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碘美普尔与碘帕醇在胸部和腹部器官增强计算机断层扫描中的对比研究

Iomeprol versus iopamidol in contrast-enhanced computed tomography of thoracic and abdominal organs.

作者信息

Valentini A L, Tartaglione T, Monti L, Marano P

机构信息

Institute for Radiological Sciences, Sacro Cuore Catholic University, Rome, Italy.

出版信息

Eur J Radiol. 1994 May;18 Suppl 1:S88-92. doi: 10.1016/0720-048x(94)90100-7.

Abstract

The aim of this double-blind, parallel-group study was to compare the safety, tolerance, and efficacy of iomeprol-350 (350 mgI/ml), iomeprol-400 (400 mgI/ml) and iopamidol-370 (370 mgI/ml) for use in contrast-enhanced body computed tomography (CT). Following written informed consent, 120 adult inpatients of either sex requiring CT of thoracic or abdominal organs were randomly assigned to receive iomeprol-350, iomeprol-400 or iopamidol-370. Pre- and post-contrast, all patients underwent clinical, instrumental and laboratory investigation to assess the safety of the test agents. Tolerance was assessed in terms of discomfort associated with contrast injection. Two experienced radiologists independently and blindly graded the quality of contrast enhancement obtained with the different contrast solutions by means of a five-point ordinal scale as follows: 1, insufficient; 2, sufficient; 3, good; 4, excellent; or E, excessive. Patients in the iomeprol groups needed fewer injections and a smaller volume of contrast medium to obtain examinations of adequate diagnostic quality. Contrast enhancement was judged as excellent or good in about 90% of the study examinations, without significant differences between the three study groups. During contrast injection, heat and pain sensations were minimal or absent in most cases. No serious adverse events occurred throughout the study. No significant changes in clinical, instrumental or laboratory safety parameters were observed. In conclusion, iomeprol-400 and iomeprol-350 appear to be contrast solutions at least as safe, well tolerated and effective as iopamidol-370 when used as contrast agents for body CT.

摘要

这项双盲、平行组研究的目的是比较碘美普尔-350(350mgI/ml)、碘美普尔-400(400mgI/ml)和碘帕醇-370(370mgI/ml)用于对比增强体部计算机断层扫描(CT)时的安全性、耐受性和有效性。在获得书面知情同意后,120名需要进行胸部或腹部器官CT检查的成年住院患者(男女不限)被随机分配接受碘美普尔-350、碘美普尔-400或碘帕醇-370。在注射造影剂前后,所有患者均接受临床、仪器和实验室检查,以评估受试药物的安全性。根据与造影剂注射相关的不适来评估耐受性。两名经验丰富的放射科医生独立且盲法地通过如下五点有序量表对不同造影剂溶液获得的对比增强质量进行分级:1,不足;2,足够;3,良好;4,优秀;或E,过量。碘美普尔组的患者在获得具有足够诊断质量的检查时需要的注射次数更少且造影剂用量更小。在约90%的研究检查中,对比增强被判定为优秀或良好,三个研究组之间无显著差异。在注射造影剂期间,大多数情况下热感和疼痛感极小或不存在。在整个研究过程中未发生严重不良事件。未观察到临床、仪器或实验室安全参数有显著变化。总之,当用作体部CT的造影剂时,碘美普尔-400和碘美普尔-350似乎是至少与碘帕醇-370一样安全、耐受性良好且有效的造影剂。

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