2018—2022年河北省二价和九价人乳头瘤病毒疫苗疑似预防接种异常反应监测分析  

Surveillance analysis of adverse events following immunization with the bivalent human papillomavirus vaccine and recombinant human papillomavirus 9-valent vaccine in Hebei province from 2018 to 2022

作　　者：王晶辉[1] 孙丽[1] 王诗璠 王易寒 李静[1] 崔世恒 许晓萌 郭玉[1] WANG Jinghui;SUN Li;WANG Shifan;WANG Yihan;LI Jing;CUI Shiheng;XU Xiaomeng;GUO Yu(Institute of Immunization Planning and Management,Hebei Province Center for Disease Prevention and Control,Shijiazhuang 050021,China)

机构地区：[1]河北省疾病预防控制中心免疫规划管理所,石家庄050021

出　　处：《中国公共卫生》2024年第9期1110-1116,共7页Chinese Journal of Public Health

摘　　要：目的分析河北省二价人乳头瘤病毒疫苗(HPV2)和九价人乳头瘤病毒疫苗(HPV9)接种后疑似预防接种异常反应(AEFI)发生特征,评价HPV2和HPV9疫苗上市后的安全性。方法通过中国疾病预防控制信息系统AEFI监测模块收集河北省2018年10月1日—2022年12月31日接种HPV2、HPV9后发生的AEFI个案,比较分析HPV2、HPV9接种后AEFI报告发生率。结果2018年10月1日—2022年12月31日河北省HPV2和HPV9接种后AEFI年均总报告发生率为2.76/10万剂,HPV2和HPV9分别为3.38/10万剂、2.39/10万剂(χ^(2)=2.422,P>0.05)。发生的AEFI主要为不良反应,总报告发生率为2.69/10万剂,其中一般反应、异常反应分别为2.42/10万剂、0.28/10万剂;HPV2一般反应、异常反应分别为2.22/10万剂、0.11/10万剂,HPV9一般反应、异常反应分别为2.74/10万剂、0.55/10万剂,2种HPV疫苗一般反应、异常反应差异均无统计学意义(χ^(2)=0.757、3.256,P均>0.05)。一般反应主要为局部红肿(1.28/10万剂),异常反应主要是过敏性休克(0.07/10万剂),多发生于HPV2、HPV9接种后24 h内,90%的AEFI治愈或好转。结论截止到2022年年底,河北省接种的HPV2和HPV9疫苗总体安全性良好,异常反应发生率极低。Objective To analyze the characteristics of adverse events following immunization(AEFI)after the administration of the bivalent human papillomavirus vaccine(HPV2)and the recombinant human papillomavirus 9-valent vaccine(HPV9)in Hebei province,and to evaluate the post-marketing safety of HPV2 and HPV9.Methods Data on AEFI cases following HPV2 and HPV9 vaccination from October 1,2018,to December 31,2022,were collected from the AEFI monitoring module of the China Information System for Disease Control and Prevention.The incidence of AEFI reports for HPV2 and HPV9 were compared and analyzed.Results From October 1,2018,to December 31,2022,the average annual incidence of total AEFI reports following HPV2 and HPV9 vaccination in Hebei province was 2.76 per 100000 doses,with HPV2 and HPV9 at 3.38 per 100000 doses and 2.39 per 100000 doses respectively(χ^(2)=2.422,P>0.05).The AEFI mainly comprised adverse reactions,with a total incidence of 2.69 per 100000 doses,including common reactions and abnormal reactions at 2.42 per 100000 doses and 0.28 per 100000 doses respectively.For HPV2,the rates of common reactions and abnormal reactions were 2.22 per 100000 doses and 0.11 per 100000 doses respectively,while for HPV9 they were 2.74 per 100000 doses and 0.55 per 100000 doses respectively.The differences in the rates of common reactions and abnormal reactions between the two vaccines were not statistically significant(χ^(2)=0.757,3.256,P>0.05 for both).The most common reaction was local redness and swelling(1.28 per 100000 doses),and the primary abnormal reaction was anaphylactic shock(0.07 per 100000 doses),mostly occurring within 24 hours post-vaccination.Ninety percent of individuals with AEFI recovered or showed improvement.Conclusions As of the end of 2022,the overall safety of HPV2 and HPV9 vaccinations in Hebei province was favorable,with a very low incidence rate of abnormal reactions.

关 键 词：二价人乳头瘤病毒疫苗 九价人乳头瘤病毒疫苗 疑似预防接种异常反应 安全性 河北省 

分 类 号：R186[医药卫生—流行病学]