摘要
疫苗在上市之前,通过安慰剂-随机对照试验,疫苗效力/效果可以得到规范的评价。但是,疫苗上市之后,如果采用安慰剂-随机对照试验来评价疫苗的效果,会产生伦理学上的问题。因此,疫苗上市后的效果评价一直是公共卫生领域面临的难题。近年来,检测阴性设计这一研究方法在国际上被广泛用于各类上市之后疫苗的效果评价中,例如流感疫苗、轮状病毒疫苗、霍乱疫苗、肺炎疫苗和EV71疫苗等。但是,目前国内关于检测阴性设计这一研究方法的文献报道很少。为此综述检测阴性设计的基本原理、应用步骤及优缺点,为我国开展检测阴性设计提供理论方法及依据。
Vaccine efficacy can be assessed by a randomized placebo-control trial prior to marketing.However,after the marketing of a vaccine,if a placebo-randomized control trial is used to evaluate the efficacy of the vaccine,ethical issues will arise.Therefore,the evaluation of the efficacy of a vaccine after marketing has become a difficult problem in the public health field.In recent years,the research method of test-negative design has been widely used in the world for the evaluations of the efficacies of different post-marketing vaccines,such as influenza vaccine,rotavirus vaccine,cholera vaccine,pneumonia vaccine and EV71 vaccine.However,there are limited reports in the domestic literature on the test-negative design.Therefore,we summarize the basic principles,application steps,advantages and disadvantages of the test-negative design to provide theoretical methods and basis for the future study of test-negative design in China.
作者
张力
金鹏飞
李靖欣
朱凤才
Zhang Li;Jin Pengfei;Li Jingxin;Zhu Fengcai(Center for Global Health,Nanjing Medical University,Nanjing 211166,China;Department of Vaccine Clinical Evaluation,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China;National Health Commission Key Laboratory of Enteric Pathogenic Microbiology,Jiangsu Provincial Center for Disease Control and Prevention,Nanjing 210009,China)
出处
《中华流行病学杂志》
CAS
CSCD
北大核心
2020年第2期280-283,共4页
Chinese Journal of Epidemiology
关键词
检测阴性设计
疫苗
效果评价
Test-negativedesign
Vaccine
Efficacy evaluation
作者简介
通信作者:李靖欣,Email:jingxin42102209@126.com;通信作者:朱凤才,Email:jszfc@vip.sina.com。
