A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome
A randomized, double-blind, placebo-controlled trial of intravenous iron sucrose in restless legs syndrome
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DOI：
10.1016/j.sleep.2007.12.006
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发表时间：
2009-02-01
期刊：
影响因子：
4.8
通讯作者：
Allen, Richard P.
中科院分区：
文献类型：
--
作者：
Earley, Christopher J.;Horska, Alena;Allen, Richard P.
目的探讨大剂量静脉注射蔗糖铁能否改善特发性类风湿关节炎患者的症状，改变脑组织铁含量。方法：采用随机、平行、双盲对照的方法，静脉注射蔗糖铁1000 mg，与安慰剂对照。临床状态的主要衡量标准是全球睡眠评定量表(GRS)和周期性腿部睡眠活动(PLMS)。脑铁状态的主要指标是脑脊液铁蛋白和MRI确定的黑质铁。结果：在中期分析期间，有7名安慰剂和11名接受铁剂治疗的受试者。在治疗后2周，铁治疗导致脑脊液铁蛋白有轻微但显著的升高，RLS严重程度(GRS)降低，但不改变PLMS或MRI铁指数。所有的次要结果都不会随着治疗而改变。所有患者中都没有明确的治疗受益案例。这项中期分析显示，无论是PLMS的主要目标结果还是任何次要结果，效应大小都太小，不足以让足够的力量来发现与计划的36名受试者登记的显著差异。由于缺乏足够的能量和任何临床显著益处的指征，这项研究在这个计划的转折点上停止了。结论：高剂量静脉注射铁未能显示出先前三项开放标签研究中报告的强劲变化。铁配方、剂量方案和外周铁状况的不同可能解释了这项研究与之前的IV铁治疗研究之间的一些差异。(C)2008爱思唯尔B.V.保留所有权利。
Objective The aim of this study was to ascertain whether high-dose intravenous (IV) iron sucrose could improve symptoms and change brain iron concentrations in idiopathic RLS.Methods: The study was a randomized, parallel-group double-blind Study of 1000 mg iron sucrose given IV versus placebo. Primary measures of the clinical status were global rating scale (GRS) and periodic leg movements of sleep (PLMS). Primary measures of brain iron status were CSF ferritin and MRI-determined iron in the substantia nigra.Results: At the time of the interim analysis there were 7 placebo and 11 iron-treated subjects. At 2-weeks post-treatment, iron treatment resulted in a small but significant increase in CSF ferritin and it decrease in RLS severity (GRS) but did not change PLMS or MRI iron index. None of the secondary outcomes changed with treatment. There was no single case of clear treatment benefit in any of the patients. This interim analysis revealed an effect size that was too small to allow for adequate power to find significant differences with the planed 36-subject enrollment for either the primary objective outcome of PLMS or any of the secondary outcomes. The Study was stopped at this planned break-point given the lack of both adequate power and any indication for clinically significant benefit.Conclusions: High-dose IV iron failed to demonstrate the robust changes reported in three prior open-label studies. Differences in iron formulation, dosing regiment, and peripheral iron status may explain some of the discrepancies between this and previous IV iron treatment Studies. (c) 2008 Elsevier B.V. All rights reserved.