适龄儿童接种无细胞百白破b型流感嗜血杆菌联合疫苗疑似预防接种异常反应主动监测  

Adverse events following immunization with diphtheria,tetanus,acellular pertussis,and Haemophilus influenzae type b combined vaccine among age-eligible children:active surveillance

作　　者：马雨佳 刘艳[2] 沈鹏 郭光令 王燕 白云骅 姜文清 章哲强 蔡承业 魏巍 陈大方[1] Ma Yujia;Liu Yan;Shen Peng;Guo Guangling;Wang Yan;Bai Yunhua;Jiang Wenqing;Zhang Zheqiang;Cai Chengye;Wei Wei;Chen Dafang(Department of Epidemiology and Biostatistics,School of Public Health,Peking University,Beijing 100191,China;Hangzhou Municipal Center for Disease Control and Prevention,Hangzhou 310021,Zhejiang,China;Yinzhou District Center for Disease Control and Prevention,Ningbo 315010,Zhejiang,China;Qianjiang Municipal Center for Disease Control and Prevention,Qianjiang 433100,Hubei,China;Ziyang Municipal Center for Disease Control and Prevention,Ziyang 641300,Sichuan,China;Chaoyang District Center for Disease Control and Prevention,Beijing 100021,China;Taocheng District Center for Disease Control and Prevention,Hengshui 053000,Hebei,China;Yunpu Street Community Health Service Center of Huangpu District,Guangzhou 510700,Guangdong,China;Beijing Minhai Biotechnology Co.,LTD.,Beijing 102600,China)

机构地区：[1]北京大学公共卫生学院流行病与卫生统计学系,北京100191 [2]杭州市疾病预防控制中心,浙江杭州310021 [3]鄞州区疾病预防控制中心,浙江宁波315010 [4]潜江市疾病预防控制中心,湖北潜江433100 [5]资阳市疾病预防控制中心,四川资阳641300 [6]朝阳区疾病预防控制中心,北京100021 [7]桃城区疾病预防控制中心,河北衡水053000 [8]黄埔区云埔街社区卫生服务中心,广东广州510700 [9]北京民海生物科技有限公司,北京102600

出　　处：《中国疫苗和免疫》2020年第6期679-683,687,共6页Chinese Journal of Vaccines and Immunization

基　　金：北京市自然基金委联合创新项目(L192054)。

摘　　要：目的评价无细胞百白破b型流感嗜血杆菌联合疫苗(DTaP-Hib)的疑似预防接种异常反应(AEFI)发生率。方法于2019年7月-2020年6月采用方便抽样,选取中国7个省份172个区县1151个接种门诊的3-24月龄健康儿童接种4剂次DTaP-Hib,通过每日电话随访收集每剂次接种后7d内发生的AEFI,描述性分析AEFI发生率。结果适龄儿童接种DTaP-Hib的AEFI总发生率为35.3/万剂(1240/351598)。局部反应发生率(/万剂)为25.3,其中肿胀、发红、硬结分别为19.2、18.2、11.7;全身反应发生率(/万剂)为9.2,其中发热、过敏反应分别为8.4、0.3。1级、2级、3级、4级AEFI发生率(/万剂)分别为18.7、12.0、2.1、0.0。结论适龄儿童接种DTaP-Hib的AEFI发生率在预期范围内,以轻微不良反应为主,严重不良反应罕见。Objective To evaluate the incidence of adverse event following immunization(AEFI) with diphtheria,tetanus,acellular pertussis,and Haemophilus influenzae type b combined vaccine(DTaP-Hib) among age-eligible children.Methods We used a convenience sampling method to enroll 3-24-month-old healthy children from 1 151 vaccination clinics of 172 districts/counties in 7 provinces of China from July 2019 to June 2020.Each child received4 doses of DTaP-Hib.We collected data on AEFIs within 7 days after each dose through daily telephone follow-up to determine AEFI incidence.Results The overall incidence of AEFIs was 35.3 cases per 10 000 doses(1 240/351 598).The incidence of local reactions per 10 000 doses was 25.3,with 19.2,18.2,and 11.7 for swelling,redness,and induration,respectively.The incidence of systemic reactions per 10 000 doses was 9.2,with 8.4 and 0.3 for fever and allergic reactions,respectively.Incidences of level 1,2,3,and 4 AEFIs per 10 000 doses were 18.7,12.0,2.1,and 0.0.Conclusion The incidence of DTaP-Hib AEFIs was not higher than the expected among age-eligible children;mild adverse reactions were common and severe adverse reactions were rare.

关 键 词：无细胞百白破b型流感嗜血杆菌联合疫苗 疑似预防接种异常反应 主动监测 

分 类 号：R186[医药卫生—流行病学]