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碘美普尔、碘海醇和碘帕醇用于静脉肾盂造影的随机、双盲、平行组试验。

A randomized, double-blind, parallel group trial of iomeprol, iohexol and iopamidol in intravenous urography.

作者信息

Harding J R, Bertazzoli M, Spinazzi A

机构信息

Department of Clinical Radiology, St Woolos Hospital, Glan Hafren NHS Trust, Newport, Gwent, UK.

出版信息

Br J Radiol. 1995 Jul;68(811):712-5. doi: 10.1259/0007-1285-68-811-712.

Abstract

The aim of this study was to compare the safety, tolerance, and diagnostic efficacy of iomeprol 350 mg I ml-1, iohexol 350 mg I ml-1, and iopamidol 370 mg I ml-1 in 90 adult patients undergoing intravenous urography. Radiographs obtained 5, 10 and 15 min after contrast injection were blindly graded for quality on a four point scale as: 0, non-diagnostic; 1, diagnostic but of limited quality; 2, diagnostic and of good quality; 3, fully diagnostic and of very good quality. The sum of these scores indicated the overall diagnostic quality (0-4, non-diagnostic; 4-8, diagnostic; 9-12, good or excellent). Contrast tolerability was evaluated by discomfort (heat or pain) associated with injection of the test compounds, and patients were monitored and questioned for adverse experiences. The quality of the individual radiographs was assessed as diagnostic and good or fully diagnostic and very good in most cases, with no significant differences between the three study groups, and overall scores were predominantly good or excellent (p = 0.55). All adverse reactions were transient and non-serious, and most of them were reported as mild in intensity. There were no significant differences between the three groups for heat sensation (p = 0.29). Pain at the injection site was reported only in the iohexol group (p = 0.104). It is concluded that iomeprol 350 mg I ml-1 is at least as safe and effective as iohexol 350 mg I ml-1 or iopamidol 370 mg I ml-1 when used for intravenous urography.

摘要

本研究旨在比较350毫克/毫升的碘美普尔、350毫克/毫升的碘海醇和370毫克/毫升的碘帕醇在90例接受静脉肾盂造影的成年患者中的安全性、耐受性和诊断效果。在注射造影剂后5、10和15分钟获得的X光片由专人按照以下四点量表对质量进行盲法分级:0级,非诊断性;1级,诊断性但质量有限;2级,诊断性且质量良好;3级,完全诊断性且质量非常好。这些分数的总和表示总体诊断质量(0 - 4分,非诊断性;4 - 8分,诊断性;9 - 12分,良好或优秀)。通过与注射测试化合物相关的不适(热感或疼痛)来评估造影剂耐受性,并对患者进行监测并询问有无不良反应。在大多数情况下,个体X光片的质量被评估为诊断性且良好或完全诊断性且非常好,三个研究组之间无显著差异,总体分数主要为良好或优秀(p = 0.55)。所有不良反应均为短暂且不严重,大多数不良反应强度为轻度。三组之间在热感方面无显著差异(p = 0.29)。仅碘海醇组报告了注射部位疼痛(p = 0.104)。结论是,当用于静脉肾盂造影时,350毫克/毫升的碘美普尔至少与350毫克/毫升的碘海醇或370毫克/毫升的碘帕醇一样安全有效。

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