Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: A multi-centred, placebo-controlled preliminary clinical trial
Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: A multi-centred, placebo-controlled preliminary clinical trial
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DOI：
10.1016/j.sleep.2011.06.009
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发表时间：
2011-10-01
期刊：
影响因子：
4.8
通讯作者：
Earley, Christopher J.
中科院分区：
文献类型：
--
作者：
Allen, Richard P.;Adler, Charles H.;Earley, Christopher J.
目的：静脉注射（IV）铁已被用作治疗，以减少不宁腿综合征（RLS）的症状，但两个双盲试验的一个经常规定的IV铁制剂，铁蔗糖，未能显示持久的疗效。本研究评估的有效性和安全性的一种新的IV铁制剂（铁羧基麦芽糖，FCM）的分子特性，可能使铁更可用于摄取到大脑比铁蔗糖does.Methods：在这28天，多中心，随机，安慰剂对照试验46例RLS患者停止所有RLS治疗。24人接受500 mg FCM，间隔5天，22人接受匹配的安慰剂。在第28天，安慰剂组给予单次1000 mg IV FCM，对初始治疗无反应的患者给予第三次500 mg FCM。结果：与安慰剂相比，FCM显著改善了主要和次要结局：国际不宁腿综合征研究组严重程度量表（IRLS）平均（SD）降低8.9（8.52）对比4.0（6.11），p = 0.040：临床总体变化量表（CGI-1）非常或非常改善48.3%对比14.3%，p = 0.004。生活质量也得到显著改善。在24例接受初始铁剂治疗的患者中，45%有反应，29%缓解（IRLS
Objective: Intravenous (IV) iron has been used as a treatment to reduce Restless Legs Syndrome (RLS) symptoms, but two double-blinded trials of a frequently prescribed IV iron formulation, iron sucrose, failed to show lasting efficacy. This study evaluates efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does.Methods: In this 28-day, multi-centre, randomised, placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment. Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo. At day 28, those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM. Patients were followed up for 24 weeks or until needing added RLS treatment.Results: FCM significantly improved primary and secondary outcomes compared to placebo: International Restless Legs Syndrome study group severity scale (IRLS) average (SD) decrease of 8.9 (8.52) versus 4.0 (6.11), p = 0.040: Clinical Global Inventory of Change (CGI-1) very much or much improved 48.3% versus 14.3%, p = 0.004. Quality of life was also significantly improved. Of the 24 with initial iron treatment 45% responded and 29% remitted (IRLS