CAJ | 학술논문

疫苗安全性备受关注.评估罕见发生的不良事件与疫苗接种的关联时,采用经典流行病学研究设计通常面临可行性不足的问题.自身对照的病例系列研究(SCCS)方法是队列研究设计的一种衍生形式,其优点是只需收集病例的暴露史等信息,估计暴露和特定事件在风险期与对照期的相对危险度；由于以自身作为对照,所有固定的混杂变量自然得到控制,因而具有较高的检验效能,且具有高效、经济的特性,适用于发生率极低的严重预防接种不良事件因果关联评估.该方法最重要的限制条件是要求结局事件不对后继暴露产生影响.
역묘안전성비수관주.평고한견발생적불량사건여역묘접충적관련시,채용경전류행병학연구설계통상면림가행성불족적문제.자신대조적병례계렬연구(SCCS)방법시대렬연구설계적일충연생형식,기우점시지수수집병례적폭로사등신식,고계폭로화특정사건재풍험기여대조기적상대위험도；유우이자신작위대조,소유고정적혼잡변량자연득도공제,인이구유교고적검험효능,차구유고효、경제적특성,괄용우발생솔겁저적엄중예방접충불량사건인과관련평고.해방법최중요적한제조건시요구결국사건불대후계폭로산생영향.
Safety on vaccine issues has been under greater concern.Epidemiologically,classical study designs on investigating the association between a rare adverse event and vaccine inoculation usually confronted with lower feasibility in practice.Self-controlled case series (SCCS) method was derived from cohort studies.The key advantage of this method is that it only uses data related to cases and trying to find relative incidence of events in the ‘ at risk' periods relative to the ‘ controlled' periods.A further benefit of this method is that all the fixed confounders are controlled implicitly,by self-control,thus provides high statistic powers.With these advantages,SCCS is suitable for the causality assessment on rare but severe adverse events caused by immunization,which has been widely used,abroad.However,the methodology of SCCS is still being developed,and the areas in use have been expanded to the studies related to the safety and effectiveness of drugs,efficacy of vaccines as well as risk factors of disease.