Bluemke David A, Weber Therese M, Rubin Daniel, de Lange Eduard E, Semelka Richard, Redvanly Richard D, Chezmar Judith, Outwater Eric, Carlos Ruth, Saini Sanjay, Holland George A, Mammone Joseph F, Brown Jeffrey J, Milestone Bart, Javitt Marcia C, Jacobs Paula
Johns Hopkins University School of Med, 600 N Wolfe St, Baltimore, MD 21287, USA.
Radiology. 2003 Aug;228(2):457-64. doi: 10.1148/radiol.2282012061.
To compare the safety and effectiveness of an undiluted direct injection of ferumoxides with those of a diluted slow infusion of ferumoxides during 30 minutes in patients with known liver lesions or in those suspected of having them.
Two hundred thirty-three patients at 16 institutions were randomized to receive either an undiluted direct injection of 0.56 mg of iron per kilogram of body weight of ferumoxides administered during 2 minutes (2 mL/min) or a diluted slow infusion administered during 30 minutes. Safety was assessed with monitoring for adverse events and laboratory tests. For sensitivity, specificity, and accuracy analysis, two independent blinded observers identified and classified lesions as benign or malignant with precontrast images and with pre- and postcontrast images combined.
There was no statistically significant difference in adverse events in the group with direct injection compared with those in the group with infusion (21 [18%] of 114 patients vs 19 [17%] of 112 patients, respectively). No serious adverse events were observed. The most common adverse events in the group with direct injection versus the group with infusion were headache (five [4%] of 114 vs three [3%] of 112, respectively) and back pain (five [4%] of 114 vs three [3%] of 112, respectively). Overall, in 68 (62%) of 109 patients with direct injection and 71 (66%) of 108 patients with infusion, additional magnetic resonance (MR) imaging information was obtained after ferumoxides administration (P =.67). Sensitivity, specificity, and accuracy for the diagnosis of malignancy were significantly improved by adding images obtained after ferumoxides administration to the images obtained before contrast agent administration (P <.05 for all comparisons).
Direct injection of ferumoxides has safety and effectiveness profiles similar to those of slow infusion of the agent. Further findings indicate that the addition of ferumoxides increases the sensitivity and specificity of hepatic MR evaluation when compared with unenhanced MR imaging.
比较在已知有肝脏病变或疑似有肝脏病变的患者中，非稀释直接注射铁氧化物与稀释后30分钟缓慢输注铁氧化物的安全性和有效性。
16家机构的233例患者被随机分为两组，一组接受每千克体重0.56毫克铁的非稀释铁氧化物直接注射，注射时间为2分钟（2毫升/分钟），另一组接受稀释后30分钟缓慢输注。通过监测不良事件和实验室检查评估安全性。对于敏感性、特异性和准确性分析，两名独立的盲法观察者利用注射造影剂前的图像以及注射造影剂前后的图像组合，对病变进行识别并分类为良性或恶性。
直接注射组与输注组的不良事件发生率无统计学显著差异（分别为114例患者中的21例[18%]和112例患者中的19例[17%]）。未观察到严重不良事件。直接注射组与输注组最常见的不良事件分别是头痛（114例中的5例[4%]对112例中的3例[3%]）和背痛（114例中的5例[4%]对112例中的3例[3%]）。总体而言，109例直接注射患者中有68例（62%），108例输注患者中有71例（66%）在注射铁氧化物后获得了额外的磁共振（MR）成像信息（P = 0.67）。将注射铁氧化物后获得的图像添加到注射造影剂前获得的图像中，显著提高了恶性肿瘤诊断的敏感性、特异性和准确性（所有比较P < 0.05）。
直接注射铁氧化物的安全性和有效性与该药物缓慢输注相似。进一步研究结果表明，与未增强的MR成像相比，添加铁氧化物可提高肝脏MR评估的敏感性和特异性。
