Pulmonary Research Institute at Hospital Grosshansdorf, Center for Pneumology and Thoracic Surgery, Woehrendamm 80, D-22927 Grosshansdorf, Germany.
Respir Med. 2012 Oct;106(10):1413-20. doi: 10.1016/j.rmed.2012.05.011. Epub 2012 Jun 28.
Data comparing two bronchodilators vs. one bronchodilator plus inhaled corticosteroid (ICS) on hyperinflation and exercise endurance in chronic obstructive pulmonary disease (COPD) are scarce, though these therapeutic strategies are widely used in clinical practice.
We performed a randomized, crossover clinical trial of two × 8 weeks comparing tiotropium (18 μg once daily) + salmeterol (50 μg twice daily) (T + S) to salmeterol + fluticasone (50/500 μg twice daily) (S + F) in COPD (forced expiratory volume in 1 s (FEV(1)) ≤65% predicted, and thoracic gas volume (TGV) ≥120% predicted). Coprimary endpoints were postbronchodilator TGV and exercise endurance time (EET).
In 309 patients, at baseline, prebronchodilator FEV(1) was 1.36 L (46% predicted), TGV was 5.42 L (165% predicted), and EET = 458 s. Relative to S + F, T + S lowered postdose TGV by 182 ± 44 ml after 4 weeks (p < 0.0001) and 87 ± 44 ml after 8 weeks (p < 0.05). EET was nonsignificantly increased following T + S treatment (20 ± 15 s at 4 weeks, 15 ± 13 s at 8 weeks) vs. S + F. BORG dyspnea score at exercise isotime was reduced in favor of T + S.
The two bronchodilators decreased hyperinflation significantly more than one bronchodilator and ICS. This difference was not reflected in EET. (ClinicalTrials.gov number, NCT00530842).
在慢性阻塞性肺疾病（COPD）中，比较两种支气管扩张剂与一种支气管扩张剂加吸入皮质类固醇（ICS）对过度充气和运动耐力的影响的数据很少，尽管这些治疗策略在临床实践中广泛应用。
我们进行了一项随机、交叉临床试验，比较了噻托溴铵（18μg，每日一次）+沙丁胺醇（50μg，每日两次）（T+S）与沙丁胺醇+氟替卡松（50/500μg，每日两次）（S+F）在 COPD（FEV1 占预计值的 1.36 升（46%），TGV 占预计值的 120%）患者中的作用。主要终点是支气管扩张剂后 TGV 和运动耐力时间（EET）。
在 309 名患者中，基线时，预支气管扩张剂 FEV1 为 1.36L（46%），TGV 为 5.42L（165%），EET=458s。与 S+F 相比，T+S 在 4 周后降低了 182±44ml 的剂量后 TGV（p<0.0001），8 周后降低了 87±44ml（p<0.05）。与 S+F 相比，T+S 治疗后 EET 略有增加（4 周时增加 20±15s，8 周时增加 15±13s）。运动等时呼吸困难评分在 T+S 治疗中降低。
两种支气管扩张剂比一种支气管扩张剂和 ICS 显著降低过度充气。这一差异并没有反映在 EET 中。（临床试验编号，NCT00530842）。
