基于真实世界数据研究肠道病毒A71型疫苗对手足口病发病影响的研究进展题录

手足口病(HFMD)是一种由多种肠道病毒感染所致, 在≤5岁儿童中广泛传播的传染病。目前我国HFMD的流行形势严峻, 发病率较高并持续上升, 造成巨大的疾病负担。肠道病毒A71型(EV-A71)是导致HFMD重症和死亡的原因, EV-A71单价疫苗于2016年上市, 尽管多项临床试验已证明EV-A71疫苗在受试对象中的有效性, 但这并不能反映在真实世界中对一般接种人群的影响。本研究进行系统地文献检索, 对评估EV-A71疫苗在真实应用中对HFMD发病影响的相关研究进行全面回顾与总结, 梳理EV-A71疫苗对HFMD发病影响的真实世界研究的相关证据。目前基于真实世界数据评估EV-A71疫苗对HFMD影响的研究较少, 并且尚无研究对影响HFMD发病的除免疫接种外的其他重要因素(如温度、相对湿度、人口年龄结构、国内生产总值等)进行综合全面考虑。本研究回顾EV-A71疫苗对HFMD影响的真实世界研究有助于清晰和全面了解研究现状, 为今后评估EV-A71疫苗及其他疫苗的短期效果、长期影响等相关研究提供指导和参考。

A review on using real-world data to study the impact of Enterovirus A71 vaccine on the incidence of hand, foot and mouth disease

Hand, foot and mouth disease (HFMD) is a widespread infectious disease mainly affecting children aged five and under. In China, the current epidemic situation of HFMD remains severe, with a persistently high and increasing incidence rate, causing a substantial disease burden. A monovalent vaccine against Enterovirus A71 (EV-A71), the most common cause of severe and fatal HFMD cases, has been available in China since 2016. Although randomized controlled trials established the vaccine''s efficacy among research subjects, this may not reflect the impact under "real world" conditions in the general population. Therefore, based on a systematic literature search, this paper comprehensively reviewed and analyzed relevant studies based on real-world data and collected real-world evidence about the EV-A71 vaccine on the controlling HFMD incidence. It was found that the real-world study of the EV-A71 vaccine on HFMD was few; most were limited to a province or city; there is no study comprehensively considered other important influencing factors in addition to immunization, such as temperature, relative humidity, the age structure of the population, gross domestic product, etc. The progress of using real-world data to study the impact of the EV-A71 vaccine on HFMD reviewed in this study is helpful to have a clear and comprehensive understanding of the status quo and will provide guidance and reference for future studies to assess the short-term and long-term effects of EV-A71 vaccine and other vaccines.