Oudkerk M, Sijens P E, Van Beek E J, Kuijpers T J
Dr. Daniel den Hoed Cancer Center, University Hospital Rotterdam, The Netherlands.
Invest Radiol. 1995 Feb;30(2):75-8. doi: 10.1097/00004424-199502000-00002.
Gd-DTPA is a well-characterized, safe contrast agent frequently used in magnetic resonance imaging (MRI) of the central nervous system. The purpose of this double-blind, comparative MRI study of brain, spine, trunk, and limbs was to evaluate the safety and efficacy of Gd-DOTA versus Gd-DTPA in a large number of patients (n = 1038).
T1-weighted MRI was performed before contrast and after the administration of Gd-DOTA or Gd-DTPA (0.1 mmol/kg). The MR images were scored for image quality, and the diagnostic efficacy also was assessed. Patients were questioned 1 hour after injection, and adverse reactions were recorded.
Image quality of the T1-weighted MR images without contrast was good or excellent in 89.7% and 91.7% of the Gd-DOTA and Gd-DTPA groups, respectively (P > 0.2). After contrast, 85.8% (Gd-DOTA) and 88.2% (Gd-DTPA) of the T1-weighted MR images were of good to excellent image quality (P > 0.2), significantly less than before contrast (P < 0.001, both groups). In 82.3% of the Gd-DOTA group and 83.5% of the Gd-DTPA group (P > 0.2), the information obtained was more accurate with the administration of contrast agents. In 82.4% (Gd-DTPA) and 81.9% (Gd-DOTA) of patients, confirmation was obtained of diagnosis without contrast, whereas in 17.0% and 17.3% of patients, therapy was modified as a result of the use of contrast (P > 0.2, both groups). The MRI investigation was reported as abnormal in 58.3% (Gd-DOTA) and 59.6% of patients (Gd-DTPA), indicating a similar prevalence of disease in each group. Patients responded that 97.8% (Gd-DOTA) and 98.5% (Gd-DTPA) of the investigations went well and adverse reactions, none of them serious, were encountered in 0.97% of Gd-DOTA and 0.77% of Gd-DTPA groups (P > 0.2, both groups).
This double-blind, randomized, clinical trial comparing Gd-DTPA and Gd-DOTA revealed no serious adverse reactions, whereas minor adverse reactions were encountered in fewer than 1% of patients. Gd-DOTA is as safe a contrast agent as Gd-DTPA and has similar diagnostic efficacy.
钆喷酸葡胺（Gd-DTPA）是一种特性明确、安全的造影剂，常用于中枢神经系统的磁共振成像（MRI）。这项针对大脑、脊柱、躯干和四肢的双盲、对比性MRI研究的目的是评估钆双胺（Gd-DOTA）与钆喷酸葡胺在大量患者（n = 1038）中的安全性和有效性。
在注射造影剂前及注射钆双胺或钆喷酸葡胺（0.1 mmol/kg）后进行T1加权MRI检查。对MR图像的图像质量进行评分，并评估诊断效能。在注射后1小时询问患者，记录不良反应。
在钆双胺组和钆喷酸葡胺组中，未注射造影剂的T1加权MR图像的图像质量分别有89.7%和91.7%为良好或优秀（P > 0.2）。注射造影剂后，T1加权MR图像有85.8%（钆双胺）和88.2%（钆喷酸葡胺）的图像质量为良好至优秀（P > 0.2），显著低于注射造影剂前（两组P均< 0.001）。在钆双胺组的82.3%和钆喷酸葡胺组的83.5%（P > 0.2）中，使用造影剂后获得的信息更准确。在82.4%（钆喷酸葡胺）和81.9%（钆双胺）的患者中，未注射造影剂时诊断已得到确认，而在17.0%和17.3%的患者中，由于使用造影剂而修改了治疗方案（两组P均> 0.2）。MRI检查报告为异常的患者在钆双胺组为58.3%，在钆喷酸葡胺组为59.6%，表明每组疾病的患病率相似。患者反馈，97.8%（钆双胺）和98.5%（钆喷酸葡胺）的检查进展顺利，钆双胺组0.97%和钆喷酸葡胺组0.77%的患者出现了不良反应，但均不严重（两组P均> 0.2）。
这项比较钆喷酸葡胺和钆双胺的双盲、随机临床试验未发现严重不良反应，而不到1%的患者出现了轻微不良反应。钆双胺与钆喷酸葡胺一样安全，且具有相似的诊断效能。
