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维瓦试验:血管内皮生长因子在血管血管生成的缺血
Timothy D Henry1, Brian H Annex, George R McKendall
1Division of Cardiology at Hennepin County Medical Center and University of Minnesota, Minneapolis, USA. henry003@tc.umn.edu
Circulation
|March 19, 2003
概括
复合人血管内皮生长因子蛋白 (rhVEGF) 输液对于稳定的强力性心痛患者是安全的. 高剂量的rhVEGF在第120天显著改善了心痛,与安慰剂不同.
科学领域:
- 心血管医学 心血管医学
- 再生医学是一种再生医学.
- 临床试验 临床试验
背景情况:
- 再组合的人体血管内皮生长因子蛋白 (rhVEGF) 促进血管生成.
- 第一个阶段的试验表明rhVEGF被人很好地容忍.
- VIVA试验评估了rhVEGF对缺血引起的血管新生.
研究的目的:
- 评估rhVEGF在患有稳定强迫性心脏病的患者中的安全性和有效性.
- 为了比较心血管内和静脉内输注的rhVEGF与安慰剂.
主要方法:
- 这是一项双盲,安慰剂控制的试验,涉及178名患有稳定炼性心痛的患者.
- 患者接受了安慰剂,低剂量rhVEGF或高剂量rhVEGF通过冠状动脉和静脉输液.
- 评估包括运动跑步机测试,胸痛类,生活质量和心肌输液成像.
主要成果:
- 在第60天,运动跑步机测试时间没有显著差异.
- 到第60天,在所有组中,胸痛类和生活质量都有所改善,没有跨组差异.
- 到第120天,高剂量的rhVEGF与安慰剂相比,在心痛类显著改善,以及改善运动能力的趋势.
结论:
- rhVEGF是安全的,并且在患有稳定的强力性心脏病的患者中耐受良好.
- 在第60天,rhVEGF没有表现出对安慰剂的优越性.
- 高剂量的rhVEGF在第120天显示出潜在的长期益处,因此需要进一步调查.
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