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使用新型非离子型造影剂的外周血管造影术:碘美普尔与碘帕醇的比较。

Peripheral arteriography with a new nonionic agent: comparison of iomeprol with iopamidol.

作者信息

Ugolotti U, Larini P, Marcato C, Cusmano F, Puccianti F

机构信息

Istituto di Scienze Radiologiche, Università di Parma, Italy.

出版信息

Eur J Radiol. 1994 May;18 Suppl 1:S77-82. doi: 10.1016/0720-048x(94)90098-1.

Abstract

Aim of this randomized, double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol and iopamidol, both at iodine concentration of 150 mgI/ml, in 100 adult patients undergoing peripheral intra-arterial digital subtraction angiography (IA-DSA). All patients underwent extensive pre- and post-contrast clinical, instrumental and laboratory evaluation for safety assessments. The tolerance to the test compounds was evaluated in terms of discomfort associated with the injection of the test compounds. Image quality was prospectively graded by two independent readers according to a five-point scale as 1, insufficient; 2, sufficient; 3, good; 4, excellent; or E, excessive. At the end of the study, two experienced radiologists working at institutions other than the study centre and not aware of patients identity, clinical profile or results of other imaging procedures, jointly evaluated study images using the same ordinal scale. The procedure was always well tolerated. None of the studied patients experienced adverse events. All angiographic examinations were rated as diagnostic. The quality of the radiographs was judged as excellent or good in most individual patient studies, without significant differences between the two study groups. No significant differences between the results of prospective on-site assessment and retrospective external assessment were detected. The results of our study show that iomeprol and iopamidol are equally effective, well tolerated and safe contrast agents when used for peripheral IA-DSA.

摘要

本随机、双盲、平行组研究的目的是比较碘浓度均为150mgI/ml的碘美普尔和碘帕醇在100例接受外周动脉数字减影血管造影(IA-DSA)的成年患者中的安全性、耐受性及诊断效能。所有患者在造影剂注射前后均接受了广泛的临床、仪器及实验室评估以进行安全性评估。根据与注射试验化合物相关的不适情况评估对试验化合物的耐受性。由两名独立阅片者根据五分制对图像质量进行前瞻性分级,1级为不足;2级为足够;3级为良好;4级为优秀;E级为过度。在研究结束时,由两名在研究中心以外机构工作且不了解患者身份、临床资料或其他成像检查结果的经验丰富的放射科医生,使用相同的顺序量表对研究图像进行联合评估。该操作的耐受性始终良好。所有研究患者均未发生不良事件。所有血管造影检查均被评为具有诊断价值。在大多数个体患者研究中,X线片质量被判定为优秀或良好,两个研究组之间无显著差异。前瞻性现场评估与回顾性外部评估结果之间未检测到显著差异。我们的研究结果表明,碘美普尔和碘帕醇在用于外周IA-DSA时,是同样有效、耐受性良好且安全的造影剂。

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