金华市2016—2019年EV71灭活疫苗接种安全性监测分析  

Safety of inactivated enterovirus 71 vaccine among children in Jinhua city, 2016–2019: a surveillance data analysis

作　　者：王凤英[1] 吴晓虹[1] 章光明[1] 陈梦安 WANG Feng-ying;WU Xiao-hong;ZHANG Guang-ming(Jinhua Municipal Center for Disease Control and Prevention,Jinhua,Zhejiang Province 321002,China)

机构地区：[1]金华市疾病预防控制中心,浙江金华321002

出　　处：《中国公共卫生》2021年第3期415-418,共4页Chinese Journal of Public Health

基　　金：浙江省医药卫生科技计划(2019KY751);金华市科学技术研究计划项目(2018–4–086)。

摘　　要：目的分析肠道病毒71型灭活疫苗(EV71疫苗)上市后的疑似预防接种异常反应(AEFI)发生情况,评价疫苗安全性,为疫苗的推广使用提供科学依据。方法采用被动监测和主动监测相结合的方式,通过AEFI信息管理系统和主动随访,收集浙江省金华市2016年9月—2019年12月接种EV71疫苗的AEFI病例资料,对相关数据进行描述流行病学分析。结果 2016年9月—2019年12月,金华市共接种EV71疫苗401 505剂次,通过AEFI信息管理系统报告AEFI 391例,报告发生率为97.38/10万剂。391例AEFI病例中,一般反应365例,异常反应15例,偶合症11例。82.86%AEFI发生在接种后1d内,异常反应以过敏性皮疹为主。不同年度、不同地区、不同种类和不同剂次报告发生率差异有统计学意义(χ^(2)分别为80.835、71.920、31.609和19.955,P均<0.001)。主动监测6 084名儿童,接种疫苗9 090剂次,发现59例AEFI,发生率为649.06/10万剂,96.61%不良反应发生在接种后30 min~3 d,72.88%表现为发热,所有AEFI均在观察期内痊愈。不同性别、月龄、接种剂次的不良反应发生率差异无统计学意义(P均> 0.05),不同疫苗种类的不良反应发生率差异有统计学意义(P <0.001)。结论 EV71疫苗接种后以3 d内发生一般反应为主,具有较好的安全性。Objective To analyze the occurrence of inactivated enterovirus 71(EV71) vaccine-related adverse events following immunization(AEFI) among children and to evaluate the safety of the vaccine for providing evidences for the promotion and use of the vaccine. Methods Passive and active surveillance data on EV71 vaccine-related AEFI reported in Jinhua city, Zhejiang province from September 2016 through December 2019 were extracted from China Information System for Planned Immunization Management and analyzed with descriptive statistics. Results During the 4-year period in the city, totally 391 AEFI were reported among 401 505 doses of inactivated EV71 vaccine vaccination, with a reported incidence rate of 97.38 per 100 000 doses;the reported incidence rate differed significantly by year(χ^(2) = 80.835),administrative region(χ^(2) = 71.920), vaccine type(χ^(2) = 31.609), and dose time(χ^(2) = 19.955)(P < 0.001 for all);the most of the reported AEFI were general reactions(n = 365), only 15 were abnormal reactions and 11 were coincidence diseases;82.86% of the AEFI occurred within one day after the inoculation, and the main abnormal reaction was allergic rash. For active surveillance among 6 084 children with a total of 9 090 doses of vaccination during the period, 59 AEFI were identified, and the detection rate was 649.06 per 100 000 doses;there were no significant gender, month age, and dose time differences in the detection rate(all P > 0.05) but the detection rate differed significantly by vaccine type(P < 0.001);the most(96.61%) of the AEFI occurred within 30 minutes to 3 days after the vaccinations and 72.88% of the AEFI were fever;all the AEFI recovered in the observation period. Conclusion Among the children in Jinhua city, the main inactivated EV71 vaccine-related AEFI are general reactions occurred within 3 days after vaccinations, indicating that the vaccination of the vaccine is safe for the children.

关 键 词：肠道病毒71型灭活疫苗 疑似预防接种异常反应 安全性 

分 类 号：R512.5[医药卫生—内科学]