Schieda Nicola, Blaichman Jason I, Costa Andreu F, Glikstein Rafael, Hurrell Casey, James Matthew, Jabehdar Maralani Pejman, Shabana Wael, Tang An, Tsampalieros Anne, van der Pol Christian B, Hiremath Swapnil
Department of Medical Imaging, The Ottawa Hospital, University of Ottawa, Ontario, Canada.
Faculty of Medicine, Department of Radiology, University of British Columbia, Vancouver, Canada.
Can J Kidney Health Dis. 2018 Jun 12;5:2054358118778573. doi: 10.1177/2054358118778573. eCollection 2018.
PURPOSE OF REVIEW: Use of gadolinium-based contrast agents (GBCA) in renal impairment is controversial, with physician and patient apprehension in acute kidney injury (AKI), chronic kidney disease (CKD), and dialysis because of concerns regarding nephrogenic systemic fibrosis (NSF). The position that GBCA are absolutely contraindicated in AKI, category G4 and G5 CKD (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m), and dialysis-dependent patients is outdated and may limit access to clinically necessary contrast-enhanced magnetic resonance imaging (MRI) examinations. This review and clinical practice guideline addresses the discrepancy between existing Canadian guidelines regarding use of GBCA in renal impairment and NSF. SOURCES OF INFORMATION: Published literature (including clinical trials, retrospective cohort series, review articles, and case reports), online registries, and direct manufacturer databases were searched for reported cases of NSF by class and specific GBCA and exposed patient population. METHODS: A comprehensive review was conducted identifying cases of NSF and their association to class of GBCA, specific GBCA used, patient, and dose (when this information was available). Based on the available literature, consensus guidelines were developed by an expert panel of radiologists and nephrologists. KEY FINDINGS: In patients with category G2 or G3 CKD (eGFR ≥ 30 and < 60 mL/min/1.73 m), administration of standard doses of GBCA is safe and no additional precautions are necessary. In patients with AKI, with category G4 or G5 CKD (eGFR < 30 mL/min/1.73 m) or on dialysis, administration of GBCA should be considered individually and alternative imaging modalities utilized whenever possible. If GBCA are necessary, newer GBCA may be administered with patient consent obtained by a physician (or their delegate) citing an exceedingly low risk (much less than 1%) of developing NSF. Standard GBCA dosing should be used; half or quarter dosing is not recommended and repeat injections should be avoided. Dialysis-dependent patients should receive dialysis; however, initiating dialysis or switching from peritoneal to hemodialysis to reduce the risk of NSF is unproven. Use of a macrocyclic ionic instead of macrocyclic nonionic GBCA or macrocyclic instead of newer linear GBCA to further prevent NSF is unproven. Gadopentetate dimeglumine, gadodiamide, and gadoversetamide remain absolutely contraindicated in patients with AKI, those with category G4 or G5 CKD, or those on dialysis. The panel agreed that screening for renal disease is important but less critical when using macrocyclic and newer linear GBCA. Monitoring for and reporting of potential cases of NSF in patients with AKI or CKD who have received GBCA is recommended. LIMITATIONS: Limited available literature (number of injections and use in renal impairment) regarding the use of gadoxetate disodium. Limited, but growing and generally high-quality, number of clinical trials evaluating GBCA administration in renal impairment. Limited data regarding the topic of Gadolinium deposition in the brain, particularly as it related to patients with renal impairment. IMPLICATIONS: In patients with AKI and category G4 and G5 CKD (eGFR < 30 mL/min/1.73 m) and in dialysis-dependent patients who require GBCA-enhanced MRI, GBCA can be administered with exceedingly low risk of causing NSF when using macrocyclic agents and newer linear agents at routine doses.
综述目的:钆基造影剂(GBCA)在肾功能损害患者中的应用存在争议,由于担心发生肾源性系统性纤维化(NSF),医生和患者在急性肾损伤(AKI)、慢性肾脏病(CKD)及透析患者中使用时均有所顾虑。认为GBCA在AKI、G4和G5期CKD(估计肾小球滤过率[eGFR]<30 mL/min/1.73 m²)及依赖透析的患者中绝对禁忌的观点已过时,可能会限制患者接受临床上必要的对比增强磁共振成像(MRI)检查。本综述及临床实践指南旨在解决加拿大现有指南中关于GBCA在肾功能损害及NSF应用方面的差异。 信息来源:检索已发表的文献(包括临床试验、回顾性队列研究、综述文章及病例报告)、在线注册库及直接的制造商数据库,以查找按类别和特定GBCA以及暴露患者群体报告的NSF病例。 方法:进行全面综述,确定NSF病例及其与GBCA类别、使用的特定GBCA、患者及剂量(若有此信息)之间的关联。基于现有文献,由放射科医生和肾病科医生专家小组制定共识指南。 主要发现:在G2或G3期CKD(eGFR≥30且<60 mL/min/1.73 m²)患者中,给予标准剂量的GBCA是安全的,无需采取额外预防措施。对于AKI、G4或G5期CKD(eGFR<30 mL/min/1.73 m²)或正在接受透析的患者,GBCA的使用应个体化考虑,尽可能采用其他成像方式。若必须使用GBCA,在医生(或其代表)获得患者同意后,可给予新型GBCA,因其发生NSF的风险极低(远低于1%)。应采用标准的GBCA剂量;不建议使用半量或四分之一剂量,且应避免重复注射。依赖透析的患者应接受透析;然而,启动透析或从腹膜透析改为血液透析以降低NSF风险的做法尚未得到证实。使用大环离子型而非大环非离子型GBCA或大环型而非新型线性GBCA以进一步预防NSF的做法也未得到证实。钆喷酸葡胺、钆双胺和钆贝葡胺在AKI患者、G4或G5期CKD患者或透析患者中仍绝对禁忌使用。专家小组一致认为,对肾脏疾病进行筛查很重要,但在使用大环型和新型线性GBCA时重要性稍低。建议对接受GBCA的AKI或CKD患者中潜在的NSF病例进行监测和报告。 局限性:关于钆塞酸二钠使用的现有文献有限(注射次数及在肾功能损害中的应用)。评估GBCA在肾功能损害中应用的临床试验数量有限,但数量在增加且总体质量较高。关于钆在脑内沉积这一主题的数据有限,尤其是与肾功能损害患者相关的数据。 意义:对于AKI、G4和G5期CKD(eGFR<30 mL/min/1.73 m²)以及需要GBCA增强MRI的依赖透析患者,在使用大环型药物和新型线性药物按常规剂量给药时,GBCA导致NSF的风险极低。
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