波生坦在中国肺动脉高压患者中的疗效、安全性和耐受性。

Efficacy, safety and tolerability of bosentan in Chinese patients with pulmonary arterial hypertension.

机构信息

Department of Pulmonary Circulation, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.

出版信息

J Heart Lung Transplant. 2010 Feb;29(2):150-6. doi: 10.1016/j.healun.2009.09.020.

DOI:10.1016/j.healun.2009.09.020

PMID:20113907

Abstract

BACKGROUND

Bosentan has an established role in the management of pulmonary arterial hypertension (PAH). This clinical trial assessed the benefits of bosentan in the Chinese population.

METHODS

We investigated the efficacy and safety of bosentan in 92 Chinese citizens (mean +/- standard deviation age, 29.0 +/- 3.8 years) with PAH for a minimum of 12 weeks. All received bosentan (62.5 mg twice daily) for 4 weeks; then, patients who weighed <40 kg received 62.5 mg bosentan twice daily and patients who weighed >40 kg received 125 mg twice daily. All patients were eligible to continue bosentan beyond 12 weeks. The primary end point was a change in exercise capacity from baseline to 12 and 24 weeks. Secondary end points included a change in World Health Organization (WHO) functional class and changes in cardiopulmonary hemodynamics.

RESULTS

At baseline, 66 patients (72%) were in WHO functional class III; presentation was 37 (40%) with idiopathic PAH (iPAH), 34 (37%) with PAH related to congenital heart disease (CHD), and 21 (23%) with PAH related to connective tissue disease (CTD). Exercise capacity increased to 67.8 m after 12 weeks and 92.6 m after 24 weeks (p < 0.001). After 24 weeks, WHO functional class decreased (-0.8 +/- 0.6; p < 0.001), mean pulmonary artery pressure and pulmonary vascular resistance decreased (p < 0.01), and cardiac output increased (p < 0.001). Twelve patients (13%) experienced at least 1 adverse event.

CONCLUSIONS

Bosentan improved exercise capacity, functional class, and cardiopulmonary hemodynamics in this patient cohort and was well tolerated.

摘要

背景

波生坦在肺动脉高压（PAH）的治疗中已有明确的作用。本临床试验评估了波生坦在中国人中的疗效和安全性。

方法

我们调查了 92 名中国 PAH 患者（平均年龄为 29.0 ± 3.8 岁）接受波生坦治疗至少 12 周的疗效和安全性。所有患者均接受波生坦（62.5 mg，每日 2 次）治疗 4 周；然后，体重<40kg 的患者接受 62.5mg 波生坦，每日 2 次；体重>40kg 的患者接受 125mg 波生坦，每日 2 次。所有患者均有资格在 12 周后继续接受波生坦治疗。主要终点为从基线到 12 周和 24 周时运动能力的变化。次要终点包括世界卫生组织（WHO）功能分级的变化和心肺血液动力学的变化。

结果

基线时，66 例患者（72%）为 WHO 功能分级 III 级；37 例（40%）为特发性 PAH（iPAH），34 例（37%）为先天性心脏病（CHD）相关 PAH，21 例（23%）为结缔组织病（CTD）相关 PAH。运动能力在 12 周时增加到 67.8m，在 24 周时增加到 92.6m（p<0.001）。24 周后，WHO 功能分级下降（-0.8 ± 0.6；p<0.001），平均肺动脉压和肺血管阻力降低（p<0.01），心输出量增加（p<0.001）。12 例患者（13%）至少发生 1 次不良事件。