The Clinical Research Of Preventing And Treating COPD Based On Root-securing Origin-supplementing Thought Of Xin’an Medicine

【Objective】Based on the stable Phase of COPD with lung-kidney qi deficiency, phlegm-stasis obstructing the lung syndrome, taking Xin’an medical "root-securing origin-supplementing" theory as the principle of treatment and using Qibai Pingfei capsule intervent clinical research, to further observe the pulmonary function, times of acute exacerbation,TCM syndrome score,western medicine syndrome score,dyspnea grade,assessment of exercise capacity and quality of life assessment scale changes in patients of COPD stable phase with lung-kidney qi deficiency, phlegm-stasis obstructing the lung syndrome, and to determinate the peripheral serum IL-10,IL-17,LTB4,MCP-1,NGAL,TGF-β1 levels. To preliminary observe the clinical effect of Xin’an medicine "root-securing origin- supplementing" theory intervent on the stable phase of COPD patients with lung-kidney qi deficiency,phlegm-stasis obstructing the lung syndrome, providing an important scientific basis for the intervention of Traditional Chinese Medicine on stable phase of COPD.【Methods】1.In this multi-center, randomized, double-blind and placebo-controlled clinical trial, we collected 45 patients of COPD on stable phase with lung-kidney qi deficiency,phlegm-stasis obstructing the lung syndrome from the multi centers, they were randomly divided into two groups, 30 patients in Qibai Pingfei group, and 15 cases in the placebo group. Drugs were given according to the number of the patients, patients on both groups were given the basic treatment of western medicine.Qibai Pingfei capsule was added in the Qibai Pingfei group, and placebo capsule was added in the placebo group. All the patients took drugs for 3 months, and then they were continue tobe observed for 6 months after drug withdrawal until the end of the observation period,a total of 9 months.2. Changes of the pulmonary function, times of acute exacerbation,TCM syndrome score,western medicine syndrome score,dyspnea grade,assessment of exercise capacity and quality of life assessment scale before treatment, after treatment in the third month and the ninth month were respectively observed in the two groups, and the peripheral serum IL-10,IL-17,LTB4,MCP-1,NGAL,TGF-β1 levels were determined using the ELISA method.【Results】1.There were no statistically significant differences in the general clinical data including gender, age, severity of illness between the two groups of patients at baseline under the spass 17.0.2.Lung function and 6 minutes walking distance were both increased in Qibai Pingfei group after taking Qibai Pingfei for 3 months compared with before(P<0.05), but trending decrease before treatment, after treatment in the third month and the ninth month in the control group(P<0.05). When comparing with the control group, lung function and 6 minutes walking distance were significantly increased before treatment and after treatment in the third month in Qibai Pingfei group(P<0.05).The dyspnea grade score,TCM syndrome score,western medicine syndrome score and CAT score in Qibai Pingfei group were significantly lower after treatment in the third month than before(P<0.05), and were still lower in the ninth month than before treatment(P<0.05), but trending increase in the three time points in the control group(P<0.05). When comparing with the control group, the scores of the four scales were significantly decreased in Qibai Pingfei group(P<0.05).3.Serum levels of IL-10 had a decrease trend as the progress of observation time in the control group, but was significantly higher after treatment in the third month in Qibai Pingfei group(P<0.05), and had no significant difference in the ninth month compared with before treatment(P>0.05), but was still significantly elevated compared with the control group(P<0.05).With the progress of observation time,serum levels of IL-17,TGF- beta1, LTB4,MCP-1 and NGAL had a gradual increasing tendency, they were significantly higher after treatment in the third month than before in Qibai Pingfei group(P<0.05), and had no significant difference in the ninth month compared with before treatment(P>0.05),but were still significantly elevated compared with the control group(P<0.05).