A randomised, controlled trial of bosentan in severe COPD
A randomised, controlled trial of bosentan in severe COPD
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DOI：
10.1183/09031936.00011308
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发表时间：
2008-09-01
影响因子：
24.3
通讯作者：
Tamm, M.
中科院分区：
文献类型：
--
作者：
Stolz, D.;Rasch, H.;Tamm, M.
运动时肺动脉高压在严重慢性阻塞性肺疾病（COPD）中很常见。假设使用内皮素受体拮抗剂波生坦可以改善运动时的心肺血流动力学，从而增加严重COPD患者的运动耐量。在目前的双盲、安慰剂对照研究中，30名重度或极重度COPD患者以2:1的比例随机分配，接受波生坦或安慰剂治疗12周。主要终点是6分钟步行距离的变化。次要终点包括与健康相关的生活质量、肺功能、心脏血流动力学、最大摄氧量和肺灌注模式的变化。与安慰剂相比，接受波生坦治疗的患者在12周内通过6分钟步行距离测量的运动能力没有显着改善（平均+/- SD 331 +/- 123对329 +/- 94米）。肺功能、肺动脉压、最大摄氧量和局部肺灌注模式均无变化。相比之下，在给予波生坦治疗的患者中，动脉氧压下降，肺泡-动脉梯度增加，生活质量明显恶化。口服内皮素受体拮抗剂波生坦不仅不能改善无严重肺动脉高压的重度慢性阻塞性肺疾病患者静息时的运动能力，还会恶化低氧血症和功能状态。
Pulmonary hypertension during exercise is common in severe chronic obstructive pulmonary disease (COPD). It was hypothesised that the use of the endothelin-receptor antagonist bosentan can improve cardiopulmonary haemodynamics during exercise, thus increasing exercise tolerance in patients with severe COPD.In the present double-blind, placebo-controlled study, 30 patients with severe or very severe COPD were randomly assigned in a 2:1 ratio to receive either bosentan or placebo for 12 weeks. The primary end-point was change in the 6-min walking distance. Secondary end-points included changes in health-related quality of life, lung function, cardiac haemodynamics, maximal oxygen uptake and pulmonary perfusion patterns.Compared with placebo, patients treated with bosentan during 12 weeks showed no significant improvement in exercise capacity as measured by the 6-min walking distance (mean +/- SD 331 +/- 123 versus 329 +/- 94 m). There was no change in lung function, pulmonary arterial pressure, maximal oxygen uptake or regional pulmonary perfusion pattern. In contrast, arterial oxygen pressure dropped, the alveolar-arterial gradient increased and quality of life deteriorated significantly in patients assigned bosentan.The oral administration of the endothelin receptor antagonist bosentan not only failed to improve exercise capacity but also deteriorated hypoxaemia and functional status in severe chronic obstructive pulmonary disease patients without severe pulmonary hypertension at rest.