Clinical Study Of Xianlian Granule Combined With XELOX Regimen In The Treatment Of Stage Ⅳ Colorectal Cancer

Obj ective:Based on the theory of cancer pathogenesis,this study was aimed at observing the clinical efficacy and safety of Xianlian Granules combined with XELOX regimen in the treatment of IV stage colorectal cancer patients with damp-heat stasis toxin syndrome.In order to better inherit and develop the academic thought and clinical experience of famous veteran teran doctors of TCM,promote the clinical application of the theory system of cancer pathogenesis,and further improve the clinical efficacy of traditional Chinese medicine in the treatment of tumor.Methods:Patients with stage IV colorectal cancer in the ward and outpatient department of Jiangsu Cancer Hospital from June 2017 to January 2019 were enrolled.Sixty patients who met the inclusion criteria were divided into treatment group and control group,29 cases in the treatment group were treated with Xianlian granule combined with xelox chemotherapy(1 case of detachment in the midway),and 30 cases in the control group were treated with xelox chemotherapy alone.The tumor lesion size,TCM syndrome score,cellular immune function,tumor markers such as CEA,CA199,CA724,serum cytoplasmic thymidine kinase,serum D-dimer,quality of life score in patients with colorectal cancer,karnofsky score,toxic and side effects were recorded before and after treatment.The above results were statistically analyzed by SPSS 20.0.Results:1.Comparison of Objective Efficacy:The ORR was 17.24%and the DCR was 82.76%in the treatment group,the ORR and the DCR in the control group were 16.67%and 83.33%respectively.There was no significant difference between the two groups(P=0.953>0.05).2.Comparison of improvement of damp-heat stasis toxin syndrome:The total effective rate was 65.52%in the treatment group and 36.67%in the control group.There was significant difference between the two groups(P=0.027<0.05).3.Comparison of cellular immune function:The values of CD4+/CD8+and NK cells in the treatment group were higher than those before treatment(P<0.05),and the values of CD3+and CD4+cells in the treatment group were significantly higher than those before treatment(P<0.01).But there was no significant difference in the indexes in the control group after treatment(P>0.05).The value of CD3+cells in the treatment group was significantly higher than that in the control group after treatment(P<0.01).4.Comparnson of serum tumor markers:The normal serum CEA,CA199,CA724 before treatment were mostly within the normal range after treatment,and a few changed to abnormal.The elevated CEA,CA199 and CA724 before chemotherapy showed a decreasing trend after two cycles of treatment,but there was no significant difference between before and after treatment(P>0.05),and there was also no statistical difference between the groups(P>0.05).5.Comparison of serum cytoplasmic thymidine kinase:After treatment,the serum cytoplasmic thymidine kinase was decreased in the treatment group(P=0.011<0.05),and in the control group(P=0.037<0.05),but there was no significant difference between the two groups after treatment(P=0.666>0.05).6.Comparison of serum D-dimer:After treatment,the serum D-dimer level in the treatment group decreased with statistical difference(P--0.015<0.05).There was a decreasing trend before and after treatment in the control group,but there was no statistical difference(P=0.478>0.05).There was also no significant difference between the groups after treatment(P=0.25 5>0.05).7.Comparison of the Functional Assessment of Cancer Therapy-Colorectal(FACT-C)score:After treatment,the treatment group was significantly higher in terms of physiological status,functional status,additional attention status and total score(P<0.01).In the control group,physiological status,additional attention and total score also increased(P<0.05).After treatment,there were statistical differences in physiological status,functional status and additional attention between the two groups(P<0.05),and there was significant difference in total score(P<0.01).8.Comparnson of karnofsky score:The karmofsky score in the treatment group increased significantly after treatment(P=0.001<0.01),but there was no significant difference in the control group(P=0.366>0.05).The difference between the two groups was statistically significant after treatment(P=0.02<0.05).9.Comparison of toxic and side effects:The incidence of diarrhea was 13.79%in the treatment group and 36.67%in the control group,there was statistical difference between the two groups(P=0.044<0.05),but other toxic and side effects were not statistically different.Conclusion:1.Compared with xelox chemotherapy alone,Xianlian granule combined with xelox regimen could significantly improve TCM syndrome,improve cellular immune function,improve the quality of life and karnofsky score in Ⅳ stage colorectal cancer patients with damp-heat stasis toxin syndrome.However,it has no advantage in reducing tumor lesion size,reducing the tumor markers CEA,CA199,CA724,decreasing serum cytoplasmic thymidine kinase and improving the coagulation function.2.Xianlian granule combined with XELOX regimen did not increase the toxic and side effects of chemotherapy,on the contrary it could alleviate the common side effects of XELOX chemotherapy such as diarrhea,and improve the tolerance of patients to chemotherapy,it was safe and reliable on the whole.