疾病诊断和证候分类：整合及未来发展

中医证候分类作为中医基础理论的核心，是中医理论指导下对不同个体生理病理整体功能状态进行分类的一种特有的诊断方法，在此基础上制定出符合证候诊断的高度针对性的治法和方剂，构成了指导中医临床实践的辨证论治体系。相比于现代疾病诊断模式基于病理金标准的局限性，证候分类以另一种分类思维模式对个体状态进行区分，既可将患有相关疾病的人群归属不同的证候类别，也将不同疾病的人群归于相同证候，更具有个体化特点。疾病诊断与证候分类进行整合，充分互补，可能改变现今生物医学的诊断模式，具有上佳的研究和应用前景。因此，证候分类原理的现代研究是中医药研究的重中之重，近年来一直受到国内外研究者们的持续关注。本文以类风湿关节炎及其典型证候的证候分类系统研究为例，对疾病证候分类整合研究和其未来发展进行阐述，以期为今后的研究提供思路。研究内容主要包括证候分类的科学基础研究、证候分类与临床有效性及安全性、异病同证研究以及证候分类指导下的组合药物研究。以上的研究工作中，采用系统生物学方法，结合临床研究理念，探索疾病证候分类科学基础，在相应基础上实施中药临床疗效评价研究和基于复方理念组合药物开发的研究，以期为未来疾病证候分类研究在思路和方法方面提供参考。

Disease Diagnosis and Pattern Classification in Chinese Medicine:Integration and Future Trends

Chinese medicine(CM)pattern classification (or Zheng differentiation, syndrome differentiation),the hallmark of the CM,is the basic unit and the key concept in CM theory.The diagnostic and therapeutic methods in CM are rested on the differentiation of CM pattern.Current disease classification should attribute to the advance in pathology.It has recognized the defects featuring both lack of sensitivity in identifying preclinical status and specificity in describing complex disease unequivocally.Given that CM pattern is remembered as the CM theoretical interpretation of the symptom profile of a disease,it is not only a group of the symptoms of one disease,but an assemblage of many different diseases.CM pattern classification has been recently complicated with disease classification or diagnosis.As a result of the integrated model,the healthy condition can be redefined and the clinical practice reshaped which are superior to the current classification methods.In this paper,we took rheumatoid arthritis(RA)as a disease model and cold/heat pattern as a typical CM pattern in RA,to explore the scientific fundamentals of pattern classification based on disease diagnosis using systematic biological approaches and evidence based medicine design,as well as developed novel approaches by means of CM clinical evaluation and R&D of combinational drug design based on Chinese herbal formula.Some unique study designs are herein introduced.