2018—2022年江苏省卡介苗疑似预防接种异常反应监测分析  

Surveillance of suspected adverse event following immunization with Bacillus Calmette-Guérin vaccine in Jiangsu Province from 2018 to 2022

作　　者：许波荣 胡冉 刘元宝[1] 于静[1] 朱媛媛 汪志国[1] XU Bo-rong;HU Ran;LIU Yuan-bao;YU Jing;ZHU Yuan-yuan;WANG Zhi-guo(Jiangsu Provincial Center for Disease Control and Prevention,Nanjing Jiangsu 210009,China)

机构地区：[1]江苏省疾病预防控制中心,江苏南京210009

出　　处：《江苏预防医学》2024年第2期201-204,共4页Jiangsu Journal of Preventive Medicine

基　　金：江苏省卫生健康委面上项目(M2021030);长三角免疫规划领军人才研究项目(CSJP001)。

摘　　要：目的 掌握江苏省卡介苗(BCG)疑似预防接种异常反应(AEFI)流行病学特征,评价BCG接种安全性。方法 通过中国疾病预防控制信息系统和江苏省预防接种综合服务管理信息系统收集2018-2022年江苏省BCG AEFI个案信息和接种数据,进行描述性流行病学分析。结果 2018-2022年共报告BCG AEFI个案544例,报告发生率由53.86/10万剂降到12.42/10万剂,平均为27.18/10万剂,呈逐年下降趋势(χ_(趋势)^(2)=126.44,P<0.01)。一般反应、异常反应、偶合症分别为271例(13.54/10万剂)、258例(12.89/10万剂)、15例(0.75/10万剂)。异常反应中,局部脓肿和BCG淋巴结炎的报告发生率较高,分别为5.84/10万剂、4.00/10万剂;全身播散性BCG感染的报告发生率为0.15/10万剂。结论 江苏省2018-2022年BCG AEFI报告发生率逐年下降,异常反应以局部脓肿为主,严重不良反应极为罕见,BCG安全性在预期范围内。Objective To investigate the epidemiological characteristics of suspected adverse event following immunization(AEFI)with Bacillus Calmette-Guérin(BCG)vaccine in Jiangsu Province and to evaluate the safety of BCG vaccination.Methods Individual data of AEFI with BCG vaccines and BCG vaccination data were collected from China Information System for Disease Control and Pre-vention and Jiangsu Province Vaccination Integrated Service Management Information System from 2018 to 2022,and AEFI was ana-lyzed with a descriptive epidemiological method.Results A total of 544 individual cases with AEFI caused by BCG vaccination were reported in Jiangsu Province from 2018 to 2022,and the reported incidence of AEFI reduced from 53.86/105 doses in 2018 to 12.42/105 doses in 2022,with annual mean incidence of 27.18/105 doses and appearing a tendency towards a decline over years from 2018 to 2022(χ^(2)=126.44,P<0.01).The numbers of general,abnormal and coincidental reactions were 271(13.54/105 doses incidence),258(12.89/105 doses incidence)cases and 15 cases(0.75/105 doses incidence).Local abscess(5.84/105 doses)and BCG lymphadenitis(4.00/105 doses)were the two most common abnormal reactions,and the reported incidence of systemic disseminated BCG infections was 0.15/105 doses.Conclusions The reported incidence of AEFI with BCG vaccines appeared a tendency towards a decline in Jiangsu Province over years from 2018 to 2022,and local abscess was the predominant abnormal reaction,with rare serious adverse events seen.The safety of BCG vaccines is within the expected limit.

关 键 词：卡介苗 疑似预防接种异常反应 监测 流行病学特征 

分 类 号：R186[医药卫生—流行病学]