| Research background:Chronic obstructive pulmonary disease (COPD) is a common clinical chronic respiratory diseases,seriously endangering the health of human beings,morbidity and mortality increasing,more and more getting the attention of domestic and foreign medical experts.Airway mucus hypersecretion is one of the main features of COPD,can increase the degree of airflow limitation and lung function damage,that is one of the main difficulties of the clinical treatment of COPD.Under the stimulation of chronic inflammation,abnormal secretion of mucin, respiratory mucociliary clearance dysfunction,leading to colonization of the respi ratory tract bzcteria,mucus plug formation,ventilatory dysfunction,in-creased disease progression.The World Health Organization(WHO)《OPD Global Initiative》(《old》) recommended in patients with stable COPD inhaled corti costeroids and long-acting beta2-agonist combinations and long-acting anticholi-nergic drugs,may reduce the number of acute exacerbation of COPD,improve the quality of life,but the price is expensive,long-term use to increasing the financial burden of patients,and increasing pneumonia incidence of cardiovascular disease and other adverse effects,these have a serious impact on the compliance and the improvement of clinical efficacy in COPD patients.Mucus regulator-carbocisteine can reduce the viscosity of the sputum,promote to eject sputum,alleviate airway mucus hypersecretion,and have anti-inflammatory and antioxidant effects.Academician Zhong Nanshan by the multi-center study of carbocisteine treatment of COPD,long-term use carbocisteine can better prevent the acute exacerbation of COPD,its efficacy is close to the international standards for the treatment of stable COPD programs,and can reduce the conventional treatment costs.The traditional Chinese medicine belongs COPD to"cough"ã€"asthma"ã€"lung inflation",often because of feelings evils resulting in disease recurrent,cough, wheezing,sputum and even swelling and other clinical manifestations.The pathologyical nature belongs to mark this virtual to real,analysis based on the observation of clinical cases,the majority of patients belong to Qi deficiency and phlegm obstruction in the stabilization period. Yiqi Huatan decoction is the experience side of teacher treatment stableCOPD of Qi deficiency and phlegm obstruction,through the addition and subtraction of Yupingfengsan,and clinical efficacy.It can effectively alleviate clinical symptoms,reduce the number of acute exacerbations.Objective:This research uses a randomized controlled study,observingYiqi Huatan decoction combined Carbocisteinto COPD stabilization deficiency phlegm syndrome in patients with acute exacerbationã€the change of main TCM syndrome score(chest tightness and wheezing,shortness of breath/fatigue, cough, sputum, cyanosis of lips)ã€the lung function(forced expiratory volum in the first second percent predictedã€forced vital capacity percent predictedã€forced expiratory volum in the first second to forced expiratory volum ratio),white blood cell count and neutrophil percentage, induced sputum neutrophil percentage,serum and induced sputum supernatant tumor necrosis factor α (TNF-α)and other objective indicators,to explore the effect of the combination Yiqi Huatan decoction with Carbocisteine Tablets on patients with COPD airway mucus hypersecretion,to discuss on syndrome differentiation treatment variation of TCM treatment of COPD airway mucus hypersecretion advantage.Method:Using simple random method,using a random number table,line11,45ã€46as the starting,odd as the test group,even as the control group,according to their visiting sequence,looking-up table group,the patients were randomly divided into two groups.Control group oral Carbocisteine Tablets of0.5g,3times a day,can be on-demand inhaled Ipratropium Bromide Aerosol(1-2press every time).Treatment for3months.In the experimental group,on the basis of the control group adds Yiqi Huatan free Decoction2times a day with1bags.Treatment for3months.Record the number of acute aggravation,the changes of the main TCM syndrome score (chest tightness and wheezing, shortness of breath/fatigue,cough,sputum.cyanosis of lips)ã€the lung function(forced expiratory volum in the first second percent predictedã€forced vital capacity percent predictedã€forced expiratory volum in the first second to forced expiratory volum ratio),white blood cell count and neutrophil percentage.induced sputum neutrophil percentage,serum and induced sputum superna-tant tumor necrosis factor a (TNF-a)and other index before and after treatment,using statistical software SPSS17.0for statistical analysis conclusion.Results:l.The study included from November2011to November2012in Wangjing Hospital of traditional Chinese medicine academy of sciences respiratory outpatient and hospitalized cases met the inclusion criteria of40cases,21cases in test group,19cases in the control group.Before treatment,the differences of age,gender,disease duration,TCM syndrome score(chest tightness and wheezing,shortness of breath/fatigue,cough,sputum,cyanosis of lips),lung function(forced expiratory volum in the first second percent predictedã€forced vital capacity percent predictedã€forced expiratory volum in the first second to forced expiratory volum ratio),white blood cell count and neutrophil percentage,induced sputum neutrophilthe percentage,serum and induced sputum supernatant TNF-acontent and other indicators were not statistically significant,comparable.2.After treatment,the TCM symptom scores compared with before treatment were significantly improved,a statistically significant difference after treatment;the difference between the two groups of patients before and after the symptom score compared,the test group the symptom score decreased higher than that that control group,a statistically difference;before and after treatment of Chinese medicine syndromes rate comparison,the experimental group was significantly higher than that in the control group,a statistically significant difference;proving carbocisteine andYiqi Huatan Decoction that can improve clinical symptoms,Yiqi Huatan Decoction combined carbocisteine effect moregood.3.After treatment,FEV1%of patients in the experimental group compared with before treatment were significantly improved with statistical significance,and the control group after treatment in patients with FEV1%treatment also has increased,there was no statistically significant difference.FVC%and FEV1/FVC had no statistical significance.Illustrate the application of Carbocisteine Tablets can delay in patients with FEV1%downward trend,while Yiqi Huatan Decoction can improve its efficacy,improve patients FEV1%.4.After treatment two group of patients,serum and induced sputum supernatant TNF-acontent levels down compared with before treatment,the difference was statistically significant;the difference of the two groups patients before and after treatment of TNF-acontent, the difference was not statistically significant;TNF-a is the mainly inflammatory of inducing airway mucus hypersecretion,the difference before and after treatment was not statistically significant,indicating that the carbocisteine can reduce TNF-a content, joint Yiqi Huatan Decoction without increasing.5.After treatment,the white blood cell count and neutrophil percentage, neutrophils percentage of induced sputum,serum C-reactive protein (CRP) levels compared with before treatment,the difference was not statistically significant. Comparison the index difference in two groups before and after treatment,no significant difference;Yiqi Huatan Decoction and carbocisteine had no effect on the above indexes.6. Comparing the frequency of acute exacerbation during the treatment of the two groups patients,the difference was not statistically significant.7.Routine blood(Red blood cell count, platelet count,hemoglobin) in the two groups of patients before and after treatment showed no significances.After treatment,liver function tests (alanine aminotransferase) and renal function (creatinine) were normal.The course of treatment in patients without allergic reactions such as rash,drug eruption;nausea,stomach upset,diarrhea,headache and other adverse reactions.The prescription drug safety,no significant adverse reactions.8.The course of treatment,patients demand to use the number of Ipratropium Bomide Aerosol comparison,the difference was not statistically significant.ConclusiomThis study proved that Yiqi Huatan Decoction combined with carbocisteine can reduce airway mucus hypersecretion of COPD patients in the stable stage with qi deficiency and phlegm obstruction;effectively decreased the phlegm of patients,can improve FEV1%,alleviate airway obstruction,lower serum and induced sputum supernatant TNF-acontent.Can be seen fromthe result of this study:the symptoms of bosom frowsty asthma suppress,shortness of breath and fatigue, cough, expectoration, cyanosis of patients in the experimental group significantly reduced, TCM syndrome score significantly improved at the same time,the curative effect of TCM syndrome and TCM syndrome scoring were significantly better than control group, fully shows the advantage of the overall concept and syndrome dfferentiation treatment variation of TCM. |