钆布醇：在对比增强 MRI 和 MRA 中的应用评价。
Gadobutrol: A Review in Contrast-Enhanced MRI and MRA.
机构信息
, Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
出版信息
Clin Drug Investig. 2018 Aug;38(8):773-784. doi: 10.1007/s40261-018-0674-9.
Abstract
Intravenous gadobutrol [Gadovist (EU); Gadavist (USA)] is a second-generation, extracellular non-ionic macrocyclic gadolinium-based contrast agent (GBCA) that is approved for use in paediatric (including term neonates) and adult patients undergoing diagnostic contrast-enhanced (CE) MRI for visualization of pathological lesions in all body regions or for CE MRA to evaluate perfusion and flow-related abnormalities. Its unique physicochemical profile, including its high thermostability and proton relaxation times, means that gadobutrol is formulated at twice the gadolinium ion concentration of other GBCAs, resulting in a narrower bolus and consequently, improved dynamic image enhancement. Based on > 20 years of experience in the clinical trial and real-world settings (> 50 million doses) and its low risk for developing nephrogenic systemic fibrosis (NSF), gadobutrol represents an effective and safe diagnostic GBCA for use in CE MRI and MRA to visualize pathological lesions and vascular perfusion and flow-related abnormalities in all body regions in a broad spectrum of patients, including term neonates and other paediatric patients, young and elderly adult patients, and those with moderate or severe renal or hepatic impairment or cardiovascular (CV) disease.
摘要
静脉注射钆布醇[加乐显（欧盟）；加显（美国）]是一种第二代、细胞外非离子型大环顺磁金属对比剂（GBCA），适用于儿科（包括足月新生儿）和成人患者进行诊断性对比增强（CE）磁共振成像（MRI），以显示所有身体部位的病理性病变，或用于 CE 磁共振血管成像（MRA）评估灌注和血流相关异常。其独特的物理化学特性，包括其高热稳定性和质子弛豫时间，意味着钆布醇的配方中所含的钆离子浓度是其他 GBCA 的两倍，这导致其形成的团注更窄，从而实现更好的动态图像增强。基于超过 20 年的临床试验和真实世界应用经验（>5000 万剂），以及其发生肾源性系统纤维化（NSF）的风险较低，钆布醇代表了一种有效的、安全的诊断性 GBCA，可用于 CE MRI 和 MRA，以可视化所有身体部位的病理性病变和血管灌注及血流相关异常，适用于广泛的患者群体，包括足月新生儿和其他儿科患者、年轻和老年成年患者以及伴有中度或重度肾功能或肝功能不全或心血管（CV）疾病的患者。
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