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静注铁(ferumoxytol):用于治疗慢性肾脏病成人缺铁性贫血。

Ferumoxytol: in iron deficiency anaemia in adults with chronic kidney disease.

机构信息

Adis, Auckland, New Zealand.

出版信息

Drugs. 2012 Oct 22;72(15):2013-22. doi: 10.2165/11209880-000000000-00000.

DOI:10.2165/11209880-000000000-00000
PMID:22994536
Abstract

Ferumoxytol is an intravenously administered iron preparation indicated in the EU and the US for the treatment of iron deficiency anaemia in adult patients with chronic kidney disease (CKD). It consists of superparamagnetic iron oxide nanoparticles coated with a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution that can be administered at relatively high dose by rapid intravenous injection. In phase III, randomized, controlled trials, two doses of ferumoxytol (510 mg iron/dose) given 2-8 days apart increased mean haemoglobin levels from baseline to week 5 significantly more than oral iron (200 mg/day for 21 days) in adult patients with iron deficiency anaemia and CKD stages 1-5. Ferumoxytol was more effective than oral iron both in patients with non-dialysis-dependent CKD and in those with haemodialysis-dependent CKD. Ferumoxytol was generally well tolerated in randomized controlled clinical trials. Most adverse events were mild or moderate in intensity; serious hypersensitivity or hypotensive reactions were uncommon. Local injection-site reactions were the most common system/organ-class adverse events in a pooled analysis of clinical studies and post-marketing experience.

摘要

费罗莫司他是一种静脉内给药的铁制剂,在欧盟和美国被批准用于治疗慢性肾脏病(CKD)成年患者的缺铁性贫血。它由超顺磁性氧化铁纳米颗粒组成,表面涂有半合成碳水化合物外壳,在等渗、中性 pH 溶液中,可通过快速静脉注射给予相对较高剂量。在 III 期随机对照试验中,Ferumoxytol(510mg 铁/剂量)每 2-8 天给予两次,与口服铁(21 天每天 200mg)相比,可显著增加缺铁性贫血和 CKD 1-5 期成年患者的平均血红蛋白水平,从基线到第 5 周。在非透析依赖型 CKD 和血液透析依赖型 CKD 患者中,Ferumoxytol 均比口服铁更有效。在随机对照临床试验中,Ferumoxytol 通常具有良好的耐受性。大多数不良事件的强度为轻度或中度;严重的过敏反应或低血压反应并不常见。在临床研究和上市后经验的汇总分析中,局部注射部位反应是最常见的系统/器官类别不良事件。

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本文引用的文献

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The pharmacokinetics and pharmacodynamics of iron preparations.铁制剂的药代动力学和药效学。
Pharmaceutics. 2011 Jan 4;3(1):12-33. doi: 10.3390/pharmaceutics3010012.
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A Comparative Look at the Safety Profiles of Intravenous Iron Products Used in the Hemodialysis Population.血液透析人群中使用的静脉铁剂产品安全性概况的比较研究
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Plasma pharmacokinetics of two consecutive doses of ferumoxytol in healthy subjects.健康受试者中连续两次给予 ferumoxytol 的血浆药代动力学。
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Tomographic Magnetic Particle Imaging With a Single-Sided Field-Free Line Scanner.使用单侧无场线扫描仪的断层磁共振粒子成像
IEEE Trans Biomed Eng. 2024 Dec;71(12):3470-3481. doi: 10.1109/TBME.2024.3427665. Epub 2024 Nov 21.
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Application of nanoparticles in the diagnosis and treatment of chronic kidney disease.纳米颗粒在慢性肾脏病诊断与治疗中的应用。
Front Med (Lausanne). 2023 Apr 17;10:1132355. doi: 10.3389/fmed.2023.1132355. eCollection 2023.
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Physically stimulus-responsive nanoparticles for therapy and diagnosis.用于治疗和诊断的物理刺激响应性纳米颗粒。
Front Chem. 2022 Sep 14;10:952675. doi: 10.3389/fchem.2022.952675. eCollection 2022.
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Hybrid magnetic nanoparticles as efficient nanoheaters in biomedical applications.混合磁性纳米颗粒在生物医学应用中作为高效纳米加热器
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A systemic review and meta-analysis on the efficacy and safety of ferumoxytol for anemia in chronic kidney disease patients.一项关于铁氧体用于治疗慢性肾脏病患者贫血的疗效和安全性的系统评价和荟萃分析。
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Biosensors (Basel). 2022 Jan 12;12(1):38. doi: 10.3390/bios12010038.
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One-pot synthesis of carboxymethyl-dextran coated iron oxide nanoparticles (CION) for preclinical fMRI and MRA applications.一锅法合成羧甲基葡聚糖修饰的超顺磁性氧化铁纳米颗粒(CION)用于临床前 fMRI 和 MRA 应用。
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Physicochemical properties of ferumoxytol, a new intravenous iron preparation.新型静脉铁制剂——蔗糖铁的物理化学性质
Eur J Clin Invest. 2009 Jun;39(6):489-96. doi: 10.1111/j.1365-2362.2009.02130.x. Epub 2009 Apr 23.
6
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Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28.
7
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Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27.
8
Ferumoxytol for treating iron deficiency anemia in CKD.费乐必妥用于治疗慢性肾脏病中的缺铁性贫血。
J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
9
KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target.《KDOQI慢性肾脏病贫血临床实践指南及临床实践建议:2007年血红蛋白目标更新》
Am J Kidney Dis. 2007 Sep;50(3):471-530. doi: 10.1053/j.ajkd.2007.06.008.
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J Nephrol. 2006 Mar-Apr;19(2):161-7.