Interferon-α2a reduces MRI disease activity in relapsing-remitting multiple sclerosis
Interferon-α2a reduces MRI disease activity in relapsing-remitting multiple sclerosis
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DOI：
10.1212/wnl.52.5.1049
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发表时间：
1999-03-23
期刊：
影响因子：
9.9
通讯作者：
Nyland, HI
中科院分区：
文献类型：
--
作者：
Myhr, KM;Riise, T;Nyland, HI
目的：评价干扰素α 2a（IFN-α 2a）治疗复发缓解型多发性硬化症（RRMS）的疗效和安全性。背景资料：IFN-α的几种免疫调节治疗方案在MS中显示出不同的结果。最近的一项初步研究表明IFN-α 2a的益处。研究方法：97名患者随机接受安慰剂（33名患者）或450万国际单位（mIU）（32名患者）或9.0 mIU（32名患者）的IFN-α 2a皮下注射，每周三次，持续6个月，并随访6个月。每月一次的钆胺增强MRI是评估疗效的主要方法。结果：IFN-α 2a治疗在治疗期间导致较少的新MRI病变（p < 0.003）。治疗期间无新病变的概率用9.0 mIU IFN-α 2a比用安慰剂高>2.5倍（p < 0.005）。治疗结束时，IFN-α 2a治疗组的中位病变数低于安慰剂组（p = 0.0004），但在随访期间差异消失。治疗期间，安慰剂组的病变总数（平均值）增加了4.78，4.5 mIU IFN-α 2a组增加了0.86，9.0 mIU IFN-α 2a组增加了0.28（p = 0.030）。未检测到对加重率、残疾进展或生活质量的治疗效果。9名患者停止治疗，5名因不良事件。结论：通过MRI测量，IFN-α 2a治疗显著降低了疾病活动度，但疗效在停止治疗后6个月内消失。需要对更多使用残疾作为主要结局指标的患者进行长期研究，以评估临床影响。
Objective: To evaluate the efficacy and safety of interferon-alpha 2a (IFN-alpha 2a) in relapsing-remitting MS (RRMS). Background: Several immune-modulating therapy regimens of IFN-alpha have shown varying results in MS. A recent pilot study suggested benefits from IFN-alpha 2a. Methods: 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-alpha 2a 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. Results: IFN-alpha 2a 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-alpha 2a than with placebo (p < 0.005). The median number of lesions at the end of treatment was lower with IFN-alpha 2a 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-alpha 2a, and 0.28 with 9.0 mIU IFN-alpha 2a 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. Conclusions: IFN-alpha 2a 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.