噻托溴铵联合沙美特罗/氟替卡松治疗慢性阻塞性肺疾病的临床研究

Clinical efficacy of the treatment of tiotropium bromide combined salmeterol/fluticasone on chronic obstructive pulmonary disease

目的评价噻托溴铵联合沙美特罗/氟替卡松治疗重度以上慢性阻塞性肺疾病(COPD)的疗效。方法 100例重度以上COPD稳定期患者随机分为对照组和试验组,各50例,对照组给予沙美特罗/氟替卡松,每次50μg/100μg,每日2次,试验组在对照组基础上给予噻托溴铵,每次18μg,每日1次,观察12周,比较2组患者用力肺活量(FVC)、1秒用力呼气容积(FEV1)、峰值呼气流速(PEF)、1秒用力呼气容积/用力肺活量(FEV1/FVC)和不良反应发生率。结果治疗后,试验组FVC、FEV1、PEF、FEV1/FVC疗效显著优于对照组(P<0.05),试验组药品不良反应发生率未见明显增加(P>0.05)。结论噻托溴铵联合沙美特罗/氟替卡松治疗重度以上COPD临床疗效优于单用沙美特罗/氟替卡松,且未增加不良反应发生率。

Objective To explore the curative effect of tiotropium bromide combined with salmeterol fluticasone on plateau severe chronic obstructive pulmonary disease（ COPD）. Methods One hundred cases of plateau severe COPD patients were divided into the control group（ 50cases） and the treatment group（ 50 cases） by a randomized way. The control group was given salmeterol / fluticasone 50 μg /100 μg,bid,and treatment group was given tiotropium bromide 18 μg,qd,on the basis of control group. The observation lasted for 12 weeks and forced vital capacity（ FVC）,forced expiratory volume in one second（ FEV1）,peak expiratory flow（ PEF）,and forced expiratory volume in one second / forced vital capacity（ FEV1 / FVC） were compared between two groups. The adverse drug reactions were also compared in two groups. Results There showed a better efficacy in FVC,FEV1,PEF,and FEV1 / FVC in the treatment group（ P〈 0. 05）,without increasing occurrence of adverse drug reactions（ P〈 0. 05）. Conclusion The curative effect of tiotropium bromide combined salmeterol / fluticasone for the treatment of plateau severe COPD is affirmative without increasing adverse drug reactions,better than single salmeterol / fluticasone treatment.