摘要Objective: To evaluate the effectiveness of a comprehensive therapy of traditional Chinese medicine (TCM) in reducing the relapse and metastasis of stage Ⅱ and Ⅲ colorectal cancer based on conventional Western medicine (WM) therapy. Methods: Two hundred and twenty-two patients in total, diagnosed as stage Ⅱ and Ⅲ colorectal cancer from February 2000 to March 2006, were recruited from Xiyuan Hospital, China Academy of Chinese Medical Sciences and the General Hospital of Beijing Military Area. They were followed-up once every 3-6 months. Twenty cases dropped out from the cohort. The remaining 202 patients were all treated with routine WM treatment [including R0 radical operation, or chemotherapy or/and radiotherapy according to national comprehensive cancer network (NCCN) clinical guidelines]. These patients were assigned to two groups based on whether or not they were additionally treated with TCM comprehensive therapy (orally administered with a decoction according to syndrome differentiation, combined with a traditional patent drug over one year). Ninety-eight patients from Xiyuan Hospital were treated with WM and TCM (combined group), and 104 patients from the General Hospital of Beijing Military Area were treated with WM alone (WM group). The demographic data at baseline were comparable, including the operation times, age, sex, TNM staging, and pathological types. The patients were followed-up for one to five years. Up to now, there are 98, 98, 77, 64, and 47 patients with 1, 2, 3, 4, and 5 years of follow-up in the combined group, respectively; and 104, 104, 97, 81, and 55 patients in the WM group, respectively. The results of the 5-year follow-up of all the patients will be available in 2011. Results: The relapse/metastasis rate of 1-, 2-, 3-, 4-, and 5-year were 0 (0/98), 2.04% (2/98), 11.69% (9/77), 14.06% (9/64), and 21.28% (10/47) in the combined group, and were 4.80%(5/104), 16.35% (17/104), 21.65 % (21/97), 25.93 % (21/81), and 38.18 % (21/55) in the WM group, respectively. A significant difference was found in the second year between the two groups ( x<'2>=12.117, P = 0.000). Median relapse/ metastasis time was 26.5 months in the combined group and 16.0 months in the WM group. Conclusion: The combined therapy of TCM and WM may have great clinical value and a potential for decreasing the relapse or metastasis rate in stage Ⅱ and Ⅲ colorectal cancer after conventional WM therapy.