两种EV71型灭活疫苗安全性比较  

Comparison of safety between two types of enterovirus 71 inactivated vaccine

作　　者：黄巍[1] 周晓红[1] 席胜军[1] 朱建慧[1] 桂娟娟 王婷婷 HUANG Wei;ZHOU Xiaohong;XI Shengjun;ZHU Jianhui;GUI Juanjuan;WANG Tingting(The Center for Disease Control and Prevention of Xiacheng District,Hangzhou,Zhejiang 31003,China)

机构地区：[1]杭州市下城区疾病预防控制中心,浙江杭州310003

出　　处：《预防医学》2018年第4期356-358,363,共4页CHINA PREVENTIVE MEDICINE JOURNAL

基　　金：杭州市下城区医药卫生科研计划项目(A201706)

摘　　要：目的评价Vero细胞和人二倍体细胞肠道病毒71型灭活疫苗(EV71疫苗)接种后的安全性。方法纳入于2016年11月—2017年5月在杭州市下城区各预防接种门诊接种EV71疫苗的儿童为观察对象,按疫苗种类分为Vero细胞EV71疫苗接种组和人二倍体细胞EV71疫苗接种组,分别在接种后30 min、3 d和30 d通过电话等方式进行随访并记录不良反应发生情况。结果共完成观察3 158人,其中Vero细胞EV71疫苗接种组观察1 529人,发生不良反应9例,发生率为0.59%;人二倍体细胞EV71疫苗接种组观察1 629人,发生不良反应9例,发生率为0.55%。两种疫苗接种后发生的不良反应均为发热、腹泻和呕吐等全身反应,两种疫苗接种后不良反应发生率和严重程度差异均无统计学意义(P>0.05),同种疫苗不同剂次间不良反应发生率和严重程度均为第一剂次高于第二剂次(P<0.05)。结论 Vero细胞EV71疫苗和人二倍体细胞EV71疫苗安全性均较高且无差异。Objective To evaluate the safety of two types of enterovirus 71(EV71)inactivated vaccine(Vero cell vs.Human Diploid cell)after inoculation.Methods Subjects were children vaccinated EV71 vaccine between November 2016 and May 2017 at vaccination clinics in Xiacheng District.According to the type of EV71 vaccine,subjects were divided into the Vero Cell group and the Human Diploid Cell group.The adverse effects were collected after 30 min,3 days and 30 days of injection,respectively.Results A total of 3 158 vaccinated children were observed,with 1 529 in Vero Cell group and 1 629 in Human Diploid Cell group.The rates of adverse effects were 0.59%(9 cases)of Vero cell group and 0.55%(9cases)of Human Diploid Cell group.All of the adverse effects were systemic reactions such as fever,diarrhea and vomiting.No significant differences were observed between the two groups above in the incidence and severity of adverse effects(P>0.05).The incidence and severity of adverse effects of the first dose were significantly higher than the second dose in two groups(P<0.05).Conclusion EV71 vaccine was safe to vaccinate,and no statistical difference in the adverse effects was found between the two types of vaccine.

关 键 词：肠道病毒71型灭活疫苗 安全性 不良反应 

分 类 号：R186[医药卫生—流行病学]