疫苗研发与免疫实施领域的方法学——循证疫苗学

Evidence-based Vaccinology～A New Methodology of Vaccine Development and Clinical Vaccinology Practice

近些年来 ,国际医学界兴起循证医学的新理念 ,并作为医学研究和实践的重要方法学在许多领域推广应用。循证疫苗学是循证医学的典范 ,其定义是指在疫苗发展的所有阶段 ,包括疫苗获得研发许可前、获得生产许可后以及研究和使用疫苗控制疾病时 ,获取并应用最佳的证据 ,以进行决策并组织实施。此文介绍了循证疫苗学作为疫苗研发和免疫实施方法学的有关内容 ,包括存在的问题和局限性 ,并对其前景进行了展望。

In recent years,a new prototype on evidence-based medicine(EBM)has been in vogue as a tool of methodology on medical study and practice in many medical fields of the world.Evidence-based vaccinology is the model(EBV)of EBM,which means the identification and use of the best evidence in making and implementing decisions during all of the stages of the life of a vaccine,including pre-licensure vaccine development and post-licensure manufacture and research,and utilization of the vaccine for disease control.Many contents of EBV including its problems,limitations and prospects were described in the article.