河北省两个流感季国产流感病毒裂解疫苗安全性分析  

Safety analysis of domestic influenza split virion vaccine during two influenza seasons in Hebei Province,China

作　　者：孙丽[1] 李静[1] 王易寒 王亚菲[1] 许晓萌 崔世恒 王诗璠 王晶辉[1] SUN Li;LI Jing;WANG Yihan;WANG Yafei;XU Xiaomeng;CUI Shiheng;WANG Shifan;WANG Jinghui(Hebei Provincial Center for Disease Control and Prevention,Shijiazhuang,Hebei 050021,China)

机构地区：[1]河北省疾病预防控制中心,河北石家庄050021

出　　处：《中国预防医学杂志》2025年第1期102-108,共7页Chinese Preventive Medicine

摘　　要：目的分析河北省国产流感病毒裂解疫苗(influenza split virion vaccine,Flu-sp)疑似预防接种异常反应(adverse events following immunization,AEFI)发生特征,评价该类疫苗的安全性。方法通过中国疾病预防控制信息系统AEFI监测模块收集2020—2022年河北省Flu-sp接种后AEFI个案,描述性分析AEFI的报告发生情况。结果2020—2022年流感季河北省共报告国产Flu-sp AEFI个案148例,年均报告发生率4.49/10万剂。国产三价流感病毒裂解疫苗(trivalent inactivated split virion influenza vaccine,IIV3-sp)的总AEFI(8.35/10万剂)、不良反应报告发生率(8.22/10万剂)均高于四价灭活流感疫苗(quadrivalent inactivated influenza vaccine,IIV4)(均为3.39/10万剂),差异有统计学意义(χ^(2)=31.214、29.717,P<0.05)。6~<36月龄婴幼儿的AEFI报告发生率(12.96/10万剂)高于≥36月龄人群(6.38/10万剂),差异有统计学意义(χ^(2)=15.998,P<0.05)。IIV3-sp的一般反应报告发生率(8.08/10万剂)高于IIV4(3.12/10万剂),差异有统计学意义(χ^(2)=33.219,P<0.05);两者异常反应的报告发生率差异无统计学意义(χ^(2)=0.432,P>0.05)。所有AEFI个案中的一般反应均以发热为主,异常反应中监测到1例吉兰-巴雷综合征,总体转归良好。结论截至2022年,河北省使用的国产Flu-sp安全性良好,不良反应报告发生率在可接受范围内。Objective To analyze the characteristics of adverse events following immunization(AEFI)of domestic influenza split virion vaccine(Flu-sp)in Hebei Province and evaluate the safety of this type of vaccine.Methods AEFI cases related to vaccination of Flu-sp in Hebei Province from 2020 to 2022 were collected by using the AEFI monitoring module of the China Disease Prevention and Control Information System.A descriptive analysis was conducted on the reported occurrences of AEFI cases.Results A total of 148 AEFI cases related to the domestic influenza split virion vaccine were reported in Hebei Province from 2020 to 2022,with an average reported incidence rate of 4.49/100000 doses.The incidence rates of total AEFI(8.35/100000 doses)and adverse vaccine reactions(8.22/100000 doses)of trivalent inactivated split virion influenza vaccine(IIV3-sp)were higher than those of quadrivalent inactivated influenza vaccine(IIV4)(all 3.39/100000 doses)(χ^(2)=31.214,29.717,P<0.05).Infants 6-<36 months of age have a higher incidence rate of AEFI than those≥36 months of age(χ^(2)=15.998,P<0.05).The incidence rates of common vaccine reactions were higher in IIV3-sp(8.08/100000 doses)than in IIV4(3.12/100000 doses)(χ^(2)=33.219,P<0.05),and no statistically significant difference was found in the incidence rates of rare vaccine reactions between these two vaccines(χ^(2)=0.432,P>0.05).The common vaccine reactions were mainly fever,and one case of Guillain-Barrésyndrome was monitored in rare vaccine reactions;the overall regression was positive.Conclusions Up to 2022,the domestic Flu-sp used in Hebei Province is safe,and the incidence rates of reported adverse reactions are within acceptable limits.

关 键 词：三价流感病毒裂解疫苗 四价灭活流感病毒疫苗 疑似预防接种异常反应 安全性 

分 类 号：R186.3[医药卫生—流行病学]