| ObjectiveTo observe the synergistic tumor suppressive effect of Xihuang capsule combined with capecitabine on advanced triple-negative breast cancer based on the theory of“stasis and toxicity”,and to investigate the tumor suppressive effect and mechanism of Xihuang capsule on mice with transplanted breast cancer,so as to clarify the efficacy and mechanism of Xihuang capsule in the treatment of advanced triple-negative breast cancer,and to provide effective and feasible therapeutic ideas and an objective basis for future clinical work.The objective basis for future clinical work was to clarify the efficacy and mechanism of Xixiang capsule in the treatment of advanced triple negative breast cancer.MethodsThis study used a combination of clinical and experimental research methods,which consisted of two main parts.Clinical part: a prospective randomized controlled study was used to include 64 cases of advanced triple negative breast cancer,32 cases in the control group and 32 cases in the observation group.The control group received capecitabine treatment,and the observation group was treated with the addition of Xihuang capsule on top of the control group for 21 days as one treatment cycle.The safety of patients in both groups was examined before and after each cycle of treatment,and the clinical efficacy was evaluated after 2 cycles.The efficacy indexes were: recent efficacy,improvement of clinical symptoms in Chinese medicine,tumor markers(CEA,CA153)levels,quantitative score of physical status,and quantitative score of quality of life.The safety evaluation indexes were: blood routine,liver and kidney function,occurrence of toxic side effects indexes(such as diarrhea,constipation,nausea and vomiting hand-foot syndrome,etc.).Experimental part: 40 Kunming mice were used to model breast cancer transplantation tumor mice by transplantation tumor tissue block method,and after successful modeling,40 mice were divided into model group,capecitabine group,western yellow capsule group and combination group by randomized grouping method,10 mice in each group.The drug intervention was started from the 7th day of inoculation,and the model group was given saline gavage,the capecitabine group was given capecitabine suspension gavage,the xiphoid capsule group was given xiphoid capsule suspension gavage,and the combination group was given capecitabine suspension and xiphoid capsule suspension gavage,and the gavage was given for 5 days per week and stopped for 2 days,for a total of 3 weeks,in which capecitabine was given for 2 weeks and stopped for 1 week in the capecitabine group and the combination group,and the rest remained unchanged.Specimens were collected 24 hours after the last dose.The general status of the mice in each group was compared,tumor dynamics were recorded,tumor weight was measured,tumor inhibition rate was calculated,and the expression status of p53 and PCNA genes in tumor tissues was determined by immunohistochemical analysis.ResultsClinical results: During the study,one patient in the control group was dropped due to loss of visit,one patient was dropped because he stopped taking Xihuang capsule for one week in the middle of the study,one patient in the observation group was dropped because he received other treatment on his own,and one patient was dropped because of incomplete imaging data.60 patients finally completed the clinical trial,30 patients in the control group and 30 patients in the observation group.The objective remission rates of patients in the observation and control groups were basically similar,and the degree of difference was not statistically significant(P=0.559>0.05),and the disease control rate in the observation group was higher than that in the control group(P=0.038<0.05);the quantitative TCM syndrome score values in both the observation and control groups decreased significantly(P<0.05),and the degree of decrease in the TCM syndrome score of patients in the observation group was significantly better than that in the(P=0.003<0.05),and the efficacy of TCM syndrome in the observation group was significant compared with the control group(P=0.042<0.05);both the control group and the observation group could reduce the level of CEA and CA153 in the patients(P<0.05),and the degree of decrease in the observation group was more significant(P<0.05);the quantitative scores of physical status KPS,quality of life FACT-B quantitative scores in the observation group were better than those in the control group(P<0.05);the occurrence of peripheral blood neutropenia,leukocytopenia,constipation,and hand-foot syndrome in the observation group was less than that in the control group(P<0.05),and the occurrence of peripheral thrombocytopenia,diarrhea,and nausea and vomiting in the two groups was basically the same(P>0.05),and during the study,no No cases of abnormal ECG,liver and kidney functions were observed in the two groups during the study.The results of the experimental study: Xihuang capsule can improve the general status of mice;compared with the model group,the remaining three groups can reduce the volume of transplanted tumors in the tumor-bearing mice(P<0.05),improve the tumor suppression rate to different degrees,and significantly reduce the weight of transplanted tumors(P<0.05);down-regulate the expression of PCNA and p53 in tumor tissues,among which the combined group has the best effect.Conclusion1.Xixiang capsule combined with capecitabine can synergistically improve the disease control rate of advanced triple-negative breast cancer patients,improve the clinical symptoms of TCM,reduce the levels of tumor markers CEA and CA153,improve the quantitative KPS score of patients,improve the quality of life of patients,and reduce the occurrence of toxic side effects(peripheral blood neutropenia,peripheral blood leukopenia,constipation,hand-foot syndrome)conditions.2.Xihuang capsule can improve the general status of mice,reduce the size of transplanted tumors,reduce tumor weight,improve tumor suppression rate,inhibit the proliferation of breast tumor cells and delay the progression of tumor disease by down-regulating the expression of p53 and PCNA. |
