[Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging].
Nihon Igaku Hoshasen Gakkai Zasshi
; 63(9): 539-50, 2003 Nov.
Article
em Ja
| MEDLINE
| ID: mdl-14699862
ABSTRACT
SH U 555 A, a new superparamagnetic iron oxide (SPIO) contrast agent for liver MR imaging, was investigated in terms of safety and efficacy. Eighty-four patients with suspected malignant liver tumor were randomly allocated to two groups the L dose group (8 mumol Fe/kg) and H dose group (12 mumol Fe/kg). Efficacy was qualitatively evaluated through blinded reading of the MR images. Assessment of the images revealed no consistent differences between the L and H dose groups. During the 3- to 4-day observation period, a total of 16 adverse events were observed in 11 patients 8 patients in the L dose group and 3 patients in the H dose group. Nasal bleeding occurred in 2 of these cases in the H dose group 2 and 4 days, respectively, after injection. Although patients in the H dose group showed a significantly larger transient decrease in Coagulation Factor XI at 4-6 hr post-injection (p.i.) than patients in the L dose group, analysis of covariance revealed an estimated 6.5% difference. There was no prolongation of APTT or change in Factor XI at 72-96 hr p.i. Because there were no clinically significant differences between the L and H doses, both were considered to be safe and effective.
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Base de dados:
MEDLINE
Assunto principal:
Óxidos
/
Imageamento por Ressonância Magnética
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Meios de Contraste
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Ferro
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Fígado
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Neoplasias Hepáticas
Tipo de estudo:
Clinical_trials
Limite:
Aged
/
Female
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Humans
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Male
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Middle aged
Idioma:
Ja
Revista:
Nihon Igaku Hoshasen Gakkai Zasshi
Ano de publicação:
2003
Tipo de documento:
Article