河北省13价肺炎球菌多糖结合疫苗安全性监测分析  

Monitoring on the safety of 13-valent pneumococcal conjugate vaccine in Hebei Province

作　　者：孙丽[1] 许晓萌 李静[1] 王易寒 崔世恒 王亚菲[1] 郭玉[1] SUN Li;XU Xiaomeng;LI Jing;WANG Yihan;CUI Shiheng;WANG Yafei;GUO Yu(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：《实用预防医学》2024年第7期829-832,共4页Practical Preventive Medicine

摘　　要：目的分析河北省13价肺炎球菌多糖结合疫苗(13-valent pneumococcal conjugate vaccine,PCV13)接种后疑似预防接种异常反应(adverse events following immunization,AEFI)的发生特征,评价该疫苗的安全性。方法通过中国疾病预防控制信息系统AEFI监测模块收集2020年1月1日—2022年12月31日河北省PCV13接种后AEFI个案,分析其接种后AEFI的报告发生情况。结果PCV13的总AEFI报告发生率为37.24/10万剂,不良反应发生率为36.84/10万剂,其中一般反应报告发生率为36.31/10万剂,异常反应报告发生率为0.27/10万剂。AEFI以一般反应为主,主要发生在接种后24 h内,且总体转归情况良好。结论截至目前,河北省所使用的PCV13安全性良好,异常反应发生率极低。Objective To analyze the occurrence features of adverse events following immunization(AEFI)of 13-valent pneumococcal conjugate vaccine(PCV13)in Hebei Province,and to evaluate the vaccine’s safety.Methods AEFI cases related to vaccination of PCV13 in Hebei Province from January 1,2020 to December 31,2022 were collected from AEFI Information Management System,China Information System for Disease Control and Prevention,and the incidence of reported AEFI cases was analyzed.Results The total reported incidence rate of AEFI of PCV13 was 37.24/100,000 doses.The incidence rate of adverse reactions was 36.84/100,000 doses,among which the incidence rate of common adverse reactions was 36.31/100,000 doses,and the incidence rate of rare adverse reactions 0.27/100,000 doses.Most of the reported AEFI cases caused by PCV13 were common adverse reactions,which occurred mainly within 24 hours after vaccination,and the overall regression was positive.Conclusion Up to now,13-valent pneumococcal conjugate vaccines used in Hebei Province are safe,and the incidence rate of rare adverse reactions is extremely low.

关 键 词：13价肺炎球菌多糖结合疫苗 疑似预防接种异常反应 被动监测 

分 类 号：R186[医药卫生—流行病学]