| ObjectiveThe clinical data of 60 cases of stable COPD patients treated with different doses of gu shen tong fei tablet based on the fei shen tong tiao therapy were retrospectively analyzed. By comparing the differences and correlation of efficacy results with airway function test results before and after the experiment, trying to analyze the different features in airway function improvement and summarize the significance of its correlation with efficacy results after treating with fei shen tong tiao therapy.Methods60 patients with stable COPD in compliance with the inclusion criteria and consistent with the diagnosis of lung and kidney deficiency in TCM were retrospectively analyzed in this research. Treatment period and follow-up period were both three months. Patients were divided into three groups and different experimental groups received different doses of drugs named gu shen tong fei tablet. By measuring the differences and correlation of efficacy results(mMRC level, CAT score, six minutes walking distance, TCM syndrome score) with lung function data(FEV1, FVC, FEV1%pred, FVC%pred, FEF25%pred, FEF50%pred, FEF75%pred, MMEF%pred) changes before and after treatment, trying to analyze its characteristics and significance of airway dilation and elucidating the airway improvement features and its correlation with efficacy results in stable COPD patients.Results1.By using gu shen tong fei tablet based on fei shen tong tiao therapy to treat COPD patients, results indicated great improvement in efficacy results(mMRC level, CAT score, six minutes walking distance, TCM syndrome score) after treatment(P<0.05).2. When referring to the differences between large and small airways improvement after treating with gu shen tong fei tablet based on fei shen tong tiao therapy, results indicated that the small airway function improved more obviously than large airway. The improvement rate of small airways indexes such as FEF50%pred, FEF75%pred, MMEF%pred were statistically significant when comparing with large airway parameters such as FEV1 improvement rate(P<0.05).3. After treating with gu shen tong fei tablet based on fei shen tong tiao therapy, results showed that the changes of small airway indexes(FEF50%pred, FEF75%pred and MMEF%pred) are positively correlated with large airway indexes (FEV1, FVC, FEV,%pred, FVC%pred, FEF25%pred) (P=0.00). Among these indexes, FEV1 and FEF50%pred (r=0.67)ã€MMEF%pred (r=0.68), FEV,%pred and FEF50%red(r=0.69)ã€MMEF%pred(r=0.61),FVC%pred and FEF50%pred (r=0.73) MMEF%pred(r=0.65), FEF23%and FEF50%pred (r=0.84)ã€MMEF%pred (r=0.80) had a significant positive correlation with the improvement of small airway function.4. Results also showed that in stable COPD patients with lung and kidney deficiency, there are significant improvements in small airway function better than large airway function after treating with gu shen tong fei tablet based on fei shen tong tiao therapy. The improvement of small airway function were consistent with changes of efficacy results, which also revealed a significant correlation between them. Further more, evidence also strengthen the importance of small airway indexes and strongly suggest that the small airway parameters should be evaluated in studies as an important test parameters, especially when evaluating clinical efficacy of Chinese medicine. It is of far-reaching significance for future creation of a new evaluation system.ConclusionBy using different doses of Gu shen tong fei tablet based on the fei shen tong tiao therapy in treating stable COPD patients who were suffering from the lung and kidney deficiency, results showed that there is significant improvements in small airway function better than large airway. It is more apparent in high-dose group as the FEF50%pred, FEF75%pred and MMEF%pred are superior to placebo and low-dose group. The improvement of small airway function were consistent with changes of efficacy results, which also revealed a significant correlation between them. Especially FEF50%pred and MMEF%pred had an better reflection of small airway function improvemrnt. The role of small airway indexes in prognosis assessment is greatly underestimated in previous studies. In future evaluation of clinical trials with TCM, FEF50%pred, FEF75%pred and MMEF%pred should be taken into consideration. Through the comprehensive analysis of airway function improvement, we hope to establish a new evaluation system and provide theoretical basis in clinical curative effect evaluation with Chinese medicine. |