2017-2021年河南省肺炎球菌疫苗疑似预防接种异常反应监测

Surveillance of adverse events following immunization for pneumococcal vaccination in Henan province between 2017 and 2021

目的分析2017-2021年河南省肺炎球菌疫苗疑似预防接种异常反应(AEFI)的发生特征,评价肺炎球菌疫苗预防接种的安全性。方法通过中国免疫规划信息管理系统收集2017-2021年河南省肺炎球菌疫苗AEFI个案数据和接种数据,采用描述流行病学方法进行分析。结果2017-2021年河南省共报告肺炎球菌疫苗AEFI个案4025例,年均报告发生率为115.02/10万剂,不同年份间AEFI的报告发生率差异具有统计学意义(χ^(2)=4.06,P<0.05)。其中13价肺炎球菌结合疫苗(PPCV13)AEFI共报告1652例,报告发生率163.97/10万剂;23价肺炎球菌多糖疫苗(PPV23)AEFI共报告2373例,报告发生率95.23/10万剂,两种疫苗AEFI报告发生率差异具有统计学意义(χ^(2)=295.11,P<0.05)。AEFI个案中,男女性别比为1.13∶1,PPCV13 AEFI发生年龄主要集中在≤1岁(88.38%),PPV23主要集中在2~5岁(85.29%);接种后≤1 d发生占96.15%;报告地区主要集中在郑州市、洛阳市、周口市、驻马店市、安阳市、信阳市和商丘市等市。4004例(99.48%)诊断为不良反应,其中一般反应3957例(98.83%),主要为发热/红肿/硬结等(3941例,占99.60%);异常反应47例(1.17%),主要为过敏性反应(31例,占65.96%)。3975例(98.76%)痊愈或好转。结论河南省肺炎球菌疫苗预防接种安全性良好;报告的AEFI以发热/红肿/硬结等一般反应为主,预后较好。

Objective To analyze the characteristics of adverse events following immunization(AEFI)for pneumococcal vaccination in Henan province between 2017 and 2021,and evaluate the immunization safety related to pneumococcal vaccination.Methods The AEFI data and vaccination data of pneumococcal vaccination in Henan province between 2017 and 2021 were collected through the China Information Management System for Immunization Programming.Descriptive epidemiological methods were used to analyze.Results A total of 4025 AEFI cases were reported in Henan province from 2017 to 2021;the average reported incidence was 115.02/105 doses.The reported incidences of AEFI were statistically significant in dfferent years(χ^(2)=4.06,P<0.05).In total,1652 AEFI cases of 13-valent pneumococcal polysaccharide conjugate vaccine(PPCV13)were reported,with the reported incidence of 163.97/105 doses,and 2373 AEFI cases of 23-valent pneumococcal polysaccharide vaccine(PPV23)were reported,with the reported incidence of 95.23/105 doses.The difference between the reported incidences of PPCV13 AEFI and PPV23 AEFI was statistically significant(χ^(2)-295.11,P<0.05).The ratio of male to female was 1.13:1.Most of cases of PPCV13 AEFI were reported less than or equal to 1 year old(88.38%).The cases of PPV23 AEFI were mainly concentrated in 2 to 5 years of age(85.29%).The cases reported within 1 day after immunization accounted for 96.15%.Most cases were mainly concentrated in the city of Zhengzhou,Luoyang,Zhoukou,Zhumadian,Anyang,Xinyang and Shangqiu 4004 cases(99.48%)were diagnosed as adverse reactions,among which 3957 cases(98.83%)were common vaccine reactions,mainly diagnosis were fever,local swelling,and scleroma(3941 cases,99.60%).47 cases were rare adverse reactions(1.17%),and the main clinical diagnosis were anaphylactic disorders(31 cases,65.96%).A total of 3957 cases(98.76%)were recovered or got better.Conclusions The pneumococcal vaccination in Henan Province is safe.Most AEFI are common adverse reactions,and prognoses are good.