在患有艾森门格综合征的患者中对Macitentan的评估
Michael A Gatzoulis1, Michael Landzberg1, Maurice Beghetti2
1The Royal Brompton Hospital and National Heart & Lung Institute, Imperial College, London, United Kingdom (M.A.G.).
Circulation
|December 28, 2018
概括
在MAESTRO研究中发现,在艾森门格综合征患者中,马西没有改善运动能力. 在16周的试验中,这种内分泌素受体抗剂与安慰剂没有显著益处.
科学领域:
- 心脏病学
- 肺病学
- 药理学
背景情况:
- 艾森门格综合征是源于先天性心脏病的严重肺高血压,
- 在MAESTRO研究中,研究了用于治疗艾森门格综合征的内啡素受体对抗剂macitentan.
研究的目的:
- 评估macitentan在改善艾森门格综合征患者的运动能力方面的疗效和安全性.
- 评估macitentan对功能类,NT-proBNP水平和血液动力学的影响.
主要方法:
- 一个多中心的,双盲的,随机的,安慰剂控制的,16周的III期试验.
- 226名患者 (年龄≥12岁,世卫组织功能类II-III) 每天接受10毫克麦西坦或安慰剂.
- 主要终点:步行6分钟距离的变化;次要:WHO功能类的变化.
主要成果:
- 与安慰剂相比,macitentan没有显著改善6分钟的步行距离 (平均差异为- 4. 7米,P=0. 612).
- 两组之间的WHO功能类改善没有显著差异 (OR0. 53).
- 在探索性分析中,macitentan降低了NT-proBNP水平和肺血管抵抗指数 (PVRi).
结论:
- 在改善艾森门格综合征的运动能力方面,马西没有比安慰剂更优越.
- 虽然在NT-proBNP和PVRi等探索性措施中显示出潜力,但主要的终点没有得到满足.
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