冻干甲型肝炎减毒活疫苗上市后的安全性评价  

Post-marketing safety evaluation of hepatitis A(live)vaccine,freeze-dried

作　　者：杨玫 夏娇慧 马千里[1] 王辰皓 刘丽珺[1] 姜崴 胡敏 郭雪 YANG Mei;XIA Jiao-hui;MA Qian-li;WANG Chen-hao;LIU Li-jun;JIANG Wei;HU Min;GUO Xue(Sichuan Provincial Center for Disease Control and Prevention,Chengdu 610041,Sichuan Province,China;不详)

机构地区：[1]四川省疾病预防控制中心,四川成都610041 [2]长春生物制品研究所有限责任公司,吉林长春130012

出　　处：《中国生物制品学杂志》2021年第7期853-856,861,共5页Chinese Journal of Biologicals

基　　金：吉林省科技发展计划项目(201603007YY)。

摘　　要：目的评价冻干甲型肝炎减毒活疫苗[hepatitis A(live)vaccine,freeze-dried,HepA-L]上市后的安全性。方法选择四川省2020年1月1日—12月31日接种HepA-L疫苗的人群为研究对象,通过全民健康保障信息化工程中国疾病预防控制信息系统免疫规划信息系统收集接种后的不良反应发生情况,回顾性分析该疫苗的疑似预防接种异常反应(adverse event following immunization,AEFI)的分类构成及报告发生率等指标。结果共接种HepA-L疫苗1008154剂次,报告AEFI 268例(报告发生率26.58/10万剂),其中一般反应223例(报告发生率22.12/10万剂),异常反应30例(报告发生率2.98/10万剂),心因性反应2例(报告发生率0.20/10万剂),偶合症13例(报告发生率1.29/10万剂)。一般反应主要为发热、红肿、硬结,异常反应主要为荨麻疹及过敏性皮疹,不良反应主要集中发生在接种当天及接种后1 d。268例AEFI均已治愈或好转。结论HepA-L疫苗具有良好的安全性,可用于适龄人群甲型肝炎的预防。Objective To evaluate the post-marketing safety of attenuated hepatitis A(live)vaccine,freeze-dried(HepA-L).Methods The data on adverse events following immunization(AEFI)of HepA-L from January 1 to December 31,2020 were collected through the National Health Insurance Informationization Project,China Information System for Disease Control and Prevention,Information System on Immunization Program,while the classification and reported incidence were analyzed retrospectively.Results A total of 1008154 doses of HepA-L were vaccinated,in which 268 cases of AEFI were reported,indicating a reported incidence of 26.58/100000 doses,including 223 cases of general reactions(reported incidence 22.12/100000 doses),30 cases of abnormal reactions(reported incidence 2.98/100000 doses),2 cases of psychogenic reactions(reported incidence 0.20/100000 doses)and 13 cases of coincidental events(reported incidence 1.29/100000 doses).The general reactions were mainly fever as well as redness and swelling and duration in injection site,while the abnormal reactions were mainly urticaria and anaphylactic rash,which mainly appeared within one day after vaccination.A total of 268 cases of AEFI were cured or improved.Conclusion The HEPA-L vaccine showed high safety,which may be used for the immune prevention of hepatitis A in the population at appropriate ages.

关 键 词：冻干甲型肝炎减毒活疫苗 疑似预防接种异常反应 安全性 

分 类 号：R186.3[医药卫生—流行病学]