辽宁省2017-2019年肠道病毒71型灭活疫苗上市后疑似预防接种异常反应监测数据分析  

Analysis of data on post-marketing surveillance of suspected adverse event following immunization with inactivated enterovirus 71 vaccine in Liaoning province,China from 2017 to 2019

作　　者：常琳[1] 孙静[1] 王燕[1] 丛博[1] 方兴[1] CHANG Lin;SUN Jing;WANG Yan;CONG Bo;FANG Xing(Liaoning Provincial Center for Disease Control and Prevention,Shenyxmg 110005,Liaoning Province,China)

机构地区：[1]辽宁省疾病预防控制中心,辽宁沈阳110005

出　　处：《中国生物制品学杂志》2021年第1期69-72,共4页Chinese Journal of Biologicals

基　　金：中华预防医学会疫苗与免疫青年人才托举项目(CPMAQTYM0230)。

摘　　要：目的对辽宁省2017-2019年肠道病毒71型(enterovirus type,EV71)灭活疫苗上市后疑似预防接种异常反应(adverse event following immunization,AEFI)监测数据进行分析,评价其预防接种安全性。方法收集中国免疫规划信息管理系统中EV71疫苗AEFI监测数据,进行描述性流行病学分析。结果 2017-2019年,辽宁省共报告EV71疫苗AEFI病例83例,发生时间集中在4-6月(31例,占37.35%,19.71/10万剂次);多数在首剂接种后发生(54例,占65.06%,18.68/10万剂次)。报告发生率为15.13/10万剂次,全省总体疫苗AEFI报告发生率为31.01/10万剂次,两者之间差异有统计学意义(χ^(2)=44.32,P <0.05)。在所有EV71疫苗AEFI分类中,一般反应74例,占89.16%;异常反应3例,占3.61%;偶合症6例,占7.23%;无严重异常反应和群体性AEFI报告。结论辽宁省EV71疫苗AEFI报告发生时间集中在4-6月,首剂接种;报告发生率低于全省总体水平,以一般反应为主,安全性在预期范围之内。Objective To analyze the data on post-marketing surveillance of suspected adverse events following immunization(AEFI)with on inactivated enterovirus 71(EV71)vaccine in Liaoning Province,China from 2017 to 2019 and evaluate the safety of vaccination.Methods The data on AEFI of EV71 vaccine were collected from the National Immunization Program Information Management System and analyzed by descriptively epidemiological method.Results A total of 83 cases of AEFI associated with inactivated EV71 vaccine were reported in Liaoning Province from 2017 to2019,which mainly appeared between April and June(31 cases,65.06%,19.71 per 100 000 doses).Most of the cases appeared after the first dose(54%,65.06%,18.68 per 100 000 doses).The reported incidence of AEFI of inactivated EV71 vaccine was 15.13 per 100 000 does,while the overall incidence of AEFI caused by various vaccines in Liaoning Province was 31.01 per 100 000 doses,which showed significant difference (χ^(2) = 44.32,P < 0.05).Among the reported cases of AEFI,74(89.16%)were common adverse reactions,while 3(3.61%)were rare adverse reactions,and 6(7.23%)were coincidental events.No severe abnormal reactions or mass AEFI were observed.Conclusion The cases of AEFI in Liaoning Province mainly appeared between April and June and after the 1 st dose,of which the reported incidence rate was lower than the overall incidence of AEFI caused by various vaccines.Most of the reported AEFI were common adverse reaction,indicating that the safety of inactivated EV71 was consistent with that expected.

关 键 词：肠道病毒71型疫苗 疑似预防接种异常反应 安全性 

分 类 号：R186[医药卫生—流行病学]