Li Chanjuan, Xia Jielai, Deng Jianxiong, Chen Wenge, Wang Suzhen, Jiang Jing, Chen Guanquan
Department of Health Statistics, Fourth Military Medical University, No 17, Changle West Road, Xian, 710032, China.
Eur J Clin Pharmacol. 2009 Jul;65(7):729-41. doi: 10.1007/s00228-009-0638-3. Epub 2009 Mar 5.
To establish a web-based quantitative signal detection system for adverse drug reactions (ADRs) based on spontaneous reporting to the Guangdong province drug-monitoring database in China.
Using Microsoft Visual Basic and Active Server Pages programming languages and SQL Server 2000, a web-based system with three software modules was programmed to perform data preparation and association detection, and to generate reports. Information component (IC), the internationally recognized measure of disproportionality for quantitative signal detection, was integrated into the system, and its capacity for signal detection was tested with ADR reports collected from 1 January 2002 to 30 June 2007 in Guangdong.
A total of 2,496 associations including known signals were mined from the test database. Signals (e.g., cefradine-induced hematuria) were found early by using the IC analysis. In addition, 291 drug-ADR associations were alerted for the first time in the second quarter of 2007.
The system can be used for the detection of significant associations from the Guangdong drug-monitoring database and could be an extremely useful adjunct to the expert assessment of very large numbers of spontaneously reported ADRs for the first time in China.
基于中国广东省药品监测数据库的自发报告，建立一个基于网络的药物不良反应（ADR）定量信号检测系统。
使用微软Visual Basic和动态服务器页面编程语言以及SQL Server 2000，编写一个具有三个软件模块的基于网络的系统，以进行数据准备和关联检测，并生成报告。国际上认可的用于定量信号检测的不成比例性衡量指标信息成分（IC）被整合到系统中，并用2002年1月1日至2007年6月30日在广东收集的ADR报告测试其信号检测能力。
从测试数据库中挖掘出包括已知信号在内的总共2496个关联。通过IC分析早期发现了一些信号（如头孢拉定引起的血尿）。此外，2007年第二季度首次发出了291个药物 - ADR关联警报。
该系统可用于检测广东省药品监测数据库中的显著关联，并且可能成为中国首次对大量自发报告的ADR进行专家评估的极其有用的辅助工具。
