Myhr K M, Riise T, Green Lilleås F E, Beiske T G, Celius E G, Edland A, Jensen D, Larsen J P, Nilsen R, Nortvedt M W, Smievoll A I, Vedeler C, Nyland H I
Department of Neurology, Haukeland University Hospital, University of Bergen, Norway.
Neurology. 1999 Mar 23;52(5):1049-56. doi: 10.1212/wnl.52.5.1049.
To evaluate the efficacy and safety of interferon-alpha2a (IFN-alpha2a) in relapsing-remitting MS (RRMS).
Several immune-modulating therapy regimens of IFN-alpha have shown varying results in MS. A recent pilot study suggested benefits from IFN-alpha2a.
Ninety-seven patients were randomized to receive subcutaneous injections of placebo (33 patients) or 4.5 million international units (mIU) (32 patients) or 9.0 mIU (32 patients) of IFN-alpha2a three times weekly for 6 months, with a further 6 months of follow-up. Monthly gadodiamide-enhanced MRI was the primary method of evaluating efficacy.
IFN-alpha2a treatment resulted in fewer new MRI lesions during the treatment period (p < 0.003). The probability of no new lesions during treatment was >2.5 times higher with 9.0 mIU IFN-alpha2a than with placebo (p < 0.005). The median number of lesions at the end of treatment was lower with IFN-alpha2a treatment than with placebo (p = 0.0004), but the difference disappeared during follow-up. The total number of lesions (mean) increased by 4.78 with placebo, 0.86 with 4.5 mIU IFN-alpha2a, and 0.28 with 9.0 mIU IFN-alpha2a during treatment (p = 0.030). No treatment effect on exacerbation rate, progression of disability, or quality of life was detected. Nine patients discontinued treatment, five because of adverse events.
IFN-alpha2a treatment significantly reduced disease activity as measured by MRI, but the efficacy disappeared within 6 months after discontinuation of treatment. A long-term study of more patients using disability as a primary outcome measure is needed to evaluate the clinical impact.
评估α-干扰素2a（IFN-α2a）治疗复发缓解型多发性硬化症（RRMS）的疗效和安全性。
几种α-干扰素免疫调节治疗方案在多发性硬化症中显示出不同的结果。最近一项初步研究表明α-干扰素2a有益处。
97例患者被随机分为皮下注射安慰剂组（33例患者）、450万国际单位（mIU）（32例患者）或900万mIU（32例患者）的α-干扰素2a组，每周3次，共6个月，并进行另外6个月的随访。每月钆双胺增强磁共振成像（MRI）是评估疗效的主要方法。
α-干扰素2a治疗在治疗期间导致新的MRI病灶较少（p<0.003）。900万mIUα-干扰素2a治疗期间无新病灶的概率比安慰剂组高2.5倍以上（p<0.005）。治疗结束时，α-干扰素2a治疗组的病灶中位数低于安慰剂组（p = 0.0004），但在随访期间差异消失。治疗期间，安慰剂组病灶总数（平均值）增加4.78，450万mIUα-干扰素2a组增加0.86，900万mIUα-干扰素2a组增加0.28（p = 0.030）。未检测到对疾病加重率、残疾进展或生活质量的治疗效果。9例患者停止治疗，5例因不良事件。
α-干扰素2a治疗通过MRI测量可显著降低疾病活动度，但停药后6个月内疗效消失。需要对更多患者进行以残疾为主要结局指标的长期研究，以评估其临床影响。
