Haustein J, Laniado M, Niendorf H P, Louton T, Beck W, Planitzer J, Schöffel M, Reiser M, Kaiser W, Schörner W
Department of Clinical Research Diagnostics, Schering AG, Berlin, Germany.
Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.
To investigate the safety, patient tolerance, and efficacy with 0.3 mmol/kg gadopentetate dimeglumine in magnetic resonance (MR) imaging of the central nervous system (CNS), a phase 3 trial was conducted in 199 patients with suspected CNS lesions. Patients received either 0.1 or 0.3 mmol/kg gadopentate dimeglumine (injection time, 15 seconds and 45 seconds, respectively). T1- and T2-weighted spin-echo sequences were performed at either 0.5 T or 1.5 T. In 80 patients with enhancing brain lesions, contrast-to-noise ratios (C/Ns) were calculated, and lesion-to-brain contrast was evaluated visually. Six patients (6%) in each dose group reported adverse events. Eight adverse events occurred with 0.1 mmol/kg and seven with 0.3 mmol/kg. Vital signs and laboratory values did not change significantly. C/N (P < .05) and visual assessment ratings were higher with 0.3 mmol/kg than with 0.1 mmol/kg. According to these preliminary results, 0.3 mmol/kg gadopentetate dimeglumine is safe and well tolerated when administered at approximately 1 mL/sec.
为研究0.3 mmol/kg钆喷酸葡胺用于中枢神经系统（CNS）磁共振（MR）成像的安全性、患者耐受性及有效性，对199例疑似CNS病变患者进行了一项3期试验。患者分别接受0.1 mmol/kg或0.3 mmol/kg钆喷酸葡胺（注射时间分别为15秒和45秒）。在0.5 T或1.5 T场强下进行T1加权和T2加权自旋回波序列检查。对80例有强化脑病变的患者计算对比噪声比（C/N），并对病变与脑的对比度进行视觉评估。每个剂量组有6例患者（6%）报告了不良事件。0.1 mmol/kg组发生8起不良事件，0.3 mmol/kg组发生7起。生命体征和实验室值无显著变化。0.3 mmol/kg组的C/N（P <.05）和视觉评估评分高于0.1 mmol/kg组。根据这些初步结果，以约1 mL/秒的速度给药时，0.3 mmol/kg钆喷酸葡胺是安全的且耐受性良好。
