艾森门格综合征患者的博森坦治疗:多中心,双盲,随机,安慰剂控制的研究
Nazzareno Galiè1, Maurice Beghetti, Michael A Gatzoulis
1Istituto di Cardiologia, Università di Bologna, Via Massarenti, 9 IT-40138, Bologna, Italy. nazzareno.galie@unibo.it
Circulation
|June 28, 2006
概括
这项研究表明,博森坦是一种内甲素受体对手,在艾森门格综合征患者中改善了运动能力和血液动力学,而不会恶化氧和度. 这是它它它它.
科学领域:
- 心脏病学 心脏病学
- 肺高血压是什么意思 肺高血压
- 药理学 药理学是指药理学的学科.
背景情况:
- 艾森门格综合征涉及肺动脉高血压,右向左转移,以及因先天性心脏病而导致的低氧化.
- 艾森门格综合征中的内分泌素表达增加表明,内分泌素受体对抗可能会带来益处.
- 人们担心,全身血管干预可能会加剧分流和低氧化.
研究的目的:
- 为了评估森坦的安全性和有效性,一个双重内甲素受体对抗剂,在世界卫生组织功能类III艾森门格综合征的患者中.
- 评估博森坦对全身脉冲氧计 (主要安全终点) 和肺血管阻力 (主要疗效终点) 的影响.
主要方法:
- 一项为期16周的多中心,随机,双盲,安慰剂对照试验 (BREATHE-5) 涉及54名患者.
- 患者被随机分为2:1接受博森坦 (n=37) 或安慰剂 (n=17).
- 血液动力学通过右心和左心导管测定;运动能力通过6分钟的步行距离来衡量.
主要成果:
- 博森坦没有恶化全身氧和,对脉冲氧度有1.0%的安慰剂校正效果 (95% CI, -0.7至2.8).
- 博森坦显著降低了肺血管阻力指数 (-472.0 dyne.s.cm(-5);P=0.0383) 和肺动脉平均压力 (-5.5 mm Hg;P=0.0363).
- 与安慰剂相比,博森坦组的运动能力增加了53.1m (P=0.0079). 不良事件停止率在各组之间是相似的 (5%对12%).
结论:
- 在患有艾森门格综合征的患者中,博森坦耐受性良好.
- 该研究表明,博森坦改善了运动能力和血液动力学.
- 重要的是,博森坦治疗在这个患者群体中没有影响周围氧和.
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