Durelli L, Bongioanni M R, Ferrero B, Ferri R, Imperiale D, Bradac G B, Bergui M, Geuna M, Bergamini L, Bergamasco B
Clinica Neurologica I, Università di Torino, Italy.
Neurology. 1996 Jul;47(1):123-9. doi: 10.1212/wnl.47.1.123.
We evaluated the long-lasting effects of systemic high-dose recombinant interferon alpha-2a (rIFNA) in relapsing-remitting (RR) MS after discontinuing treatment in a single-blind randomized placebo-controlled trial with 20 RR clinically definite MS patients using either nine million IU intramuscular rIFNA (n = 12) or placebo (n = 8) every other day for 6 months. Follow-up continued for a further 6 months without IFN treatment. In rIFNA-treated patients, main outcome measures, significantly different from placebo during treatment, returned, after discontinuing treatment, to values similar to placebo or baseline. Active MRI lesions per patient increased from 0.08 +/- 0.08 to 1.2 +/- 0.4 (p < 0.02), number of patients with clinical MRI signs of disease activity from 2 of 12 to 8 to 12 (P < 0.04), lymphocyte IFN gamma production from 3.0 +/- 0.7 to 12.4 +/- 2.2 IU/mL (p < 0.01), lymphocyte tumor necrosis factor alpha production from 5.8 +/- 0.9 to 18.9 +/- 6.3 pg/mL (p < 0.05). All side effects of rIFNA treatment disappeared after discontinuing the drug. The reduction of clinical MRI signs of disease activity and the immunologic effects were temporary and restricted to the period of rIFNA administration. The depression of many immunologic and clinical MRI responses during drug administration and their simultaneous return to baseline after discontinuing the drug strongly argue all observed changes were related to drug administration.
我们在一项单盲随机安慰剂对照试验中，对20例复发缓解型（RR）临床确诊的MS患者进行了研究，评估了全身高剂量重组干扰素α-2a（rIFNA）在停药后对RR型MS的长期影响。患者每隔一天接受900万国际单位肌肉注射rIFNA（n = 12）或安慰剂（n = 8），共治疗6个月。停药后继续随访6个月，期间不使用干扰素治疗。在接受rIFNA治疗的患者中，治疗期间与安慰剂有显著差异的主要结局指标，在停药后恢复到与安慰剂或基线相似的值。每位患者的活动性MRI病灶从0.08±0.08增加到1.2±0.4（p < 0.02），有疾病活动临床MRI征象的患者数量从12例中的2例增加到8例再到12例（P < 0.04），淋巴细胞干扰素γ产生量从3.0±0.7增加到12.4±2.2 IU/mL（p < 0.01），淋巴细胞肿瘤坏死因子α产生量从5.8±0.9增加到18.9±6.3 pg/mL（p < 0.05）。rIFNA治疗的所有副作用在停药后消失。疾病活动临床MRI征象的减少和免疫效应是暂时的，仅限于rIFNA给药期间。给药期间许多免疫和临床MRI反应的降低以及停药后同时恢复到基线强烈表明所有观察到的变化与药物给药有关。
