| Objective: Using prospective research methods to explore the clinical efficacy and immune effects of "Kaiyu Tongbi" Shenge Yifei Capsules in the treatment of chronic obstructive pulmonary disease in the stable stage,and observe the patients’ TCM syndrome score,mMRC scale score,CAT score,and lung function,Serum cytokines IFN-γ and IL-4,immunoglobulin IgA and safety indicators.It provides a clinical basis for the treatment of patients with chronic obstructive pulmonary disease in the stable stage by the "kaiyutongbi" method,and initially explores the immune mechanism of Shenge Yifei Capsule in patients with chronic obstructive pulmonary disease in the stable stage.Methods: Select the patients with stable chronic obstructive pulmonary disease who were treated in the Traditional Chinese Medicine Hospital of Southwest Medical University from October 2018 to October 2019,and 76 patients who met the inclusion and exclusion criteria were divided into control groups according to the randomized controlled study method(Conventional Western medicine treatment)and treatment group(conventional Western medicine + Shenge Yifei Capsule treatment),38 cases in each group,3 months as an observation period.Observe the changes in TCM syndrome scores,lung function,mMRC scale scores,CAT scores,serum cytokines IFN-γ,IL-4,immunoglobulin IgA and safety indicators before and after treatment in each group,using SPSS19.0 Statistical software,statistics and analysis of data.Results:(1)Comparison of symptom scores and curative effect of TCM: TCMSS after treatment in both groups decreased compared with before treatment(P <0.05),and the decrease in treatment group was more obvious(P <0.05).The effective rate of the control group was 78.9%,and the effective rate of the treatment group was 94.7%.The treatment group was higher than the control group,and the difference was statistically significant(P <0.05).(2)Comparison of mMRC scale score and CAT score: The mMRC scale score and CAT score of the control group and the treatment group decreased after treatment and before treatment(P <0.05),and the mMRC scale score and CAT score of the treatment group decreased more significantly after treatment(P <0.05).(3)Pulmonary function comparison: Before and after treatment,the FEV1% of the two groups improved(P <0.05),and the treatment group improved lung function more significantly(P <0.05).(4)Comparison of serum IFN-γ and IL-4: After treatment and before treatment,IFN-γ decreased and IL-4 increased(P <0.05).After treatment,IFN-γ decreased and IL-4 increased more significantly(P <0.05).(5)Comparison of IgA: There was no significant change in IgA before and after treatment in the control group(P> 0.05).Compared with before treatment,the level of IgA in the treatment group increased significantly(P <0.05).(6)Safety index: There was no significant change in WBC,PLT,HGB,ALT,AST,BUN,Cr before and after treatment in the treatment group and the control group(P> 0.05).Conclusion:(1)"Kaiyutongbi" method of Shenge Yifei Capsule combined with Western medicine treatment can significantly alleviate the clinical symptoms of patients with COPD stable stage,reduce the mMRC scale score and CAT score,improve lung function,and have better clinical efficacy and safety(2).The therapeutic effect of Shenge Yifei Capsule on patients with COPD stable stage shows that the "Kaiyutongbi" method is reliable,effective and safe in the treatment of COPD stable stage,which provides strong evidence for the treatment of pulmonary diseases by Xuanfu theory.(3)Shenge Yifei Capsule may improve the imbalance of Th1 / Th2 differentiation by reducing the level of IFN-γ and increasing the level of IL-4,and at the same time increase the expression of IgA,and jointly improve the immune imbalance of the body and enhance the body’s immune ability effect. |