| The colorectal cancer, including colon cancer and rectal cancer, is one of common malignant tumors. Viewed from the global, the incidence of colorectal cancer is rising year by year, and its incidence rate has been up to No. 4 from No. 6 among the incidence of malignant cancer, just preceded by gastric carcinoma, lung carcinoma and liver carcinoma in china. Moreover, in the Western countries, it occupies the second as a cause of death owing to cancer. The early stage colorectal cancer gives priority to surgical treatment, chemotherapy and radiotherapy have the first consideration in the middle and late stages. Surgery is a major therapy way which regarded as the only means of curative colorectal cancer, that is why operation was considered as the most important way in the treatment of colorectal cancer. However, the prognosis of colorectal cancer is not very satisfactory, especially for those with advanced colorectal carcinoma. According to the recently literatures reported, one quarter of the colorectal cancer will recurrence inevitablely after operation. Therefore, it is of great significance to improve immunity, re duce chemotherapy side effects and improve patient quality for the way that we combined traditional Chinese medicine with western medicine. We decided to undertake a systematic prospective study of the"ShuangXian capsule"combined with chemotherapy in the mid-advanced colorectal cancer patients with a twofold aim:1. To evaluate the curative effect in the near future, adjust immune function and reduce toxicity during chemotherapy in patients with colorectal cancer; 2. To provide a strong basis for improving quality of life and adjuvant therapy with colorectal cancer patients. Methods: In this study, 60 individuals with mid-advanced colorectal cancer were randomly divided into two groups, one group constitutes of 30 patients who received the chemotherapy (FOLFOX4 regimen) and the"ShuangXian capsule", the others administered the chemotherapy(FOLFOX4 regimen) alone as the control group. They were followed up for 8 weeks during chemotherapy. The objective effects and immune function were compared for both groups. Results: Two groups were compared in our study, the immune indexes, the clinical symptoms, quality of life indictors, the tumor markers were all significantly improved in the treatment group, better than in the other one(P <0.05). In particular, the activity of NK cell activity and ratio of CD3+,CD4+,CD4+/CD8+ in treatment group were extraordinary enhancement (P<0.01). Although the ratio of CD3+ decreased a little in the control group, it had statistically significant (P<0.05). There was no significant difference in the IgA and IgM, as well as the result of tumor size and cancer markers(CEA)compared to the control group(P>0.05). Besides, there was no significant toxic of liver and kidney in the test.Conclusion: Combined the"ShuangXian capsule"with chemotherapy (FOLFOX4 regimen) have a curative effect on treating mid-advanced colorectal cancer, which can improve the immune function of cancer patients and reduce the toxicity of chemotherapy, keep the tumor mass steadied, and make the patient's quality of life better. We obtained the quantitative indicators of"ShuangXian capsule"have the advantages of strengthening effect and reducing toxicity during the course of chemotherapy, which partial explained the good clinical efficacy of the preparation in the past decades. To provide convincing basis for further study the"ShuangXian capsule". |