RESUMEN
Iodixanol (Visipaque) is a dimeric, non-ionic iodinated contrast medium that is isotonic with blood at all clinically relevant concentrations. Iodixanol was compared in a randomized, double blind, parallel group, phase III multicentre trial with a monomeric, non-ionic contrast medium, iohexol (Omnipaque), at two concentrations assessing safety, tolerability and radiographic efficacy during contrast enhanced gastrointestinal radiography examinations of children. 154 children entered the trial; 152 formed the safety population and 147 the efficacy population. All examinations were performed following standard departmental practice. Children were assigned into either a high or low concentration group (iodixanol, 150 mgI ml(-1) and 320 mgI ml(-1) vs iohexol, 140 mgI ml(-1) and 300 mgI ml(-1)). The primary outcome measure for efficacy was the overall quality of visualization, which was assessed using a 100 mm visual analogue scale (VAS). The secondary efficacy variables assessed were quality of contrast opacification, mucosal coating and overall quality of diagnostic information. Safety evaluation involved patient follow-up for at least 48 h. Taste acceptance was also assessed. There was no statistically significant difference between the two contrast media with regard to the primary and secondary efficacy variables assessed, although higher ratings were observed for iodixanol. The 100 mm VAS score overall was 86 mm for iodixanol and 82 mm for iohexol (95% confidence interval -2.56, 10.42). The frequency of adverse events was lower for patients receiving iodixanol. Adverse events, mainly diarrhoea, occurred in 12 patients (16.2%) in the iodixanol group and 28 patients (35.9%) in the iohexol group. This reached statistical significance (p=0.006). Overall, iodixanol is well suited for examinations of the gastrointestinal tract, giving good efficacy results and fewer adverse events than iohexol.
Asunto(s)
Sistema Digestivo/diagnóstico por imagen , Yohexol , Ácidos Triyodobenzoicos , Adolescente , Niño , Preescolar , Medios de Contraste/administración & dosificación , Medios de Contraste/efectos adversos , Diarrea/inducido químicamente , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Lactante , Recién Nacido , Yohexol/administración & dosificación , Yohexol/efectos adversos , Masculino , Radiografía , Ácidos Triyodobenzoicos/administración & dosificación , Ácidos Triyodobenzoicos/efectos adversosRESUMEN
A cubital intravenous iodine contrast agent enhancement is used to visualize coronary arteries using EBT. The quality of the coronary artery visualization however is limited by the nearly simultaneous approximation of CT values in coronary arteries and myocardial tissue. The objective of the study was to evaluate if "under real clinical circumstances" the lower iodine concentration and the dimeric based characteristic of iodixanol may effect the kinetic of the applied contrast agent and the visualization of coronary arteries studied noninvasively by EBT. A double-blind, randomized, parallel study was performed in 111 cardiac patients, using iodixanol 270 mg I/ml or iohexol 300 mg I/ml. The kinetics of contrast enhancement was studied in the flow mode measuring following parameters: mean arrival time and mean time to reach peak CT values in the pulmonary trunk, transit time from the pulmonary trunk to the aorta as well as mean and maximum CT values in the left ventricular chamber and in the myocardium with respect to the body mass index. The mean difference of CT values in the left ventricular chamber and the myocardium was calculated. The length of the visualized coronary arteries was assessed and the diagnostic quality of coronary artery visualization scored on a visual analogue scale. Although iodixanol was used with a lower iodine concentration than iohexol there was no significant statistical difference between both groups with respect to the diagnostic visualization and length assessment of the coronary arteries as well as in the mean difference of CT values in the left ventricular chamber and the myocardium. This means that the advantageous dimeric characteristics of iodixanol may be used to reduce the amount of applicated iodine in contrast agents without loss of diagnostic image quality and information.
Asunto(s)
Medios de Contraste , Angiografía Coronaria , Tomografía Computarizada por Rayos X , Enfermedad Coronaria/diagnóstico por imagen , Método Doble Ciego , Electrocardiografía , Femenino , Corazón/diagnóstico por imagen , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Yohexol , Masculino , Persona de Mediana Edad , Cintigrafía , Ácidos TriyodobenzoicosRESUMEN
RATIONALE AND OBJECTIVES: Enhancement characteristics of a nonionic, dimeric, isotonic contrast medium (iodixanol [Visipaque]) were compared with a nonionic, monomeric contrast medium (ioversol [Optiray]) of the same iodine concentration in spiral computed tomography angiography (CTA) of the abdominal aorta. METHODS: Spiral CTA was performed in 78 patients referred for suspected renal artery stenosis (n = 35) and abdominal aortic aneurysm (n = 43). A test bolus was used to time the scan delay, and all patients were injected with 150 ml contrast medium (320 mgI/ml) of either iodixanol (n = 40) or ioversol (n = 38). Contrast enhancement was measured in the aorta, renal arteries, and renal parenchyma. RESULTS: All mean aortic enhancement was slightly higher with iodixanol than ioversol, measured at three different levels (celiac trunk 315 Hounsfield units [HU] versus 300 HU, renal arteries 325 HU versus 312 HU, aortic bifurcation 276 HU versus 266 HU). However, none of them were statistically significant (e.g., P = 0.26 at the celiac trunk level). Similar results were observed in renal artery and parenchyma enhancements. CONCLUSIONS: Iodixanol and ioversol had similar enhancement characteristics in the early arterial phase. Both substances were well tolerated and seem to be well suited for spiral CTA.
Asunto(s)
Aorta Abdominal/diagnóstico por imagen , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Medios de Contraste , Tomografía Computarizada por Rayos X , Ácidos Triyodobenzoicos , Adulto , Anciano , Anciano de 80 o más Años , Angiografía/métodos , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Obstrucción de la Arteria Renal/diagnóstico por imagen , Reproducibilidad de los Resultados , Tomografía Computarizada por Rayos X/métodos , Ácidos Triyodobenzoicos/administración & dosificaciónRESUMEN
A prospective, double-blind study of 392 patients randomized into four groups was performed to establish whether diagnostic intravenous urograms could be obtained with a lower dose of iodine when using the dimeric, non-ionic contrast medium iodixanol compared with the monomeric, non-ionic iohexol. Patients received iodixanol or iohexol containing either 9 or 12 g of iodine (gI). The primary parameter was the diagnostic quality of the 6 min film, assessed in a blinded fashion, by consensus, by four radiologists. Iodixanol at both doses was diagnostic in over 90% of cases. Iohexol was only diagnostic in 74% (9 gI) and 81.8% (12 gI). Pairwise comparisons revealed that iodixanol 9 gI was significantly better than both iohexol 9 gI (p = 0.0005) and 12 gI (p = 0.014). No significant difference was present for different doses within the same contrast medium group. Iodixanol resulted in poorer bladder distension than iohexol. Iodixanol caused significantly less discomfort than iohexol.