自身对照病例系列研究及其在疫苗不良事件因果关联评价中的应用

Self-controlled case series studies and their application for evaluating causal association between a vaccine and an adverse event

自身对照病例系列研究(Self-controlled case series study,SCCS)是一种只需要病例信息且以病例自身为对照,研究瞬时暴露与事件之间关联性的流行病学研究。SCCS最初用于评估疫苗安全性,可以比较快速地获得疫苗与不良事件之间的潜在因果关联。本文总结了SCCS的原理、研究设计和常见问题的解决思路。

A self-controlled case series study(SCCS)is an epidemiological study that requires only cases and uses the cases themselves as their controls to determine the association between a transient exposure and an adverse event.SCCSs were originally used to evaluate vaccine safety,allowing for relatively rapid evaluation of potential causal associations between a vaccine and an adverse event.In this article,we summarize the principles,research design,and solutions for common problems in SCCSs.