Torres C G, Lundby B, Sterud A T, McGill S, Gordon P B, Bjerknes H S
Nycomed Imaging AS, Oslo, Norway.
Acta Radiol. 1997 Jul;38(4 Pt 2):631-7. doi: 10.1080/02841859709172393.
To evaluate the diagnostic efficacy and safety of MnDPDP (Teslascan) in enhanced MR imaging.
In 2 multiple independent trials in Europe 624 patients were given MnDPDP intravenously at 5 mumol/kg b.w. Patients underwent an unenhanced MR examination comprising T1-weighted spin-echo and breath-hold gradient-echo sequences and a T2-weighted spin-echo sequence. The T1 sequences were repeated after the administration of MnDPDP. In a subgroup of 137 patients the results of the enhanced MR images were compared with the results of contrast-enhanced CT (CECT) images.
For both types of T1-weighted sequences and when evaluating the maximum numbers of lesions seen in all imaging sequences, the total numbers of lesions seen were significantly higher in the MnDPDP-enhanced images than in the unenhanced images (p = 0.0005 and p = 0.0001, respectively). The investigators considered the enhanced images to contain "other additional information not found in the unenhanced images" in 279 (45%) of the 621 patients examined. The MnDPDP-enhanced images were also superior to the CECT images in the detection of lesions (p = 0.02). Adverse events were reported by 46 patients (7%) and infusion-associated discomfort by 26 (4%). Heart rates and systolic and diastolic blood pressures showed no clinically significant changes from baseline as a result of the administration of the contrast medium.
MnDPDP was shown to be effective and safe in enhanced MR imaging of the liver.
评估锰福地吡（泰乐影）在增强磁共振成像中的诊断效能及安全性。
在欧洲进行的2项多中心独立试验中，624例患者按5 μmol/kg体重静脉注射锰福地吡。患者先接受包括T1加权自旋回波和屏气梯度回波序列以及T2加权自旋回波序列的平扫磁共振检查。注射锰福地吡后重复T1序列检查。在137例患者的亚组中，将增强磁共振图像结果与对比增强CT（CECT）图像结果进行比较。
对于两种类型的T1加权序列，以及在评估所有成像序列中观察到的最大病变数量时，锰福地吡增强图像中观察到的病变总数显著高于平扫图像（分别为p = 0.0005和p = 0.0001）。在621例接受检查的患者中，有279例（45%）研究者认为增强图像包含“平扫图像中未发现的其他额外信息”。在病变检测方面，锰福地吡增强图像也优于CECT图像（p = 0.02）。46例患者（7%）报告了不良事件，26例（4%）报告了与输注相关的不适。注射造影剂后，心率、收缩压和舒张压与基线相比无临床显著变化。
锰福地吡在肝脏增强磁共振成像中显示出有效且安全。
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