1前言自发不良事件报告已成为上市后药品安全信息的主要来源之一。对于通过自发报告鉴别出的具体事件,经常会开展一些有选择的研究以便更加严格地评估药物与事件之间的相互关系。在过去的20年里,通过采用书面或电子形式的数据库等已有的健康档案, 1 Introduction The report of spontaneous adverse events has become one of the major sources of post-marketing drug safety information. For specific incidents identified through spontaneous reporting, there is often a selection of selective studies to more rigorously assess the interplay between drugs and events. Over the past two decades, through the use of existing health records, such as databases, in writing or in electronic form,