摘要
目的评价适龄儿童肠道病毒71型(Enterovirus type 71,EV71)灭活疫苗预防接种后不良反应发生率。方法通过中国疑似预防接种异常反应监测信息管理系统收集甘肃省2017-2021年6-71月龄儿童EV71疫苗不良反应个案,估算一般反应和异常反应报告发生率。结果甘肃省2017-2021年儿童接种EV71疫苗后一般反应、异常反应报告发生率分别为70.14/10万(447例)、0.31/10万(2例);其中注射部位红肿、硬结分别为7.22/10万、2.35/10万,发热、食欲下降、乏力/嗜睡、恶心/呕吐、腹泻等全身反应分别为57.75/10万、7.53/10万、6.43/10万、5.81/10万、5.18/10万;热性惊厥、过敏性紫癜均为0.16/10万。结论甘肃省2017-2021年适龄儿童EV71预防接种不良反应发生率在预期范围内,严重反应极为罕见。
Objective To evaluate the incidence of adverse reactions following vaccination with inactivated enterovirus type 71(EV71) vaccine among age-eligible children.Methods We obtained data on adverse reactions associated with EV71 vaccine among 6-71-month-old children of Gansu province during 2017-2021 from the National Information Management System for Surveillance of Adverse Events Following Immunization. We estimated reported incidences of common and rare adverse reactions.Results Overall reported incidences of common and rare adverse reactions of EV71 vaccine among children of Gansu during 2017-2021 were 70.14 per 100 000 doses(447 cases) and 0.31 per 100 000 doses(2 cases), respectively. Incidences per 100 000 doses for injection-site redness/swelling and induration were 7.22 and 2.35;for systemic reactions of fever, decreased appetite, fatigue/lethargy, nausea/vomiting, and diarrhea were 57.75, 7.53, 6.43, 5.81, and 5.18;and for febrile convulsion and Henoch-Schonlein purpura were both 0.16.Conclusions The incidence of adverse reactions following EV71 vaccination among children of Gansu during 2017-2021 was no higher than the expected;serious reactions was extremely rare.
作者
安婧
梁雪枫
金娜
焦永卓
鲍俊屹
方延学
张晓曙
An Jing;Liang Xuefeng;Jin Na;Jiao Yongzhuo;Bao Junyi;Fang Yanxue;Zhang Xiaoshu(Gansu Provincial Center for Disease Control and Prevention,Lanzhou 730000,Gansu,China;Gansu Provincial Center for Drug Inspection of National Medical Products Administration,Lanzhou 730000,Gansu,China)
出处
《中国疫苗和免疫》
CSCD
北大核心
2022年第2期229-232,共4页
Chinese Journal of Vaccines and Immunization
基金
甘肃省药品监督管理局药品安全监管科研项目(2019GSMPA010)。
