Objective:To compare and analyse the progression-free survival(PFS),tumour markers,body weight,Chinese Medicine Symptom Score,Carpenter’s score and adverse drug reactions of patients with advanced colorectal cancer treated with Additive Shen Ling Bai Zhu decoction and Capecitabine maintenance therapy through a clinical study to evaluate the efficacy and application advantages of Additive Shen Ling Bai Zhu decoction in the maintenance treatment of patients with advanced colorectal cancer.Methods:Patients with stage IV colorectal cancer(colon or rectal cancer)treated at the Department of Oncology,The First Affiliated Hospital of Heilongjiang University of Chinese Medicine from October 2021 to March 2022,including outpatients and inpatients,were selected.According to the inclusion and exclusion criteria,60 patients who met the study criteria were randomly divided into 30 patients each in the Chinese medicine group(experimental group)and the capecitabine group(control group)using the random number table method.The Chinese medicine group was given Ginseng and Atractylodes Plus maintenance treatment,while the capecitabine group was given capecitabine maintenance treatment.Patients in both groups continued to take the drug until the disease progressed or the patients could not tolerate the adverse drug reactions.The patients were monitored by imaging review after every 2-3 treatment cycles until disease progression or the end of the study,with the long-term observation index being progression-free survival(PFS).The data were statistically analysed using the software Graph Pad Prism9.0.Results:The study included 60 patients who met the criteria,30 each in the herbal group and the capecitabine group.There were no significant differences in gender,age,tumour site,degree of differentiation and metastatic site between the Chinese herbal medicine group and the capecitabine group at the time of enrolment at baseline data,which were comparable.The mean PFS in the TCM group was 6.44±2.34 months,with a median PFS of 6.65 months;the mean PFS in the capecitabine group was 5.74±2.12 months,with a median PFS of5.6 months;the data of the two groups suggested a trend of prolonged progression-free survival in the TCM group compared with the capecitabine group,but there was no statistical difference(P>0.05).the CEA and CA199 values between the two groups P-values before and after treatment were >0.05,with no statistical difference;P-values before and after treatment in the same group were <0.001,with a statistically significant difference.Weight was statistically different with P-values <0.05 before and after treatment in the same group.Chinese Medicine Symptom Scores were statistically different between the two groups before and after treatment in the same group(P <0.05).There was no statistical difference in the cardinality score between the two groups before treatment(P > 0.05)and after treatment(P < 0.05);when compared before and after treatment in the same group,there was a statistical difference in the Chinese medicine group(P < 0.05)and no statistical difference in the capecitabine group(P > 0.05).In terms of adverse drug reactions,the incidence of blood,liver and kidney toxicity,diarrhea and hand-foot syndrome in the Chinese medicine group was significantly lower than that in the capecitabine group,and the difference was statistically significant(P < 0.05).Conclusion:1.In the treatment of advanced colorectal cancer with spleen deficiency and dampness stagnation,Shenling Baizhu Powder can prolong PFS to a certain extent,and its effect is no less than capecitabine maintenance.2.The treatment of advanced colorectal cancer of the type of spleen deficiency and dampness stagnation with Additive Shen Ling Bai Zhu decoction can significantly improve the clinical symptoms and the quality of survival of the patients.3.The treatment of advanced colorectal cancer of the spleen deficiency and dampness type with Additive Shen Ling Bai Zhu decoction can effectively improve patients’ KPS scores and keep them in good physical condition.4.The treatment of advanced colorectal cancer with spleen deficiency and dampness stagnation is safe with Additive Shen Ling Bai Zhu decoction. |