Department of Pharmacy, Duke University Hospital, Durham, NC, USA.
Ann Pharmacother. 2011 Dec;45(12):1571-5. doi: 10.1345/aph.1Q431. Epub 2011 Nov 1.
To evaluate the efficacy and safety of ferumoxytol for use in magnetic resonance angiography (MRA) of the vasculature.
Literature was accessed through MEDLINE (1946-September 2011) and EMBASE (1947-September 2011) using the terms ferumoxytol, magnetic resonance imaging and angiography, blood pool agent, and superparamagnetic iron oxide. Reference citations from identified publications were reviewed for relevant information.
All English-language articles and human studies (N = 9) were identified that evaluated ferumoxytol use in magnetic resonance imaging (MRI). Articles that evaluated the use of the drug in first-pass and equilibrium phase imaging of the vasculature were included (n = 4).
Contrast agents for MRI improve disease characterization and diagnosis. Ferumoxytol, a medication approved for treatment of iron deficiency anemia in adults with chronic kidney disease, has superparamagnetic properties. As a blood pool agent, ferumoxytol remains primarily in the intravascular space. Therefore, its use in MRI may increase image sensitivity and specificity and have a decreased adverse effect profile compared to other contrast agents. Specifically, ferumoxytol may be an option for MRA, a specific type of MRI that images blood vessels. In the 4 studies evaluated here, ferumoxytol was administered primarily to healthy adults as an accumulative dose of 4 mg Fe/kg injected at 1 mL/sec. Not all studies reported adverse events and addressed safety monitoring. The evaluated studies are limited by small size, open-label design, and noncomparative methodology.
Data from small pilot studies suggest that ferumoxytol may improve image quality in MRA; however, further investigation is necessary to establish its efficacy and safety. Large randomized, active-comparator trials are needed to establish optimal dosing, imaging procedures, and safety monitoring.
评估菲立磁用于血管磁共振血管造影(MRA)的疗效和安全性。
通过 MEDLINE(1946 年-2011 年 9 月)和 EMBASE(1947 年-2011 年 9 月)检索文献,使用铁磁共振成像和血管造影、血池造影剂、超顺磁性氧化铁等术语。查阅确定的出版物的参考文献以获取相关信息。
确定了所有评估菲立磁在磁共振成像(MRI)中应用的英文文献和人体研究(N = 9)。包括评估该药物在血管初次通过和平衡期成像中应用的文献(n = 4)。
磁共振成像对比剂可改善疾病特征和诊断。菲立磁是一种用于治疗慢性肾脏病成人缺铁性贫血的药物,具有超顺磁性。作为血池造影剂,菲立磁主要保留在血管腔内。因此,与其他对比剂相比,其在 MRI 中的应用可能会提高图像的敏感性和特异性,且不良反应谱较低。具体而言,菲立磁可能是磁共振血管造影(MRA)的一种选择,MRA 是一种专门用于成像血管的磁共振成像类型。在本文评估的 4 项研究中,菲立磁主要以 4 mg Fe/kg 的累积剂量在 1 mL/sec 时给予健康成年人。并非所有研究都报告了不良事件并讨论了安全性监测。评估的研究受到样本量小、开放性设计和非对照方法的限制。
来自小型试点研究的数据表明,菲立磁可能会改善 MRA 的图像质量;但是,需要进一步的研究来确定其疗效和安全性。需要进行大型随机、活性对照试验来确定最佳剂量、成像程序和安全性监测。