中国2014-2020年水痘减毒活疫苗疑似预防接种异常反应监测  

Surveillance of adverse events following immunization with varicella attenuated live vaccine in China, 2014-2020

作　　者：李媛 李克莉[1] 张丽娜 李燕[1] 樊春祥[1] 任敏睿 余文周[1] 曹雷[1] 曹玲生[1] 尹遵栋[1] Li Yuan;Li Keli;Zhang Lina;Li Yan;Fan Chunxiang;Ren Minrui;Yu Wenzhou;Cao Lei;Cao Lingsheng;Yin Zundong(National Immunization Program,Chinese Center for Disease Control and Prevention,Beijing 100050,China)

机构地区：[1]中国疾病预防控制中心免疫规划中心,北京100050

出　　处：《中国疫苗和免疫》2022年第3期356-361,共6页Chinese Journal of Vaccines and Immunization

基　　金：中国CDC公共卫生应急反应机制的运行(131031001000150001)。

摘　　要：目的分析中国水痘减毒活疫苗(Varicella attenuated live vaccine,VarV)疑似预防接种异常反应(Adverse events following immunization,AEFI)发生特征。方法通过中国疾病预防控制信息系统收集2014-2020年VarV AEFI个案,描述性分析AEFI分布特征和报告发生率;采用两种比例失衡分析(Disproportionality analysis,DPA)检测异常反应可疑信号。结果中国2014-2020年VarV AEFI年均报告发生率为297.92/100万剂(30619例),其中一般反应、异常反应分别为257.66/100万剂(26481例)、31.15/100万剂(3201例)。在异常反应中过敏性皮疹、血管性水肿、过敏性休克年均报告发生率分别为26.38/100万剂(2711例)、0.67/100万剂(69例)、0.55/100万剂(57例);DPA检测显示过敏性休克可疑信号(IC_(025)=1.01;PRR=2.94,PRRL0.05=2.25)出现在2014-2015年。结论中国2014-2020年VarV不良反应报告水平在可接受范围内,自2016年以来未检测到异常反应可疑信号。ObjectiveTo analyze adverse events following immunization(AEFI) with varicella attenuated live vaccine(VarV) in China.MethodsWe obtained data on VarV AEFI cases during 2014-2020 from the China Information System for Disease Control and Prevention and conducted descriptive analyses of AEFI distribution and reported incidence. We used two methods of disproportionality analysis(DPA) to detect signals of rare adverse reactions.ResultsThe annual average reported AEFI incidence per million doses of VarV administered during 2014-2020 was 297. 92(30 619 cases): 257. 66(26 481 cases)common reactions and 31. 15(3 201 cases) rare adverse reactions. Incidences per million doses for anaphylactic rash, angioedema, and anaphylactic shock were 26. 38(2 711 cases), 0. 67(69 cases),and 0. 55(57 cases). The two DPA methods showed a potential signal of anaphylactic shock(IC_(025)=1. 01;PRR = 2. 94, PRRL0. 05= 2. 25) in 2014-2015.ConclusionsThe reported incidence of VarV adverse reaction during 2014-2020 in China was acceptable;no suspected signals has been detected since 2016.

关 键 词：水痘减毒活疫苗 疑似预防接种异常反应 监测 信号检测 比例失衡分析 

分 类 号：R186[医药卫生—流行病学]