2021-2022年中国疑似预防接种异常反应监测  

Surveillance of adverse events following immunization in China,2021-2022

作　　者：张丽娜 李媛 李克莉[1,2] 李燕[1,2] 樊春祥[1,2] 任敏睿 余文周[1,2] 曹雷[1,2] 尹遵栋[1,2] Zhang Lina;Li Yuan;Li Keli;Li Yan;Fan Chunxiang;Ren Minrui;Yu Wenzhou;Cao Lei;Yin Zundong(National Key Laboratory of Intlligent Tracking and Forecasting for Infectious Diseases,Chinese Center for Disease Control and Prevention,Bejing 102206,China;National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)

机构地区：[1]传染病溯源预警与智能决策全国重点实验室,中国疾病预防控制中心,北京102206 [2]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》2024年第4期470-484,共15页Chinese Journal of Vaccines and Immunization

基　　金：中国CDC公共卫生应急反应机制的运行(102393220020010000017)。

摘　　要：目的分析中国2021-2022年疑似预防接种异常反应(Adverse event following immunization,AEFI)监测数据。方法通过中国疾病预防控制信息系统收集2021-2022年上市疫苗(不含紧急使用和附条件上市疫苗)接种后报告的AEFI个案信息和接种剂次数,描述性分析AEFI发生特征和报告发生率。结果2021-2022年中国41种疫苗AEFI总报告发生率为32.52/10万剂(323627例),其中严重AEFI报告发生率为0.15/10万剂(1468例,0.45%);一般反应、异常反应报告发生率分别为31.07/10万剂(309163例,95.53%)、1.14/10万剂(11381例,3.52%);严重异常反应报告发生率为0.08/10万剂次(759例,0.23%)。在异常反应中,过敏性皮疹、血管性水肿、血小板减少性紫癜/血小板减少症报告发生率分别为0.96/10万剂(9528例)、0.02/10万剂(232例)、0.02/10万剂(230例)。结论2021-2022年中国AEFI报告发生率略有下降,以一般反应为主,严重异常反应极其罕见。Objective To analyze surveillance data for adverse events following immunization(AEFIs)in China during 2021-2022.Methods We obtained data on AEFI reports and numbers of post-marketed vaccine doses administered during 2021-2022 from the Chinese Immunization Information Management System(excluding emergency-use or conditional-market vaccines).We analyzed characteristics and reported incidences of AEFIs using descriptive epidemiological method.Results A total of 323627 AEFI cases for 41 vaccines were reported in China during 2021-2022,yielding an overall incidence of 32.52 cases per 100000 doses administered,with 0.15 per 100000 doses(1468 cases,0.45%)for serious AEFIs.The incidence per 100000 doses was 31.07(309163 cases,95.53%of all cases)for common adverse reactions and 1.14(11381 cases,3.52%)for rare adverse reactions,with 0.08(759 cases,0.23%)for serious adverse reactions.Incidences per 100000 doses for anaphylactic rash,angioedema,and thrombocytopenic purpura/thrombocytopenia were 0.96(9528 cases),0.02(232 cases),and 0.02(230 cases),respectively.Conclusions The reported incidence of AEFIs deceased slightly in China in 2021-2022.Most adverse reactions were mild,and serious reactions were extremely rare.

关 键 词：疫苗 疑似预防接种异常反应 监测 

分 类 号：R186[医药卫生—流行病学]