Keogh Anne M, McNeil Keith D, Wlodarczyk John, Gabbay Eli, Williams Trevor J
Victor Chang Research Institute, St. Vincent's Hospital, Sydney, Australia.
J Heart Lung Transplant. 2007 Feb;26(2):181-7. doi: 10.1016/j.healun.2006.11.009.
Bosentan (an oral dual endothelin receptor antagonist) improves symptoms and cardiac hemodynamics and reduces clinical worsening in patients with pulmonary arterial hypertension (PAH). The VITAL study assessed the effect of bosentan on quality of life in patients with WHO Functional Class III or IV PAH (idiopathic or associated with connective tissue diseases).
Quality of life was assessed prospectively using the MOS SF-36 and AQOL questionnaires. Baseline readings and scores at 3 and 6 months were collected, in addition to other efficacy and safety data.
Among the 177 study patients, SF-36 scores were significantly improved at 3 months in the domains of physical functioning (27.3 to 34.8; p < 0.0001), role-physical (16.6 to 30.9; p < 0.0001), vitality (35.2 to 41.1; p = 0.0003), social functioning (48.0 to 58.6; p < 0.0001), mental health (64.2 to 72.0; p = 0.005) and role-emotional (44.8 to 58.1; p = 0.001). Improvements were seen in all etiologic sub-groups and were maintained in patients who remained on bosentan. An improvement in AQOL measures at 3 months was also noted for patients with baseline WHO Functional Class III.
Bosentan significantly improves quality of life in patients with idiopathic PAH or PAH associated with connective tissue diseases.
波生坦(一种口服双重内皮素受体拮抗剂)可改善肺动脉高压(PAH)患者的症状和心脏血流动力学,并减少临床病情恶化。VITAL研究评估了波生坦对世界卫生组织功能分级为III或IV级的PAH患者(特发性或与结缔组织病相关)生活质量的影响。
使用MOS SF-36和AQOL问卷对生活质量进行前瞻性评估。除其他疗效和安全性数据外,还收集了基线读数以及3个月和6个月时的评分。
在177例研究患者中,3个月时SF-36评分在身体功能(从27.3提高到34.8;p<0.0001)、身体角色(从16.6提高到30.9;p<0.0001)活力(从35.2提高到41.1;p = 0.0003)、社会功能(从48.0提高到58.6;p<0.0001)、心理健康(从64.2提高到72.0;p = 0.005)和情感角色(从44.8提高到58.1;p = 0.001)等领域有显著改善。所有病因亚组均有改善,且继续使用波生坦的患者保持了这种改善。基线为世界卫生组织功能分级III级的患者在3个月时AQOL指标也有改善。
波生坦可显著改善特发性PAH或与结缔组织病相关的PAH患者的生活质量。