进口五价轮状病毒减毒活疫苗上市后疑似预防接种异常反应监测分析  

Surveillance and analysis on adverse events following immunization of RotaTeq

作　　者：龚睿婕 刘景壹[1] 陈远方[1] 茅淑倩 周祺[1] 周业宏 吴强松[1] GONG Rui-jie;LIU Jing-yi;CHEN Yuan-fang;MAO Shu-qian;ZHOU Qi;ZHOU Ye-hong;WU Qiang-song(Xuhui District Center for Disease Control and Prevention,Shanghai,200237,China;不详)

机构地区：[1]上海市徐汇区疾病预防控制中心,上海200237 [2]上海市徐汇区长桥街道社区卫生服务中心,上海200037

出　　处：《预防医学论坛》2021年第3期169-171,共3页Preventive Medicine Tribune

基　　金：上海市徐汇区医学科研项目(SHXH201945);复旦大学公共卫生安全教育部重点实验室开放基金资助(GW2019-9)。

摘　　要：目的通过主动监测结合被动监测,收集并分析我国于2018年新上市的5价人-牛重配口服轮状病毒减毒活疫苗(RotaTeqTM,RV5)疑似接种异常反应(adverse events following immunization, AEFI)的情况。方法对来自上海市徐汇区4个社区预防接种门诊的320名至少接种1剂次RV5的婴幼儿,在接种疫苗后开展主动监测,收集不良事件(adverse event, AE)。同时,与在"中国疑似预防接种异常反应信息管理系统"获得的接种RV5后的被动监测数据进行卡方检验。结果共纳入320名接种RV5的婴幼儿开展疫苗安全性主动监测,95.31%的主动监测对象完成全程3剂次RV5接种。通过主动监测观察到12起与RV5接种相关的AE事件,均属一般反应(包括腹泻、食欲不振、呕吐和发热),报告发生率为1 275.24/10万剂次(12/941)。被动监测数据显示,2019年徐汇区RV5接种后AEFI报告发生率为70.27/10万剂次(4/5 692)。主动监测观察到的AEFI发生率显著高于被动监测(P<0.01)。结论 RV5在上海市徐汇区上市后监测的AEFI的发生率处于产品说明书范畴之内,但主动监测的AEFI报告率远高于被动监测结果。Objective To evaluate the safety of RotaTeqTM(RV5),newly launched in China in 2018 by active and passive surveillance for adverse events following immunization(AEFI). Methods A total of 320 children who had received at least 1 dose of RotaTeqTM were evolved from 4 community vaccination clinics in Xuhui district in Shanghai city.The occurrence of adverse events(AE) were collected by active surveillance.The incidence of AEFI of RotaTeqTM was monitored by passive surveillance which was collected from China AEFI Information Management System. Results 95.31% of the 320 participants have completed the 3 doses of RotaTeqTM.12 AEs were observed by active surveillance, all of which were vaccination-related.The reported incidence was 1 275.24/105 doses(12/941).Total 12 AEs referred diarrhea, anorexia, vomiting and fever.The incidence of AEFI observed by active surveillance was significantly higher than that by passive surveillance with an incidence of 70.27/105 doses(P<0.01). Conclusion The incidence of AEFI was within the range of product description.However, the incidence monitored by active surveillance was significantly higher than passive surveillance.

关 键 词：轮状病毒减毒活疫苗 安全性 疑似预防接种异常反应 主动监测 被动监测 

分 类 号：R186[医药卫生—流行病学]