基于SMART设计建立中医药随机对照试验“随证施治”决策模型的研究

传统随机对照试验要求干预措施保持相对恒定，与中医临床“辨证论治、随症加减”基本原则相冲突，从而导致中医药临床试验要么缺乏科学性，要么远离临床实际，无法获得高级别的证据。体现适应性设计理念的顺序多次分配随机临床试验(SMART)通过两阶段分配和交互效应分析，能体现中医药“随证施治”用药特点，但尚待建立可行的实施方法。因此本项目在前期成组序贯试验和适应性设计研究基础上，以金匮泽泻汤治疗痰湿型良性阵发性位置性眩晕为例，采用治疗组“随证施治”式入组、两阶段评价、样本量两次评估，评价经方“随证施治”治疗策略的有效性，通过Q-learning评估主症特征、伴随证/症状对用药决策的影响，进而建立“症证-方药-疗效”决策判别模型。该模型的建立，有助于建立中医方剂随证加减的“适应性治疗策略”的疗效评价方法，为中医药获得高级别的循证证据提供适宜的研究工具，为探索具有中医药特点的临床试验设计提供方法学参考。

Randomized controlled trial for traditional interventions remain relatively constant, and the Chinese medicine clinical syndrome differentiation and treatment ", along with the disease and subtract "is in conflict with the basic principles, leading to clinical trials of traditional Chinese medicine or the lack of scientific, or away from the clinical practice, unable to get high level of evidence. Reflect the order of the adaptive design concept dispersing randomized clinical trials (SMART), through the analysis of the two phase distribution and interaction effect reflects the traditional Chinese medicine treats characteristics. This project in the previous group sequential test and adaptability, on the basis of design research in alisma golden soup treating phlegm wet BPP as an example, the treatment group treats disease type into the internal group and two stage evaluation, sample size two assessment, evaluation by the party with the disease treats the effectiveness of the treatment strategy, age, primary symptom characteristics through Q-learning evaluation, the influence of the accompanying symptoms of medical decision making, and then set up the disease-clinical curative effect of decision-making discriminant model. The establishment of the model helps to establish a prescription of traditional Chinese medicine with the card to add and subtract the curative effect of treatment strategy adaptive evaluation method, for the clinical efficacy of Chinese medicine to provide high-level evidence-based evidence of appropriate research tools, in order to establish a randomized controlled trial design patterns of TCM characteristics provide methodology reference.