适应性治疗策略及其在中医药领域应用前景

Adaptive Treatment Strategies and Prospective of Their Application in Traditional Chinese Medicine Research

中医辨证论治是建立在整体观理念上体现个体化诊疗和动态治疗的技术。然而,目前中医临床试验经常采用的随机对照设计并不能体现辨证论治的个体化诊疗和动态治疗观。适应性治疗策略是根据个体患者不断变化的状态调整治疗措施的一组决策规则,整个决策过程体现了个体化治疗和动态治疗。从这个角度来看,中医辨证论治的过程就是一个适应性治疗决策的过程。因此,在开展中医临床疗效评价时,引入开发最优适应性治疗策略的设计方法可以真实客观反映不同治疗策略的疗效。在已发表的国外文献中可以看到已有一些探索开发适应性治疗策略的临床研究,而国内真正使用适应性治疗策略的临床研究还鲜有报道。本文详细介绍了适应性治疗策略的概念及其重要组成部分,并概述了3种能够考虑远期疗效并能比较不同适应性治疗策略整体疗效的方法,以期为未来在中医科研工作中开发最优临床路径奠定基础及提供新的科研思路和方法。

Traditional Chinese medicine （TCM） emphasizes treatment based on syndrome differentiation, which is the core technology that can embody the characteristics and advantages of TCM diagnosis and treatment. This is based on holistic view to illustrate individual diagnosis and treatment and dynamic treatment. However, RCT, which is frequently used in TCM clinical studies, can not reflect the concept of treatment based on syndrome differentiation. The use of adaptive treatment strategies in clinical researches can adjust therapy in patients according to the changes of diseases, so it can reflect individual diagnosis and treatment and dynamic treatment. From this perspective, the process of treatment based on syndrome differentiation is a process of decision-making of adaptive treatment. So the method for developing adaptive treatment strategies can effectively evaluate the efficacy of different treatment strategies in TCM clinical studies. Adaptive treatment strategies have been used in some clinical studies from some published foreign literatures. However, the use of adaptive treatment strategies in domestic clinical researches is seldom reported. This article discussed the concept of adaptive treatment strategies and their important components in detail. In addition, it presented three methods which can take the delayed effects of the current treatment action into consideration and can compare the overall effect of different adaptive treatment strategies, with a purpose to lay some foundation for future TCM researches in the development of optimal clinical pathway and provide new ideas and methods for researches.