TY - T1的甲氨蝶呤的随机对照试验广义重症肌无力患者JF -神经学乔-神经病学SP - 57 LP - 64 - 10.1212 / WNL。首页0000000000002795六世- 87 - 1 AU - Mamatha Pasnoor盟——Jianghua他非盟-劳拉Herbelin盟-泰德·m·伯恩斯盟沙龙国家非盟-维拉成Bril盟安娜贝利k王盟——Bakri h Elsheikh AU -约翰·t·Kissel盟·大卫·萨珀斯坦AU - j·阿齐兹Shaibani AU -杰克逊Carlayne盟-安德里亚·斯文森盟-詹姆斯·f·霍华德,小盟Namita Goyal AU -威廉·大卫盟马修·威克伦AU -迈克尔滑轮盟-马拉贝克尔盟Tahseen Mozaffar AU -迈克尔·贝纳塔尔AU -罗伯特Pazcuzzi盟艾丽卡辛普森盟-杰弗里·罗森菲尔德盟-阿巴斯m . Dimachkie盟-杰弗里·m·Statland AU -理查德•j•Barohn盟MG调查员的甲氨蝶呤肌肉研究小组Y1 - 2016/07/05 UR - //www.ez-admanager.com/content/87/1/57.abstract N2 -目的:确定steroid-sparing影响患者的甲氨蝶呤(MTX)的广义重症肌无力症状(毫克)。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 ER -