Efficacy Of Montelukast Combined With Tiotropium Bromide In The Treatment Of Group B Patients Of Stable Chronic Obstructive Pulmonary Disease

Objective:Chronic obstructive pulmonary disease(COPD)is the 3rd leading cause of death and a serious threat to human health.Despite numerous studies on montelukast and tiotropium in treatment of COPD,few study focused on combination of montelukast and tiotropium.Most COPD studies have focused on patients with acute exacerbations of COPD,as well as patients in groups C and D,while attention to patients with mild to moderate COPD is far from enough.However,epidemiological surveys show that most of the COPD patients are mild to moderate patients,so exploring the drug treatment effect of mild to moderate COPD patients is of great significance for the individualized treatment of COPD.In the present study,we aimed to investigate efficacy and safety for combination of montelukast and tiotropium in treatment of COPD patients of group B.Methods:A prospective randomized,single-blind study included a total of 94 COPD group B patients who went to our hospital during January 2017～January 2018.All patients were consecutively enrolled and were randomly divided into two groups,the combination group(n=47)using combination of montelukast(10 mg/d)and tiotropium(18 μg/d)and the control group(n=47)using only tiotropium(18 μg/d).The treatment regimen lasted for 6 months and no antibiotics or glucocorticoids were used during the treatment period.If the patient has an acute exacerbation during treatment,withdraw from the study.All patients were followed up for half a year after the start of treatment by outpatient review or telephone interview.The lung function indexes FEV1,FVC,FEV1/FVC were measured before treatment and in the third and sixth months after treatment.The modified MRC score was used to evaluate the patient’s dyspnea before treatment and at the 3rd and 6th months after the start of treatment.Results:During the study period,7 cases were lost to follow-up and 6 cases showed acute exacerbation and thus were excluded from the study in the combined trentment group;6 cases were lost to follow-up and 8 cases showed acute exacerbation and thus were excluded from the study in the control group.There were no significant differences in gender,duration of disease,dyspnea symptom scores,and baseline lung function.Indexes of FEV1 and FVC were significantly increased along with the treatment and all values of FEV1/FVC,FEV1 and FVC were dramatically higher in the combined group than the control at 3 months,6 months after the beginning of the treatment.The mMRC scores were remarkably lower after treatment,and the combined group showed significantly lower mMRC scores than the control group.Conclusion:1.Mono-application of tiotropium could significantly improve the FEV1、FVC and dyspnea condition for COPD group B patients;2.Compared with tiotropium bromide alone,tiotropium bromide combined with Montelukast the improvement of lung function and dyspnea in patients with COPD group B was more significant.