Siegrist Claire-Anne, Lewis Edwin M, Eskola Juhani, Evans Stephen J W, Black Steven B
Center for Vaccinology and Neonatal Immunology, University of Geneva, Geneva, Switzerland.
Pediatr Infect Dis J. 2007 Nov;26(11):979-84. doi: 10.1097/INF.0b013e318149dfea.
The large-scale implementation of human papilloma virus (HPV) immunization will be followed by cases of autoimmune diseases occurring in temporal association with immunizations. To anticipate events that might be mistakenly assumed to be caused by immunization, their prevalence was monitored before vaccine introduction.
Cohort study carried out within a database of female adolescents (n = 214,896) and young adults (n = 221,472) followed in the pre-HPV vaccine era (2005), computing rates of emergency consultations, hospitalizations and outpatient consultations, and estimation of risks of coincident associations.
Immune-mediated conditions were a frequent cause (10.3%) of emergency room consultation by adolescent girls. Nonallergic immune-mediated conditions affected 86 per 100,000, diabetes ranking first. In 2005, 53 per 100,000 adolescents and 389 per 100,000 women were hospitalized for diseases of presumed autoimmune origin, thyroiditis being the most frequent diagnosis. If HPV immunization had been used with 80% coverage, 3 per 100,000 adolescents would have required emergency care for asthma/allergy within 24 hours and 2 per 100,000 for diabetes within 1 week of an injection. The risks of hospitalization in temporal association with immunization are 4 times higher for thyroiditis than for multiple sclerosis or Guillain-Barré's syndrome, and more than 20 times higher in young women than in adolescents.
The distinction between HPV vaccine-caused adverse reactions and events only observed by chance in temporal association is difficult. The prior use of population-based data allows for identification of issues of potential concern, for monitoring the impact of large-scale interventions and for addressing rapidly vaccine-safety issues that may compromise vaccine programs.
大规模实施人乳头瘤病毒(HPV)免疫接种后,会出现与免疫接种存在时间关联的自身免疫性疾病病例。为了预测可能被错误地认为是由免疫接种引起的事件,在引入疫苗之前对其患病率进行了监测。
在HPV疫苗接种前时代(2005年)对一个女性青少年(n = 214,896)和年轻成年人(n = 221,472)数据库进行队列研究,计算急诊会诊、住院和门诊会诊率,并估计同时发生关联的风险。
免疫介导疾病是青春期女孩急诊室会诊的常见原因(10.3%)。非过敏性免疫介导疾病的发病率为每10万人86例,糖尿病居首位。2005年,每10万青少年中有53例、每10万女性中有389例因疑似自身免疫性疾病住院,甲状腺炎是最常见的诊断。如果HPV免疫接种的覆盖率为80%,每10万青少年中会有3例在注射后24小时内需因哮喘/过敏接受急诊治疗,每10万中有2例在注射后1周内需因糖尿病接受急诊治疗。与免疫接种存在时间关联的住院风险,甲状腺炎是多发性硬化症或吉兰 - 巴雷综合征的4倍,在年轻女性中比青少年高出20倍以上。
区分HPV疫苗引起的不良反应和仅在时间关联上偶然观察到的事件很困难。基于人群的数据的预先使用有助于识别潜在关注问题,监测大规模干预的影响,并迅速解决可能影响疫苗计划的疫苗安全问题。