Comparison of weakness progression in inclusion body myositis during treatment with methotrexate or placebo

Comparison of weakness progression in inclusion body myositis during treatment with methotrexate or placebo
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DOI:
10.1002/ana.10121
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发表时间:
2002-03-01
影响因子:
11.2
通讯作者:
Wintzen, AR
Wintzen, AR
中科院分区:
医学1区
文献类型:
--
作者:
Badrising, UA;Maat-Schieman, MLC;Wintzen, AR

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在一项为期48周的随机双盲安慰剂对照研究中,我们研究了每周5 - 20mg口服甲氨蝶呤是否可以减缓44例包涵体肌炎患者的疾病进展。定量肌力测试总分的平均变化是主要的研究结果衡量指标。两个治疗组的定量肌力测试总分均下降,甲氨蝶呤组下降0.2%,安慰剂组下降3.4%(95%置信区间= -2.5%至+9.1%)。治疗48周后,两组手工肌肉测试总分、活动量表评分及患者自我评价均无差异。甲氨蝶呤组血清肌酸激酶活性明显降低。我们得出结论,口服甲氨蝶呤不能减缓肌肉无力的进展,但降低血清肌酸激酶活性。
We investigated whether 5 to 20mg per week oral methotrexate could slow down disease progression in 44 patients with inclusion body myositis in a randomized double-blind placebo-controlled study over 48 weeks. Mean change of quantitative muscle strength testing sum scores was the primary study outcome measure. Quantitative muscle strength testing sum scores declined in both treatment groups, -0.2% for methotrexate and -3.4% for placebo (95% confidence interval = -2.5% to +9.1% for difference). There were also no differences in manual muscle testing sum scores, activity scale scores and patients' own assessments after 48 weeks of treatment. Serum creatine kinase activity decreased significantly in the methotrexate group. We conclude that oral methotrexate did not slow down progression of muscle weakness but decreased serum creatine kinase activity.