风咳证异病同治临床研究设计思路与方法

Design ideas and methods of clinical research on the different diseases and the same treatment of wind cough syndrome

参考现代精准癌医学的篮式设计方法,在异病同治理论指导下,将中医证与西医病相结合,选择同一中医风咳证下3个不同西医疾病进行临床研究,突出以证候为中心的设计理念。通过对风咳证异病同治临床研究在总体研究设计、病证诊断标准、受试者选择、对照药物选择、疗程及观察时点设计、统计分析、有效性评价和安全观察等方面技术要点和特色的系统条理阐述,探索异病同治的临床研究设计思路及治疗法则的可行性,为证候类中药新药研发提供科学依据。

Referring to the basket design method of modern precision cancer medicine,under the guidance of the theory of same treatment for different diseases,we combined TCM syndrome with western medicine disease,selected three different western medicine diseases under the same TCM wind cough syndrome for clinical research,and highlighted the design concept of syndrome centered.Through the systematic description of the technical points and characteristics of the clinical research on the different diseases with the same treatment of wind cough syndrome in terms of overall research design,disease syndrome diagnostic criteria,subject selection,control drug selection,course of treatment and observation time point design,statistical analysis,effectiveness evaluation and safety observation,this paper explores the feasibility of the clinical research design ideas and treatment rules of the different diseases with the same treatment,to provide scientific basis for the research and development of new TCM drugs of syndrome class.