Department of Radiology and Nuclear Medicine, University Clinics Bergmannsheil, Ruhr-University-Bochum, Buerkle-de-la-Camp Platz 1, 44789 Bochum, Germany.
Eur Radiol. 2011 May;21(5):1058-67. doi: 10.1007/s00330-010-2008-z. Epub 2010 Dec 21.
To prove that 1.0 M gadobutrol provides superior contrast enhancement in suspicion of osteomyelitis of the feet compared with 0.5 M gadoterate.
MRI of feet was performed on 2 separate occasions. Independent injections of 1.0 M gadobutrol and 0.5 M gadoterate at doses of 0.1 mmol Gd/kg body weight were administered per patient. The interval between the two MR examinations was between 24 h and 7 days. Evaluation was performed in an off-site blinded read.
41 patients were eligible for efficacy analysis. Results of secondary efficacy variables did not show statistically significant differences. For the primary efficacy variable, a trend in favour of gadobutrol was seen in the full analysis set (ITT) population resulting in at least non-inferiority. In the per protocol (PP) analysis set gadobutrol had better contrast than gadoterate (Wilcoxon signed rank test, p = 0.0466).
Imaging of the distal lower limb in this special patient population requires a large number of patients to obtain enough comparative images where non-contrast-agent-dependent factors do not disturb contrast agent efficacy. The ITT analysis showed at least non-inferiority of gadobutrol in comparison to gadoterate. The avoidance of imaging artefacts demonstrates a better outcome for gadobutrol.
证明在疑似足部骨髓炎的情况下，与 0.5 M 钆特酸相比，1.0 M 钆布醇提供了更好的对比增强效果。
在两次独立的检查中对足部进行 MRI 检查。每位患者分别注射 1.0 M 钆布醇和 0.5 M 钆特酸，剂量为 0.1 mmol Gd/kg 体重。两次 MRI 检查之间的间隔时间为 24 小时至 7 天。评估在异地盲法阅读中进行。
41 名患者符合疗效分析的条件。次要疗效变量的结果没有显示出统计学上的显著差异。对于主要疗效变量，在全分析集（ITT）人群中，看到了倾向于钆布醇的趋势，从而至少达到了非劣效性。在符合方案（PP）分析集中，钆布醇的对比效果优于钆特酸（Wilcoxon 符号秩检验，p=0.0466）。
在这个特殊的患者群体中，对下肢远端进行成像需要大量的患者来获得足够的对比图像，其中非对比剂依赖性因素不会干扰对比剂的疗效。ITT 分析显示，与钆特酸相比，钆布醇至少具有非劣效性。避免成像伪影表明钆布醇的结果更好。
