实用性随机对照试验设计方法在针刺临床研究中的应用分析

Application of Pragmatic Randomized Controlled Trial′s Design in Clinical Research of Acupuncture

随机对照试验是现今公认的临床治疗性试验的金标准。根据设计形式的不同可分为解释性和实用性两种,在针刺临床试验设计时可根据研究目的的不同加以选择。本文主要介绍实用性随机对照试验的设计特点及其在针刺临床研究领域中的应用。今后应深入探讨如何在针刺临床试验中将实用性随机对照试验与其他设计方法进行有机地结合,尽可能设计高质量的,符合针刺自身特点的临床试验,以期更准确、客观地评价针刺疗效,推动针刺疗法在国际上的应用。

Currently, the randomized controlled trial （RCT） becomes the generally accepted golden standard for clinical trials. It can be classified into two types based on different design, that is, the explanatory randomized controlled trial （ERCT） and the pragmatic randomized controlled trial （PRCT）. In designing a clini- cal trial, researcher may select either of them according to the goal of research. The design feature of PRCT and its application in designing clinical trials of acupuncture were introduced in this paper. Further attention should be paid on resolvent of how to apply PRCT in combining with other design methods organically to work out clinical trial scheme with high quality and consistent with the characteristics of acupuncture as possible, for evaluating the effect of acupuncture more accurately and objectively, so as to promote the international application and development of acupuncture therapy.