冻干甲型肝炎减毒活疫苗与免疫规划疫苗同时接种疑似预防接种异常反应监测数据分析  

Adverse Events Induced by Immunization of Concomitant Inoculation of Freeze-dried Hepatitis A(Live)Vaccine with Vaccines for National Immunization Program from Surveillance Data

作　　者：蒋蕊鞠[1] 殷琼洲 徐明珏[1] 赵志梅[1] 邓燕[1] 宁若彤 车艳春[1] JIANG RuiJu;YIN QiongZhou;XU MingJue;ZHAO ZhiMei;DENG Yan;NING Ruotong;CHE YanChun(Institute of Medical Biology,Chinese Academy of Medical Sciences,Peking Union Medical College,Research Management Department,Kunming Yunnan 650118,China)

机构地区：[1]中国医学科学院,北京协和医学院医学生物学研究所,云南昆明650118

出　　处：《中国药物警戒》2020年第10期710-714,719,共6页Chinese Journal of Pharmacovigilance

基　　金：北京协和医学院协和青年科研基金(公共卫生及软科学研究项目)(3332015066):疫苗评价质量管理规范建设。

摘　　要：目的分析国家免疫规划(NIP)主要使用的冻干甲型肝炎减毒活疫苗产品(HepA-L)与其他NIP疫苗同时接种后疑似预防接种异常反应(AEFI)的发生特征,初步评价其安全性,为日常同时接种提供参考。方法采用描述流行病学方法对中国免疫规划信息管理系统收集的2013~2018年Hep A-L与其他NIP疫苗同时接种AEFI个案数据进行分析。结果 2013~2018年,HepA-L与其他NIP疫苗同时接种AEFI共报告482例,主要人群为1~2岁儿童,男童多于女童。同时接种NIP疫苗共有10种,AEFI报告数排前3位为麻腮风联合减毒活疫苗、无细胞百白破联合疫苗、流行性乙型脑炎减毒活疫苗。Hep A-L分别与3类疫苗同时接种后,一般反应占86.11%~88.69%、异常反应占10.24%~13.89%。同时接种98.21%AEFI发生在0~3 d,各症状转归情况良好,无死亡病例。经与各NIP疫苗单独接种国家AEFI监测数据对比,同时接种未发生新的异常反应,未增加接种风险。结论在受种者身体健康、无禁忌症的情况下,HepA-L可与适龄段其他NIP疫苗同时接种,但需关注罕见严重异常反应的发生。Objective To analyze the characteristics of adverse events following immunization(AEFI)after concomitant inoculation of freeze-dried Hepatitis A Attenuated Live Vaccine(HepA-L)with other national immunization program(NIP)vaccines so as to tentatively evaluate the safety of concomitant inoculation and to provide reference for daily concomitant inoculation.Methods Descriptive epidemiology were adopted to analyze AEFI case data of concomitant inoculation of HepA-L with other NIP vaccines between 2013 and 2018,which was collected from the China Information Management System for Immunization Programming.Results A total of 482 AEFI cases were reported due to the concomitant inoculation of HepA-L with other NIP vaccines.Children aged 1 to 2 were the main population.Boys outnumbered girls in these reported cases.A total of ten vaccines were involved in the concomitant inoculation.The top three vaccines that resulted in AEFI cases were MMR,DTaP and JEV-L.When HepA-L was co-inoculated with one of the three vaccines respectively,general reactions accounted for 86.11%-88.69%and abnormal reactions 10.24%~13.89%.A total of 98.21%AEFIs occurred within 3 days of concomitant inoculation,but all the symptoms were improved and no death occurred.Compared with the national AEFI monitoring data on inoculation with NIP vaccine alone,no new abnormal reactions occurred in concomitant inoculation and the risk of inoculation was not increased.Conclusion A recipient who is healthy and has no contraindication to vaccination can be co-inoculated with HepA-L in conjunction with other NIP vaccines.However,the occurrence of rare and severe abnormal reactions should be a focus of attention.

关 键 词：疑似预防接种异常反应 监测 冻干甲型肝炎减毒活疫苗 国家免疫规划疫苗 同时接种 

分 类 号：R954.5[医药卫生—药学]