基于发生时间间隔的信号检测及其在疑似预防接种异常反应监测中的应用  

Time-to-onset based signal detection and its application in surveillance of adverse event following immunization

作　　者：夏兰芳[1] 李克莉[1] 王华庆[1] Xia Lanfang;Li Keli;Wang Huaqing(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)

机构地区：[1]中国疾病预防控制中心免疫规划中心,北京100050

出　　处：《中国疫苗和免疫》2021年第5期604-608,共5页Chinese Journal of Vaccines and Immunization

摘　　要：疑似预防接种异常反应(Adverse event following immunization,AEFI)被动监测是疫苗安全性评估的重要途径之一,通常采用传统的AEFI发生率比较或比例失衡分析方法检测可疑的疫苗安全性信号。近年来,基于反应发生时间间隔(Time-to-onset,TTO)的检测方法应用于AEFI信号检测,且具有一定的优势和良好的检测能力。本文介绍了TTO间隔检测方法的原理、步骤和在AEFI信号检测中的应用,为中国疫苗上市后安全性评估提供参考。Passive surveillance of adverse event following immunization(AEFI)is one of the most important tools of vaccine safety assessment.Suspected vaccine safety signals were usually detected using traditional comparison of AEFI incidences or using a disproportionality analysis.In recent years,a timeto-onset(TTO)based method was used to detect AEFI signals,which has a certain of advantages and a good performance.In this review,we describe principles and procedures of TTO-based method and its application in AEFI signal detection to provide reference for safety assessment of vaccines licensed in China.

关 键 词：疫苗 疑似预防接种异常反应 发生时间间隔 信号检测 

分 类 号：R186[医药卫生—流行病学]