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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
9
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pubmed:dateCreated |
2003-12-31
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pubmed:abstractText |
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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pubmed:language |
jpn
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
Nov
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pubmed:issn |
0048-0428
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pubmed:author |
pubmed-author:GokanTakehikoT,
pubmed-author:HachiyaJunichiJ,
pubmed-author:HirohashiShinjiS,
pubmed-author:IchikawaTomoakiT,
pubmed-author:IsobeYoshinoriY,
pubmed-author:IsodaHiroyoshiH,
pubmed-author:KuwatsuruRyoheiR,
pubmed-author:MurakamiTakamichiT,
pubmed-author:NakanoShigeyukiS,
pubmed-author:NishimuraHiroshiH,
pubmed-author:SaitoKazuhiroK,
pubmed-author:SeriuTakuT,
pubmed-author:TanimotoAkihiroA
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pubmed:issnType |
Print
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pubmed:volume |
63
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pubmed:owner |
NLM
|
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pubmed:authorsComplete |
Y
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pubmed:pagination |
539-50
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:14699862-Aged,
pubmed-meshheading:14699862-Contrast Media,
pubmed-meshheading:14699862-Dextrans,
pubmed-meshheading:14699862-Female,
pubmed-meshheading:14699862-Ferumoxytol,
pubmed-meshheading:14699862-Humans,
pubmed-meshheading:14699862-Iron,
pubmed-meshheading:14699862-Liver,
pubmed-meshheading:14699862-Liver Neoplasms,
pubmed-meshheading:14699862-Magnetic Resonance Imaging,
pubmed-meshheading:14699862-Magnetite Nanoparticles,
pubmed-meshheading:14699862-Male,
pubmed-meshheading:14699862-Middle Aged,
pubmed-meshheading:14699862-Oxides,
pubmed-meshheading:14699862-Safety
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pubmed:year |
2003
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pubmed:articleTitle |
[Dose investigation of superparamagnetic iron oxide (SPIO) SH U 555 A in liver MR imaging].
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pubmed:affiliation |
Department of Radiology, Nara Medical University.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
English Abstract,
Randomized Controlled Trial
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