• 主题
高级搜索  >
历史搜索 清空历史
首页> 美国卫生研究院文献>Wiley-Blackwell Online Open >A Phase III randomized open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy
【2h】

A Phase III randomized open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy

机译：阿魏酸与蔗糖铁比较的III期随机开放标签试验用于治疗口服铁疗法不佳的患者中的铁缺乏性贫血

代理获取
本网站仅为用户提供外文OA文献查询和代理获取服务，本网站没有原文。下单后我们将采用程序或人工为您竭诚获取高质量的原文，但由于OA文献来源多样且变更频繁，仍可能出现获取不到、文献不完整或与标题不符等情况，如果获取不到我们将提供退款服务。请知悉。
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Iron deficiency anemia (IDA) is the most common form of anemia worldwide. Although oral iron is used as first-line treatment, many patients are unresponsive to or cannot take oral iron. This Phase III, open-label, non-inferiority study compared the efficacy and safety of ferumoxytol, a rapid, injectable intravenous (IV) iron product with low immunological reactivity and minimal detectable free iron, with IV iron sucrose in adults with IDA of any cause. Patients (N = 605) were randomized 2:1 to receive ferumoxytol (n = 406, two doses of 510 mg 5 ± 3 days apart) or iron sucrose (n = 199, five doses of 200 mg on five nonconsecutive days over 14 days) and followed for 5 weeks. Ferumoxytol demonstrated noninferiority to iron sucrose at the primary endpoint, the proportion of patients achieving a hemoglobin increase of ≥2 g dL−1 at any time from Baseline to Week 5 (ferumoxytol, 84.0% [n = 406] vs. iron sucrose, 81.4% [n = 199]), with a noninferiority margin of 15%. Ferumoxytol was superior to iron sucrose (2.7 g dL−1 vs. 2.4 g dL−1) in the mean change in hemoglobin from Baseline to Week 5 (the alternative preplanned primary endpoint) with P = 0.0124. Transferrin saturation, quality-of-life measures, and safety outcomes were similar between the two treatment groups. Overall, ferumoxytol demonstrated comparable safety and efficacy to iron sucrose, suggesting that ferumoxytol may be a useful treatment option for patients with IDA in whom oral iron was unsatisfactory or could not be used. Am. J. Hematol. 89:646–650, 2014. © 2014 Wiley Periodicals, Inc.
机译：缺铁性贫血（IDA）是全世界最常见的贫血形式。尽管口服铁剂被用作一线治疗，但许多患者对口服铁剂无反应或无法服用。这项III期开放性，非劣效性研究比较了在任何IDA的成人中，阿魏酸，一种快速，可注射的静脉注射（IV）铁产品，免疫反应性低，游离铁含量极低的功效和安全性与IV蔗糖铁比较。原因。患者（N = 605）被随机以2：1的比例接受阿魏酸（n = 406，两次服用510 mg，间隔5±3天）或铁蔗糖（n = 199，五次服用200 mg，连续14天连续5天），并持续5周。 Ferumoxytol在主要终点显示不劣于蔗糖铁，从基线到第5周的任何时间血红蛋白增加≥2g dL -1 的患者比例（ferumoxytol，84.0％[n = 406] ]与蔗糖铁的比例为81.4％[n = 199]，非劣质性为15％。从基线到第5周，血红蛋白的平均变化（从替代基线到第5周），Ferumoxytol优于蔗糖铁（2.7 g dL -1 与2.4 g dL -1 ）端点），P = 0.0124。两个治疗组之间的转铁蛋白饱和度，生活质量测度和安全性结果相似。总的来说，阿魏酸证明了可与蔗糖铁媲美的安全性和有效性，这表明阿魏酸可能是IDA患者口服铁不能令人满意或不能使用的有效治疗选择。上午。 J. Hematol。 89：646–650，2014年。©2014 Wiley Periodicals，Inc.

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
代理获取

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号