Kopp A F, Laniado M, Dammann F, Stern W, Grönewäller E, Balzer T, Schimpfky C, Claussen C D
Department of Diagnostic Radiology, Eberhard-Karls University, Tübingen, Germany.
Radiology. 1997 Sep;204(3):749-56. doi: 10.1148/radiology.204.3.9280254.
To evaluate the safety, efficacy, and pharmacodynamic properties of a new superparamagnetic parenteral iron oxide contrast agent for magnetic resonance (MR) imaging.
Thirty-six patients with liver lesions received a bolus injection of Resovist (SH U 555 A; Schering, Berlin, Germany) at a dose of 4, 8, or 16 micromol iron per kilogram body weight (micromol Fe/kg). Fast low-angle shot, spin-echo, and turbo gradient spin-echo MR images were obtained before and 10, 40, and 70 minutes after injection. Blood samples were obtained, vital signs were monitored, and adverse events were recorded. Lesion detection was assessed by two independent, blinded readers.
No drug-related adverse events occurred. Serum iron and ferritin levels were increased at all dose levels. Partial thromboplastin time increased and factor XI level decreased 4 hours after injection of 16 micromol Fe/kg. Lesion detection and diagnostic confidence were increased in patients who received 4 or 8 micromol Fe/kg, with no further increase with a 16-micromol dose.
Resovist is safe and effective. The best MR imaging results were obtained 40 minutes after injection of 8 micromol Fe/kg.
评估一种用于磁共振（MR）成像的新型超顺磁性胃肠外铁氧化物造影剂的安全性、有效性和药效学特性。
36例肝脏病变患者接受了一次静脉注射Resovist（SH U 555 A；德国柏林先灵公司），剂量为每千克体重4、8或16微摩尔铁（微摩尔铁/千克）。在注射前以及注射后10、40和70分钟获取快速低角度激发、自旋回波和快速梯度自旋回波MR图像。采集血样，监测生命体征，并记录不良事件。由两名独立的、不知情的阅片者评估病变检测情况。
未发生与药物相关的不良事件。所有剂量水平下血清铁和铁蛋白水平均升高。注射16微摩尔铁/千克后4小时，部分凝血活酶时间延长，Ⅺ因子水平降低。接受4或8微摩尔铁/千克的患者病变检测及诊断可信度提高，16微摩尔剂量时未进一步提高。
Resovist安全有效。注射8微摩尔铁/千克后40分钟获得最佳MR成像结果。
