Verkindre C, Bart F, Aguilaniu B, Fortin F, Guérin J-C, Le Merre C, Iacono P, Huchon G
Centre Hospitalier Germon et Gauthier, Béthune, France.
Respiration. 2006;73(4):420-7. doi: 10.1159/000089655. Epub 2005 Nov 7.
Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation, which results in the progressive development of dyspnea and exercise limitation.
To compare the effect of tiotropium with placebo on forced vital capacity (FVC) in patients with moderate-to-severe COPD and lung hyperinflation, using exercise endurance, dyspnea and health-related quality of life (HRQoL) as secondary endpoints. One hundred patients were randomized to receive either tiotropium 18 mug once daily or placebo for 12 weeks.
Trough (predose) FVC was significantly improved with tiotropium compared to placebo on day 42 (0.27 +/- 0.08 liters) and 84 (0.20 +/- 0.08 liters; p < 0.05 for both). Trough inspiratory capacity (IC) was also significantly improved with tiotropium compared to placebo on day 42 (0.16 +/- 0.07 liters) and 84 (0.15 +/- 0.07 liters; p < 0.05 for both). Tiotropium increased the mean distance walked during the shuttle walking test by 33 +/- 12 (day 42) and 36 +/- 14 m (day 84) compared to placebo (p < 0.05 for both). On day 84, 59% of the patients in the tiotropium group and 35% of the patients in the placebo group had significant and clinically meaningful improvements in the St. George's Respiratory Questionnaire total score (p < 0.05). Numerical decreases in the focal score in the Transition Dyspnea Index in patients receiving tiotropium versus placebo suggest that tiotropium also improved dyspnea during activities of daily living.
Tiotropium 18 mug once daily reduced hyperinflation with consequent improvements in walking distance and HRQoL in patients with COPD and lung hyperinflation.
慢性阻塞性肺疾病(COPD)的特征是气流受限,这会导致呼吸困难和运动受限的逐步发展。
为比较噻托溴铵与安慰剂对中重度COPD和肺过度充气患者用力肺活量(FVC)的影响,将运动耐力、呼吸困难及健康相关生活质量(HRQoL)作为次要终点。100例患者被随机分为两组,分别接受每日一次18μg噻托溴铵或安慰剂治疗,为期12周。
与安慰剂相比,在第42天(0.27±0.08升)和第84天(0.20±0.08升;两者p均<0.05)时,噻托溴铵显著改善了谷值(给药前)FVC。与安慰剂相比,在第42天(0.16±0.07升)和第84天(0.15±0.07升;两者p均<0.05)时,噻托溴铵也显著改善了谷值吸气量(IC)。与安慰剂相比,噻托溴铵使穿梭步行试验期间的平均步行距离在第42天增加了33±12米,在第84天增加了36±14米(两者p均<0.05)。在第84天,噻托溴铵组59%的患者和安慰剂组35%的患者在圣乔治呼吸问卷总分上有显著且具有临床意义的改善(p<0.05)。接受噻托溴铵的患者与接受安慰剂的患者相比,过渡性呼吸困难指数中的焦点评分数值下降,这表明噻托溴铵也改善了日常生活活动中的呼吸困难。
每日一次18μg噻托溴铵可减轻肺过度充气,从而改善COPD和肺过度充气患者的步行距离及HRQoL。