基于病机指导研制中医基本证候量表及构建临床复杂证候评价体系的构想

Development of traditional Chinese medicine basic syndrome scale and construction of clinical complex syndrome evaluation system under the guidance of pathogenesis

生活质量量表在中医临床研究中备受关注,是中医药临床疗效评价的重要工具。中医的病机并不是一成不变的,很多常见病、慢性病在病程进展过程中,一直存在着多元的病机、复杂的证候,而且其中的病机与证候也在不断地演变中。以往多元证候的固有量表很难满足临床病机演变的需求,不能灵活运用于临床。中医基本证候是组成临床复杂证候的最小单元,以中医基本证候为切入点,选取阴阳辨证、气血津液辨证下的中医基本证型:阴虚证、阳虚证、气虚证、气滞证、血虚证、血热证、血瘀证、痰浊证等,参照患者报告结局(PRO)研制指南,研制中医基本证候量表。在病机演变规律下,对所研制的基本证候量表进行拆分组合,形成新的多元证候量表;并通过临床试验,验证上述量表用于评价病机多元化、证候复杂化的临床实践的可行性,这将大大满足中医临床及科研需求,解决中医证候复杂多样、相兼并存难以评价的难题。

Quality of life scale has attracted much attention in clinical research of traditional Chinese medicine(TCM).It is an important tool for clinical efficacy evaluation of TCM. The pathogenesis of traditional Chinese medicine is not invariable.Many common diseases and chronic diseases have multiple pathogenesis and complex syndromes in the process of disease progression, and the pathogenesis and syndromes are constantly evolving. In the past, the inherent scale of multiple syndromes was difficult to meet the needs of clinical pathogenesis evolution, and could not be flexibly used in clinic. The basic syndrome of traditional Chinese medicine is the smallest unit of clinical complex syndrome. According to FDA ‘Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims’, we will select basic TCM syndromes, such as Yin deficiency syndrome, yang deficiency syndrome, qi deficiency syndrome, qi stagnation syndrome,blood deficiency syndrome, blood stasis syndrome, blood-heat syndrome and phlegm turbidity syndrome and so on, to develop these Traditional Chinese Medicine Syndrome Specific Questionnaires(TCM-SSQs) respectively. Under the rule of pathogenesis evolution, these TCM-SSQs will be disassembled and integrated into a new multi-syndrome scale, in order to evaluate multiple pathogenesis and complex syndrome in clinical practice. This will greatly meet the clinical and scientific research needs of TCM,and solve the difficult problems of complex and diverse TCM syndromes.