Interferon-alpha is effective in HTLV-I-associated myelopathy: A multicenter, randomized, double-blind, controlled trial
Interferon-alpha is effective in HTLV-I-associated myelopathy: A multicenter, randomized, double-blind, controlled trial
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DOI：
10.1212/wnl.46.4.1016
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发表时间：
1996-04-01
期刊：
影响因子：
9.9
通讯作者：
Osame, M
中科院分区：
文献类型：
--
作者：
Izumo, S;Goto, I;Osame, M
对HTLV-I相关性脊髓病（HAM）患者进行了一项双盲、多中心研究，以评价天然干扰素-α（HLBI）治疗的疗效。入组48例HAM患者，并接受0.3 MU（n = 15）、1.0 MU（n = 17）或3.0 MU（n = 16）HLBI治疗28天。临床评价包括运动功能障碍、排尿障碍和神经系统体征的变化。治疗开始后4周和治疗完成后4周，0.3-MU组被判定为极好至良好的治疗反应频率分别为7.1%（1/14）和8.3%（1/12），1.0-MU组为23.5%（4/17）和26.7%（4/15），3.0-MU组为66.7%（10/15）和61.5%（8/13）。3.0-MU组的治疗获益显著高于0.3-MU组。两组间症状性副作用的发生率无显著差异。在1.0-MU和3.0-MU组的一些患者中获得了异常实验室数据;然而，大多数患者可以继续治疗方案。这些结果表明，HAM患者可以安全地每天使用HLBI 3.0 MU治疗4周，具有良好的临床效果。
A double-blind, multi-center study was performed on patients with HTLV-I-associated myelopathy (HAM) to evaluate the therapeutic effect of treatment with natural interferon-alpha (HLBI). Forty-eight HAM patients were enrolled and treated with either 0.3 MU (n = 15), 1.0 MU (n = 17), or 3.0 MU (n = 16) of HLBI for 28 days. Clinical evaluation included motor dysfunction, urinary disturbances, and changes of neurologic signs. The frequency of therapeutic response judged as excellent to good 4 weeks after starting therapy and 4 weeks after completion of therapy were 7.1% (1 of 14) and 8.3% (1 of 12) in the 0.3-MU group, 23.5% (4 of 17) and 26.7% (4 of 15) for the 1.0-MU group, and 66.7% (10 of 15) and 61.5% (8 of 13) for the 3.0-MU group. The therapeutic benefit in the 3.0-MU group was significantly higher than in the 0.3-MU group. There was no significant difference in the incidence of symptomatic side effects between groups. Abnormal laboratory data were obtained for some patients in the 1.0-MU and 3.0-MU groups; however, the treatment schedule could be continued in most patients. These results suggest that HAM patients may be safely treated with HLBI 3.0 MU every day for 4 weeks with favorable clinical effects.