| Objective: This study observed the efficacy and safety of Fuzheng Guben Decoction in the immune maintenance treatment stage of advanced NSCLC through clinical research,and explored the mechanism of its action on the immune microenvironment by detecting the serum of patients before and after treatment,so as to provide scientific basis and data support for clinical application.Methods:(1)Clinical study: In this study,a single-center cohort study was used.Patients diagnosed with advanced/advanced NSCLC were divided into experimental group and control group according to the patients’ wishes,with 24 cases in each group.On the basis of publicity,education and medication guidance,the experimental group was given Fuzheng Guben Decoction combined with immune checkpoint inhibitor maintenance treatment,and the control group was given immune checkpoint inhibitor maintenance treatment.Clinical intervention was carried out respectively,with a course of 6 weeks.Quality of life assessment,TCM syndrome score,incidence of adverse events,incidence of immune-related adverse events,discontinuation or delay of medication were selected as the main efficacy evaluation indexes,and ORR,3-month and 6-month PFS rate,DCR,tumor markers,and safety were selected as the secondary evaluation indexes.(2)Experimental research: According to the clinical inclusion and exclusion criteria,patients with locally advanced/advanced NSCLC immune maintenance therapy were treated with Fuzheng Guben Decoction combined with standard Western medicine treatment.Peripheral blood 6ml of patients before and after treatment were collected and stored in the biobank,and blood samples before and after treatment were detected and analyzed.To explore the regulatory effects of Fuzheng Guben Decoction treatment on lymphocytes and cytokines related to anti-tumor immunity and promoting tumor development in peripheral blood,and explore the therapeutic efficacy prediction markers of immune combined with traditional Chinese medicine,and identify the beneficiary groups.Results:(1)Clinical study: The experimental group was superior to the control group in improving KPS score,TCM symptom score,physical function field,role function field and total health status of patients in quality of life scale,symptom field fatigue,insomnia,loss of appetite,constipation symptoms and reducing tumor marker(CEA)(P<0.05).(2)Fuzheng Guben Decoction could improve CD3+,CD4+ percentage and CD4+/CD8+ ratio in NSCLC patients(P< 0.05).Regulate the decrease of immunosuppressive factors IL-6,IL-10 and TGF-β,and up-regulate the secretion of IFN-γcytokines(P < 0.05).Conclusion: Fuzheng Guben Decoction,based on the guiding principle of "Fuzheng",has a definite curative effect in the adjuvant treatment of stage IIIA-IV NSCLC.Compared with Western medicine alone,it can enhance the quality of life of patients in the stage of NSCLC immune maintenance treatment,alleviate clinical symptoms,stabilize or improve the physical scores of patients,and reduce the sensitive tumor markers of NSCLC.Its mechanism of action may be related to the effect of Fuzheng Guben Decoction on lymphocyte subpopulations and cytokines in the immune microenvironment.Meanwhile,this prescription can help improve the prevention of treatment-related adverse reactions,and can be used as an adjuvant therapy in the stage of immune maintenance therapy for NSCLC. |
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