经Respimat吸入器给予不同剂量噻托溴铵干粉吸入剂在慢性阻塞性肺疾病维持治疗中的疗效及安全性研究

Efficacy and safety of different doses of tiotropium bromide dry powder by Respimat inhaler in the maintenance treatment of chronic obstructive pulmonary disease

目的探讨经Respimat吸入器给予不同剂量噻托溴铵干粉吸入剂在慢性阻塞性肺疾病维持治疗中的疗效及安全性。方法选取240例慢性阻塞性肺疾病患者作为研究对象,所有患者均经Respimat吸入器给予噻托溴铵干粉吸入剂连续治疗1年,随机将其分成高剂量组(5μg/d,n=120)和低剂量组(2.5μg/d,n=120),比较两组患者的临床疗效、血氧饱和度、血气分析、肺功能及呼吸肌功能指标水平、不良反应及死亡率。结果:两组患者治疗总有效率数据比较,差异无统计学意义(P>0.05);两组患者治疗前后血氧饱和度、血气分析、肺功能及呼吸肌功能指标水平数据比较差异均有统计学意义(P<0.05);低剂量组患者口干和胃肠道反应的发生率显著低于高剂量组,数据比较差异均有统计学意义(P<0.05);两组患者死亡率数据比较差异无统计学意义(P>0.05)。结论经Respimat吸入器给予低剂量的噻托溴铵干粉吸入剂可以用于慢性阻塞性肺疾病维持治疗,且不良反应低,值得临床进一步大数据分析。

Objective To investigate the efficacy and safety of different doses of tiotropium bromide dry powder by Respimat inhaler in the maintenance treatment of chronic obstructive pulmonary disease.Methods 240 patients with chronic obstructive pulmonary disease(COPD)were selected as subjects.All patients were treated with tiotropium bromide dry powderby Respimat inhaler for one year.They were randomly divided into the high dose group(5μg/d)and the low dose group(2.5μg/d).Their clinical efficacy,blood oxygen saturation,pulmonary function and respiratory muscle function were compared between the two groups.Results There was no significant difference in the total effective rate between the two groups(P>0.05).There were significant differences in pulmonary function and respiratory muscle function before and after treatment between the two groups(P<0.05),and the incidence of dry mouth and gastrointestinal tract reaction in the low dose group was significantly lower than that in the high dose group.There was no significant difference in mortality between the two groups(P>0.05).Conclusion Low dose tiotropium bromide dry powder by Respimat inhaler can be used in maintenance treatment of chronic obstructive pulmonary disease,and the adverse reaction is low,which is worthy of further clinical analysis.