| Objective: To evaluate the clinical efficacy and safety of Jiawei Shengxian Decoction in the treatment of chronic obstructive pulmonary disease(COPD)patients with qi deficiency and phlegm and blood stasis syndrome,and to explore its mechanism.Methods: 1.A "single-center,prospective,randomized,controlled" design was used to enrolled 72 COPD patients with qi deficiency,phlegm and blood stasis syndrome.The patients were divided into experimental group and control group.The control group was treated with glonium bromide and formoterol aerosol,and the experimental group was treated with Jiawei shengxian decoction on the basis of the control group.The clinical efficacy and safety of Jiawei Shengxian decoction in the treatment of COPD patients with qi deficiency,phlegm and blood stasis obstruction were evaluated by lung function,CAT score,TCM syndrome total score and blood routine,liver and kidney function.2.To detect the expression level of Sirt1 mRNA in peripheral blood mononuclear cells(PBMCs)of patients,and to explore the mechanism of Jiawei shengxian decoction in the treatment of COPD patients with qi deficiency and phlegm stasis syndrome.Results: 1.Comparison of baseline data: There was no statistically significant difference between the two groups in age,course of disease,sex and GOLD grading,P>0.05.Before treatment,there was no statistically significant difference between the two groups in lung function(FEV1 /FVC%,FEV1% of the expected value,FVC),the relative expression of Sirt1 mRNA in PBMCs,CAT score and TCM syndrome score,P>0.05,so the two groups were comparable.2.Clinical efficacy 2.1 Pulmonary function: After treatment,the pulmonary function(FEV1/FVC%,FEV1%pred,FVC)of the control group and the experimental group were significantly improved compared with those before treatment,P < 0.01,and there was no significant difference between the two groups,P > 0.05.2.2 CAT score and TCM syndrome score: After treatment,the CAT score and TCM syndrome score of the control group and the experimental group were significantly lower than those before treatment,P < 0.01;And the experimental group was lower than the control group,P < 0.05.3.Safety There were no significant differences in liver function(ALT,AST),renal function(SCr,BUN),and blood routine(WBC,PLT)between the two groups before and after treatment,P > 0.05.4.Sirt1 mRNA expression in PBMCs After treatment,the relative expression of Sirt1 mRNA in the control group and the experimental group was significantly higher than that before treatment P<0.05,P<0.001.The relative expression of mRNA in the experimental group increased more significantly than that in the control group,P < 0.001.Conclusion: 1.Jiawei shengxian decoction combined with glyronium bromide formoterol inhalation aerosol can effectively reduce the CAT score and TCM syndrome score of COPD patients with qi deficiency and phlegm and blood stasis syndrome in stable stage,and its effect is better than that of simple western medicine treatment group,and can improve the level of lung function of patients.2.The mechanism of Jiawei Shengxian decoction in the treatment of COPD patients with qi deficiency and phlegm stasis syndrome may be related to increasing the relative expression of Sirt1 mRNA,delaying cell senescence,and combating oxidative stress and inflammatory response. |