Selective and Sustained Delivery of Basic Fibroblast Growth Factor (bFGF) for Treatment of Peripheral Arterial Disease: Results of a Phase I Trial
Selective and Sustained Delivery of Basic Fibroblast Growth Factor (bFGF) for Treatment of Peripheral Arterial Disease: Results of a Phase I Trial
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DOI：
10.1016/j.ejvs.2009.02.005
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发表时间：
2009-07-01
影响因子：
5.7
通讯作者：
Nagawa, H.
中科院分区：
文献类型：
--
作者：
Hashimoto, T.;Koyama, H.;Nagawa, H.
目的：本研究的目的是评估酸性明胶水凝胶微球（AGHMs）选择性和持续递送碱性成纤维细胞生长因子（bFGF）治疗外周动脉疾病（PAD）的安全性。材料和方法：我们进行了一项非随机、非对照试验，对8名PAD患者（8条肢体）进行了前瞻性观察，其中5条肢体患有动脉硬化闭塞性，3条肢体患有血栓闭塞性脉管炎，5条肢体（3臂和2腿）患有重度肢体缺血（CLI）和3条肢体患有间歇性跛行（IC），随访6个月或更长时间。将含有100 μ g bFGF的AGHM悬液注入患肢动脉。除了评估安全性和症状变化外，在基线和不同时间点分别进行静息踝关节-肱压力指数测量和经皮PO2 （tcPO(2)）、血管造影。皮肤灌注压作为CLI的指标，跛行距离作为IC的指标，也被用来评估临床改善和肢体灌注。结果:未见严重不良事件。所有病例均表现出症状的改善，尽管这在一些患者中是暂时的。结论：在PAD患者中，使用AGHMs选择性递送bFGF是安全且耐受性良好的。2009年，爱思唯尔有限公司代表欧洲血管外科学会出版。版权所有。
Objectives: The aim of this study was to evaluate the safety of selective and sustained delivery of basic fibroblast growth factor (bFGF) using acidic gelatine hydrogel microspheres (AGHMs) for the treatment of peripheral arterial disease (PAD).Materials and methods: We conducted a non-randomised and uncontrolled trial involving prospective observation of eight patients (eight limbs) with PAD - five limbs with arteriosclerosis obliterans and three limbs with thromboangiitis obliterans, five limbs (three arms and two legs) with critical limb ischaemia (CLI) and three limbs with intermittent claudication (IC) - who were followed up for 6 months or more. AGHM suspension containing 100 mu g bFGF was infused into the artery of the affected limb. Besides evaluation of safety and changes in symptoms, resting ankle-brachial pressure index measurement and transcutaneous PO2 (tcPO(2)), angiography were conducted at baseline and then at various time points. Skin perfusion pressure as an index of CLI and claudication distance as an index of IC were also used to assess clinical improvement and limb perfusion.Results: No serious adverse events were observed. All cases showed improvement in symptoms, although this was temporary in some patients.Conclusion: Selective delivery of bFGF using AGHMs was suggested to be safe and well-tolerated in patients with PAD. Crown Copyright (C) 2009 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. All rights reserved.