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首页> 外文期刊>Expert opinion on biological therapy >Trafermin for stroke recovery: is it time for another randomized clinical trial?
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Trafermin for stroke recovery: is it time for another randomized clinical trial?

机译：Trafermin用于中风恢复：是时候进行另一项随机临床试验了吗？

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INTRODUCTION: Basic fibroblast growth factor (bFGF) has been shown to reduce volume in acute ischemic stroke models, and to promote functional recovery as well as new synapse formation when given to animals with completed cerebral infarction. A recombinant native form of human bFGF, trafermin, has been tested in Phase III clinical trials in patients with stroke. AREAS COVERED: The role of trafermin in stroke. Data were identified by searching PubMed for single or combined terms including: trafermin, basic fibroblast growth factors, neuroprotection, neuroprotective drugs, stroke therapy, stroke rehabilitation and acute stroke. Original research papers, clinical series and reviews are included. Our research covered all relevant data up until 1 April 2011. EXPERT OPINION: To date, all Phase III trials have failed to demonstrate the superiority of trafermin over placebo when given within 6 h from stroke onset because trafermin causes a dose-dependent hypotension and an increased mortality rate in treated patients. However, a 24-h intravenous infusion seems to be safe for stroke patients and may result in an improved outcome when given 5 - 6 h after infarct. This finding may open renewed interest in restorative treatment for stroke, which could enhance recovery mechanisms rather than immediate neuroprotection. Studies suggest that growth factors can produce improvement in animal models of stroke, even when administered at postischemic intervals from many hours to days, when conventional neuroprotective approaches are typically ineffective. Because of the number of side effects and increased mortality reported in the first clinical studies with high dose of FGF, further experimental studies are necessary to asses whether it is possible to achieve a pharmacologically significant therapeutic level in the brain, by minimizing peripheral side effects. Another randomized clinical trial is needed to test trafermin in stroke patients but to enhance functional recovery.
机译：简介：已证明碱性成纤维细胞生长因子（bFGF）在急性缺血性中风模型中可减少体积，并向完全脑梗死的动物给药时可促进功能恢复以及新的突触形成。人bFGF的重组天然形式trafermin已在中风患者的III期临床试验中进行了测试。覆盖的区域：trafermin在中风中的作用。通过在PubMed中搜索单个或组合术语来识别数据，这些术语包括：trafermin，碱性成纤维细胞生长因子，神经保护，神经保护药物，中风治疗，中风康复和急性中风。包括原始研究论文，临床系列文章和评论。我们的研究覆盖了直到2011年4月1日的所有相关数据。专家意见：迄今为止，所有的III期试验都未能证明从中风发作起6小时内给予trafermin优于安慰剂，因为trafermin会引起剂量依赖性低血压和增加了治疗患者的死亡率。但是，对于脑卒中患者，24小时静脉输注似乎是安全的，并且在梗死后5-6小时给予可能会改善预后。这一发现可能会引起人们对中风恢复治疗的新兴趣，这可能会增强恢复机制，而不是立即的神经保护作用。研究表明，即使在传统的神经保护方法通常无效的情况下，即使缺血后间隔数小时至数天，生长因子也可以改善中风动物模型。由于在第一个使用高剂量FGF进行的临床研究中报道的副作用数量和死亡率增加，因此有必要进行进一步的实验研究，以评估是否有可能通过最大程度地降低外周副作用来达到大脑中药理学上显着的治疗水平。需要另一项随机临床试验来测试中风患者的铁蛋白，但可增强功能恢复。

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