RT期刊文章SR电子T1甲氨蝶呤的随机对照试验广义重症肌无力患者摩根富林明神经病学神经学乔FD Lippincott Williams &威尔金斯SP 57 OP 64 10.1212 / WNL。首页87签证官0000000000002795是1 A1 Mamatha Pasnoor A1 Jianghua他A1劳拉Herbelin A1泰德·m·伯恩斯A1沙龙国家A1维拉成Bril A1安娜贝利k王A1 Bakri h Elsheikh A1约翰·t·Kissel A1·大卫·萨珀斯坦A1 j·阿齐兹Shaibani A1 Carlayne杰克逊A1安德里亚·斯文森A1詹姆斯·f·霍华德,小威廉A1 Namita Goyal A1大卫A1马修·威克伦A1迈克尔滑轮A1马拉贝克尔A1 Tahseen Mozaffar A1迈克尔·贝纳塔尔A1罗伯特Pazcuzzi A1艾丽卡辛普森A1杰弗里·罗森菲尔德A1 Mazen m . Dimachkie A1杰弗里·m·Statland A1 (Richard j . Barohn A1 MG调查员的甲氨蝶呤肌肉研究小组2016年UL //www.ez-admanager.com/content/87/1/57.abstract AB目的:确定steroid-sparing影响患者的甲氨蝶呤(MTX)的症状广义重症肌无力(MG)。首页方法:我们进行了一个12个月的多中心、随机、双盲、安慰剂对照试验的MTX 20毫克口服每周和安慰剂在50乙酰胆碱受体抗体阳性患者毫克2009年4月至2014年8月。主要结果测量是强的松dose-time曲线下面积(AUDTC)从4个月到12个。次要结果定量重症肌无力的措施包括12个月的变化分数,重症肌无力的综合得分,人工肌肉测试,重症肌无力的生活质量,重症肌无力日常生活活动。结果:58例筛选和50了。MTX不会降低4 - 12月强的松AUDTC相比安慰剂(区别MTX−安慰剂:−488.0毫克,95%置信区间2443−到1467。3,p = 0.26);然而,两组的平均每日强的松的剂量减少。MTX没有改善二次措施MG相比安慰剂超过12个月。八个参与者退出过程中研究(1 MTX, 7安慰剂)。没有严重的MTX-related不良事件。最常见的不良事件是特异性的疼痛(19%)。Conclusions: We found no steroid-sparing benefit of MTX in MG over 12 months of treatment, despite being well-tolerated. This study demonstrates the challenges of conducting clinical trials in MG, including difficulties with recruitment, participants improving on prednisone alone, and the need for a better understanding of outcome measure variability for future clinical trials.Classification of evidence: This study provides Class I evidence that for patients with generalized MG MTX does not significantly reduce the prednisone AUDTC over 12 months of therapy.AUC=area under the curve; AUDTC=area under the dose-time curve; CI=confidence interval; LOCF=last observation carried forward; MG=myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living scale; MGC=Myasthenia Gravis Composite Score; MGFA=Myasthenia Gravis Foundation of America; MMT=manual muscle testing; MTX=methotrexate; QMG=Quantitative Myasthenia Gravis Score

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