From the Department of Radiology, Emory University, 1364 Clifton Rd NE, Atlanta, GA 30322.
Radiology. 2015 Sep;276(3):741-7. doi: 10.1148/radiol.2015142423. Epub 2015 Apr 15.
To determine the incidence of nephrogenic systemic fibrosis (NSF) in patients with renal disease who received gadobenate dimeglumine at a single medical center.
This was an institutional review board-approved HIPAA-compliant retrospective study with waiver of informed consent. Patients either underwent dialysis or not, had an abnormal estimated glomerular filtration rate (eGFR), and underwent magnetic resonance (MR) imaging and/or MR angiography with gabobenate dimeglumine in 2010. Dialysis status, eGFR, time to transplantation, waiting list status, contrast material volume at index imaging, and additional imaging examinations between 2007 and 2014 were recorded. Clinical notes with and without integument examinations, pathologic records, and additional patient communication were evaluated for development of NSF through September 2014. Dates of latest documented integument examination and latest interaction were recorded. Mean, standard deviation, and median values were obtained, along with incidence percentage of NSF.
Of 401 patients (172 women, 229 men; mean age, 50 years), 75.5% were dialysis dependent (n = 303) and 24.4% (n = 98) were not undergoing dialysis, with a mean eGFR ± standard deviation of 17 mL/min per 1.73 m(2) ± 5.6 (range, 6-41 mL/min per 1.73 m(2); median, 16.3 mL/min per 1.73 m(2)). Mean and median contrast material volume at index imaging were 24 mL ± 5.7 (range, 9-45 mL). Additional contrast material volume administered was 23 mL ± 12.9 (range, 6-64 mL; median, 20 mL; n = 66). One hundred twenty-six patients (31%) received a transplant; mean time to transplantation was 1.72 years ± 1.25 (range, 0-4.46 years; median, 1.4 years). No patients received diagnoses of NSF. Mean follow-up was 2.35 years ± 1.61 (range, 0.00-4.61 years; median, 2.75 years) with documented integument examination and 3.08 years ± 1.36 (range, 0.16-4.66 years; median, 3.66 years) with direct patient communication.
No patients undergoing peritoneal dialysis, hemodialysis, or nondialysis who experienced renal failure developed NSF after administration of gadobenate dimeglumine after more than 2 years' mean follow-up. Gadobenate dimeglumine may be safe in this population.
在单一医疗中心，评估接受钆贝葡胺的肾病患者中肾源性系统性纤维化（NSF）的发生率。
这是一项经机构审查委员会批准的 HIPAA 合规性回顾性研究，豁免了知情同意。2010 年，患者要么接受透析治疗，要么不接受透析治疗，要么估算肾小球滤过率（eGFR）异常，要么接受磁共振（MR）成像和/或 MR 血管造影检查，并使用钆贝葡胺。记录透析状态、eGFR、移植时间、等待名单状态、指数成像时的对比剂体积以及 2007 年至 2014 年之间的其他影像学检查。2014 年 9 月前，通过临床记录（有或无皮肤检查）、病理记录和其他患者交流，评估 NSF 的发生情况。记录最新的皮肤检查和最新的皮肤检查日期。获取平均值、标准差和中位数，以及 NSF 的发生率。
在 401 名患者（172 名女性，229 名男性；平均年龄 50 岁）中，75.5%（n=303）依赖透析，24.4%（n=98）未进行透析，平均 eGFR ±标准差为 17mL/min/1.73m²±5.6（范围，6-41mL/min/1.73m²；中位数，16.3mL/min/1.73m²）。指数成像时平均和中位数的对比剂体积为 24mL±5.7（范围，9-45mL）。另外还给予了 23mL±12.9（范围，6-64mL；中位数，20mL；n=66）的对比剂。126 名患者（31%）接受了移植；平均移植时间为 1.72 年±1.25（范围，0-4.46 年；中位数，1.4 年）。没有患者被诊断为 NSF。平均随访时间为 2.35 年±1.61（范围，0.00-4.61 年；中位数，2.75 年），有记录的皮肤检查和 3.08 年±1.36（范围，0.16-4.66 年；中位数，3.66 年），与患者有直接沟通。
在平均 2 年多的随访后，接受钆贝葡胺治疗的腹膜透析、血液透析或非透析肾衰竭患者中，没有发生 NSF。钆贝葡胺在该人群中可能是安全的。
