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在当前中医药治疗研究中,由于寻求中医药治疗的患者多对干预措施存在选择性偏好,而在此方面传统的随机分组会带来伦理学的挑战。提出一种考虑患者偏好的改良随机临床试验的设计方法,介绍该方法的方法学原理,并将其与传统随机对照试验进行比较。通过分析考虑患者偏好的改良临床试验的应用现状,提出这种设计方案在中医非药物疗法评价中使用的可行性、优势和注意事项,根据该研究模式的特点,认为考虑患者偏好的部分随机临床试验适合于中医药非药物治疗的临床研究,特别适合招募对干预措施有明确要求的研究对象进行研究。
In the current study of TCM treatment, there are ethical challenges in traditional randomization in this respect because there is a selective preference for interventions among those seeking TCM treatment. A design approach to improved randomized clinical trials that considers patient preferences is presented. The methodological rationale for the method is presented and compared with traditional randomized controlled trials. By analyzing the application status of improved clinical trials considering patient preferences, the feasibility, advantages and precautions of using this design scheme in the evaluation of non-drug traditional Chinese medicine therapy are proposed. According to the characteristics of the research model, some patients who consider the patient’s preference are randomly assigned to clinical trials The trial is suitable for clinical studies of non-drug treatment of Chinese medicine and is particularly suitable for the study of subjects recruited with specific requirements for interventions.