噻托溴铵吸入对慢性阻塞性肺疾病D组患者稳定期的疗效观察

Observation of therapeutic effects of Tiotropium bromide in treatment of stable COPD patients of group D

目的:探讨慢性阻塞性肺疾病(COPD)D组患者稳定期使用噻托溴铵吸入剂的临床症状及其肺功能的改善作用。方法:96例稳定期COPD的D组(按GOLD 2011分组)患者随机分为治疗组和对照组,每组各48例。治疗组患者给予噻托溴铵吸入剂(18μg,1吸,1次/d)联合布地奈德/福莫特罗吸入剂(160μg/4.5μg,2吸,2次/d)治疗;对照组患者仅给予布地奈德/福莫特罗吸入剂(160μg/4.5μg,2吸,2次/d)治疗。治疗前后第1、3、6、9、12个月,观察两组患者的COPD急性发作次数、临床症状评分、呼吸困难评分、运动耐量和肺功能的变化。结果:12个月中,治疗组患者的COPD急性加重次数较对照组少;治疗后各个时期的6 min步行距离(6MWD值)、肺功能(FVC、FEV1和FEV1%pred)较前增加,临床症状评分(CAT)、呼吸困难评分(m MRC)减少;治疗组患者各指标均较治疗前好转,且改善优于对照组。结论:噻托溴铵与布地奈德/福莫特罗联合吸入治疗COPD稳定期患者,优于布地奈德/福莫特罗单药吸入治疗。

Objective： To investigate the improvement effects of Tiotropium bromide on the clinical symptoms and lung function of stable chronic obstructive pulmonary disease（ COPD） patients of group D. Methods： Ninety-six subjects with stable COPD in group D（ classified by combined COPD assessment in GOLD 2011） were randomly divided into treatment group（ n = 48） and control group（ n= 48）. The treatment group was treated with Tiotropium bromide（ 18μg,1 inhalation,once daily） plus Budesonide/Formoterol（ 160μg/4.5μg,2 inhalations,twice a day）,while the control group was treated only with Budesonide/Formoterol（ 160μg/4.5μg,2inhalations,twice a day）. The times of acuteexacerbation,clinical symptoms scores,dyspnea scores,exercise tolerance,and lung function of the two groups were measured before and 1,3,6,9 and 12 months after the treatment,and the changes were observed. Results： 12 months after the treatment,there were smaller times of acute exacerbation in the treatment group than the control group. After the treatment,6-min walking distance（ 6MWD） and pulmonary function（ FVC,FEV1,FEV1% pred） increased,but the clinical symptoms scores and dyspnea scores decreased in both groups,especially in the treatment group. The improvement of each indicator of the treatment group was superior to the control group. Conclusions： Tiotropium bromide combined with Budesonide / Formoterol in the treatment of stable COPD patients of group D has better effects than Budesonide / Formoterol inhalation therapy alone.