LOW-DOSE (7.5-MG) ORAL METHOTREXATE REDUCES THE RATE OF PROGRESSION IN CHRONIC PROGRESSIVE MULTIPLE-SCLEROSIS

被引:250
作者
GOODKIN, DE
RUDICK, RA
MEDENDORP, SV
DAUGHTRY, MM
SCHWETZ, KM
FISCHER, J
VANDYKE, C
机构
[1] CLEVELAND CLIN FDN, MELLEN CTR MULTIPLE SCLEROSIS TREATMENT & RES, CLEVELAND, OH USA
[2] CLEVELAND CLIN FDN, DEPT BIOSTAT & EPIDEMIOL, CLEVELAND, OH USA
[3] CLEVELAND CLIN FDN, DEPT RADIOL, CLEVELAND, OH USA
关键词
D O I
10.1002/ana.410370108
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
A randomized, double-blinded, placebo-controlled, clinical trial of low-dose, weekly, oral methotrexate was performed in 60 patients with clinically definite chronic progressive multiple sclerosis (MS) attending a referral-based outpatient MS clinic. Study patients were 21 to 60 years old with a disease duration of longer than 1 year. Patients' Expanded Disability Status Scale scores were 3.0 to 6.5 (ambulatory with moderate disability). Patients were first stratified by Expanded Disability Status Scale scores, 3.0 to 5.5 and 6.0 to 6.5, and then were randomized to receive methotrexate or placebo treatment. Treatment consisted of weekly, oral, low-dose (7.5 mg) methotrexate or identical placebo for 2 years, followed by observation for as long as 1 year. A composite outcome measurement instrument was used and consisted of (1) Expanded Disability Status Scale, (2) ambulation index, (3) Box and Block Test, and (4) 9-Hole Peg Test. Failure of therapy was Indicated by a designated change that was sustained for more than 2 months in one or more components of this composite measure. Significantly less progression of impairment as measured by validated tests of upper-extremity function was observed in the methotrexate treatment group in the absence of clinically significant toxicity. We conclude that low-dose, weekly, oral methotrexate offers a new, relatively nontoxic treatment option foe patients with chronic progressive MS.
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页码:30 / 40
页数:11
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