基于循证医学原则探讨针刺双盲试验装置与举例  

Probing into the device of acupuncture double-blind test and its examples based on evidence-based medicine

作　　者：宁百乐 邓启粤 吴倩[1,2] 王舢泽 梁雪松 符文彬[1,2] NING Baile;DENG Qiyue;WU Qian;WANG Shanze;IANG Xuesong;FU Wenbin(The Second School Clinical Medicine,Guangzhou University of Chinese Medicine,Guangzhou 510120,China;Guangdong Hospital of Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]广州中医药大学第二临床医学院,广州510120 [2]广东省中医院,广州510120

出　　处：《中华中医药杂志》2024年第3期1566-1569,共4页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：广东省重点领域研发计划--岭南中医药现代化重点专项资助项目(No.2020B1111100007);广东省中医院拔尖人才科研专项资助(No.BJ2022KY10);广州中医药大学“双一流”与高水平大学学科协同创新团队项目(No.2021xk22);广东省中医药高质量发展传承创新提升工程专项(No.粤财社[2022]102号);国家自然科学基金项目(No.81804166,No.81774411,No.82074522);广东省中医药科学院资助项目(No.YN2019ML13)。

摘　　要：循证医学中强调随机对照临床试验是目前评估医学干预措施临床效果最严谨、最可靠的科学方法,但目前针刺试验面临着棘手的问题——如何设计规范的安慰针对照组。针对此问题,本团队研发了一款针刺临床双盲试验装置,该装置有如下特点:安慰组与治疗组所用装置外观一致,操作简易,对操作者及受试者都有良好的蒙蔽作用;装置由针管与球体的螺纹连接,其可实现360°试验角度,满足斜刺等多角度针刺试验;装置可调节针刺深度,也满足留针要求,可应用于针刺手法临床试验;可配合已有针具,一根针一个器具使用,降低针刺感染等风险,适用范围广。本装置可在临床试验研究中推广应用,为针刺双盲试验中安慰针组设计提供思路。From the perspective of evidence-based medicine,randomized controlled clinical trials are currently the most rigorous and reliable scientific method for evaluating the clinical effects of medical interventions.However,acupuncture trials currently face a thorny problem:How to design a standardized placebo injection control group.Therefore,our team had come up with a double-blind experimental device for evaluating the efficacy of acupuncture.The device has the following characteristics:the device used in the placebo group and the treatment group has the same appearance,is easy to operate,and has a good blinding effect on both the operator and the subjects;the device is connected by threads between the needle tube and the sphere,which can achieve a 360°test angle and meet multi-angle acupuncture tests such as oblique pricking;the device can adjust the acupuncture depth and also meet the needle retention requirements,and can be used in clinical trials of acupuncture techniques;it can in conjunction with existing needles,one needle is used per device to reduce the risk of needle stick infection and has a wide range of applications.This device can be promoted and applied in clinical trial research,and provides ideas for the design of placebo injection groups in double-blind acupuncture trials.

关 键 词：临床随机试验 安慰组 针刺 循证医学 双盲试验装置 

分 类 号：R246[医药卫生—针灸推拿学]