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1.
Clin J Am Soc Nephrol ; 4(9): 1465-76, 2009 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-19696213

RESUMEN

BACKGROUND & OBJECTIVES: Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT: Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180. RESULTS: Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were < or =300 pg/ml (weeks 16 through 180) and median CaxP values were < or =55 mg(2)/dl(2) (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events. CONCLUSIONS: Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk.


Asunto(s)
Calcio/sangre , Hiperparatiroidismo Secundario/tratamiento farmacológico , Enfermedades Renales/terapia , Naftalenos/uso terapéutico , Hormona Paratiroidea/sangre , Diálisis Peritoneal , Fósforo/sangre , Diálisis Renal , Adulto , Anciano , Biomarcadores/sangre , Canadá , Quelantes/uso terapéutico , Enfermedad Crónica , Cinacalcet , Método Doble Ciego , Quimioterapia Combinada , Europa (Continente) , Femenino , Humanos , Hiperparatiroidismo Secundario/sangre , Hiperparatiroidismo Secundario/etiología , Enfermedades Renales/sangre , Enfermedades Renales/complicaciones , Enfermedades Renales/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Naftalenos/efectos adversos , Fosfatos/sangre , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos , Vitamina D/uso terapéutico
2.
Am J Nephrol ; 24(2): 268-74, 2004.
Artículo en Inglés | MEDLINE | ID: mdl-15031630

RESUMEN

BACKGROUND: Serum protein profiling patterns can reflect the pathological state of a patient and therefore may be useful for clinical diagnostics. Here, we present results from a pilot study of proteomic expression patterns in hemodialysis patients designed to evaluate the range of serum proteomic alterations in this population. METHODS: Surface-enhanced laser desorption/ionization time-of-flight mass spectrometry (SELDI-TOF-MS) was used to analyze serum obtained from patients on periodic hemodialysis treatment and healthy controls. Serum samples from patients and controls were first fractionated into six eluants on a strong anion exchange column, followed by application to four array chemistries representing cation exchange, anion exchange, metal affinity and hydrophobic surfaces. A total of 144 SELDI-TOF-MS spectra were obtained from each serum sample. RESULTS: The overall profiles of the patient and control samples were consistent and reproducible. However, 30 well-defined protein differences were observed; 15 proteins were elevated and 15 were decreased in patients compared to controls. Serum from 1 patient exhibited novel protein peaks suggesting possible additional changes due to a secondary disease process. CONCLUSION: SELDI-TOF-MS demonstrated consistent serum protein profile differences between patients and controls. Similarity in protein profiles among dialysis patients suggests that patient physiological responses to end-stage renal disease and/or dialysis therapy have a major effect on serum protein profiles.


Asunto(s)
Proteínas Sanguíneas/análisis , Diálisis Renal , Insuficiencia Renal/sangre , Insuficiencia Renal/terapia , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad
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