分层分析在药品不良反应信号检测中的应用

摘要

药品上市后不良反应监测无法实现用药人群的随机化,因此无法控制数据中的混杂偏倚.如何在分析数据时控制可疑混杂因素的影响,准确有效地检测出信号,一直是国内外关注的焦点.通过采用分层分析的思想控制混杂因素,将上海市2009年药品不良反应监测中心的数据用三种方法进行分析,比较分层前后混杂因素对信号检测的影响,以期为药品上市后不良反应的准确监测提供帮助.%As is well known, it is impossible to allocate the drug users in a randomized way under the post-marketing surveillance.Therefore, it is hard to control the confounding factor in signal detection of adverse drug reaction (ADR) databases.It is important to control the potential confounding effects during the analysis of ADR databases and detect signals in a more accurate way.This article briefly used the method of stratification analysis in controlling confounding factors.We analyzed the spontaneous reporting database of shanghai in 2009 with some methods.We compared the difference between stratification analyze and non-stratification analysis.We expect that this article can provide some effective information for the post-marketing surveillance.