ANN NEUROL ：多发性硬化联合治疗与单一疗法的比较

2013-03-28 晓静 编译 医学论坛网

复发—缓解型多发性硬化干扰素醋酸格拉替雷

　　一项大型临床试验（CombiRx研究）对比了干扰素-β1a（IFN）和醋酸格拉替雷（glatiramer acetate，GA）联合治疗与这两种药物单一疗法治疗复发—缓解型多发性硬化的疗效，结果显示，在减少复发风险方面，联合治疗不优于单一疗法。 　　研究还发现，随时间进展，联合治疗和GA在减少复发风险方面明显优于IFN；与单一疗法相比，联合治疗未减少确定的残疾进展。在减少新损害活动

　　一项大型临床试验（CombiRx研究）对比了干扰素-β1a（IFN）和醋酸格拉替雷（glatiramer acetate，GA）联合治疗与这两种药物单一疗法治疗复发—缓解型多发性硬化的疗效，结果显示，在减少复发风险方面，联合治疗不优于单一疗法。

　　研究还发现，随时间进展，联合治疗和GA在减少复发风险方面明显优于IFN；与单一疗法相比，联合治疗未减少确定的残疾进展。在减少新损害活动和总体损害体积的累积方面，联合治疗优于单一疗法。在事后分析MRI结果中，与单一疗法组患者相比，联合治疗导致受试者疾病活动静止状态比例更高。

　　研究3月11日在线发表于《神经病学年鉴》，同时于第65届美国神经病学学会（AAN2013）年会公布。


Randomized study combining interferon and glatiramer acetate in multiple sclerosis

Objective
A double-blind, randomized, controlled study was undertaken to determine whether combined use of interferon β-1a (IFN) 30μg intramuscularly weekly and glatiramer acetate (GA) 20mg daily is more efficacious than either agent alone in relapsing–remitting multiple sclerosis.
Methods
A total of 1,008 participants were randomized and followed until the last participant enrolled completed 3 years. The primary endpoint was reduction in annualized relapse rate utilizing a strict definition of relapse. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score, and magnetic resonance imaging (MRI) metrics.
Results
Combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed Expanded Disability Status Scale progression or change in MSFC over 36 months. The combination was superior to either agent alone in reducing new lesion activity and accumulation of total lesion volumes. In a post hoc analysis, combination therapy resulted in a higher proportion of participants attaining disease activity-free status (DAFS) compared to either single arm, driven by the MRI results.
Interpretation
Combining the 2 most commonly prescribed therapies for multiple sclerosis did not produce a significant clinical benefit over 3 years. An effect was seen on some MRI metrics. In a test of comparative efficacy, GA was superior to IFN in reducing the risk of exacerbation. The extension phase for CombiRx will address whether the observed differences in MRI and DAFS findings predict later clinical differences. Ann Neurol 2013;

    

作者：晓静 编译



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