中国中西医结合杂志2025，Vol.45Issue(10)：1173-1180,8.DOI:10.7661/j.cjim.20250821.278
序贯多重分配随机试验慢性病中医药临床研究应用
Sequential Multiple Assignment Randomized Trials in Clinical Research of Chinese Medicine for Chronic Diseases
摘要
Abstract
The fixed intervention model of traditional randomized controlled trials(RCT)is difficult to restore the dynamic diagnosis and treatment process of chronic diseases in Chinese Medicine(CM),which may lead to bias in efficacy assessment.The sequential multiple assignment randomized trial(SMART)has become a reliable choice for clinical research on chronic diseases in CM because of its dynamic adjustment and individualized intervention,which is highly compatible with the concept of "treatment based on syndrome differentiation" in CM.In this paper,the authors demonstrate its practical value in the optimization of dynamic treatment sequences,the customization of individualized pathways,the assessment of long-term efficacy,and the quantitative validation of syndrome through a SMART case study applied to the exploration of dynamic therapeutic strategies in CM.To address the standardization of CM interventions,matching syndrome dynamics with decision points,sample size estimation,and the adaptability of statistical analyses,the authors propose solutions such as incorporating the CM syndrome differentiation approach into trial design,establishing a decision-making system that integrates CM and Western Medicine,optimizing statistical models,and strengthening interdisciplinary collaboration,therefore to promote the in-depth integration of SMART and CM clinical research,and help breakthroughs in the methodology of CM clinical research.关键词
序贯多重分配随机试验/慢性病/适应性治疗策略/个体化异质性Key words
sequential multiple assignment randomized trial/chronic disease/adaptive treatment strategies/individual heterogeneity引用本文复制引用
潘知玉,武红莉,张道培,姜燕华,钱真真,朱健,刘冰阳,张永辉,荆志伟..序贯多重分配随机试验慢性病中医药临床研究应用[J].中国中西医结合杂志,2025,45(10):1173-1180,8.基金项目
国家自然科学基金面上项目(No.82074584) （No.82074584）
中国中医科学院科技创新工程项目(No.CI2021A04702) （No.CI2021A04702）
