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未发现钆塞酸葡胺给药后发生肾源性系统纤维化病例。

No Cases of Nephrogenic Systemic Fibrosis after Administration of Gadoxetic Acid.

机构信息

From the Departments of Radiology (J.S., R.J.B., E.A.S., S.B.R.), Obstetrics and Gynecology (E.A.S.), Medical Physics (S.B.R.), Biomedical Engineering (S.B.R.), Medicine (S.B.R.), and Emergency Medicine (S.B.R.), University of Wisconsin, 600 Highland Ave, Madison, WI 53792.

出版信息

Radiology. 2020 Dec;297(3):556-562. doi: 10.1148/radiol.2020200788. Epub 2020 Sep 29.

DOI:10.1148/radiol.2020200788
PMID:32990511
Abstract

Background Gadoxetic acid (GA) has distinctive pharmacokinetic properties with important applications in hepatobiliary imaging. However, there are limited data evaluating the safety of GA administration in patients with impaired kidney function and the incidence of nephrogenic systemic fibrosis (NSF). Purpose To evaluate safety of GA regarding risk of NSF in patients with impaired kidney function. Materials and Methods This retrospective study identified all GA-enhanced MRI (hereafter, GA MRI) examinations performed between July 2008 and December 2019 through a search of the electronic medical record. Serum creatinine values within 180 days or less of each GA MRI examination were retrieved and estimated glomerular filtration rate (eGFR) was calculated. The eGFR value nearest to each MRI examination was used. A separate search in the electronic medical record was also performed to identify patients with NSF. Dermatologists, nephrologists, and nephrologists at our institution were surveyed for any cases of NSF. In patients with NSF, all MRI examinations performed and contrast agents administered to these patients were recorded. Results Overall, 7820 GA MRI examinations were identified, performed in 5351 patients (3022 women and 2329 men). These included 299 examinations (242 patients) with eGFR of 30-44 mL/min/1.73 m and 183 examinations (157 patients) with eGFR less than 30 mL/min/1.73 m. There were 109 examinations (in 94 patients) with eGFR of 15-29 mL/min/1.73 m, 40 examinations (in 39 patients) with eGFR less than 15 mL/min/1.73 m, and 34 examinations in 27 patients undergoing hemodialysis. Seventeen patients with eGFR less than 30 mL/min/1.73 m or undergoing dialysis underwent GA MRI two or more times. Eighteen patients with biopsy-confirmed NSF were identified, none of whom were exposed to GA. The mean follow-up period for GA MRI examinations performed in patients with severe kidney impairment was 4.2 years (range, 0.2-11.3 years). Conclusion Gadoxetic acid may be safe with respect to nephrogenic systemic fibrosis in this patient population, although further studies are needed to confirm this. © RSNA, 2020 See also the editorial by Davenport and Shankar in this issue.

摘要

背景

钆塞酸(GA)具有独特的药代动力学特性,在肝胆成像中有重要应用。但是,对于肾功能受损患者中 GA 给药的安全性和肾源性系统纤维化(NSF)的发生率,相关数据有限。目的:评估肾功能受损患者中 GA 给药的安全性,即发生 NSF 的风险。材料与方法:本回顾性研究通过电子病历检索,确定了 2008 年 7 月至 2019 年 12 月间进行的所有 GA 增强磁共振成像(GA MRI)检查。检索每个 GA MRI 检查前 180 天内或以内的血清肌酐值,并计算估算肾小球滤过率(eGFR)。使用最接近 MRI 检查的 eGFR 值。在电子病历中还进行了单独检索,以确定 NSF 患者。我们的机构皮肤科医生、肾病医生和肾病学家对 NSF 的任何病例进行了调查。在 NSF 患者中,记录了所有进行的 MRI 检查和给这些患者使用的造影剂。结果:共确定了 7820 次 GA MRI 检查,涉及 5351 名患者(3022 名女性和 2329 名男性)。其中 299 次检查(242 名患者)的 eGFR 为 30-44 mL/min/1.73 m,183 次检查(157 名患者)的 eGFR 小于 30 mL/min/1.73 m。109 次检查(94 名患者)的 eGFR 为 15-29 mL/min/1.73 m,40 次检查(39 名患者)的 eGFR 小于 15 mL/min/1.73 m,34 次检查在 27 名接受血液透析的患者中进行。17 名 eGFR 小于 30 mL/min/1.73 m 或接受透析的患者进行了两次或更多次 GA MRI。共确定了 18 名经活检证实为 NSF 的患者,他们均未接触过 GA。严重肾功能受损患者接受 GA MRI 检查的平均随访时间为 4.2 年(范围,0.2-11.3 年)。结论:在该患者人群中,GA 可能与肾源性系统纤维化无关,但仍需要进一步研究来证实这一点。©2020RSNA

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