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重组人干扰素β-1a治疗复发缓解型多发性硬化症的短期磁共振成像变化研究

Magnetic resonance imaging changes with recombinant human interferon-beta-1a: a short term study in relapsing-remitting multiple sclerosis.

作者信息

Pozzilli C, Bastianello S, Koudriavtseva T, Gasperini C, Bozzao A, Millefiorini E, Galgani S, Buttinelli C, Perciaccante G, Piazza G, Bozzao L, Fieschi C

机构信息

Department of Neurological Science, University of Rome, La Sapienza, Italy.

出版信息

J Neurol Neurosurg Psychiatry. 1996 Sep;61(3):251-8. doi: 10.1136/jnnp.61.3.251.

Abstract

OBJECTIVE

To evaluate whether recombinant human interferon-beta-1a significantly affects disease activity as measured by a reduction in the number and volume of Gd enhancing lesions on monthly MRI. The study also evaluated the effect on six-monthly T2 weighted abnormality and relapse frequency.

METHODS

After a baseline scan and a six month pretreatment period, 68 patients were randomly assigned to receive either 3 MIU or 9 MIU of interferon-beta-1a by subcutaneous injection three times a week for six months. All patients were examined by Gd enhanced MRI every month in both pretreatment and treatment periods. The evaluation of Gd enhancing lesions was performed blind at the end of the study.

RESULTS

The mean number of Gd enhancing lesions was higher during the pretreatment period than during treatment. This difference was statistically significant for the two different dose subgroups (3.5 v 1.8, P < 0.001 for the 3 MIU group and 2.4 v 0.9, P < 0.001 for the 9 MIU group, corresponding to a reduction of 49% and 64% respectively). The mean volume of Gd enhancing lesions also significantly decreased by 61% (3 MIU group) and 73% (9 MIU group). These reductions were evident only after the first month of treatment. The six-monthly rate of new lesions as seen in T2 weighted images showed a similar trend of reduction with treatment (65% and 70% respectively). Lesion volume on T2 scans significantly increased during the pretreatment period whereas it remained almost stable during the treatment period in both groups. Clinical relapse rate was significantly reduced by treatment (53% for the 3 MIU group, P < 0.001; 69% for the 9 MIU group, P < 0.001).

CONCLUSION

Interferon-beta-1a seemed effective in reducing disease activity in relapsing-remitting multiple sclerosis at both the doses used.

摘要

目的

通过每月磁共振成像(MRI)上钆增强病灶数量和体积的减少来评估重组人干扰素β-1a是否显著影响疾病活动度。该研究还评估了对每六个月的T2加权异常和复发频率的影响。

方法

在进行基线扫描和为期六个月的预处理期后,68例患者被随机分配,分别接受3百万国际单位(MIU)或9 MIU的干扰素β-1a皮下注射,每周三次,共六个月。在预处理期和治疗期,所有患者每月均接受钆增强MRI检查。在研究结束时对钆增强病灶的评估是在盲态下进行的。

结果

预处理期钆增强病灶的平均数量高于治疗期。这种差异在两个不同剂量亚组中具有统计学意义(3 MIU组为3.5对1.8,P<0.001;9 MIU组为2.4对0.9,P<0.001,分别对应减少49%和64%)。钆增强病灶的平均体积也显著减少,3 MIU组减少61%,9 MIU组减少73%。这些减少仅在治疗的第一个月后才明显。T2加权图像上每六个月出现的新病灶率显示出与治疗相似的下降趋势(分别为65%和70%)。T2扫描上的病灶体积在预处理期显著增加,而在治疗期两组均几乎保持稳定。治疗使临床复发率显著降低(3 MIU组为53%,P<0.001;9 MIU组为69%,P<0.001)。

结论

在所使用的两种剂量下,干扰素β-1a似乎对降低复发缓解型多发性硬化症的疾病活动度有效。

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Interferon in relapsing-remitting multiple sclerosis.干扰素在复发缓解型多发性硬化症中的应用
Cochrane Database Syst Rev. 2001;2001(4):CD002002. doi: 10.1002/14651858.CD002002.

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