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[碘海醇在儿童“全身”计算机断层扫描中的诊断效能及临床耐受性评估。一项非对照III期试验]

[Evaluation of diagnostic efficacy and clinical tolerability of ioversol in "whole body" computed tomography in children. A non comparative phase III trial].

作者信息

Panuel M, Devred P, Faure F, Bourlière-Najean B, Ternier F, Le Bail C

机构信息

Service de Radiologie Pédiatrique, Hôpital d'Enfants, CHU Timone, Marseille.

出版信息

Ann Radiol (Paris). 1992;35(4 Pt 2):280-3.

PMID:1296492
Abstract

An open-label noncomparative clinical study was conducted to evaluate the efficacy and tolerance of ioversol (Optiray 300), a new low-osmolality non ionic contrast medium, in body contrast-enhanced CT scanning in infants and children. Fourty pediatric patients who required contrast-enhanced CT scanning for evaluation of chest, abdominal or pelvic masses participated in the study. The vascular enhancement was judged to be excellent or good in 72.5% of the cases and the CT scans were judged to be diagnostic in 95% of the cases. Ioversol was well tolerated in the study with only two mild adverse reactions (nausea and vomiting, and metallic taste).

摘要

开展了一项开放标签的非对照临床研究,以评估新型低渗非离子型造影剂碘佛醇(欧乃影300)在婴幼儿及儿童体部增强CT扫描中的有效性和耐受性。40例因评估胸部、腹部或盆腔肿块而需要进行增强CT扫描的儿科患者参与了该研究。72.5%的病例血管强化被判定为优或良,95%的病例CT扫描被判定为具有诊断价值。在该研究中,碘佛醇耐受性良好,仅出现两例轻度不良反应(恶心呕吐和金属味)。

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