The Clinical Study Of Replenishing Qi To Invigorate The Spleen And Relieve Stasis Formula On Immunity In Treating Patients With Gastric Cancer

Background:Gastric cancer(GC)rant tumor originefers to the malignating from gastric epithelial cells,with common incidence of gastric adenocarcinoma,the incidence and mortality of which rank the top three malignant tumors in China.At present,chemotherapy is one of the commonly used clinical treatments of gastric cancer.However,the clinical symptoms associated with chemotherapy and the reduction of immune function have become important factors influencing the curative effect and reducing the quality of life of patients.Replenishing Qi to invigorate the spleen and relieve stasis prescription has been used in clinic by Professor Shenlin Liu for many years,which is an experienced prescription for treating gastric cancer with a solid foundation of clinical efficacy.Combined with chemotherapy drugs,it can reduce patient discomfort and improve immune function.In order to further evaluate the clinical effect of the prescription in the treatment of GC,the study will follow the GCP and adopt random double-blind,single simulation and parallel control methods to objectively evaluate the efficacy differences between conventional chemotherapy and the chemotherapy combining with traditional Chinese medicine(TCM),providing objective evidence for the clinical application.Objective:To observe and evaluate the formular's clinical efficacy of reliefing symptoms and regulating immune function on GC chemotherapy patients.Methods:The experiment was designed according to good clinical practice(GCP)and adopted random double-blind,single simulation and parallel control methods.40 GC patients who met the standard were divided into two groups according to the random blind method by computer,namely the treatment group(DC chemotherapy combining with replenishing Qi to invigorate the spleen and relieve stasis prescription boil-free granule)and the control group(DC chemotherapy combining with replenishing Qi to invigorate the spleen and relieve stasis prescription simulation granule).After two courses chemotherapy(fifty six days),symptoms and signs of TCM and cell immunologic function indexes(CD4,CD8,CD4/CD8,NK cell values)and the changes of blood routine examination,liver and kidney function(ALT,AST,Cr,BUN)were observed and compared.The concentration of tumor necrosis factor-a(TNF-a)and interferon-?(IFN-?)in peripheral blood were measured by enzyme linked immunosorbent assay(ELISA)before and after treatment.Results:First,the treatment group was superior to the control group in the classification of TCM symptoms and signs in patients with gastric cancer,especially in the improvement of symptoms and signs.Second,in terms of the detection of cell immunologic function indexes,the number of CD4,CD4/CD8 and NK cells in the treatment group increased while the number of CD8 decreased.Compared with the control group,the cell immunologic function of the patients was improved significantly in the treatment group.Third,the number of TNF-a in the treatment group decreased while it increased in the control group after treatment.Even the difference was not obvious,the treatment group was obviously superior to the control group.The number of IFN-y increased in the treatment group while it showed an slightly increase in the control group.There existed significant difference between the two groups and the treatment group was superior to the control group.Forth,the change of blood routine examination and liver and kidney functions(ALT,AST,Cr,BUN)didn't show regularity.There wasn't significant differentiation between groups before and after treatment.Conclusion:The DC combining with replenishing Qi to invigorate the spleen and relieve stasis prescription has synergistic effect on the patients with gastric cancer,the comprehensive effect of which is superior to the group only treated with DC.Based on the synergistic efficacy and the regulation of the number of CD4,CD4/CD8 and NK and the change of TNF-a and IFN-y,the prescription can improve the body's immune function of patients,obviously improve the symptoms during chemotherapy,enhance the cell immune function and improve the quality of survival.