RESUMEN
KIMS study is an international, observational study initiated in 1994 in which France has been involved since 2003. Its aim is to collect on a widespread basis long-term data from GH-deficient adults treated or not treated with growth hormone in daily practice. Among 330 patients already enrolled by 128 centers in France at the data lock point for this first interim analysis, 122 patients were followed up for at least 12 months and their results are presented herein. After one year of treatment, IGF-1 level adjusted for age and sex was normalized for 77% of patients naive of GH-treatment, 71% of semi-naive patients and 85% of non naive patients. Lean mass increase was 5.1% and fat mass decrease 5.7%. Quality of life assessed through QoL-AGHDA questionnaire was improved with a median score decrease from 10 to 6. These are the first results available from French patients and suggest that growth hormone is an appropriate indication for adults with severe GH deficiency.
Asunto(s)
Hormona del Crecimiento/deficiencia , Hormona del Crecimiento/uso terapéutico , Adulto , Estudios de Cohortes , Estudios de Seguimiento , Francia , Humanos , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
ENDOREM (Guerbet, Sulzbach) is a superparamagnetic contrast agent for magnetic resonance imaging of the liver and spleen. The contrast agent consists of dextran-coated iron oxide particles with a size distribution between 120 and 180 nm and an iron concentration of 0.2 mol/l. Before ENDOREM received approval in Germany and other European countries, clinical trials were performed in Japan, the USA, and Europe. At a dose of 10 micromol Fe/kg (Japan, USA) and 15 micromol Fe/kg (Europe). ENDOREM was slowly infused in 100 ml of glucose 5% over approximately 30 min in 163 (Japan), 213 (USA), and 467 patients (Europe). The rate of side effects ranged between 6.1% (Japan) and 10.3% (Europe). The most frequent side effect was lower back pain. However, infusion was stopped or medication was necessary because of lower back pain in only very few cases. Transient increases of serum iron and ferritin and decreases of iron binding capacity occurred. No clinically relevant changes of heart rate and arterial blood pressure were observed. With the recommended biphasic infusion (2 ml/min over 10 min and 4 ml/min over 20 min) and at a dose of 15 micromol Fe/kg in 100 ml of glucose 5% ENDOREM is a well tolerated contrast agent
Asunto(s)
Medios de Contraste/efectos adversos , Hierro/efectos adversos , Hepatopatías/diagnóstico , Neoplasias Hepáticas/diagnóstico , Imagen por Resonancia Magnética/métodos , Óxidos/efectos adversos , Adulto , Ensayos Clínicos Fase III como Asunto , Dextranos , Diagnóstico Diferencial , Tolerancia a Medicamentos , Óxido Ferrosoférrico , Humanos , Hígado/patología , Hepatopatías/patología , Neoplasias Hepáticas/patología , Nanopartículas de MagnetitaAsunto(s)
Carcinoma Hepatocelular/diagnóstico , Medios de Contraste , Hierro , Neoplasias Hepáticas/diagnóstico , Imagen por Resonancia Magnética/métodos , Óxidos , Carcinoma Hepatocelular/patología , Ensayos Clínicos Fase II como Asunto , Ensayos Clínicos Fase III como Asunto , Medios de Contraste/efectos adversos , Dextranos , Europa (Continente) , Óxido Ferrosoférrico , Humanos , Hierro/efectos adversos , Hígado/patología , Neoplasias Hepáticas/patología , Neoplasias Hepáticas/secundario , Nanopartículas de Magnetita , Óxidos/efectos adversos , Sensibilidad y EspecificidadRESUMEN
OBJECTIVE: Superparamagnetic iron oxide (SPIO) particles are phagocytosed by cells of the macrophage-monocytic phagocytic system. They are usually used in MRI as a negative contrast agent, because of their strong T2* effect, to improve detection of tumors in the liver and spleen. However, they also have a potent T1 relaxivity. In the current study, we describe this T1 effect in liver hemangiomas. MATERIALS AND METHODS: Twelve patients (nine women and three men, aged from 38 to 76 years) with liver hemangiomas were examined by means of MRI at 1.5 T before and after intravenous administration of SPIO particles at a dose of 15 mumol Fe/kg body wt. Signal intensity was measured from regions of interest. RESULTS: Whereas on postcontrast T2-weighted SE images the hemangiomas showed on average a signal drop of 20% (p = 0.011) and 49% (p = 0.001) (first and second echo, respectively), their signal increased by 106% (p = 0.001) on postcontrast T1-weighted SE images. CONCLUSION: The T1 effect (signal enhancement) we observed in liver hemangiomas after infusion of SPIO particles could prove to be a useful new diagnostic feature that would help characterize these common lesions and differentiate them from other liver tumors.