钆塞酸二钠肝脏磁共振成像：一项关于检测肝脏局灶性病变安全性和有效性的多中心临床试验。
Hepatic MR imaging with ferumoxides: a multicenter clinical trial of the safety and efficacy in the detection of focal hepatic lesions.
作者信息
Ros P R, Freeny P C, Harms S E, Seltzer S E, Davis P L, Chan T W, Stillman A E, Muroff L R, Runge V M, Nissenbaum M A
机构信息
Department of Radiology, University of Florida College of Medicine, Gainesville 32610, USA.
出版信息
Radiology. 1995 Aug;196(2):481-8. doi: 10.1148/radiology.196.2.7617864.
PURPOSE
To assess the safety and diagnostic efficacy of intravenous ferumoxides, a superparamagnetic iron oxide, for depiction of focal hepatic lesions on magnetic resonance (MR) images.
MATERIALS AND METHODS
This open-label study included 208 patients with known or suspected focal hepatic lesions. MR images were obtained before and 45 minutes to 4 hours after intravenous infusion of ferumoxides (10 mumol/kg). The effect of ferumoxides on signal intensity of the liver was assessed with quantitative analysis. Safety was evaluated with patient monitoring and laboratory measurements.
RESULTS
Mean lesion-to-liver contrast-to-noise ratio on T2-weighted images was 9.1 on unenhanced images and 12.7 on enhanced images. Signal intensity of normal liver on enhanced images decreased to 37% of that on unenhanced images. In blinded image evaluations, additional lesions were identified on 27% of enhanced images. No serious adverse events occurred.
CONCLUSION
Ferumoxides is a safe and efficacious contrast agent for the detection of focal liver lesions on T2-weighted images.
目的
评估超顺磁性氧化铁静脉注射剂 ferumoxides 在磁共振（MR）图像上对肝脏局灶性病变的显示效果及安全性。
材料与方法
这项开放标签研究纳入了 208 例已知或疑似肝脏局灶性病变的患者。在静脉注射 ferumoxides（10 μmol/kg）前及注射后 45 分钟至 4 小时获取 MR 图像。通过定量分析评估 ferumoxides 对肝脏信号强度的影响。通过患者监测和实验室检测评估安全性。
结果
在 T2 加权图像上，未增强图像的平均病变与肝脏对比噪声比为 9.1，增强图像为 12.7。增强图像上正常肝脏的信号强度降至未增强图像的 37%。在盲法图像评估中，27%的增强图像发现了额外病变。未发生严重不良事件。
结论
Ferumoxides 是一种用于在 T2 加权图像上检测肝脏局灶性病变的安全有效的对比剂。
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