The Clinical Study Of Indacaterol Maleate Combined With Glycopyrronium Bromide On Moderate To Severe Chronic Obstructive Pulmonary Disease Of Stabilization Period

ObjectiveTo observe the clinical efficacy and safety of fixed dose combination?FDC?of Indacaterol Maleate and Glycopyrronium Bromide in the treatment of moderate to severe chronic obstructive pulmonary disease?COPD?of stabilization period,and we can further understand the clinical significance of the FDC of Indacaterol Maleate and Glycopyrronium Bromide by comparing with the FDC of Budesonide and Formoterol.Methods60 patients with moderate to severe stable chronic obstructive pulmonary disease were randomly divided into observation group?n=30?and control group?n=30?by computer.The observation group,which inhaled the FDC of Indacaterol Maleate and Glycopyrronium Bromide?110?g/50?g?,once a day.The control group,which inhaled the FDC of Budesonide and Formoterol?160?g/4.5?g?,twice a day,one inhalation each time.After a 3-month treatment,the pulmonary function was reexamined and the relevant questionnaires were completed.The changes of FEV₁,FVC,IC,CAT,CCQ were compared before and after treatment,and to evaluate the improvement degree of pulmonary function and quality of life in patients with COPD.According to the grouping criteria in the global initiative for chronic objective lung disease gold in 2018,each group was further divided into B and D subgroups for further comparative analysis.The adverse reactions of the two groups were recorded.Results1.A total of 60 patients were included in the study.in the observation group,2 patients in the observation group withdrew from the study due to the acute upper respiratory tract infection and palpitation,and the rest 28 patients completed the follow-up;3 patients in the control group withdrew from the study due to oral fungal infection,tremor and lost,and the rest 27 patients completed the follow-up.At the beginning of treatment,there was no significant difference between the two groups in age,BMI,smoking history,the duration of COPD,history of acute exacerbation in the past year,pulmonary function,m MRC,CAT and CCQ?P>0.05?.2.Comparison of pulmonary function before and after treatment:there was no significant difference in FEV1,FVC,IC between the observation group and the control group?P>0.05?.After 3 months of treatment,FEV1,FVC and IC in the observation group and the control group were compared with those in the group before treatment respectively and then statistical analysis,the pulmonary function of the two groups after treatment was increased?P<0.05?;in the comparison of the two groups,the improvement of FEV1,FVC and IC in the observation group was better than that in the control group?P<0.05?.3.Comparison of the score of life quality before and after treatment:Before treatment,there was no significant difference in CAT score and CCQ score between the observation group and the control group?P>0.05?.After the treatment,the CAT score and CCQ score of the observation group and the control group were compared with those of the pre-treatment group.It can be seen that the CAT score and CCQ score of the two groups were significantly reduced?P<0.05?;in the comparison of the improvement level of the quality of life in the two groups,the improvement level of the CAT score and CCQ score of the observation group was better than that of the control group?P<0.05?.4.In the analysis of subgroup B and D,it was further verified that FEV₁?FVC?IC,CAT score and CCQ score of the patients in the observation group and the control group could be improved?P<0.05?.Whether in group B or group D,FEV₁?FVC?IC,CAT score and CCQ score of the observation group were better than those of the control group?P<0.05?.5.The occurrence of adverse reactions during the treatment:the total incidence of adverse reactions with clinical symptoms in the control group was slightly higher than that in the experimental group,but the difference was not statistically significant?P>0.05?.Conclusion1.The FDC of Indacaterol Maleate and Glycopyrronium Bromide and the FDC of budesonide and formoterol can improve the the quality of life and pulmonary function of patients with moderate to severe chronic obstructive pulmonary disease in stable stage.2.Compared with The FDC of budesonide and formoterol,The FDC of Indacaterol Maleate and Glycopyrronium Bromide can improve lung function and airflow obstruction and the quality of life better,and it was further verified in the analysis of subgroup B and D.3.During the follow-up period,the incidence of adverse reactions of the two drugs was similar,no serious adverse events occurred,and the safety and tolerance are good.The FDC of Indacaterol Maleate and Glycopyrronium Bromide has the value of clinical application.