A Study To Assess The Effects Of Combining Tiotropium And Salmeterol/fluticasone Propionate On Patients With COPD

Chronic obstructive pulmonary disease(COPD)is a kind of chronic disease with very high morbidity rate and mortality rate.In recent years ,the surgery treatment for COPD has made a certain progress and lung transplantation has become the only option that can cure COPD.But strict operation indicatio,contraindication and lung supply limit clinical application of surgery treatment.At present,pharmacologic treatment is still the main treatment for COPD.Bronchodilators are the mainstay of drug therapy. Anticholinergic agents,as a kind of bronchodilators, because of it's unusual mechanism of action ,have become first-line treatment and hold important position in treatment for COPD.Tiotropium bromide(trade name:Spiriva),which approved for use in our country in early 2006,is an agent in a new class of anticholinergics and provides sustained bronchodilation due to prolonged occupancy of M3 receptor. Some studies at home and aborad have indicated: tiotropium bromide can improve lung function and release symptom.But now ,there are few study about treatment for COPD by combining other kind of bronchdilators and/or inhaled corticosteroids.The present study evaluates the effects of combining tiotropium bromide and salmeterol/fluticasone propionate on patients with COPD by analysising lung function and arterial blood gas relevant parameters.This study observed 42 patients with COPD,who were in the third hospital of Jilin University during 2006.6~2007.3.There were 28 men and 14 women.Their age was 43~84 years.The history of disease was 3~45 years.All patients's diagnosis answered to"the diagnosis standard of COPD".The patients were excluded if they required corticosteroids during 2 months or used bronchodilators during 3 days before entering the study.In addition ,patients were excluded from severe heart, liver, kidney,endocrine and general disease.42 patients were randomly divided into two groups:20 cases in experimental group(treated with tiotropium bromide and salmeterol/ fluticasone propionate),22 cases in control group(treated with tiotropium bromide).Sex,age,BMI,history of disease, lung function and arterial blood gas relevant parameters before treatment in both groups are not statistically different (P>0.05).The basic regimens for the two groups were oxygen , antibiotics ,aminophylline , stopping coughing and eliminating sputum.The experimental group was given tiotropium bromide (Spiriva?,produced by Boehringer Ingelheim, Ingelheim am Rhein, Germany)18ug ,once-daily before sleeping and salmeterol/fluticasone propionate (Seretide?, produced by GlaxoSmithKline Group of Companies,United Kingdom) one dose (salmeterol / fluticasone propionate : 50ug / 100ug) twice-daily.The control group was given Spiriva 18ug once-daily before sleeping.After leaving hospital , the experimental group continued using Spirive and Seretide;the control group continued using Spirive during 6 weeks.All patients underwent pulmonary function test and arterial blood gas analysis before treatment,7 days and 6 weeks after therapy.All date was delivered through means value±standard deviation ( x±s) and conducted by SPSS 11.5.It has significant difference when P<0.05.Results demonstrated that there were significant improvement of FVC,FEV1 and FEV1%Pred of two groups 7 days after therapy (P<0.01). The changes of 6 weeks after therapy were similar to changes of 7 days after therapy.Compired with control group ,there was more significant improvement in experimental group(P<0.05). There were significant improvement of PaO2 and PaCO2 of two groups 7 days after therapy (P<0.01). The changes of 6 weeks after therapy were similar to changes of 7 days after therapy.Compired with control group ,there was more significant improvement in experimental group(P<0.05).Only one patient felt dry mouth ,but he didn't end the therapy.Other patients didn't show significant adverse event.So we can draw a conclusion :by comparison with using tiotropium bromide alone,combination therapy can improve lung function and arterial blood gas relevant parameters of patients with COPD more significantly and hasn't more adverse event.The decline of lung function is the main sign of COPD.At present there are not medicine that has been shown to slow the accelerated decline in lung function in patients with COPD ,but there are many medicine that can release symptom,decrease complication and even delay the rate of lung function's decline. Bronchodilators that can release bronchial smooth muscle,dilate bronchi and improve airflow are the mainstay of therapy for COPD.There are cholinergic and sympathomimetic nervous system to control airway smooth muscle mainly.Anticholinergics provide bronchodilation by occupancy of M receptors and andβ2-agonist provides bronchodilation by agitatingβ2-receptors selectively.Both of them have not same mechanism of action,so we infer that combining two kinds of medicine can get better therapeutic effect. Inhaled corticosteroids can act on many links of inflammation,inhibit activation of many kinds of inflamed cell and formation of inflamed agents,ease the airway inflammation and increase sensitiveness ofβ2-receptors.And combination withβ2-agonist has synergism So it is inferred that COPD appears to be more effectively treated by combining anticholinergics,β2-agonist and glucocorticosteroid than by single drug therapy.The result of this study confirmed it. On the other hand,we also observed that after 6 weeks therapy,the lung function of experimental group and control group didn't descend,which still retain the better level.It demonstrated that tiotropium bromide could make the lung function of the patients retain the better level and delay the rate of lung function's decline. And the combination therapy could make the lung function retain more higher level.To sum up, it is concluded that combining tiotropium bromide and salmeterol/fluticasone propionate to treat COPD is safe and efficient.The combination therapy can improve lung function and arterial blood gas relevant parameters more significantly ,so it can effectively release symptom,decrease complication and improve health status.It can become reference for clinical application.