Likosky W H, Fireman B, Elmore R, Eno G, Gale K, Goode G B, Ikeda K, Laster J, Mosher C, Rozance J
Department of Neurology, Kaiser Permanente Medical Center, Santa Clara, CA 95051.
J Neurol Neurosurg Psychiatry. 1991 Dec;54(12):1055-60. doi: 10.1136/jnnp.54.12.1055.
The value of a short course of intensive immunosuppression with cyclophosphamide in stabilising chronic progressive multiple sclerosis (MS) was examined in a randomised single-blinded, placebo-controlled clinical trial. Forty two patients, from the Kaiser Permanente Medical Care Program, Northern California, were studied. Twenty two patients received a short course of cyclophosphamide in an outpatient neurology clinic until their leucocyte counts fell below 4000/mm3, and 20 patients received folic acid. Level of disability, impairment of functional systems, and performance of social roles were assessed before randomisation and reassessed 12, 18, and 24 months after therapy. In both the cyclophosphamide and folic acid groups, the mean level of disability increased from the baseline examination to the 12 month follow up examination (the primary endpoint) by 0.5 on Kurtzke's Expanded Disability Status Scale, indicating similar disease progression in the two groups. Although immunosuppression therapy can be safely administered to MS patients in an outpatient clinic, evidence of substantial benefits was not found.
在一项随机单盲、安慰剂对照的临床试验中，研究了短期强化免疫抑制疗法联合环磷酰胺对稳定慢性进展性多发性硬化症（MS）的价值。对来自北加利福尼亚凯撒医疗保健计划的42名患者进行了研究。22名患者在门诊神经科诊所接受了短期环磷酰胺治疗，直至白细胞计数降至4000/mm³以下，20名患者接受了叶酸治疗。在随机分组前评估了残疾程度、功能系统损害和社会角色表现，并在治疗后12、18和24个月进行了重新评估。在环磷酰胺组和叶酸组中，从基线检查到12个月随访检查（主要终点），根据库茨克扩展残疾状态量表，残疾平均水平均增加了0.5，表明两组疾病进展相似。尽管免疫抑制疗法可在门诊安全地应用于MS患者，但未发现有显著益处的证据。
