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

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.