中药不良反应信号检测系统的建立

Establishment of Signal Detection System for Adverse Drug Reactions of Traditional Chinese Medicine

目的:探讨适合我国中药不良反应监测体系的信号检测方法,实现对中药不良反应病例报告的快速分析。方法:比较分析了报告比值比、比例报告比值比、卡方法、MHRA法、Yule’sQ、序贯概率比检验等6种常用的信号检测方法,利用PHP和MySQL数据库建立中药不良反应病例数据库与标准名称数据库,并编写了信号检测等相关模块。结果:建立了具有数据规整、数据查询、统计分析、不良反应信号检测和病例对照研究等功能的中药不良反应信号检测系统。结论:中药不良反应信号检测系统能对中药不良反应信息进行有效分析,发掘中药不良反应预警信号,提高中药不良反应监测工作效率。

ABSTRACT OBJECTIVE： To investigate signal detection system for adverse drug reactions （ADR） of traditional Chinese medi- cine （TCM） , and to analyze ADR case reports of TCM rapidly. METHODS： The signal detection system of ROR, PRR, Chi-square, MHRA, Yule＇s Q, SPRT and other methods were compared. By means of computer technology of PHP and MySQL, the ADR case reports database of TCM and relevant standard terminology databases were built and the functional modules was de- signed. RESULTS： The signal detection system for ADR of TCM was built with functional modules which including data-revise, data-query, statistical analysis, ADR signal detection, case-control study. CONCLUSION： The signal detection system for ADR of TCM can analyze the information of ADR of TCM effectively, explore ADR precaution signals of TCM and promote the efficiency of the monitoring.