随机对照试验在外科领域应用的指南对中医药循证实践和科研的启示

Inspiration of Guidelines for Randomized Controlled Trials Applied in Surgery on Chinese Medicine Evidence Based Practice and Scientific Research

西医外科干预措施与中医药干预措施存在较多的共性特征,如对技术和技能的体现与要求,中医药与外科领域的随机对照试验在实施过程中有相似之处并存在共同的方法学难点,包括对操作性、技术性要求高且过程复杂等。针对临床操作的标准化程度容易受到限制、盲法难以实施导致的信息偏倚等问题,通过系统介绍2016年发表的外科领域随机对照试验应用指南,讨论其对中医药循证临床实践和科研的启示。借鉴外科领域随机对照试验的经验,探讨将该试验方法学指南用于中医药领域的可行性与方法,并提出了相关的指导建议。

Western medicine surgical interventions and Chinese medicine interventions have many common features,such as embodiment and requirement of technology and skill. Randomized controlled trials（ RCT） in Chinese medicine and in surgery field have similarities in the practice process and have common methodological difficulties,including high operability,technical requirements and complex process. Aiming at the problems that standardization of clinical operation easily limited and information bias due to blind method difficult to implement,by systematically introducing RCT application guidelines in surgery filed published in 2016,the authors discuss the inspiration on Chinese medicine evidence based clinical practice and scientific research. By learning the experience of RCT in surgery filed,the authors explore the feasibility and method of applying the test methodology guideline in Chinese medicine field and put forward related guiding suggestion.