Study On The Effects Of Tiotropium Combined With Salmeterol/Fluticasone Propionate In Patients With Moderate To Severe Stable Chronic Obstructive Pulmonary Disease

Background:Chronic obstructive pulmonary disease(COPD) is characterized by a chronic airflow imitation that is not fully reversible and progressive.2006GOLD provided that COPD is a preventable and treatable disease, at the same time provided that the use of inhaled long-acting bronchodilators can reduce deterioration of the clinical symptoms and delay disease progression in patients with COPD. Long-acting bronchodilators include long-acting β agonists, long-acting anticholinergic drug, salmeterol/fluticasone propionate is a classics drug which is composed by long-acting β agonists and inhaled glucocorticoid. Tiotropium is a long-acting anticholinergic drug. Boh of them have been widely applied in the clinical, and the therapeutic effect seems well. At present combination therapy of these two drugs is little, this study aims to study on the effect of these drugs in patients with moderate to severe stable COPD, to evaluate the clinical effects and laboratory indicators.Objective:the purpose of this study is to observe the effects of tiotropium combined with salmeterol/fluticasone propionate, and to observe the effects of salmeterol/fluticasone propionate in patients with moderate to severe stable COPD. Including pulmonary function、6MWD、SGRQ、serum inflammatory factors, so as to provide helps for clinical treatments, observe the effects of inflammatory factors in patients with COPD.Method:Patients who are diagnosed as stable moderate to severe COPD in our outpatient department and inpatient department during the period from Oct.2010to Jun. 2011.These patients are randomly divided into two groups in which each group consists of20cases:the group treated with Tiotropium combined with salmeterol/fluticasone propionate (treatment group) and the group treated with salmeterol/fluticasone propionate (comparison group). Treatment group:Patients treated with tiotropium once a day and once an inhaling (18ug); combined with salmeterol/fluticasone propionate (50/500μg)—twice a day and once an inhaling; in addition, treat patients with regular cough relieving treatment; the total treatment and observation amounts to3months; Comparison group:Patients treated with Salmeterol/Fluticasone Propionate (50/500μg)—twice a day and once an inhaling with regular treatment; the total treatment and observation amounts to3months. Clinical observation indexes:1. pulmonary function indexes:FEV1(forced expiratory volume in1second), FVC (forced vital capacity), FEV1%(the percentage of first second forced expiratory volume accounting for the predicative value). Test the pulmonary function indexes before treatment,1month after treatment and3months after treatment, respectively, amounting to3times.2.6MWT: test6MWT (6-minute walking test) before treatment,1month after treatment and3months after treatment, respectively, amounting to3times.3. SGRQ:test SGRQ before treatment,1month after treatment and3months after treatment, respectively, amounting to3times.4. Inflammatory factors:To determine the levels of Interleukin-32(IL-32) in serum, tumor necrosis factor-a (TNF-a) and monocyte chemoattractant protein-1(MCP-1) before treatment and3months after treatment.Results:1. Comparison of pulmonary function:as to the three parameters of FEV1, FVC and FEV1%, the curative effect in patients1month after treatment and3months after treatment in both treatment group and comparison group get no improvement; the data of1month after treatment and the data of3months after treatment show no significant difference. Comparing the treatment group and comparison group, the three parameters of pulmonary functions3months after treatment show no significant difference from those before treatment.2. Comparison of6MWT:after treatment for1month or3months, the6MWT in both treatment group and comparison group show significant extension (P<0.01) when compared with that before treatment; according to the comparison of2groups, we found that Salmeterol/Fluticasone Propionate combined with Tiotropium can value in more significant6MWD extension and the excess part is approximately6meters (P<0.01), which shows significant difference.3. Comparison of SGRQ:the test values of SGRQ in both treatment group and comparison group decrease after1month of treatment and3months of treatment when compared with that before treatment. Comparing the value of1month after treatment and that of3months after treatment, the values of clinical part, activity part and influence part show significant difference except that the total value of comparison group shows no clear difference.4. Cell factors:comparing the levels of serum IL-32, TNF-α and MCP-1with those before treatment, both treatment group and comparison group decrease and the difference is statistically significant, but the values of treatment group and comparison group show no significant difference.Conclusion:1. The combining-use of Tiotropium with Salmeterol/Fluticasone Propionate and single-use of Salmeterol/Fluticasone Propionate for3months can both improve the life quality of patients with stable moderate to severe Chronic Obstructive Pulmonary Disease and extend their exercise tolerance, and the combining-use can have a more significant effect than that by single-use.2. The combining-use of Tiotropium with Salmeterol/Fluticasone Propionate and single-use of Salmeterol/Fluticasone Propionate for3months can both decrease the levels of serum IL-32, TNF-α and MCP-1in patients with stable moderate to severe Chronic Obstructive Pulmonary Disease, but the two groups show no significant difference.3. The combining-use of Tiotropium with Salmeterol/Fluticasone Propionate and single-use of Salmeterol/Fluticasone Propionate for3months can not improve pulmonary function in patients with moderate to severe stable COPD.