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.
OBJECTIVE: To evaluate the efficacy and safety of ferumoxytol for use in magnetic resonance angiography (MRA) of the vasculature. DATA SOURCES: 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. STUDY SELECTION AND DATA EXTRACTION: 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). DATA SYNTHESIS: 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. CONCLUSIONS: 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.
目的:评估菲立磁用于血管磁共振血管造影(MRA)的疗效和安全性。
资料来源: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。
研究选择和资料提取: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)。
资料综合: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。
结论: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。
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