针刺临床研究中的盲法及其关键问题  

Blinding Designs and Critical Issues in Acupuncture Clinical Trials

作　　者：刘婷兰 张浩然 刘晓玉 熊芝怡 孙承颐 闫世艳 LIU Tinglan;ZHANG Haoran;LIU Xiaoyu;XIONG Zhiyi;SUN Chengyi;YAN Shiyan(School of Acupuncture-Moxibustion and Tuina,Beijing University of Chinese Medicine,Beijing 100029,China;College of Preschool Education,Beijing Youth Politics College,Beijing 100102,China;College of Acupuncture and Massage,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China)

机构地区：[1]北京中医药大学针灸推拿学院,北京100029 [2]北京青年政治学院学前教育学院,北京100102 [3]天津中医药大学针灸推拿学院,天津301617

出　　处：《世界科学技术-中医药现代化》2024年第7期1765-1770,共6页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家自然科学基金委员会面上项目(82174234):基于网络与传统方式结合的混合队列和嵌套RCT研究模式,负责人:闫世艳。

摘　　要：盲法是临床研究中控制测量偏倚的重要手段。作为一种复杂的侵入性干预措施,与药物相比,在盲法设计及实施方面针刺面临更大的困难和更高的破盲风险。本文对目前针刺临床研究中盲法进行了概述,并就目前存在的关键问题进行了总结分析,主要包括:假针刺设计及实施需进行规范、仍需研发合适的假针具、尚无解决针刺操作者盲法的有效方法、盲法评价未得到应有的重视、假针刺和盲法需规范化报告。研究者应针对上述关键问题和挑战开展深入研究,为提高和促进针刺临床研究质量提供方法学支撑。Blinding is an important method to control the measure bias in clinical trials.As a complex and invasive intervention,acupuncture has more difficulty in blinding implementation compared to drugs and has a higher risk of unblinding breakage.This article provides an overview of the blinding in acupuncture clinical study and summarized the key aspects,including:there is no standard for the application and reporting of sham acupuncture design and blinding measures,appropriate sham acupuncture devices still need to be developed,currently there are no effective methods of operator blinding,blinding assessment has not been given due attention,sham acupuncture design should be standardized and reported.Researchers should conduct further studies to address critical questions and challenges to provide methodological support to improve and promote the quality of acupuncture clinical research.

关 键 词：盲法 盲法评价 假针刺 临床研究 针刺 

分 类 号：R245.31[医药卫生—针灸推拿学]