阶梯设计在疫苗临床研究中的应用  

Add to Favorite Application of stepped-wedge design in vaccine clinical research

作　　者：张笑银 吴燕飞 金来润 朱凤才[3,4] 李靖欣 ZHANG Xiaoyin;WU Yanfei;JIN Lairun;ZHU Fengcai;LI Jingxin(Taizhou Center for Disease Control and Prevention,Taizhou,Jiangsu 225300,China;不详)

机构地区：[1]泰州市疾病预防控制中心,江苏泰州1225300 [2]上海市浦东新区疾病预防控制中心免疫预防科复旦大学浦东预防医学研究院 [3]东南大学公共卫生学院 [4]江苏省疾病预防控制中心,国家卫生健康委员会肠道病原微生物重点实验室江苏省医学创新中心

出　　处：《中国预防医学杂志》2024年第7期936-942,共7页Chinese Preventive Medicine

基　　金：国家自然科学基金资助项目(82173584);国家自然科学基金优秀青年科学基金资助项目(82222062);江苏省基础研究计划自然科学基金杰出青年基金项目(BK20220064)。

摘　　要：阶梯设计是一种以分阶段实施干预措施的研究设计,多用于评估群体层面上某种“利大于弊”的政策干预效果。该设计的主要特点是不需要单独设立对照组,在资源有限只能分阶段逐步实施干预的情况下仍保持传统随机对照试验的优势。近年来,阶梯设计在国外被越来越多地应用于各类疫苗的临床效力评估及上市之后的保护效果评估,如流感疫苗、人乳头瘤病毒疫苗、乙肝疫苗、埃博拉疫苗等。本研究从基本原理、适用情况、设计类型、设计要素以及应用实例等方面对阶梯设计在疫苗评价中的应用进行了介绍,旨在为我国今后开展阶梯设计的疫苗临床研究提供参考。The stepped-wedge design is a research design that implements intervention measures in stages,often used to evaluate the"benefits outweigh the harms"policy intervention effects at the population level.The main feature of this design is that it does not require a separate control group,and it maintains the advantages of the traditional randomized controlled trials even when resources are limited and interventions can only be implemented in stages.Recently,the stepped-wedge design has been increasingly applied in the evaluation of clinical efficacy and the evaluation of protective effects after market approval,such as influenza vaccines,human papillomavirus vaccines(HPV),hepatitis B virus vaccines(HBV),and Ebola vaccines.In this review,the basic principles,applicability,,design types,design elements,application example of the stepped-design in vaccine evaluation were introduced,aiming to provide a reference for future implementation of vaccine clinical research using the stepped wedge design in China.

关 键 词：阶梯设计 疫苗 临床试验 研究设计 

分 类 号：R18[医药卫生—流行病学]