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Clinical Trial
. 2002 Mar 21;346(12):896-903.
doi：10.1056/nejmoa012212。

Bosentan therapy for pulmonary arterial hypertension

刘易斯·J·鲁宾1, David B Badesch, Robyn J Barst, Nazzareno Galie, Carol M Black, 安妮·基奥（Anne Keogh）, Tomas Pulido, Adaani Frost, Sebastien Roux, Isabelle Leconte, 迈克尔·兰兹伯格, Gerald Simonneau
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Clinical Trial

Bosentan therapy for pulmonary arterial hypertension

刘易斯·J·鲁宾et al. N Engl J Med. .
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  • N Engl J Med 2002 Apr 18;346(16):1258

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Background:内皮素-1是一种有效的血管收缩剂和光滑肌肉丝分裂原。在一项初步研究中，口服双皮素 - 受体拮抗剂波森坦改善了肺动脉高压患者的运动能力和心肺血液动力学。本试验调查了波森坦对大量患者运动能力的影响，并比较了两种剂量。

方法：In this double-blind, placebo-controlled study, we randomly assigned 213 patients with pulmonary arterial hypertension (primary or associated with connective-tissue disease) to receive placebo or to receive 62.5 mg of bosentan twice daily for 4 weeks followed by either of two doses of bosentan (125 or 250 mg twice daily) for a minimum of 12 weeks. The primary end point was the degree of change in exercise capacity. Secondary end points included the change in the Borg dyspnea index, the change in the World Health Organization (WHO) functional class, and the time to clinical worsening.

Results:在第16周，接受波森坦治疗的患者的步行距离有所提高。安慰剂组和联合波森坦组之间的平均差异为44 m（95％的置信区间，21至67； p <0.001）。波森坦还改善了Borg呼吸困难指数和功能性类别，并增加了临床恶化的时间。

Conclusions:The endothelin-receptor antagonist bosentan is beneficial in patients with pulmonary arterial hypertension and is well tolerated at a dose of 125 mg twice daily. Endothelin-receptor antagonism with oral bosentan is an effective approach to therapy for pulmonary arterial hypertension.

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