湖北省2016-2017年肠道病毒71型灭活疫苗上市后安全性  

Post-marketing safety surveillance of inactivated enterovirus 71 vaccine in Hubei province,2016-2017

作　　者：王雷[1] 王四全[1] 胡樱 刘凯[3] 赵明江[1] Wang Lei;Wang Siquan;Hu Ying;Liu Kai;Zhao Mingjiang(Hubei Provincial Center for Disease Control and Prevention,Wuhan 430079,Hubei,China;School of Health Science of Wuhan University,Wuhan 430072,Hubei,China;Xiaogan Municipal Center for Disease Control and Preven-tion,Xiaogan 432100,Hubei,China)

机构地区：[1]湖北省疾病预防控制中心,湖北武汉430079 [2]武汉大学健康学院,湖北武汉430072 [3]孝感市疾病预防控制中心,湖北孝感432100

出　　处：《中国疫苗和免疫》2018年第4期471-474,共4页Chinese Journal of Vaccines and Immunization

基　　金：中华预防医学会疫苗与免疫青年人才托举项目(Q2017A4201)

摘　　要：目的分析湖北省肠道病毒71型（Enterovirus 71,EV71）灭活疫苗上市后疑似预防接种异常反应（Adverse events following immunization,AEFI）的发生特征和预防接种安全性。方法通过中国AEFI信息管理系统收集2016-2017年EV71疫苗AEFI个案数据,进行描述性流行病学分析。结果 2016-2017年湖北省共报告EV71疫苗AEFI 497例（57.11/10万剂）,其中一般反应、异常反应分别为429例（49.29/10万剂）和64例（7.35/10万剂）;三个企业生产的疫苗分别为401例（60.92/10万剂）、75例（49.60/10万剂）、21例（34.49/10万剂）。一般反应主要为发热（42.40/10万剂）、局部红肿（0.69/10万剂）和局部硬结（0.23/10万剂）,异常反应主要为过敏性皮疹（6.32/10万剂）。结论 EV71疫苗AEFI报告发生率较低,三个企业生产的EV71疫苗均具有良好的安全性。Objective To determine clinical features of adverse events following immunization（ AEFIs）associated with inactivated enterovirus 71（ EV71） vaccine and evaluate its safety profile in Hubei.Methods AEFI cases associated with EV71 vaccine were collected from the China AEFI Information Management System during 2016-2017 for descriptive epidemiological analysis. Results In total,497 AEFI cases associated with EV71 vaccine were reported in Hubei during 2016-2017,for an incidence of 57. 11 per 100 000 doses. Among the 497 AEFI cases,429（ 49. 29 per 100 000） were common vaccine reactions,and 64（ 7. 35 per 100 000） were rare vaccine reactions; 401（ 60. 92 per 100 000）,75（ 49. 60 per 100 000）,and 21（ 34. 49 per 100 000） were from vaccines of the three different manufacturers. Common reactions were fever（ 42. 40 per 100 000）,injection-site swelling（ 0. 69 per100 000）,and induration（ 0. 23 per 100 000）; allergic rash occurred at a rate of 6. 32 per 100 000.Conclusions AEFI associated with EV71 vaccine had a low incidence,demonstrating a good safety profile for three manufacturers＇ vaccines.

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：R186[医药卫生—流行病学]