Romine J S, Sipe J C, Koziol J A, Zyroff J, Beutler E
Division of Neurology, Scripps Clinic, La Jolla, CA 92037, USA.
Proc Assoc Am Physicians. 1999 Jan-Feb;111(1):35-44. doi: 10.1046/j.1525-1381.1999.09115.x.
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.
我们进行了一项为期18个月的安慰剂对照双盲研究，以评估克拉屈滨治疗52例复发缓解型多发性硬化症患者的效果。患者接受安慰剂或皮下注射克拉屈滨0.07mg/kg/天，连续5天，每6个月为一个疗程，累积总剂量为2.1mg/kg。结果分析显示，克拉屈滨对复发的联合频率和严重程度以及磁共振成像（MRI）结果具有统计学上显著的有利影响。在治疗的第6个月时，接受克拉屈滨治疗的患者中MRI强化病灶被完全抑制。两名接受克拉屈滨治疗的患者和一名接受安慰剂治疗的患者出现了轻度节段性带状疱疹。除此之外，未出现副作用或不良事件。我们得出结论，克拉屈滨有望成为复发缓解型多发性硬化症的一种治疗方法。
