联合吸入布地奈德/福莫特罗和噻托溴铵治疗老年慢性阻塞性肺疾病临床研究

目的观察联合吸入布地奈德/福莫特罗和噻托溴铵治疗老年慢性阻塞性肺疾病（chronic obstructivepulmonary diseases,COPD）,对减少老年COPD急性发作,改善患者的肺功能和健康状况的效果。方法 128例（男86例,女42例）COPD患者（年龄60~70岁）按随机数字表法分为4组：联合治疗组32例（男20例,女12例）,吸入布地奈德/福莫特罗160/4.5μg,每次2喷,每日2次,并且吸入噻托溴铵干粉胶囊18μg,每日1次;布地奈德/福莫特罗组32例（男23例,女9例）,吸入布地奈德/福莫特罗160/4.5μg,每次2喷,每日2次;噻托溴铵组32例（男22例,女10例）,吸入噻托溴铵干粉胶囊18μg,每日1次。疗程为3个月。空白对照组32例（男21例,女11例）。结果 3个实验组治疗后临床症状和健康状况均有显著改善,联合治疗组使用缓解药中位数（95%CI）为1（0~6）次,较空白对照组的2（0~30）次、布地奈德/福莫特罗组的2（0~11）次和噻托溴铵组的1（0~10）次明显减少,差异有统计学意义（F=4.813,P〈0.01）;联合治疗组的平均急性发作次数为（0.6±0.5）次,明显低于空白对照组[（1.5±0.7）次]、布地奈德/福莫特罗组[（1.1±0.6）次]和噻托溴铵组[（1.0±0.6）次],差异有统计学意义（F=8.352,P〈0.01）;实验后联合治疗组的FEV1为（1.20±0.02）L,较实验前的（1.07±0.04）L明显提高,实验前后FEV1提高的百分率（12.1%）也显著高于空白对照组（0.9%）、噻托溴铵组（8.9%）和布地奈德/福莫特罗组（8.5%）,差异均有统计学意义（t=-5.105~-15.53,均P〈0.01）。结论联合吸入布地奈德/福莫特罗和噻托溴铵治疗老年COPD,可以改善患者的临床症状和肺功能,疗效优于单药治疗,不良反应并未增多。

Combination of inhaled budesonide/formoterol and tiotropium in treatment of old patients with chronic obstructive pulmonary diseases:a randomised controlled trial

Objective： To observe the efficacy of combination therapy with inhaled budesonide/formoterol and tiotropium in reducing the frequency of acute episodes of symptom exacerbation and improving lung function and health status in the old patients with chronic obstructive pulmonary diseases（COPD）.Methods： 128 subjects with diagnosed COPD（age 60-70） were randomly divided into 4 groups： the combination group（n=32） were treated with budesonide/formoterol（160/4.5μg,twice-daily） and tiotropium（18μg,once-daily）;the budesonide/formoterol group（n=32） were treated with budesonide/formoterol（160/4.5μg,twice-daily）;the tiotropium group（n=32） were treated with tiotropium（18μg,once-daily）;and the control group were 32.Results： The clinic symptoms and health conditions of the experimental groups were improved.95%CI of the combination group was 1（0-6） and reduced more evidently than the other groups（F=4.813,P0.01）;Mean acute attack of the combination group was lower than that of other groups（F=8.352,P0.01）;In the combination group,FEV1 prior to the test improved more than that after the test,and the percentage was higer than that in the other groups（t=-5.105~-15.53,P0.01）.Conclusion： The combination treatment with budesonide/formoterol plus tiotropium in the old patients with COPD may improve clinical symptoms and lung function,and it is better than the single drug,and does not have bad effects.