動脈疾患患者を対象とした腹部～下腿部領域の造影3D-MRA検査におけるガドペンテト酸ジメグルミン(0.1mmol/kgおよび0.2mmol/kg)静脈内単回投与による用量比較試験

摘要

The objective of the study was to compare the efficacy of Gadopentetate Dimeglumine at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-MRA in 3 regions (abdominal, femoral, and leg regions) for visualization of arteries, using the ratio of "not assessable: related to contrast media" arteries per patient as an index for the assessment. Efficacy variables were analyzed for 12 patients. Presumed diagnoses (multiple answer) before MRA examination were arteriosclerosis obliterans in 12 patients (100.0%) and aneurysm in 1 patients (8.3%). The ratio of "not assessable: related to contrast media" arteries per patient out of 21 arteries in the 3 regions in blinded readers' assessment (the primary efficacy variable) was lower at the 0.2 mmol/kg dose compared with the 0.1 mmol/kg dose. The difference was statistically significant (p=0.001 using analysis of variance) in terms of the mean values from 3 blinded readers, being 16.2% (0%-33.9%) at the 0.1 mmol/kg dose and 1.9% (0%-6.3%) at the 0.2 mmol/kg dose on the average (minimum - maximum) of 12 patients.