基于针刺要素探讨针刺解释性随机对照试验的优化设计框架

Exploration on optimal design framework for acupuncture explanatory randomized controlled trial based on acupuncture elements

关键词:  针刺临床试验  关键针刺要素  解释性随机对照试验  设计框架

Key words:  acupuncture clinical trial  key acupuncture element  interpretive randomized controlled trial  design framework

摘要:

设计出合格的真针刺干预和安慰针刺对照是研究针刺疗法的解释性随机对照试验（ERCT）的迫切需求。在ERCT中准确地纳入针刺要素并从中筛选出关键针刺要素是满足这一需求的关键。为此，文章首先概述了针刺要素的4个属性和11种类型的名称和内容，探讨了针刺要素的定义并论述了能够产生关键针刺要素的要素类型。然后，以此为参照，论述了当前针刺ERCT在针刺要素的纳入和关键针刺要素筛选中的偏颇之处。最后，以“辨病位”为核心，结合对针刺疗法量效关系理论中“刺激量”“作用量”和“治疗量”的理解，提出了包含6个环节的ERCT的设计框架，每个环节的核心内容分别是：辨病位、估量效、定极限治疗量、定最弱关键针刺要素、剔除或修改、预试验验证。希望文章能抛砖引玉，促进ERCT设计的优化和针刺疗法的推广。

Abstract:

The design of competent acupuncture interventions and placebo acupuncture controls is an urgent need for explanatory randomized controlled trials(ERCT) of investigating acupuncture. Accurate inclusion of acupuncture elements and screening of critical acupuncture elements from them are critical to meet this need in ERCT. To this end,this paper first outlines the names and contents of the four attributes and eleven types of acupuncture elements,discusses the definition of the needling element,and discusses the types of elements which can produce critical acupuncture elements. Afterwards,taking this as a reference,the paper discusses the bias of the current acupuncture ERCT in the inclusion of acupuncture elements and the screening of critical acupuncture elements. Finally,with the "differentiating the location of the disease" as the core,combined with the understanding of the "stimulus quantity","action quantity" and "treatment quantity" in the theory of quantity-effect relationship of acupuncture,a design framework of ERCT containing six segments is proposed,and the core contents of each segment are as following:differentiating the location of the disease,evaluation of quantity-effect relationship of acupuncture,determination of ultimate treatment quantity,determination of the weakest critical acupuncture element,elimination or modification,and pre-test validation,respectively. It is hoped that this paper will throw light on the optimization of ERCT design and the promotion of acupuncture therapy.