| As one of the common tumor, colorectal cancer is being a rising tendency. In China, as a part in the combined therapy of colorectal cancer, Traditional Chinese medicine (TCM) educes important action. This article will conduct a prospective clinical research of TCM treating postoperative colorectal cancer by two parts.Part 1 Clinical Randomize Double-blind Controlled Study on Quxie capsule Reducing Relapse and Metastasis of Postoperative Colorectal CancerBackground: Quxie Capsule was uncovered by arranging the chemical preparation in ancient times' books. It possesses efficacy of activating yang and diminishing stagnation by detoxification. In early days, cohort study indicated that it was possible that it could delay relapse and metastasis of colorectal cancer. At present, RCT is the best design proposal of clinical research. Therefore, it is essential to approach and research the action of Quxie capsule in reducing relapse and metastasis of postoperative colorectal cancer.Objective: The clinical importance of Quxie capsule used in solidified therapy of postoperative colorectal cancer will be discussed and the idea of treating tumor with activating yang and pyretic purgation will be validated in clinical treatment.Method: This research continued from August of 2005 to October of 2006 according to the RCT requirement strictly. By designing a prospective randomized double-blind controlled research program, 44 patients with stage II and stage III postoperative colorectal cancer were included. There were 44 patients after rejecting 2 and 2 missed, including 28 patients with stage II who have 15 patients in treatment group and 13 patients in control group, and 16 patients with stage III who have 8 patients in treatment group and 8 patients in control group. Both have been treated by intervention study after adjuvant treatment, patients in treatment group were treated by Quxie capsule; patients in control group were treated by placebo capsule for six months. The rate of relapse-metastasis for two groups and the changes of symptoms, KPS score, immunological function and security of Quxie Capsule were observed.Result: Until the follow up to April in 2007, the rate of relapse-metastasis in the treatment group1-year, 2-year and 3-year relapse-metastasis rate of treat group were 0,0 and 50% respectively, those were 9.52"%,18.18% and 50% in control group. Two groups had not significant difference, P>0.05. Average time appearing relapse and metastasis in treatment group was 31.500±7.778 months and it was 19.000±13.856 months in control group. The difference between them was not significant, P=0.3425, t=1.125. In treatment group, symptoms and KPS score were improved obviously, P<0.05. The immunological function of the treatment group were all obvious batter than the control group, and there was significant difference between the two group in absolute value and percentage of CD4 and B lymphocyte, P<0.05.Conclusion: Quxie Capsule was possible that it could delay relapse and metastasis of colorectal cancer, but we need 1 to 2 years to prove it. It used in postoperative colorectal cancer could protect relapse and metastasis as well as improve quality of life. They will have advantage for postoperative colorectal cancer. Therefore it has clinical significance of the treatment of activating yang and pyretic purgation.Part2 the Clinical Research in the Regular Pattern of Differentiation of Symptoms and Signs of Postoperative Early Metaphase Colorectal CancerObjective: For providing the objective and scientific evidence of determination of treatment based in pathogenesis obtained through differentiation of symptoms and signs, this research will summarize objectively the regular pattern of differentiation of symptoms and signs of postoperative early metaphase colorectal cancer by mathematical statistics and multiplicity integrating clinical practice.Method: This research continued from December of 2005 to March of 2007. According to large sample, multicentre, transaction, prospective clinical epidemiology, we investigated 218 patients with postoperative early metaphase colorectal cancer in Beijing and Shanghai. The contents included common data, the TNM staging, the grade of oncopathology, the previous treatment, the symptoms, the physical sign and the single pattern of syndrome of TCM. We set up and managed the database with EPIdata 3.1, and auditinged the data by twice-enter. The major statistical method was multiplicity, including Frequencies, Classify, Factor and Correlate. We summarized objectively the regular pattern of differentiation of symptoms and signs of postoperative early metaphase colorectal cancer by mathematical statistics and multiplicity integrating clinical practice.Result: We investigated 60 experts in TCM oncology department from whole country with questionnaire about the regular pattern of differentiation of symptoms and signs of colorectal cancer. It's been thought commonly that carcinogenesis of large intestine is correlated to spleen, lung, liver, large intestine and stomach. According to the viewpoint of experts, splenasthenic syndrome is the fundamental the single pattern of syndrome. Both blood deficiency and insufficiency of spleen-YANG is the most frequent asthenia syndrome, and both stagnant blood and humid heat is the most frequent sthenia syndrome. Most experts think that damp invasion of lower energizer, stagnant blood and toxin junction and damp toxin junction are frequent pattern of syndrome of colorectal cancer. According to single pattern of syndrome, it is discovered that most patients with postoperative early metaphase colorectal cancer appearance asthenia syndrome which most is syndrome of deficiency of vital energy or YIN asthenia, or asthenia and sthenia inclusion which most is syndrome of stagnation of QI. On the basis of clinical investigation and mathematical statistics, we instituted the initial DC of differentiation of symptoms and signs for classification of syndrome of TCM in postoperative early metaphase colorectal cancer and determined 7 pattern of syndromes which is 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 retention of damp heat, the syndrome of incoordination between the liver and stomach, the syndrome of deficiency and exhaustion of kidney-QI, the syndrome of YANG asthenia and retention of phlegmatic, respectively. At the same time, we defined the present symptoms and minor symptoms of the 7 patterns of syndrome. According further analyzing, it is discovered that accompanying advancing of TNM staging, disease aggravates from superficies to interior and from FU-organs to ZANG-organs and sthenia syndrome turns conspicuous. The KPS core of the patients with asthenia syndrome is lower than asthenia and sthenia inclusion syndrome; that as patients growing old, asthenia syndrome becoming more and more.Conclusion: According to the results of mathematical statistics combining with theory of TCM, it is discovered that pattern of differentiation of symptoms and signs of postoperative colorectal cancer has its regular and objectivity. And it is a modus operandi for researching the regular pattern of differentiation of symptoms and signs of postoperative colorectal cancer that prospective clinical investigation combines to mathematical statistics and multiplicity, and is worth extending and studying further.
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