 杜文民[2] 徐建龙[2] 陈斌艳[1] 王永铭[1] 

机构地区：[1]复旦大学药学院药理学教研室,上海200032 [2]上海市药品不良反应监测中心,上海200040

出　　处：《复旦学报（医学版）》2006年第4期475-478,490,共5页Fudan University Journal of Medical Sciences

基　　金：上海市科委资助项目(04DZ19218)

摘　　要：目的建立上海市药品不良反应自发呈报数据库定量信号检测系统。方法借鉴目前国际上五种针对自发呈报数据库的定量信号检测方法,采用PowerBuilder与SQL2000编程,建立了信息编码、信号检测和报表生成三个模块,并应用于上海市2003-2004年自发呈报数据库,验证其检测效果。结果1.该系统能准确检出已知信号;2.不同定量信号检测方法联合使用能够提高信号检测的准确性;3.本系统可以早期检出两种新的药品不良反应信号(莲必治致急性肾功能衰竭,头孢拉定致血尿)。结论不良反应定量信号检测系统的建立可以极大地提高药品不良反应监测工作的效率。Purpose To establish a quantitative signal detection system on adverse drug reaction （ADR） spontaneous reporting database of Shanghai. Methods With database developing tool PowerBuilder and SQL2000, we programmed three software modules to perform data coding, signal detection and report generation respectively. Five internationally recognized methods for quantitative signal detection were integrated into the system, and its capacity for signal detection was tested with the ADR reports collected in year 2003 and 2004 from the ADR spontaneous reporting database of Shanghai. Results 1. The system was workable in finding out known signals in the database; 2. Combination use of different quantitative methods improved the accuracy of signal detection; 3. The system succeeded in detecting two new signals from the database, earlier than regular expert review： andrographolide induced acute renal failure and cefradine induced hematuria. Conclusions Establishment of quantitative signal detection system can greatly enhance the efficiency of ADR monitoring.

关 键 词：自发呈报系统 药品不良反应 数据库 信号检测 

分 类 号：R954[医药卫生—药学]