A double-blind, placebo-controlled, randomized trial of cladribine in relapsing-remitting multiple sclerosis.

J S Romine, J C Sipe, J A Koziol, J Zyroff, E Beutler
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引用次数: 146

Abstract

We conducted an 18-month, placebo-controlled, double-blind study to evaluate cladribine in the treatment of 52 patients with relapsing-remitting multiple sclerosis. Patients received either placebo or cladribine 0.07 mg/kg/day by subcutaneous injection for 5 consecutive days as six monthly courses for a total cumulative dose of 2.1 mg/kg. Analysis of results revealed a statistically significant favorable effect of cladribine on the joint frequency and severity of relapses and magnetic resonance imaging (MRI) findings. MRI-enhancing lesions were completely suppressed in the cladribine patients by the sixth month of treatment. Mild segmental herpes zoster occurred in two cladribine-treated patients and one patient receiving placebo. Otherwise, there were no side effects or adverse events. We conclude that cladribine shows promise as a treatment for relapsing-remitting multiple sclerosis.

克拉德里滨治疗复发缓解型多发性硬化症的双盲、安慰剂对照、随机试验。
我们进行了一项为期18个月的安慰剂对照双盲研究,以评估克拉德里滨治疗52例复发-缓解型多发性硬化症患者的疗效。患者接受安慰剂或克拉宾0.07 mg/kg/天皮下注射,连续5天,共6个月疗程,总累积剂量为2.1 mg/kg。分析结果显示,克拉德滨对关节复发的频率和严重程度以及磁共振成像(MRI)结果有统计学上显著的有利影响。在克拉德滨治疗的第六个月,mri增强病变被完全抑制。轻度节段性带状疱疹发生在两名接受克拉德里滨治疗的患者和一名接受安慰剂治疗的患者。除此之外,没有副作用或不良事件。我们的结论是,克拉德滨作为一种治疗复发缓解型多发性硬化症的药物有希望。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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