钆特酸葡甲胺给药后肾功能损害患者肾源性系统性纤维化发生率的观察性研究：NSsaFe研究
Observational study on the incidence of nephrogenic systemic fibrosis in patients with renal impairment following gadoterate meglumine administration: the NSsaFe study.
作者信息
McWilliams Richard G, Frabizzio Jennifer V, De Backer Adelard I, Grinberg Anna, Maes Bart D, Zobel Bruno Beomonte, Gottschalk Andreas
机构信息
The Department of Radiology, Royal Liverpool University Hospital, Liverpool, UK.
Abington Memorial Hospital, Abington, Pennsylvania, USA.
出版信息
J Magn Reson Imaging. 2020 Feb;51(2):607-614. doi: 10.1002/jmri.26851. Epub 2019 Jul 9.
BACKGROUND
Nephrogenic systemic fibrosis (NSF) is a rare life-threatening condition strongly associated with the administration of gadolinium-based contrast agents in patients with severe or endstage renal impairment.
PURPOSE
To prospectively determine the incidence of NSF in patients with renal impairment after administration of gadoterate meglumine.
STUDY TYPE
Prospective.
POPULATION
In all, 540 patients with moderate, severe, or endstage renal impairment, scheduled to undergo a routine contrast-enhanced MRI with gadoterate meglumine. Mean age was 69.7 ± 12.7 years (range: 21-95) with 58.4% of males.
FIELD STRENGTH/SEQUENCE: 1.5T or 3.0T, sequence according to each site practice.
ASSESSMENT
Medical history, indication(s) for current MRI and adverse events were recorded for each patient. Patients were followed up over 2 years after administration with three visits separated by at least 3 months to detect any signs/symptoms suggestive of NSF.
STATISTICAL TESTS
Descriptive.
RESULTS
Renal impairment was graded as moderate for 69.4% of patients, severe for 16.0% and endstage for 12.1%; 2.6% had undergone a kidney transplant. Estimated glomerular filtration rate ranged from 4 to 59 mL/min/1.73 m except one value of 74 mL/min/1.73 m in a patient with kidney transplant. Central nervous system exploration was the main MRI indication (34.7%) and mean dose injected was 0.22 ± 0.09 mL/kg. Overall, 446 patients (82.6%) attended at least one follow-up visit and completed the NSF questionnaire and 329 (60.9%) attended the 2-year visit. No suspicion of NSF was reported in all 446 patients, including 119 patients with severe or endstage renal impairment. No deaths and no adverse events were reported during the MRI examination and the usual period of follow-up after gadoterate meglumine administration.
DATA CONCLUSION
No cases of NSF were observed in the 446 patients with moderate to endstage renal impairment followed up over a maximum of 2 years after injection of gadoterate meglumine.
LEVEL OF EVIDENCE
2 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:607-614.
背景
肾源性系统性纤维化（NSF）是一种罕见的危及生命的疾病，与在严重或终末期肾功能损害患者中使用钆基造影剂密切相关。
目的
前瞻性确定注射钆喷酸葡胺后肾功能损害患者中NSF的发生率。
研究类型
前瞻性研究。
研究对象
总共540例中度、重度或终末期肾功能损害患者，计划接受钆喷酸葡胺常规对比增强MRI检查。平均年龄为69.7±12.7岁（范围：21 - 95岁），男性占58.4%。
场强/序列：1.5T或3.0T，根据各部位实际情况选择序列。
评估
记录每位患者的病史、当前MRI检查的适应证及不良事件。给药后对患者进行2年随访，分三次就诊，每次间隔至少3个月，以检测任何提示NSF的体征/症状。
统计分析
描述性分析。
结果
69.4%的患者肾功能损害为中度，16.0%为重度，12.1%为终末期；2.6%的患者接受过肾移植。估计肾小球滤过率范围为4至59 mL/min/1.73 m²，肾移植患者中有一例值为74 mL/min/1.73 m²。中枢神经系统检查是主要的MRI适应证（34.7%），平均注射剂量为0.22±0.09 mL/kg。总体而言，446例患者（82.6%）至少参加了一次随访并完成了NSF问卷，329例（60.9%）参加了2年随访。在所有446例患者中均未报告疑似NSF病例，包括119例重度或终末期肾功能损害患者。在MRI检查及注射钆喷酸葡胺后的常规随访期间未报告死亡及不良事件。
数据结论
在注射钆喷酸葡胺后最多随访2年的446例中度至终末期肾功能损害患者中未观察到NSF病例。
证据水平
2 技术效能阶段：4 《磁共振成像杂志》2020年；51:607 - 614。
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