Unidad de Esclerosis Múltiple, Servicio de Neurología, Hospital Universitario y Politécnico La Fe, Valencia, España.
Neurologia. 2013 Mar;28(2):65-72. doi: 10.1016/j.nrl.2012.03.014. Epub 2012 Jul 28.
Evaluate safety and tolerance levels for intravenous immunoglobulins (IVIG) as treatment for neuromyelitis optica (NMO).
Eight patients meeting Wingerchuk's revised diagnostic criteria were treated with IVIG every 2 months (0.7 g per kg body weight per day for 3 days). The primary outcome measure was the occurrence of serious adverse effects, defined according to NIH guidelines for clinical trials. Secondary outcome measures were changes in the yearly rate of attacks and in the degree of neurological disability measured with the Expanded Disability Status Scale (EDSS).
All 8 patients were treated; 5 had relapsing optic neuritis with or without myelitis and 3 had recurrent longitudinally extensive transverse myelitis. The mean age of onset was 20.5 years (range, 7-31 years) and 87,5% were female. The mean duration of the disease before beginning treatment was 9.0 years (range, 3-17 years). Following 83 infusions (range, 4-21 per patient) and a mean follow-up time of 19.3 months (range, 6-39 months), minor adverse events had occurred (headache in 3 patients and a mild cutaneous eruption in a single patient). The relapse rate decreased from 1.8 in the previous year to 0.006 during follow-up (z=2,5, P=.01). The EDSS score fell from 3.3±1.3 to 2.6±1.5 (z=-2.0, P=.04).
Treatment with IVIG is safe and well-tolerated, and it may be used as a treatment alternative for NMO spectrum disorders.
评估静脉注射免疫球蛋白（IVIG）作为治疗视神经脊髓炎（NMO）的安全性和耐受水平。
8 名符合 Wingerchuk 修订诊断标准的患者接受 IVIG 治疗，每 2 个月一次（0.7 g/kg 体重/天，连续 3 天）。主要结局指标是严重不良事件的发生情况，根据 NIH 临床试验指南定义。次要结局指标是每年攻击率的变化和扩展残疾状况量表（EDSS）测量的神经功能障碍程度的变化。
8 名患者均接受了治疗；5 名患者有视神经炎伴或不伴脊髓炎复发，3 名患者有复发性长节段横贯性脊髓炎。发病年龄平均为 20.5 岁（范围，7-31 岁），87.5%为女性。开始治疗前疾病的平均病程为 9.0 年（范围，3-17 年）。接受 83 次输注（范围，每名患者 4-21 次）和平均 19.3 个月的随访（范围，6-39 个月）后，出现了轻微的不良反应（3 名患者出现头痛，1 名患者出现轻度皮疹）。复发率从前一年的 1.8 下降到随访期间的 0.006（z=2.5，P=.01）。EDSS 评分从 3.3±1.3 下降到 2.6±1.5（z=-2.0，P=.04）。
IVIG 治疗安全且耐受良好，可作为 NMO 谱系障碍的治疗选择。
