| Objective:To observe the effects of Kechuanning capsules on airway inflammation in patients with COPD and inflammatory cells, inflammatory mediators and clinical efficacy; To explore the action mechanism and C urative effect evaluation of Kechuanning capsules for COPD. Methods:110 patients with stable COPD were randomly divided into the therapy group and the control group, 55 cases in each group. Both of the groups were given compound isopropyl bromide solution aerosol for inhalation. On the basis of the treatment of western medicine, patients in the therapy group took Kechuanning capsules orally, 4 softgels each time, 3 times a day. O n the basis of western medicine treatment, patients in the control group took the same amount of placebo capsules, 4 softgels each time, 3 times a day. The treatment lasted three months. Differential counting of inflammatory cells and levels of inflammatory factors in serum and sputum supernatant were observed. Meanwhile, the clinical efficacy, BODE index, CAT score and ADRs of patients in the two groups were observed.Results:1. In terms of differential counting of inflammatory cells, the sputum neutrophils of the therapy group decreased significantly(P<0.05) and macrophages increased(P<0.05) after treatment, with statistical significance compared with the control group.2. In terms of inflammatory mediators, the levels of IL-6, IL-8, LTB4 in serum did not change significantly(P<0.05) in two groups before and after treatment;IL-6, IL-8, LTB4 levels in the sputum supernatant of the therapy group were lower than those before treatment(P<0.05), with statistical significance compared with the control group.3. The clinical efficacy in the therapy group was 96.00%(48/50), and 88.24%(45/51) in the control group, with statistical significance(P<0.05).4. Making the analysis of ITT and PP, the two therapy groups with compared clinical efficacy are superior to the control group ITT:z=-2.062,P=0.039;PP:z=-2.091,P=0.037.5. BODE index and C AT score in the two groups decreased and the therapy group was lower than the control group(P<0.05).6. Liver and kidney function had no obvious abnormalities in the treatment group before and after treatment. Conclusions:Kechuanning capsules have an obvious inhibitory effect on airway inflammatory cells in patients with stable COPD as well as the release of inflammatory mediators. And effectively reduce the BODE index and C AT score in patients with stable COPD, improve patients’ life quality and clinical outcomes, and no obvious side effect has been found. |