Reimer Peter, Balzer Thomas
Department of Radiology, Städtisches Klinikum Karlsruhe, Moltkestrasse 90, 76133 Karlsruhe, Germany.
Eur Radiol. 2003 Jun;13(6):1266-76. doi: 10.1007/s00330-002-1721-7. Epub 2002 Nov 1.
Ferucarbotran (Resovist) is the second clinically approved superparamagnetic iron oxide developed for contrast-enhanced MRI of the liver. The purpose of this review is to provide an overview on the properties, clinical development, and application of ferucarbotran. Safety data obtained during clinical phases I-III revealed a total of 162 adverse events within 1053 patients, of which 75 were classified as possibly, probably, or definitely drug related. The majority of events occurred within the first 3 h (73 of 75) and was of mild intensity. The agent significantly improves the detection of hypovascular focal liver lesions with a comparable sensitivity in lesion detection to CTAP but without a relevant loss in specificity. Furthermore, ferucarbotran leads to a significant improvement of the sensitivity for lesion classification and characterization of the most frequent liver lesions. Contrast-enhanced MRA is not feasible and the angiographic effect is not sufficient to allow for postprocessing of data into maximum intensity projections. Intraindividual studies at low-field (0.2 T) and high-field (1.5 T) showed similar rates for lesion detection. The time window for contrast-enhanced MRI of the liver is at least 1 day up to 4 days. The compound can be regarded as safe and well tolerated. Even bolus injections caused no cardiovascular side effects, lumbar back pain, or clinically relevant laboratory changes. The examination time can be kept short with T1- and T2-weighted pre-contrast sequences, dynamic MRI over 10 min, and finally accumulation phase T2-weighted MRI. Patients who may benefit in particular are surgical candidates for resection, transplantation, or interventional therapies, and patients with liver cirrhosis and/or suspected hepatocellular carcinoma to either exclude malignancy or to define the extent of disease, the location of lesions, and the type of newly detected lesions.
ferucarbotran（Resovist）是第二种临床批准用于肝脏对比增强磁共振成像（MRI）的超顺磁性氧化铁。本综述旨在概述ferucarbotran的特性、临床开发及应用情况。在I - III期临床试验中获得的安全性数据显示，1053例患者中共有162例不良事件，其中75例被归类为可能、很可能或肯定与药物相关。大多数事件发生在最初3小时内（75例中的73例），且强度较轻。该药物显著提高了对乏血供局灶性肝病变的检测能力，在病变检测方面与CT动脉门静脉造影（CTAP）具有相当的敏感性，但特异性无明显损失。此外，ferucarbotran显著提高了对最常见肝脏病变的分类和特征描述的敏感性。对比增强磁共振血管造影（MRA）不可行，其血管造影效果不足以将数据后处理为最大强度投影。在低场（0.2T）和高场（1.5T）进行的个体内研究显示病变检测率相似。肝脏对比增强MRI的时间窗至少为1天至4天。该化合物可被视为安全且耐受性良好。即使大剂量注射也未引起心血管副作用、腰痛或临床相关的实验室变化。通过T1加权和T2加权的对比前序列、10分钟的动态MRI以及最后的T2加权MRI积聚期，可以缩短检查时间。特别可能受益的患者包括手术切除、移植或介入治疗的候选者，以及患有肝硬化和/或疑似肝细胞癌的患者，以排除恶性肿瘤或确定疾病范围、病变位置及新检测病变的类型。
