韩国成均馆大学Ju-Young Shin团队研究了韩国少女接种人乳头瘤病毒疫苗与严重不良事件之间的关系。2021年1月29日，该研究发表在《英国医学杂志》上。
为了评估人乳头瘤病毒（HPV）疫苗接种与韩国少女严重不良事件之间的相关性，2017年1月至2019年12月，研究组通过连接韩国免疫登记信息系统和国家卫生信息数据库，建立了一个大型链接数据库，进行了一项队列研究。
研究组招募了2017年接种疫苗的441399名11-14岁的少女：其中382020人接种了HPV疫苗，59379人未接种HPV疫苗。主要结局为33个严重不良事件，包括内分泌、胃肠道、心血管、肌肉骨骼、血液学、皮肤学和神经系统疾病。一级分析采用队列设计，二级分析采用自我控制风险区间设计；两种分析均采用HPV疫苗接种后一年的风险期。
在33种预先确定的严重不良事件中，除观察到偏头痛风险增加外（接种和未接种组每10万人-年的发病率分别为1235.0与920.9），队列分析未发现与HPV疫苗接种相关的不良事件，包括桥本甲状腺炎和类风湿性关节炎。采用自我控制风险区间的二次分析证实，HPV疫苗接种与严重不良事件（包括偏头痛）之间没有关联。对于不同的随访期和疫苗亚型来说，该结果都是可靠的。
在这项全国性队列研究中，研究组使用了超过50万剂的人乳头瘤病毒疫苗，通过队列分析和自我控制风险区间分析，未发现人乳头瘤病毒疫苗接种与严重不良事件之间有相关性。
附：英文原文
Title: Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study
Author: Dongwon Yoon, Ji-Ho Lee, Hyesung Lee, Ju-Young Shin
Issue&Volume: 2021/01/29
Abstract:
Objective To evaluate the association between human papillomavirus (HPV) vaccination and serious adverse events in adolescent girls in South Korea.
Design Cohort study.
Setting A large linked database created by linking the Korea Immunization Registry Information System and the National Health Information Database, between January 2017 and December 2019.
Participants 441399 girls aged 11-14 years who had been vaccinated in 2017: 382020 had been vaccinated against HPV and 59379 had not been vaccinated against HPV.
Main outcome measures Outcomes were 33 serious adverse events, including endocrine, gastrointestinal, cardiovascular, musculoskeletal, haematological, dermatological, and neurological diseases. A cohort design was used for the primary analysis and a self-controlled risk interval design for the secondary analysis; both analyses used a risk period of one year after HPV vaccination for each outcome. Incidence rate and adjusted rate ratios were estimated using Poisson regression in the primary analysis, comparing the HPV vaccinated group with the HPV unvaccinated group, and adjusted relative risks were estimated using conditional logistic regression in the secondary analysis.
Results Among the 33 predefined serious adverse events, no associations were found with HPV vaccination in the cohort analysis, including Hashimoto’s thyroiditis (incidence rate per 100000 person years: 52.7 v 36.3 for the vaccinated and unvaccinated groups; adjusted rate ratio 1.24, 95% confidence interval 0.78 to 1.94) and rheumatoid arthritis (incidence rate per 100000 person years: 168.1 v 145.4 for the vaccinated and unvaccinated groups; 0.99, 0.79 to 1.25), with the exception of an increased risk observed for migraine (incidence rate per 100000 person years: 1235.0 v 920.9 for the vaccinated and unvaccinated groups; 1.11, 1.02 to 1.22). Secondary analysis using self-controlled risk intervals confirmed no associations between HPV vaccination and serious adverse events, including migraine (adjusted relative risk 0.67, 95% confidence interval 0.58 to 0.78). Results were robust to varying follow-up periods and for vaccine subtypes.
Conclusions In this nationwide cohort study, with more than 500000 doses of HPV vaccines, no evidence was found to support an association between HPV vaccination and serious adverse events using both cohort analysis and self-controlled risk interval analysis. Inconsistent findings for migraine should be interpreted with caution considering its pathophysiology and the population of interest.
DOI: 10.1136/bmj.m4931
Source: https://www.bmj.com/content/372/bmj.m4931
BMJ-British Medical Journal:《英国医学杂志》，创刊于1840年。隶属于BMJ出版集团，最新IF：93.333
官方网址：http://www.bmj.com/
投稿链接：https://mc.manuscriptcentral.com/bmj
本期文章：《英国医学杂志》：Online/在线发表
