Herborn C U, Jäger-Booth I, Lodemann K P, Spinazzi A, Goyen M
Universitätsklinikum Hamburg-Eppendorf, Medizinisches PräventionsCentrum Hamburg.
Rofo. 2009 Jul;181(7):652-7. doi: 10.1055/s-0028-1109202. Epub 2009 Mar 16.
Retrospective analysis of the occurrence of adverse events and the diagnostic efficacy of a paramagnetic contrast agent with weak intermittent protein binding and high relaxivity.
Postmarketing surveillance studies for gadobenate dimeglumine (MultiHance, BRACCO Altana Pharma, Constance) were conducted in Germany between 1998 and 2006 and then retrospectively analyzed. Demographic data, relevant comorbidities, and allergies were recorded. The safety and tolerability of MultiHance were logged on a standardized data sheet.
A total of 38,568 patients were included in the study. 829 patients (2.1%) had a known intolerance against contrast media. The examined regions included the central nervous system, the liver, and the vascular bed. The injection rate with automated injectors (n = 10456) varied between 1.0 und 3.0 ml/sec in 86.5% of patients. Adverse events totaled 1.2%. 11 patients (0.03%) experienced serious adverse events. The most frequent findings were nausea, vomiting and a feeling of warmth.
MultiHance is a safe and very well tolerated contrast agent for magnetic resonance imaging (MRI) with a profile and frequency of adverse events similar to other extracellular MR contrast materials.
回顾性分析一种具有弱间歇性蛋白结合和高弛豫率的顺磁性造影剂的不良事件发生率及诊断效能。
1998年至2006年在德国进行了钆贝葡胺（MultiHance，博莱科安塔娜制药公司，康斯坦茨）的上市后监测研究，然后进行回顾性分析。记录人口统计学数据、相关合并症和过敏情况。将MultiHance的安全性和耐受性记录在标准化数据表上。
共有38568例患者纳入研究。829例患者（2.1%）已知对造影剂不耐受。检查区域包括中枢神经系统、肝脏和血管床。使用自动注射器（n = 10456）的注射速率在86.5%的患者中为1.0至3.0 ml/秒。不良事件总计1.2%。11例患者（0.03%）发生严重不良事件。最常见的表现为恶心、呕吐和发热感。
MultiHance是一种用于磁共振成像（MRI）的安全且耐受性良好的造影剂，其不良事件的特征和发生率与其他细胞外磁共振造影剂相似。
