Evaluation of the clinical safety of gadodiamide injection, a new nonionic MRI contrast medium for the central nervous system: a European perspective.
Neuroradiology
; 38(6): 537-41, 1996 Aug.
Article
em En
| MEDLINE
| ID: mdl-8880714
ABSTRACT
Gadodiamide injection is a new nonionic paramagnetic, extracellular contrast medium. Its safety at a dose of 0.1 mmol/kg body weight was evaluated in a large European multicentre trial on adults referred for contrast-enhanced MRI of the central nervous system. Safety analysis was performed on 2102 patients, in whom adverse events during and up to 24 h after injection were recorded. Adverse events related or possibly related to gadodiamide injection were observed in 102 patients. Injection-associated reactions classified as discomfort (sensation of heat or coldness, pain or pressure at the injection site) occurred in 37 patients (1.8%) and other adverse events (e.g. headache, nausea) were observed in 65 patients (3.1%). No serious adverse event was reported. Efficacy analysis, performed on 2273 patients, and based on comparison of T1- and T2-weighted images before and T1-weighted images after injection showed that more diagnostic information was obtained after gadodiamide injection in 1424 (62.6%) patients management of 386 (17.0%) patients was affected by the new information given and that a new diagnosis was made in 755 (33.3%) patients. Gadodiamide injection was shown to be safe and well tolerated. It represents a nonionic alternative to the current products for MRI of the central nervous system.
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Base de dados:
MEDLINE
Assunto principal:
Compostos Organometálicos
/
Imageamento por Ressonância Magnética
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Doenças do Sistema Nervoso Central
/
Meios de Contraste
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Gadolínio DTPA
/
Ácido Pentético
Tipo de estudo:
Clinical_trials
Limite:
Adolescent
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Adult
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Aged
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Aged80
/
Female
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Humans
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Male
/
Middle aged
País como assunto:
Europa
Idioma:
En
Ano de publicação:
1996
Tipo de documento:
Article