自身对照设计在疫苗安全性关联研究中的应用进展

Progress in applications of self-controlled designs in association study of vaccine safety

疫苗安全性主动监测是疫苗安全性证据链,尤其是接种后严重不良反应评价的关键一环。随着健康医疗信息化建设及其应用的快速发展,这为疫苗安全性主动监测及关联评估提供了可行途径。目前,全球已有20余个国家利用电子健康档案、医疗索赔、电子病历等开展疫苗安全性主动监测,这些监测常采用队列研究、病例对照研究、自身对照研究等设计类型。其中,自身对照设计的自身对照病例系列研究、自身对照风险区间研究在该领域的应用越来越广泛,但在我国相关研究报道仍不常见。本文综述自身对照设计在疫苗安全性关联研究中的方法学与应用进展,为今后疫苗上市后安全性评价的真实世界研究提供参考。

Active surveillance of vaccine safety is a crucial and essential part of the whole evidence chain of vaccine safety,especially for the surveillance of serious adverse reactions following immunization.In recent years,electronic health care databases have been facilitating the active surveillance of vaccine safety and association study.Globally,more than a dozen countries have performed active surveillance of vaccine safety using the electronic health records,medical claim,electronic medical records.The surveillance designs involved cohort study,case control study,and self-controlled study.Self-controlled designs,such as self-controlled case series study and self-controlled risk interval study,have been increasingly used in vaccine safety monitoring outside China.The review outlines the applications of and progress in self-controlled studies in association study of vaccine safety in the hope of contributing to post-marketing surveillance of vaccine risks in the real world.