中国2010-2022年乙型肝炎疫苗疑似预防接种异常反应监测分析

Surveillance for adverse events following immunization with hepatitis B vaccine in China,2010-2022

目的分析中国乙型肝炎疫苗(Hepatitis B vaccine,HepB)疑似预防接种异常反应(Adverse event following immunization,AEFI)监测数据。方法从中国疾病预防控制信息系统免疫规划系统获得2010-2022年HepB接种剂次和AEFI报告个案数据,描述性分析报告发生率。结果中国2010-2022年共报告HepB AEFI 119940例,总报告发生率为15.33/10万。一般反应、异常反应报告发生率分别为13.97/10万、0.99/10万;严重异常反应报告发生率为0.07/10万。在一般反应中发热(腋温≥38.6℃)、红肿(直径>2.5 cm)、硬结(直径>2.5 cm)报告发生率分别为4.22/10万、2.33/10万、1.03/10万;在异常反应中过敏性皮疹、血小板减少性紫癜、血管性水肿报告发生率分别为0.76/10万、0.03/10万、0.02/10万。结论中国2010-2022年HepB不良反应报告发生率低,以一般反应为主,严重异常反应极罕见。

Objective To analyze surveillance data of adverse events following immunization(AEFI)with hepatitis B vaccine(HepB)in China.Methods We obtained data on HepB doses administered and AEFI reports during 2010-2022 from the National Immunization Program System of China Disease Prevention and Control Information System for a descriptive analysis of AEFI incidence.Results In total,119940 HepB AEFI cases were reported in China from 2010 to 2022,for an overall incidence of 15.33 cases per 100000 doses.Incidences per 100000 doses for common and rare reactions were 13.97 and 0.99,respectively,with 0.07 for serious reactions.Incidences per 100000 doses for hyperthermia(axillary temperature≥38.6℃),redness(diameter>2.5 cm),and induration(diameter>2.5 cm)were 4.22,2.33,and 1.03;for allergic rash,thrombocytopenic purpura,and angioedema,incidences per 100000 doses were 0.76,0.03,and 0.02.Conclusions The reported incidence of adverse reactions associated with HepB was low between 2010 and 2022 in China.Most reactions were common,and severe reactions were extremely rare.