Chan Charles K N, Maltais François, Sigouin Chris, Haddon Jennifer M, Ford Gordon T
University Health Network, Toronto General Hospital, Toronto, Canada.
Can Respir J. 2007 Nov-Dec;14(8):465-72. doi: 10.1155/2007/192961.
Patients with chronic obstructive pulmonary disease (COPD) who smoke have a greater annual rate of decline in forced expiratory volume in 1 s (FEV(1)) than those patients who have stopped smoking.
To assess the effect of tiotropium on pre-dose (trough) FEV(1) in patients with COPD followed in Canada.
A total of 913 patients were randomly assigned to receive either tiotropium 18 mug once daily (n=608) or placebo (usual care minus inhaled anticholinergics) (n=305) for 48 weeks in the present randomized, double-blind, parallel-group study. The effect of tiotropium on measurements of lung function (FEV(1), FEV(6) and forced vital capacity), symptoms, health-related quality of life (St George's Respiratory Questionnaire) and exacerbations were examined.
Tiotropium improved trough FEV(1) in both current and ex-smokers compared with placebo. Baseline FEV(1) in smokers and ex-smokers was 1.03 L and 0.93 L, respectively (P<0.001). At week 48, the mean difference between the tiotropium and placebo groups was 0.14+/-0.04 L (P<0.001) in the smoker group and 0.08+/-0.02 L (P<0.0001) in the ex-smoker group. Tiotropium also significantly improved trough forced vital capacity and FEV(6) compared with placebo throughout the treatment period (P<0.05, for all). Furthermore, tiotropium significantly improved the St George's Respiratory Questionnaire total score compared with placebo at week 48 (40.9 versus 43.7 units, P<0.005).
Compared with the placebo group, tiotropium provides sustained improvements in lung function in patients with COPD, with improvements for smokers and ex-smokers.
吸烟的慢性阻塞性肺疾病（COPD）患者1秒用力呼气容积（FEV₁）的年下降率高于已戒烟的患者。
评估噻托溴铵对加拿大随访的COPD患者给药前（谷值）FEV₁的影响。
在这项随机、双盲、平行组研究中，共913例患者被随机分配，分别接受每日一次18μg噻托溴铵（n = 608）或安慰剂（常规治疗减去吸入性抗胆碱能药物）（n = 305）治疗48周。研究了噻托溴铵对肺功能测量指标（FEV₁、FEV₆和用力肺活量）、症状、健康相关生活质量（圣乔治呼吸问卷）和急性加重的影响。
与安慰剂相比，噻托溴铵改善了现吸烟者和已戒烟者的谷值FEV₁。吸烟者和已戒烟者的基线FEV₁分别为1.03L和0.93L（P<0.001）。在第48周时，吸烟者组中噻托溴铵组与安慰剂组的平均差值为0.14±0.04L（P<0.001），已戒烟者组中为0.08±0.02L（P<0.0001）。在整个治疗期间，与安慰剂相比，噻托溴铵还显著改善了谷值用力肺活量和FEV₆（所有P<0.05）。此外，在第48周时，与安慰剂相比，噻托溴铵显著改善了圣乔治呼吸问卷总分（40.9对43.7分，P<0.005）。
与安慰剂组相比，噻托溴铵可使COPD患者的肺功能持续改善，对吸烟者和已戒烟者均有改善作用。
