The CombiRx trial of combined therapy with interferon and glatiramer cetate in relapsing remitting MS: Design and baseline characteristics.
The CombiRx trial of combined therapy with interferon and glatiramer cetate in relapsing remitting MS: Design and baseline characteristics.
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DOI：
10.1016/j.msard.2012.01.006
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发表时间：
2012-04-01
影响因子：
4
通讯作者：
Lublin, F. D.
中科院分区：
文献类型：
--
作者：
Lindsey, J. W.;Scott, T. F.;Lynch, S. G.;Cofield, S. S.;Nelson, F.;Conwit, R.;Gustafson, T.;Cutter, G. R.;Wolinsky, J. S.;Lublin, F. D.
关键词：
干扰素-β1a(IFNB)和醋酸格列酮(GA)是两种不同的治疗方法，对复发的MS都有部分有效，目前尚不清楚联合使用这两种治疗方法是否会更有效。回顾IFNB和GA联合治疗的CombiRx研究的原理、设计和基线特征。主要纳入标准包括复发性多发性硬化症的诊断，在过去3年中至少有2次多发性硬化症活动，扩大的残疾状况评分0到5.5，以及没有接受IFNB或GA的先前治疗。受试者被随机分为IFNB+GA、IFNB单一治疗或GA单一治疗，比例为2：1：1。从2005年到2009年，我们招收了1008名受试者。参与者中72.4%为女性，87.6%为高加索人，平均年龄为37.7岁。进入研究时，症状持续时间的中位数为2年，平均EDSS为2.1。在基线MRI上，平均总病变负荷为12.2毫升，40%的参与者有强化病变。我们招募了一组具有早期MS典型临床和MRI特征的患者，研究结果将有助于决定最佳的早期治疗。这项试验应该成为未来联合治疗研究的模式。
Interferon-β1a (IFNB) and glatiramer acetate (GA) are distinct therapies which are both partially effective for relapsing MS. It is not known if combining the two treatments would be more effective. To review the rationale, design, and baseline characteristics of the CombiRx study of combined treatment with IFNB and GA. The key inclusion criteria included a diagnosis of relapsing MS, at least 2 episodes of MS activity in the previous 3 years, expanded disability status scale of 0 to 5.5, and no prior treatment with either IFNB or GA. Subjects were randomized to IFNB+GA, IFNB monotherapy, or GA monotherapy in a 2:1:1 ratio. From 2005 to 2009, we enrolled 1008 subjects. The participants were 72.4% female and 87.6% Caucasian with a mean age of 37.7 years. The median duration of symptoms was 2 years at entry into the study, and the mean EDSS was 2.1. On the baseline MRI, the mean total lesion load was 12.2 ml, and 40% of the participants had enhancing lesions. We have recruited a population of patients with clinical and MRI characteristics typical for early MS. The study results will aid in deciding on the optimum early treatment. This trial should serve as a model for future studies of combination therapy.
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影响因子：
11.2
作者：
POSER, CM;PATY, DW;TOURTELLOTTE, WW
通讯作者：
TOURTELLOTTE, WW
DOI：
10.1177/1352458509358088
发表时间：
2010-03
期刊：
Multiple sclerosis (Houndmills, Basingstoke, England)
影响因子：
--
作者：
Ford C;Goodman AD;Johnson K;Kachuck N;Lindsey JW;Lisak R;Luzzio C;Myers L;Panitch H;Preiningerova J;Pruitt A;Rose J;Rus H;Wolinsky J
通讯作者：
Wolinsky J
影响因子：
11.2
作者：
McDonald, WI;Compston, A;Wolinsky, JS
通讯作者：
Wolinsky, JS
影响因子：
--
作者：
Cohen, JA;Cutter, GR;Whitaker, JN
通讯作者：
Whitaker, JN
DOI：
10.1177/1352458507083189
发表时间：
2008-04-01
期刊：
MULTIPLE SCLEROSIS
影响因子：
--
作者：
Cohen, J. A.;Calabresi, P. A.;Zhang, H.
通讯作者：
Zhang, H.