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钆喷酸葡胺用于评估神经病理学的III期临床研究。欧洲视角。

Phase III clinical studies with gadoteridol for the evaluation of neurologic pathology. A European perspective.

作者信息

Seiderer M

机构信息

Department of Radiology, University of Munich, Klinikum Grosshadern, Germany.

出版信息

Invest Radiol. 1992 Aug;27 Suppl 1:S33-8.

PMID:1506151
Abstract

OBJECTIVES AND RATIONALE

The use of paramagnetic contrast agents has improved the diagnostic sensitivity and specificity of magnetic resonance imaging (MRI) for evaluating diseases of the central nervous system. To assess the safety and imaging properties of the nonionic, gadolinium-based MRI contrast agent gadoteridol, 151 patients and controls were evaluated for safety, and 118 patients with cerebral or spinal pathology were evaluated for imaging efficacy.

METHODS

Precontrast T1- and T2-weighted spin-echo images and postcontrast (0.10 mmol/kg) T1-weighted spin-echo images were read by unblinded investigators at each site.

RESULTS

The rate of adverse events possibly or probably related to gadoteridol was 4.0% (vasodilation [facial flushing], 1 patient; nausea, 3 patients; urticaria, 2 patients). Laboratory changes were reported in 6.0%. None of these events or changes was considered to be clinically significant. Contrast enhancement was noted in 75% of cases with brain pathology and 64% of cases involving spine lesions.

CONCLUSIONS

Gadoteridol is safe in routine clinical use at a dose of 0.10 mmol/kg and provides improved lesion detection compared to plain MRI.

摘要

目的与原理

使用顺磁性造影剂提高了磁共振成像(MRI)评估中枢神经系统疾病的诊断敏感性和特异性。为评估非离子型钆基MRI造影剂钆特醇的安全性和成像特性,对151例患者及对照者进行了安全性评估,对118例患有脑部或脊髓病变的患者进行了成像效果评估。

方法

每个研究点由未设盲的研究人员读取造影前T1加权和T2加权自旋回波图像以及造影后(0.10 mmol/kg)T1加权自旋回波图像。

结果

可能或很可能与钆特醇相关的不良事件发生率为4.0%(血管扩张[面部潮红],1例患者;恶心,3例患者;荨麻疹,2例患者)。报告有实验室指标变化的占6.0%。这些事件或变化均未被认为具有临床意义。75%的脑部病变病例和64%的脊柱病变病例出现了造影剂增强。

结论

钆特醇以0.10 mmol/kg的剂量用于常规临床是安全的,与普通MRI相比,能更好地检测病变。

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Phase III clinical studies with gadoteridol for the evaluation of neurologic pathology. A European perspective.钆喷酸葡胺用于评估神经病理学的III期临床研究。欧洲视角。
Invest Radiol. 1992 Aug;27 Suppl 1:S33-8.
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