Clinical Research Based On Xin’an Medicine Compensating Qi Method Of Intervention In Chronic Obstructive Pulmonary Disease In Stabilization Period Of Lung And Kidney Deficiency Syndrome

【Objective】1Evaluate the clinical effect of six flavors compensating qi capsule on patients in COPD stabilization of lung and kidney deficiency syndrome.Evaluate whether it can improve lung function and exacerbation occurrence of COPD and the degree of reducing the clinical curative effect;2 Evaluate the clinical effect of six flavors compensating qi capsule on patients in COPD stabilization of lung and kidney deficiency syndrome.Evaluate whether it can improve clinical symptoms and patients’ quality of life.【 Method 】 This research adopts positive drug parallel contrast,which features randomized,double-blind and double simulation.According to the basic principles of epidemiological clinical trials in the sample,the characteristics and the study purpose of this subject,based on the used findings of our team research and the calculation of sample size.2-1,according to the subject,the sample size is 2-1,α= 0.05,β= 0.1,using parallel group design(unilateral),excellent efficiency test formula,consider 20% loss rate and sample size of 60 cases;The treatment group recruits 30 cases;the control group recruits 30 cases.Treatment group: oral slow-release theophylline simulation agent plus the six flavors compensating qi capsule plus acupuncture therapy;Control group: oral slow-release theophylline simulation agent plus the six flavors compensating qi capsule plus acupuncture therapy.The appearance and smell of drug of control group and treatment group are the same.In complete accord with drugs,the simulate agent does not contain any effective ingredients.Foundation treatment: according with the 2013 GOLD guide for COPD stabilization treatment,mainly long-term home oxygen therapy and pulmonary rehabilitation,bronchodilator drugs,hormones,expectorant drug treatment,etc.At the same time let the patients have health education. The control group treatment plan include the cases were randomly divided into 2groups,given treatment group oral slow-release theophylline simulation agent plus the six flavors compensating qi capsule plus stimulating acupuncture therapy;Give Control group oral slow-release theophylline simulation agent plus the six flavors compensating qi capsule plus acupuncture therapy.Both groups are having the same health education activities.The source of drugs contains Doxofylline sustained-release capsules,specifications:0.2 g/bead X10,batch number: H20010041;Shanghai Kai Bao pharmaceutical co.,LTD.Production;Doxofylline slow-release simulation capsule,specifications: 0.2 g/X10 grain,grain batch number: H20010041;The first affiliated hospital of Anhui TCM university drug preparation center production;The six flavors compensating qi capsule,specifications: 0.4 g/X36 grain,grain batch number: BZ20080023;The first affiliated hospital of Anhui TCM university drug preparation center production;The six flavors compensating qi simulation capsule,specifications: 0.4 g/X36 grain,grain batch number: BZ20080023;The first affiliated hospital of Anhui TCM university drug preparation center production,packaging and the six flavors fill gas capsule is exactly the same;Gubenshufei acupuncture therapy is hospital preparations,the drug include euphorbia kansui,ephedra asarum,ginger,cloves,yanhusuo,musk,cinnamon,raw pinellia,etc.;The first affiliated hospital of Anhui TCM university drug preparation center production;the acupuncture therapy also made of The first affiliated hospital of Anhui TCM university drug preparation center production.The method of giving pills include two groups.Treatment group: doxofylline slow-release simulation capsules,each time 1 grain,2 times a day;The six flavors compensating qi capsule,3 pills each time,3 times a day,warm water after a meal.Gubenshufei application for external use,10,1,5 times,acupuncture point: lung yu,shen shu,big shu,anti-asthma,plump;treating for 2 months,were followed up for 6 months.Control group: doxofylline sustained-release capsules and capsules,the six flavors compensating qi simulation,Gubenshufei application,usage and dosage and dosing way with treatment group respectively.Treatment 2 months,were followed up for 6months.【Results】1.After spss19.0 statistical analysis,the two groups of patients with general information including gender,age,severity of the disease were no difference,no statistical significance(p>0.05),comparable.2.The six flavors compensating qi capsule group during its two month treatment period and the follow-up period was three months and six months in the times of acute exacerbation and TCM syndrome integral compare to doxofylline group was decreased(p<0.05).In the six flavors compensating qi capsule group six minutes walking distance is higher than that of treatment after treatment,in fifth months,in August is still higher than that before treatment(p<0.05);reduce the western medicine syndrome score and dyspnea scale after treatment than before treatment(p<0.05),fifth and eighth months and before treatment were statistically significant difference(p<0.05);integral TCM syndrome,CAT questionnaire after treatment than before treatment low(p<0.05).Doxofylline group after treatment of acute exacerbation than before treatment decreased(P < 0.05);six minutes walk than before treatment increased(P < 0.05);TCM Syndrome Scale of TCM medicine syndrome questionnaire table,CAT were lower than before treatment,(P < 0.05);follow-up period of March,June before the treatment of acute exacerbation times had no significant difference(P > 0.05).