Cardio-Thoracic and Vascular Department, Section of Pneumology, University of Pisa, Italy.
Pulm Pharmacol Ther. 2011 Feb;24(1):49-54. doi: 10.1016/j.pupt.2010.10.008. Epub 2010 Oct 21.
Exercise intolerance is a major feature in patients with Chronic Obstructive Pulmonary Disease (COPD). Bronchodilators increase endurance time (ET) and reduce dynamic hyperinflation (DH). We evaluated whether a single-dose of salbutamol/ipratropium + flunisolide (BD+ICS), added on top of the regular treatment, may improve ET in COPD patients. In a single-blind randomized crossover pilot trial, nebulised BD+ICS or placebo (PL) was administered 30 min before a constant load cardiopulmonary test, in 22 moderate-to-severe COPD patients (FEV₁: 53.9% pred). ET was the primary outcome measured. BD+ICS did not improve ET or VO₂ peak with respect to PL. BD+ICS increased pre-test FEV₁ and pre-test Inspiratory Capacity but did not modify DH. In a retrospective analysis, patients were divided in Improvers (N=11) and Non-Improvers (N=11) according to the difference in ET between BD+ICS and PL (> 25 s). Improvers had a worst BODE index, a higher static hyperinflation and poorer Vd/Vt ratio at peak of exercise with respect to Non-Improvers. Improvers only had a significant increase from BD+ICS on pre-test FEV₁ and IC. In conclusion, although a single-dose BD+ICS did not improve ET in COPD patients under regular treatment, a subgroup of more severe patients may have some benefit from that.
运动不耐受是慢性阻塞性肺疾病(COPD)患者的主要特征。支气管扩张剂可增加耐力时间(ET)并减少动态过度充气(DH)。我们评估了在常规治疗的基础上单次给予沙丁胺醇/异丙托溴铵+氟替卡松(BD+ICS)是否可以改善 COPD 患者的 ET。在一项单盲随机交叉试验中,22 名中重度 COPD 患者(FEV₁:预测值的 53.9%)在进行恒负荷心肺测试前 30 分钟接受了雾化 BD+ICS 或安慰剂(PL)。ET 是主要的观察终点。与 PL 相比,BD+ICS 并未改善 ET 或 VO₂峰值。BD+ICS 增加了预测试 FEV₁和预测试吸气量,但未改变 DH。在回顾性分析中,根据 ET 差值(BD+ICS 与 PL 差值>25 秒)将患者分为改善者(N=11)和未改善者(N=11)。与未改善者相比,改善者的 BODE 指数更差,静态过度充气更高,运动峰值时的 Vd/Vt 比值更差。仅改善者在预测试 FEV₁和 IC 方面从 BD+ICS 获得了显著的改善。总之,尽管常规治疗下 COPD 患者单次使用 BD+ICS 并未改善 ET,但病情更严重的患者可能会从中受益。