Endrikat Jan, Kim So Yeon, Sakaguchi Toshiaki, Dohanish Susan, Breuer Josy
1 Bayer HealthCare Pharmaceuticals, Medical Care, Radiology & Interventional, Berlin, Germany.
2 Department of Gynecology, Obstetrics and Reproductive Medicine, University Medical School of Saarland, Homburg/Saar, Germany.
Acta Radiol. 2016 Nov;57(11):1326-1333. doi: 10.1177/0284185115588126. Epub 2016 Jul 21.
Background Safety data on routine clinical use of gadoxetate disodium for liver magnetic resonance imaging (MRI) is not reported yet. Purpose To assess the safety profile of gadoxetate disodium for liver MRI in the routine clinical setting. Material and Methods Six multicenter studies were performed in Europe, USA, Australia, and Asia to evaluate the safety and efficacy of gadoxetate disodium (Primovist®/Eovist®) enhanced liver MRI. Patients received a single intravenous bolus injection of the standard approved dose of 0.025 mmol/kg body weight (0.1 mL/kg). The number of patients, the characteristics of adverse events, related adverse events, and serious adverse events were analyzed. Results A total of 8194 patients were included in the database. A total of 141 patients (1.7%) reported 230 AEs of which 129 were considered being related to the use of gadoxetate disodium by the investigators. None of the AEs in the pediatric population ( n = 52) were related. The most frequent AEs independent of relationship to the drug included dyspnea (25/0.31%), nausea (22/0.27%), liver disorders (13/0.16%), and renal disorders (9/0.11%). Nine related SAEs were recorded. No patient died during the studies. Conclusion Gadoxetate disodium for liver MRI is safe and well tolerated in the routine clinical setting.
关于钆塞酸二钠用于肝脏磁共振成像（MRI）的常规临床使用的安全性数据尚未报道。目的：评估钆塞酸二钠在常规临床环境中用于肝脏MRI的安全性。材料与方法：在欧洲、美国、澳大利亚和亚洲进行了六项多中心研究，以评估钆塞酸二钠（普美显®/优维显®）增强肝脏MRI的安全性和有效性。患者接受单次静脉推注标准批准剂量0.025 mmol/kg体重（0.1 mL/kg）。分析了患者数量、不良事件特征、相关不良事件和严重不良事件。结果：数据库共纳入8194例患者。共有141例患者（1.7%）报告了230起不良事件，其中129起被研究者认为与使用钆塞酸二钠有关。儿科患者（n = 52）中无一例不良事件相关。与药物无关的最常见不良事件包括呼吸困难（25/0.31%）、恶心（22/0.27%）、肝脏疾病（13/0.16%）和肾脏疾病（9/0.11%）。记录了9起相关严重不良事件。研究期间无患者死亡。结论：钆塞酸二钠用于肝脏MRI在常规临床环境中是安全且耐受性良好的。
