BackgroundChronic obstructive pulmonary disease (COPD), characterized by its high morbidity and mortality, is a very important respiratory disease, which could be an outcome in the later stage of several pulmonary diseases. For its slow but progressive course, it could have great effect on the patients'life quality. Although the clinical symptoms may relieve during its stable phase, COPD could keep aggravating in pulmonary function and have recurrent attacks. Treatment for stable phase has great significance on the prevention and release of COPD, which could improve pulmonary function and benefit the other systems of the body. The effectiveness and optimization should be evaluated by therapeutic effect. The comprehensive treatment of Chinese medicine has great experiences and advantages on syndrome differentiation and treatment of COPD, but so far there is no systematic study to show its clinical instructive significance.ObjectiveBy applying the lung-spleen correlation theory and strengthening earth to generate metal therapy, to observe its clinical effect on stable phase of COPD. Probing the advantages of Chinese medicine comprehensive treatment on COPD by using the statistical analysis, thus to validate the instructive significance of lung-spleen correlation theory on COPD. Methods192 out and in hospital patients, from 40-80 years old, with disease of COPD classified into asthenia of pulmonosplenic qi and phlegm-clot internal resistance syndrome were enrolled in the study from 8 hospitals, such as Guangdong Provincial Hospital of TCM,, Shenzhen City Hospital of TCM, Foshan City Hospital of TCM, etc. All patients were allocated into Chinese medicine therapeutic group and placebo group by randomization, with a 2-month course of treatment and 4-month follow up. The patients'life quality, acute exacerbation times, BODE index, zheng hou curative effect evaluation, lung function and nutrition index were recorded in the case report form (CRF). The data was analyzed by SPSS17.0 with the statistical methods of x2 test, t test and non parametric test.ResultsThe Chinese medicine comprehensive treatment can enhance the patients' 6-minite walking distance, cut down the total score of SGRQ, increase the value of FEV1%pred in patients with 2nd stage COPD, cut down the total score of BODE in patients with over 10 years course, reduce the Chinese medicine syndrome scores in patients with less than 10 years course, reduce the combined medicine in patients cured by Phosphodiesterase Inhibitors and long actionβ-2 receptor agonist combined with inhaled corticosteroid, thus to improve the patients' exercise tolerance, life quality, and to relieve the clinical symptoms. The grading analysis and ITT analysis show that it has a potential to improve the FEV1 value and to reduce the TCM syndrome scores in patients with over 10 years course. It also has a potential of cutting down cough and stethocatharsis scores in patients under 65.ConclusionThe treatment under the instruction of lung-spleen correlation theory has a better clinical effect than simple western medicine treatment on stable phase of COPD. It can be seen in the following aspects:improving the patients' exercise tolerance, life quality, and to relieve the clinical symptoms; slowing down the aggravation of lung function in patients with moderate COPD; stabilizing the lung ventilation function and to improve the prognosis of patients with a longer course; improving the clinical syndromes and whole body condition of patients with a shorter course; reducing the occurrence of cough in younger patients. |