Shellock Frank G, Parker John R, Venetianer Carole, Pirovano Gianpaolo, Spinazzi Alberto
Keck School of Medicine, University of Southern California and Institute for Magnetic Resonance Safety, Education, and Research, Los Angeles, CA, USA.
Invest Radiol. 2006 Jun;41(6):500-9. doi: 10.1097/01.rli.0000209661.99225.c2.
Prospective studies and retrospective analyses were undertaken to evaluate the clinical safety of gadobenate dimeglumine (MultiHance) and to assess tolerability in special populations.
A total of 3092 subjects received MultiHance in 79 clinical trials. Data from comparisons with other contrast agents and studies in children, subjects with hepatic or renal impairment, or subjects with coronary artery disease were reviewed. Postmarketing safety surveillance data after more than 1.5 million applications were also evaluated.
In total, 413 of 2982 (14%) adult subjects receiving MultiHance reported at least one adverse event (AE) definitely or potentially related to MultiHance, an incidence that was similar to that observed with placebo (21/127, 17%) or active controls (59/723, 8%). In crossover studies, 23 of 287 (8%) subjects receiving MultiHance experienced AE compared with 25 of 295 (9%) receiving gadopentetate dimeglumine (Magnevist). No increased AE rate was observed in children and no worsening of renal or liver function was observed in subjects with hepatic or renal impairment. No detrimental effect on cardiac electrophysiology could be observed from a retrospective analysis of ECG parameters in more than 1000 patients and healthy volunteers. The AE reporting rate from postmarketing safety surveillance of MultiHance was 0.05%. Serious AEs were rarely reported and included dyspnea, nausea, urticaria, hypotension, and anaphylactoid reactions.
MultiHance appears to be well tolerated in adults and children and in subjects with impaired liver or kidney function or coronary artery disease. In controlled trials, MultiHance demonstrated a similar safety profile to that of Magnevist.
开展前瞻性研究和回顾性分析，以评估钆贝葡胺（MultiHance）的临床安全性，并评估特殊人群的耐受性。
79项临床试验中共有3092名受试者接受了MultiHance。回顾了与其他造影剂比较的数据以及儿童、肝或肾功能损害受试者或冠状动脉疾病受试者的研究数据。还评估了超过150万次用药后的上市后安全性监测数据。
在接受MultiHance的2982名成年受试者中，共有413名（14%）报告了至少一项肯定或可能与MultiHance相关的不良事件（AE），这一发生率与安慰剂组（21/127，17%）或活性对照组（59/723，8%）观察到的发生率相似。在交叉研究中，接受MultiHance的287名受试者中有23名（8%）出现AE，而接受钆喷酸葡胺（Magnevist）的295名受试者中有25名（9%）出现AE。儿童中未观察到AE发生率增加，肝或肾功能损害受试者中未观察到肾功能或肝功能恶化。对1000多名患者和健康志愿者的心电图参数进行回顾性分析，未观察到对心脏电生理有不利影响。MultiHance上市后安全性监测的AE报告率为0.05%。严重AE很少报告，包括呼吸困难、恶心、荨麻疹、低血压和类过敏反应。
MultiHance在成人和儿童以及肝或肾功能损害或冠状动脉疾病受试者中似乎耐受性良好。在对照试验中，MultiHance的安全性与Magnevist相似。
