半剂量噻托溴铵对中重度慢性阻塞性肺疾病患者肺功能的研究

Effect of semi dose of tiotropium on lung function in severe chronic obstructive pulmonary disease

目的 评价每日1次吸入9μg噻托溴铵对中重度慢性阻塞性肺疾病（COPD）患者的疗效.方法 采用随机数字表法将171例中重度COPD患者分成两组,半量组86例采用每日1次吸入9μg噻托溴铵粉吸入剂,对照组85例则采用推荐剂量每日1次吸入18 μg噻托溴铵粉吸入剂,应用6个月.在用药前、用药后3个月、用药后6个月分别测定患者肺功能和6 min步行试验.结果 两组患者无论肺功能指标还是6 min步行试验距离在两个研究时间段的增加值均高于用药前.用药后6个月两组患者与用药前比较,对照组第1秒用力呼气容积（FEV1）增加（0.21±0.12）L,上升率（19.31±10.61）％;半量组FEV1增加（0.22±0.13）L,上升率（19.25±11.52）％.对照组用力肺活量（FVC）增加（0.22±0.10）L,上升率（11.63±5.31）％,半量组FVC增加（0.23 ±0.15）L,上升率为（11.62±6.45）％.6 min步行试验距离两组患者较用药前均有明显改善,对照组患者用药后6个月较用药前增加（29.24±11.92）m,上升率（18.30±3.77）％.半量组患者用药后6个月较用药前增加（29.14±11.89）m,上升率（18.20±3.85）％.在两个时间段内患者急性加重和再入院情况组间比较差异无统计学意义（P＞0.05）,半量组6个月与3个月比较虽然急性加重和再入院例数均有所减少但差异无统计学意义（P＞0.05）.结论 噻托溴铵9μg每日1次吸入疗法对于国人长期（6个月后）疗效与推荐18μg每日1次吸入疗法相当.

Objective To evaluate the efficacy of 9 μ g tiotropium inhalation once daily in patients with moderate to severe chronic obstructive pulmonary disease（COPD）.Methods One hundred seventy-one patients with moderate to severe COPD were divided into two groups by random digits table methods：86 patients in test group who used 9 μ g tiotropium powder inhaler once daily,and 85 patients in control group who used the recommended dose 18 μ g once daily,both for 6 months.Patients＆#39; pulmonary function and 6-minute walk test were measured before treatment,3 months after treatment and 6 months after treatment.Results Two groups were compared 6 months after treatment.The level of forced expiratory volume in first second（FEV1） in the control group increased an average of （0.21 ± 0.12） L,and the rising rate was （19.31 ± 10.61）%.The level of FEV1 in test group increased （0.22 ±0.13） L,and the rising rate was （19.25 ± 11.52）%.The level of forced vital capacity （FVC） in control group increased an average of （0.22 ±0.10） L,and the rising rate was （11.63 ±5.31）%.The level of FVC in test group increased （0.23 ± 0.15） L,and the rising rate was （11.62 ± 6.45）%.The distance of 6-minute walk test in control group increased an average of （29.24 ± 11.92） m after treatment for 6 months,and the rising rate was （18.30 ± 3.77）%.The distance of 6-minute walk test in test group increased an average of （29.14 ± 11.89） m,and the rising rate was （18.20 ± 3.85）%.The number of acute exacerbations and rehospitalizations in two groups at these period had no significant difference （P 〉 0.05）.As for the test group,though the number of acute exacerbations and rehospitalizations decreased,there were no significant differences （P 〉 0.05）.Conclusions The effect of inhalation therapy of 9 μ g tiotropium once daily is more or less the same with that of 18 μ g once daily.