钆基对比剂钆塞酸不良反应：系统评价和荟萃分析。
Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis.
机构信息
From the Department of Medical Imaging, The Ottawa Hospital, 1053 Carling Ave, Room C159, Ottawa, ON, Canada K1Y 4E9 (N.S., D.W.); Department of Diagnostic Imaging, Juravinski Cancer Centre, Hamilton, Canada (C.B.v.d.P.); Clinical Research Unit, Children's Hospital of Eastern Ontario, Ottawa, Canada (A.K.T.); Department of Radiology, Sunnybrook Health Sciences Centre, Toronto, Canada (P.J.M.); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY (S.W.); and Department of Radiology, University of Michigan Medical Center, Ann Arbor, Mich (M.S.D.).
出版信息
Radiology. 2020 Dec;297(3):565-572. doi: 10.1148/radiol.2020200073. Epub 2020 May 26.
Background Gadoxetic acid is classified by the American College of Radiology as a group III gadolinium-based contrast agent (GBCA), which indicates that there are limited data regarding nephrogenic systemic fibrosis (NSF) risk, but there are few if any unconfounded cases of NSF. Purpose To perform a systematic review and meta-analysis of gadoxetic acid adverse events, including immediate hypersensitivity reactions, NSF, and intracranial gadolinium retention. Materials and Methods Original research studies, case series, and case reports that reported adverse events in patients undergoing gadoxetic acid-enhanced MRI were searched in MEDLINE (1946-2019), Embase (1947-2019), CENTRAL (March 2019), and Scopus (1946-2019). The study protocol was registered at Prospero (number 162811). Risk of bias was evaluated by using Quality Assessment of Diagnostic Accuracy Studies-2, or QUADAS-2. Meta-analysis of proportions was performed by using random-effects modeling. Upper bound of 95% confidence interval (CI) for risk of NSF was determined. Results Seventy-one studies underwent full-text review. From 17 studies reporting 14 850 administrations, hypersensitivity reactions occurred in 0.3% (31 of 14 850; 95% CI: 0.2%, 0.4%) with zero deaths. From four studies reporting 106 administrations in patients with stage 4 or 5 chronic kidney disease or undergoing dialysis, the upper bound 95% CI for the risk of NSF was 2.8%. Five studies evaluating intracranial retention of gadolinium after gadoxetic acid administration were at high risk of bias. Conclusion Gadoxetic acid had a similar safety profile to American College of Radiology group 2 gadolinium-based contrast agents for hypersensitivity reactions and nephrogenic systemic fibrosis (NSF) but had lower confidence for risk of NSF because of fewer administrations in patients with severe kidney impairment. There is incomplete information documenting intracranial gadolinium retention in patients administered gadoxetic acid. © RSNA, 2020
背景 钆塞酸按美国放射学院的分类属于 III 类基于钆的造影剂（GBCA），这表明关于肾源性系统性纤维化（NSF）风险的数据有限，但几乎没有未经混杂的 NSF 病例。目的 对钆塞酸不良事件进行系统回顾和荟萃分析，包括即刻过敏反应、NSF 和颅内钆蓄积。材料与方法 在 MEDLINE（1946-2019 年）、Embase（1947-2019 年）、CENTRAL（2019 年 3 月）和 Scopus（1946-2019 年）中检索了报告接受钆塞酸增强 MRI 的患者发生不良事件的原始研究、病例系列和病例报告。研究方案在 PROSPERO（编号 162811）上进行了注册。使用诊断准确性研究质量评估 2（QUADAS-2）评估偏倚风险。采用随机效应模型进行比例的荟萃分析。确定 NSF 风险的 95%置信区间（CI）上限。结果 71 项研究进行了全文审查。17 项报告了 14850 次给药的研究中，过敏反应发生率为 0.3%（31/14850；95%CI：0.2%，0.4%），无死亡。4 项报告了 106 例 4 或 5 期慢性肾脏病或透析患者的研究中，NSF 风险的 95%CI 上限为 2.8%。五项评估钆塞酸给药后颅内钆蓄积的研究存在较高的偏倚风险。结论 与美国放射学院 2 类基于钆的造影剂相比，钆塞酸在过敏反应和 NSF 方面具有相似的安全性，但由于严重肾功能损害患者的给药次数较少，NSF 的风险置信度较低。在接受钆塞酸治疗的患者中，关于颅内钆蓄积的信息不完整。
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