| Obj ective:1.To observe the clinical efficacy of modified Danzhi Xiaoyao powder in the treatment of patients with advanced triple-negative breast cancer of liver depression and fire;2.To explore the mechanism and potential targets of Danzhi Xiaoyao powder in the treatment of triple negative breast cancer using network pharmacology research methods.Methods:Clinical observation part:A total of 60 patients with advanced triple-negative breast cancer of liver stagnation and fire type who met the inclusion criteria were collected from the Oncology Department of the First Affiliated Hospital of Heilongjiang University of Chinese Medicine from December 2021 to December 2022,and treated with modified DanzhiXiaoyao powder.Tumor size,tumor markers(CEA,CA15-3),TCM syndrome score,quality of life score and T cell subsets were observed before treatment,6 weeks after treatment and 12 weeks after treatment,and the clinical efficacy was evaluated.Network pharmacology:TCMSP and other data platforms were used to screen the main Chinese medicinal active ingredients in Danzhi Xiaoyao powder and predict their targets,and the disease database was used to screen the triple negative breast cancer related targets.Cytoscape software was used to analyze the core active components,and STRING and DAVID platforms were used to analyze the core targets and related pathways.Molecular docking was performed by AutoDockTools and other tools.Results:Clinical observation part:60 patients were enrolled,4 patients dropped out during the treatment,and 56 patients were finally observed.1.The objective response rate of solid tumors was 1.79%after 6 weeks of treatment and increased to 5.36%after 12 weeks of treatment.After 12 weeks of treatment,the disease control rate was 69.64%.2.The levels of CEA and CA15-3 decreased significantly after 12 weeks of treatment(P<0.05).3.The clinical symptoms of dizziness,bitter mouth,dry throat,nausea and vomiting,loss of appetite,breast pain,chest tightness,irritability were significantly improved(P<0.01),constipation symptoms were slightly relieved.4.The KPS score was not significantly improved after 6 weeks of treatment,but significantly improved after 12 weeks of treatment(P<0.05).5.After 12 weeks of treatment,CD3+,CD4+,CD4+/CD8+were increased(P<0.0 1),and CD8+percentage was decreased(P<0.0 1).6.After treatment,the patient’s blood routine,liver and kidney function,etc.showed no abnormal changes,and the safety was good.Network Pharmacology:1.Kaempferol,quercetin,isorhamnetin,luteolin andβ-sitosterol were screened as core components.2.TP53,Src,MAPK3,PIK3R1,MAPK1,PIK3CA,HDAC1,ESR1,AKT1,EGFR and related pathways such as PI3K/AKT,MAPK,RAS were screened.3.Molecular docking showed that the core components had strong binding activity with the core targets.Conclusions:The modified Danzhi Xiaoyao powder is effective in reducing tumor markers,improving clinical symptoms,improving quality of life and regulating immune function in the treatment of patients with advanced triple-negative breast cancer of liver stagnation and fire type,and also has a certain effect on the objective efficacy of solid tumors,with good safety.The network pharmacology prediction results showed that the modified Danzhi Xiaoyao powder could treat triple-negative breast cancer through multi-components,multi-targets and multi-pathways. |