北京市朝阳区婴幼儿接种EV71疫苗的安全性调查.docVIP

北京市朝阳区婴幼儿接种EV71疫苗的安全性调查 白云骅 李淑萍 李丽 芦强 杨立清 张军楠 张政 邵昕晔 朱敬杰 时念民 北京市朝阳区疾病预防控制中心 河北医科大学 X 关注成功！ 加关注后您将方便地在 我的关注中得到本文献的被引频次变化的通知！ 新浪微博 腾讯微博 人人网 开心网 豆瓣网 网易微博 摘????要： 目的 观察肠道病毒71型灭活疫苗 (简称EV71疫苗) 接种635月龄婴幼儿后的安全性。方法 选择635月龄无接种禁忌且自愿接种的健康婴幼儿为研究对象。采用上臂三角肌肌内注射, 间隔大于或等于28 d接种2剂次。现场观察每次接种后30 min内的即时反应, 通过电话询问获得每次接种后3 d、28 d内的局部和全身反应, 同时统计每名入组儿童是否全程接种2剂次EV71疫苗情况, 将观察结果填写到每个受种者的《EV71疫苗接种观察记录表》中。采用Excel2013软件录入和分析。结果 2016年8月—2017年3月共收集到北京市朝阳区3 965名635月龄婴幼儿接种EV71疫苗信息, 总不良事件发生率为1.16% (46/3 965) 。完成2剂次全程接种的2 392名婴幼儿, 不良事件发生率为1.21% (29/2 392) , 多数不良事件发生在30 min3 d内, 以发热为主。仅接种首剂次的1 237名婴幼儿, 收集到16例不良事件;仅接种末剂次的336名婴幼儿, 收集到1例不良事件。结论 该EV71疫苗上市后在635月龄婴幼儿接种中具有良好的安全性。 关键词： 手足口病; EV71; 灭活疫苗; 安全性; 作者简介：白云骅 (1975—) , 男, 本科, 副主任医师, 研究方向:疫苗临床试验、疫苗安全性、疫苗免疫原性、冷链、人狂犬病。 作者简介：时念民, E-mail:shinianmin@ 收稿日期：2017-08-30 Safety evluation of a domestic enterovirus 71 inactivated vaccine in Chaoyang District, Beijing BAI Yunhua LI Shuping LI Li LU Qiang YANG Liqing ZHANG Junnan ZHANG Zheng SHAO Xinye ZHU Jinjie SHI Nianmin Chaoyang District Center for Diseases Prevention and Control, Beijing; Abstract： Objective To evaluate the safety of a domestic enterovirus 71 (EV71) vaccine being applied to infants andchildren among 6 to 35 months old. Methods The health volunteer without contraindication were accepted as the researchobjects, and thay received two doses of EV71 vaccine (intramuscular injection) with a 28-day interval. The adverse events wereinvestigated and recorded in 30 minutes, 3 days, and 28 days after each vaccination. At the same time, whether completing thewhole course of vaccination (2 does of EV71 vaccine) were also investigated. Results A total of 3 965 infants and childrenwere vaccinated from August 2016 to March 2017. The overall incidence of adverse reactions was 1.16% (46/3 965) . Thenumber of people who got two doses of vaccination was 2 392, and 29 people had adverse events (1.21%) . Of the all 29 adverseevents, 23 occurred after the first vaccination and 4 occurred after the sec