目的：采用数理统计和多因素分析方法，结合临床实践，对根治术后大肠癌患者中医辨证分型进行客观总结，提供中医辨证论治大肠癌的客观科学的证据。方法：运用大样本、多中心、横断面、前瞻性的临床流行病学调查方法对北京和上海两地218 例根治术后大肠癌病例进行调查，调查内容包括：患者一般资料、肿瘤分期、肿瘤病理学分级、既往治疗、症状、体征、中医单证证型症状表现。运用EPIdata3.1 进行数据库的建立及管理，并采用二次录入的方式进行审核。统计方法主要采用聚类分析、因子分析等多因素分析方法，结合临床实践，对大肠癌根治术后的患者辨证规律进行客观总结和分析。结果：根据临床调查和数理统计结果，初步制定了根治术后大肠癌中医辨证分型诊断标准，暂定根治术后大肠癌7 大证型分别为：肠燥津亏证、脾胃不足证、脾气亏虚证、肝阴亏虚，湿热内蕴证、肝胃不和证、肾气亏虚证、阳虚湿停证，并确定相应的主、次症。结论：通过数理统计的结果与中医理论相结合，我们发现根治术后大肠癌中医证候分布确有其规律，中医证候是客观存在的。前瞻性的临床调查与多因素数理分析相结合是进行大肠癌术后患者辨证规律客观化研究的一种有效方法，值得推广和进一步深入研究。

The study was aimed to provide objective and scientific evidences in the treatment determination based on pathogenesis obtained through traditional Chinese medicine (TCM) syndrome differentiation. Symptoms and signs of postoperative early metaphase colorectal cancer were objectively summarized and differentiated by TCM syndrome differentiation. Mathematical statistics and multivariate analysis were applied in the clinical research. A total of 218 patients with postoperative early metaphase colorectal cancer were investigated in both Beijing and Shanghai. The contents included common data, TNM staging, and the grade of oncopathology, previous treatment, symptoms, physical sign and TCM syndrome differentiation pattern. The database was established and managed with EPIdata 3.1.The data was twice-enter as auditing. Main statistical methods were multivariate analysis, including cluster analysis and factor analysis. Regular TCM syndrome pattern of postoperative early metaphase colorectal cancer were summarized objectively by mathematical statistics and in combination with clinical practice. Through clinical investigation and mathematical statistics, diagnostic criteria of TCM syndrome differentiation of postoperative early metaphase colorectal cancer were made initially. The seven determined TCM syndrome patterns are the syndrome of dryness of the intestine, the syndrome of insufficient of spleen and stomach, the syndrome of deficient and exhaustion of spleen-qi,the syndrome of deficiency and exhaustion of liver-yin and endoretention of damp heat, the syndrome of incoordination between the liver and stomach, the syndrome of deficiency and exhaustion of kidney-qi, and the syndrome of yang asthenia and phlegmatic hygrosis. Meanwhile, main symptoms and minor symptoms were also defined in each of the seven patterns. It is concluded that according to results of mathematical statistics in combination with TCM theories, there are rules in the TCM syndrome patterns of postoperative colorectal. Further studies should be conducted in this area.

国家自然科学基金项目（30572451）：大肠癌中医辨证规律研究与评价，负责人：杨宇飞