Basic fibroblast growth factor in patients with intermittent claudication: Results of a phase I trial
Basic fibroblast growth factor in patients with intermittent claudication: Results of a phase I trial
复制标题
DOI：
10.1016/s0735-1097(00)00882-2
复制
发表时间：
2000-10-01
影响因子：
24
通讯作者：
Quyyumi, AA
中科院分区：
文献类型：
--
作者：
Lazarous, DF;Unger, EF;Quyyumi, AA
本I期研究旨在评价动脉内碱性成纤维细胞生长因子（bFGF）在动脉粥样硬化性外周动脉疾病（PVD）和间歇性跛行患者中的安全性、耐受性和药代动力学。我们还评估了碱性成纤维细胞生长因子（bFGF）对小牛血流量的影响，作为衡量生物activity. Background临床前研究表明，bFGF，血管生成肽，促进心肌和后肢缺血的动物模型中的侧支发展。bFGF在患者中的安全性和有效性尚不清楚，在冠状动脉和外周动脉疾病中的早期临床试验正在进行中。方法在证实踝/臂指数的跛行患者中进行双盲、安慰剂对照、剂量递增试验
OBJECTIVES This phase I study was designed to evaluate the safety, tolerability and pharmacokinetics of intra-arterial basic fibroblast growth factor (bFGF) in patients with atherosclerotic peripheral arterial disease (PVD) and intermittent claudication. We also assessed the effects of basic fibroblast growth factor (bFGF) on calf blood flow as a measure of biologic activity.BACKGROUND Preclinical studies have shown that bFGF, an angiogenic peptide, promotes collateral development in animal models of myocardial and hind limb ischemia. The safety and efficacy of bFGF in patients is unknown, and early clinical trials are underway in coronary and peripheral arterial disease.METHODS A double-blind, placebo-controlled, dose-escalation trial was conducted in patients with claudication demonstrating ankle/brachial index