| Background The Chronic obstructive pulmonary disease (COPD) is a serious disease that is harm to human's health. Because of its high incidence, morbidity, mortality and economic burden, COPD has caught the great attention of scholars around the world. In the past 10 years, western medicine has made a lot of research and exploration on COPD not only in epidemiology, pathogenesis, diagnosis, treatment and evaluation, also the new and multi-dimensional management model which have made quiet great and substantial progress, but the mechanism of COPD was not fully understood. Now it is widely recognized that COPD is characterized by chronic inflammation in airway, lung parenchyma and lung vessels.Airway inflammation is a key step in the process of the disease. There is still no effective prevention or treatment of COPD. Chinese medicine therapy has better efficacy on COPD which includes significantly shortening the course and improving life quality and decreasing complications especially in patients with stable COPD but few researches on its mechanism. Therefore, it's of important significance to evaluate scientifically the efficacy of patients with stable COPD, explore the mechanism of prevention and treatment on patients with stable COPD and improve the level of TCM Syndrome Differentiation.Objective The main aim of this study was to observe the changes of pulmonary function ,clinical symptoms and signs, exacerbation frequency, the six-minute walking distance(6MWD), dyspnea grading, the body-mass index (BMI) and Serum C-reactive protein(CRP), interleukin-8(IL-8) and tumor necrosis factor-alpha(TNF-α) levels of the stable phase of COPD patients,and to evaluate the efficacy of these patients and response of Serum CRP ,IL-8 and TNF-α,exploring the mechanism of prevention an- treatment of the stable phase of COPD by Traditional Chinese Medicine.Methods Through a randomized, controlled clinical trial, we selected 216 patients with stable COPD randomly divided into the test group and the control group. The test group are used fixed prescription of TCM therapy combined with Western standard treatment; the control group receives standard Western treatment.Both groups are observed for 6 months. The patients are observed of pulmonary function, clinical symptoms and signs, acute exacerbation frequency, dyspnea grade, six-minute walking distance, body mass index changes before treatment and after 3 months and 6 months treatment. Meanwhile we also test the levels of Serum CRP, IL-8 and TNF-α.Results1 Evaluation of the effect of differentiation treatment on patients with stable COPD.Patients with stable COPD included 216 cases, excluding 21 cases with incomplete information and no prescribed medication and 195 cases met the study requirements. The clinical efficacy of differential treatments in patients with stable COPD were evaluated in the following seven aspects.The results are as follows:1.1 Pulmonary Function: before treatment, FVC (Forced vital capacity), FEV1 (the forced expiratory volume in one second), and FEV1%(forced vital capacity in one second percentage of predicted value percentage) in either groups were not statistically different (P>0.05); After treatments, FVC in two groups were not statistically different (P>0.05), while FEV1 and FEV1% were significant higher than before (P<0.05);the FEV1 and FEV1% of the text group after treatments for 6 months are all higher than the control group (P<0.05);the repeated measure analysis of variance showed that the FEV1 and FEV1% of different points of treatment were significantly different with the text group (P<0.001), it was significantly different between the two groups indicators (P<0.05).1.2 Clinical symptoms and signs: there wan no significant difference in total score of symptoms and signs before treatment(P>0.05);after treatment, the total score of symptoms and signs was declining, and the text group was significantly lower than the control group (P<0.05);the repeated measures analysis of variance between two groups showed the total score of symptoms and signs between different treatment point were significantly different (P<0.001), there was significant difference between the two groups (P<0.05).1.3 The number and the extent of acute exacerbation: two groups had no significant differences before treatment(P>0.05) ; the number of acute exacerbation of the control group after treatment was significantly higher than the text group (P <0.05); the extent of acute exacerbation before or after treatment had no differences between two groups(P>0.05).1.4 Dyspnea grade: two groups had no significant differences before treatment and after 3 months of treatment (P> 0.05), but the control group was significantly higher than the text group after 6 months of treatment (P<0.001).1.5 6MWD: before treatment and 3 months, 6 months of treatment there were no significant differences between two groups (P>0.05); two groups increased after treatment(P<0.05); the repeated measures analysis of variance showed that 6MWD of different treatment points between two groups was significantly different(P <0.001)and no significant difference between the two groups (P>0.05).1.6 BMI: before treatment and 3 months, 6 months of treatment there were no significant differences between two groups (P>0.05);BMI at either time point were not significantly different (P>0.05);the repeated measure analysis of variance between the two groups showed the BMI of different treatment points were no significantly different (P>0.05)and there's no significant difference between two groups ( P>0.05).2 Influence of systemic inflammatory response on stable COPD patients affected by differentiation therapy.70 patients, one of which was lost to follow up. were randomly selected from 216 patients. the average age was 62.78±10.87. Serum CRP, IL-8 and TNF-αwere tested to observate the influence of Systemic Inflammatory Response on stable COPD patients affected by Differentiation treatment.2.1 CRP: before and after treatment, the serum CRP levels of two groups were higher than the healthy group (P<0.01), before treatment, there was no significant difference between two groups (P>0.05); after treatment,the CRP levels of two groups were lower than before (P<0.01, P<0.05),and the text group after treatment was significantly lower than the control group (P<0.01); the repeated measures analysis of variance between the two groups showed the CRP levels of different treatment points had significant difference (P<0.001), and there was significant difference between the two groups (P<0.05).2.2 IL-8: before and after treatment the serum IL-8 levels of two groups were higher than the healthy group (P<0.05), before treatment, there was no significant difference (P>0.05);after treatment, IL-8 levels of two groups were declining,and the text group were statistically different (P<0.01).After 3 months and 6 months of treatment, the IL-8 levels of the text group were lower than the control group (P <0.05); the repeated measures analysis of variance showed IL-8 levels of different treatment points had significant difference with the text groups (P<0.001), between two groups there was significant difference (P<0.05).2.3 TNF-α:before treatment, the TNF-αlevels of each group were higher than healthy group (P<0.001); the control group after treatment was significantly higher than the healthy group (P<0.01); the serum TNF-αlevels were higher in the text group than the healthy group,but there was no statistical difference(P>0.05). After treatment, TNF-αlevels of two groups were declining, including the text group(P<0.01) and the control group (P<0.05);after 6 months of treatment, the TNF-αlevel of the text group was lower than the control group (P<0.05); the repeated measures analysis of variance showed the TNF-αlevels of different treatment points had significant difference (P<0.05);between the two groups there was no significant difference (P>0.05).Conclusion1 Evaluation of the effect of differentiation treatment on patients with stable COPD. Western medicine conventional treatment based on differential treatment for stable COPD patients is more effective than simple western medicine conventional treatment,performance in improving pulmonary function,clinical symptoms and signs,dyspnea grade and reduce the frequency of acute exacerbation.2 Influence of systemic inflammatory response on stable COPD patients affected by differentiation treatment. Differential treatment of TCM on patients with stable COPD has better efficacy, its mechanism may be associated with significantly reduce levels of the serum IL-8, TNF-αand CRP to be further study.
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