基于真实世界国际针灸病例注册登记研究的关键技术

摘要

针灸目前已经在全球180多个国家得到应用,但是关于针灸有效性、安全性、高质量等方面证据不足,仍然是制约针灸发展的关键问题.结合针灸学科特色,采用注册登记研究方法,面向国际,基于真实世界收集临床数据,纳入具有临床意义的结局指标,能够挖掘真实世界针灸疗效和安全性,为验证性研究提供重要的基础和补充.本文总结了基于真实世界进行国际性针灸病例注册登记研究的关键技术,以期指导针灸病例注册登记研究的设计、实施与评估.%Acupuncture-moxibustion has been used in more than 180 countries,but high quality evidences for its efficacy and safety are still insufficient,which is a key issue limiting the development of acupuncture-moxibustion.Combined with characteristics of acupuncture-moxibustion discipline,this study was aimed to use international patient registry to collect real world clinical data and design meaningful clinical outcome in order to exploit the efficacy and safety of acupuncture-moxibustion and to provide important basis and supplement for confirmatory research.This paper summarized key technologies of international patient registry study for acupuncture-moxibustion based on real world to guide the design,implementation and evaluation.