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Two decades of subcutaneous glatiramer acetate injection: current role of the standard dose and new high-dose low-frequency glatiramer acetate in relapsing–remitting multiple sclerosis treatment

机译:皮下注射醋酸格拉替雷二十年:标准剂量的最新作用以及新型高剂量低频醋酸格拉替雷在复发性多发性硬化症治疗中的作用

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摘要

Glatiramer acetate, a synthetic amino acid polymer analog of myelin basic protein, is one of the first approved drugs for the treatment of relapsing–remitting multiple sclerosis. Several clinical trials have shown consistent and sustained efficacy of glatiramer acetate 20 mg subcutaneously daily in reducing relapses and new demyelinating lesions on magnetic resonance imaging in patients with relapsing–remitting multiple sclerosis, as well as comparable efficacy to high-dose interferon beta. Some preclinical and clinical data suggest a neuroprotective role for glatiramer acetate in multiple sclerosis. Glatiramer acetate is associated with a relatively favorable side-effect profile, and importantly this was confirmed also during long-term use. Glatiramer acetate is the only multiple sclerosis treatment compound that has gained the US Food and Drug Administration pregnancy category B. All these data support its current use as a first-line treatment option for patients with clinical isolated syndrome or relapsing–remitting multiple sclerosis. More recent data have shown that high-dose glatiramer acetate (ie, 40 mg) given three times weekly is effective, safe, and well tolerated in the treatment of relapsing–remitting multiple sclerosis, prompting the approval of this dosage in the US in early 2014. This high-dose, lower-frequency glatiramer acetate might represent a new, more convenient regimen of administration, and this might enhance patients’ adherence to the treatment, crucial for optimal disease control.
机译:醋酸格拉替雷是一种髓磷脂碱性蛋白的合成氨基酸聚合物类似物,是最早被批准用于治疗复发缓解型多发性硬化症的药物之一。多项临床试验显示,每天皮下注射20mg醋酸格拉替雷在减少复发复发型多发性硬化症患者的磁共振成像方面具有持续且持续的功效,可减少复发和新的脱髓鞘病变,并具有与大剂量干扰素β相当的功效。一些临床前和临床数据表明醋酸格拉替雷在多发性硬化症中具有神经保护作用。醋酸格拉替雷与相对有利的副作用有关,重要的是在长期使用中也证实了这一点。醋酸格拉替雷是唯一获得美国食品和药物管理局妊娠B级认证的多发性硬化症治疗化合物。所有这些数据均支持其目前用作临床孤立综合征或复发缓解型多发性硬化症患者的一线治疗选择。最近的数据显示,大剂量醋酸格拉替雷(每周40毫克)在复发性-释放性多发性硬化症的治疗中是有效,安全且耐受性良好的,促使其在美国早期获批。 2014年。这种高剂量,低频率的醋酸格拉替雷可能代表了一种新的,更方便的给药方案,这可能会增强患者对治疗的依从性,这对于控制最佳疾病至关重要。

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