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1.
Aliment Pharmacol Ther ; 43(1): 61-72, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26548868

RESUMEN

BACKGROUND: Reliable tools for patient selection are critical for clinical drug trials. AIM: To evaluate a consensus-based, standardised magnetic resonance enterography (MRE) protocol for selecting patients for inclusion in Crohn's disease (CD) multicenter clinical trials. METHODS: This study recruited 20 patients [Crohn's Disease Activity Index (CDAI) scores: <150 (n = 8); 150-220 (n = 4); 220-450 (n = 8)], to undergo ileocolonoscopy and two MREs (with and without colonic contrast) within a 14-day period. Procedures were scored centrally using, Magnetic Resonance Index of Activity (MaRIA), and both Crohn's Disease Endoscopic Index of Severity (CDEIS) and Simplified Endoscopic Score (SES-CD). RESULTS: 37 MREs were acquired. Both MREs were evaluable in 16 patients for calculation of test-retest and inter-reader reliability scores. The MaRIA scores for the terminal ileum had excellent test-retest and inter-reader reliability, with correlations >0.9. The proximal ileum showed strong within-reader agreement (0.90-0.96), and fair between-reader agreement (0.59-0.72). MRE procedures were tolerable. MaRIA scores correlated with CDEIS and SES-CD (0.63 and 0.71), but not with CDAI (0.34). MRE identified 3 patients with intra-abdominal complications, who would otherwise have been included in clinical trials. Furthermore, both MRE and ileocolonoscopy identified active bowel wall inflammation in 2 patients with CDAI <150, and none in 1 patient with CDAI > 220. Data quality was good/excellent in 85% of scans, and fair or better in 96%. CONCLUSIONS: Magnetic resonance enterography of high-quality and reproducibility was feasible in a global multi- centre setting, with evidence for improved selectivity over CDAI and ileocolonoscopy in identifying appropriate CD patients for inclusion in therapeutic intervention trials.


Asunto(s)
Enfermedad de Crohn/patología , Endoscopía Gastrointestinal/métodos , Espectroscopía de Resonancia Magnética/métodos , Estudios Multicéntricos como Asunto/métodos , Selección de Paciente , Adulto , Colon/patología , Endoscopía Gastrointestinal/normas , Femenino , Humanos , Íleon/patología , Inflamación/patología , Espectroscopía de Resonancia Magnética/normas , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados
2.
Aliment Pharmacol Ther ; 38(4): 397-406, 2013 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-23799922

RESUMEN

BACKGROUND: Long-acting lanreotide (LAN) 120 mg every 4 weeks reduces liver volume (LV) in patients with polycystic liver diseases (PCLD). Animal studies demonstrated that the inhibition of hepatic and renal cystogenesis is dose dependent. AIM: To investigate the safety and efficacy of two different LAN doses in PCLD patients. METHODS: The 6-month results of the LOCKCYST I trial, its extension study and the LOCKCYST II trial were pooled. LV at baseline and month 6 was measured by CT-scan and blindly re-analysed by two independent radiologists. RESULTS: The study population [132 treatment periods, age 49 years (IQR: 45-55), 114 women] consisted of three groups. Each received treatment every 4 weeks during 6 months: placebo (n = 26); LAN 90 mg (n = 55) or LAN 120 mg (n = 51). The inter-observer variability and agreement in the calculation of LV were excellent. Severe side effects occurred with placebo, LAN 90 mg and LAN 120 mg in respectively 0%, 7% and 16%. Change in LV's after 6 months in these three groups were respectively: increase of +36 mL [(-45)-(+138)]; decrease of -82 mL [(-285)-(+92)] and decrease of -123 mL [(-312)-(+4)] (Kruskal-Wallis One Way anova on Ranks; P = 0.002). Based on ROC analysis, a reduction of ≥120 mL in LV has a positive predictive value of 64% for improving symptoms (ROC analysis AUC: 0.729; sensitivity 73%, specificity 69%, P < 0.0001). CONCLUSIONS: Both LAN 90 mg and LAN 120 mg reduce liver volume. LAN 90 mg has less side effects. This suggests that in case of intolerance to LAN 120 mg, a dose reduction to LAN 90 mg is meaningful.


Asunto(s)
Antineoplásicos/administración & dosificación , Quistes/tratamiento farmacológico , Hepatopatías/tratamiento farmacológico , Hígado/efectos de los fármacos , Péptidos Cíclicos/administración & dosificación , Somatostatina/análogos & derivados , Animales , Antineoplásicos/efectos adversos , Relación Dosis-Respuesta a Droga , Femenino , Humanos , Masculino , Persona de Mediana Edad , Péptidos Cíclicos/efectos adversos , Curva ROC , Somatostatina/administración & dosificación , Somatostatina/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
3.
Aliment Pharmacol Ther ; 35(2): 266-74, 2012 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-22111942

RESUMEN

BACKGROUND: Polycystic liver disease (PLD) is a phenotypical expression of autosomal dominant polycystic kidney disease and isolated polycystic liver disease. Somatostatin analogues, such as lanreotide, reduce polycystic liver volume. AIM: To establish long-term outcome and safety of lanreotide. METHODS: This was an open-label, observational extension study of a 6-month, randomised, placebo-controlled trial with lanreotide (120 mg/month) in PLD. The length of total treatment was 12 months. Primary endpoint was relative change in liver volume, as determined by CT-volumetry after 12 months of treatment. We offered patients a CT scan 6 months after stopping lanreotide. RESULTS: A total of 41/54 (76%) patients participated in the extension study. Liver volume decreased by 4% (IQR -8% to -1%) after 12 months of treatment. The greatest effect was observed during the first 6 months of treatment (decrease of 4% (IQR -6% to -1%)). Liver volume remained unchanged during the following 6 months. We found that liver volume increased by 4% (IQR 0-6%) 6 months after end of treatment (n = 22). CONCLUSIONS: Lanreotide reduces liver volume within the first 6 months of treatment and the beneficial effect is maintained in the following 6 months. Stopping results in recurrence of polycystic liver growth. This suggests that continuous use of lanreotide is needed to maintain its effect.


Asunto(s)
Antineoplásicos/uso terapéutico , Quistes/tratamiento farmacológico , Hepatopatías/tratamiento farmacológico , Péptidos Cíclicos/uso terapéutico , Somatostatina/análogos & derivados , Adulto , Quistes/fisiopatología , Femenino , Humanos , Hígado/efectos de los fármacos , Hepatopatías/fisiopatología , Pruebas de Función Hepática , Masculino , Persona de Mediana Edad , Somatostatina/uso terapéutico , Estadística como Asunto , Factores de Tiempo , Resultado del Tratamiento
5.
J Belge Radiol ; 80(5): 229-30, 1997 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-9400054

RESUMEN

A 40-year-old woman presented with acute left upper quadrant pain due to torsion of an accessory spleen around its long vascular pedicle, causing infarction. Torsion of an accessory spleen is extremely rare. As far as we known only 14 cases have previously been reported in the literature, and more than half patients were children. MRI can be helpful in the differential diagnosis of infarction by suggesting haemorrhagic necrosis on the T2-weighted images.


Asunto(s)
Imagen por Resonancia Magnética , Bazo/anomalías , Arteria Esplénica/diagnóstico por imagen , Enfermedades del Bazo/diagnóstico , Tomografía Computarizada por Rayos X , Dolor Abdominal/diagnóstico , Adulto , Angiografía , Diagnóstico Diferencial , Femenino , Arteria Hepática/diagnóstico por imagen , Humanos , Arteria Ilíaca/diagnóstico por imagen , Arterias Mesentéricas/diagnóstico por imagen , Bazo/diagnóstico por imagen , Bazo/patología , Enfermedades del Bazo/complicaciones , Enfermedades del Bazo/diagnóstico por imagen , Infarto del Bazo/diagnóstico , Infarto del Bazo/diagnóstico por imagen , Infarto del Bazo/etiología , Anomalía Torsional/complicaciones , Anomalía Torsional/diagnóstico
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