RESUMO
Background: Recombinant human erythropoietin (EPO) is used for the treatment of last stage renal anemia. A new EPO preparation was obtained in Cuba in order to make this treatment fully nationally available. The aim of this study was to compare the pharmacokinetic, pharmacodynamic and safety properties of two recombinant EPO formulations in patients with anemia due to end-stage renal disease on hemodialysis. Methods: A parallel, randomized, double blind study was performed. A single 100 IU/Kg EPO dose was administered subcutaneously. Heberitro (Heber Biotec, Havana, formulation A), a newly developed product and Eprex (CILAG AG, Switzerland, formulation B), as reference treatment were compared. Thirty-four patients with anemia due to end-stage renal disease on hemodialysis were included. Patients had not received EPO previously. Serum EPO level was measured by enzyme immunoassay (EIA) during 120 hours after administration. Clinical and laboratory variables were determined as pharmacodynamic and safety criteria until 216 hours. Results: Both groups of patients were similar regarding all demographic and baseline characteristics. EPO kinetics profiles were similar for both formulations; the pharmacokinetic parameters were very close (i.e., AUC: 4667 vs. 4918 mIU.h/mL; Cmax: 119.1 vs. 119.7 mIU/mL; Tmax: 13.9 vs. 18.1 h; half-life, 20.0 vs. 22.5 h for formulations A and B, respectively). The 90 percentconfidence intervals for the ratio between both products regarding these metrics were close to the 0.8 1.25 range, considered necessary for bioequivalence......(AU)
Eritropoyetina humana recombinante (OEP) se utiliza para el tratamiento de la última etapa de la anemia renal. Una nueva preparación OEP se obtuvo en Cuba a fin de que este tratamiento plenamente disponible a nivel nacional. El objetivo de este estudio fue comparar la farmacocinética, farmacodinámica y de seguridad de dos formulaciones OEP recombinante en pacientes con anemia debido a una enfermedad renal terminal en hemodiálisis. Métodos:Un paralelo, randomizado, doble ciego se llevó a cabo. Un solo 100 UI / Kg OEP dosis se administra por vía subcutánea. Heberitro (Heber Biotec, La Habana, la formulación A), un nuevo desarrollo de productos y Eprex (CILAG AG, Suiza, la formulación B), como tratamiento de referencia se compararon. Treinta y cuatro pacientes con anemia debido a una enfermedad renal terminal en hemodiálisis fueron incluidos. Los pacientes no habían recibido previamente OEP. OEP nivel sérico se midió por inmunoensayo enzimático (EIA) durante 120 horas después de la administración. Variables clínicas y de laboratorio se determinará de la farmacodinámica y los criterios de seguridad, hasta 216 horas. Resultados: Ambos grupos de pacientes fueron similares en relación con todas las características demográficas y basales. OEP cinética perfiles fueron similares para ambas formulaciones, los parámetros farmacocinéticos fueron muy cerca (es decir, de las AUC: 4667 vs 4918 mIU.h / mL; Cmax: 119,1 frente a 119,7 mUI / ml; Tmáx: 13,9 vs 18,1 h; media la vida, 20,0 vs 22,5 h en el caso de las formulaciones A y B, respectivamente). Los intervalos de confianza del 90por ciento para la relación entre ambos productos con respecto a estas cifras se aproximaron a los 0,8 - 1,25 gama, que se consideren necesarios para la bioequivalencia........
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Eritropoetina/uso terapêutico , Hemina/efeitos adversos , Hemina/farmacocinética , Hemina/uso terapêutico , Insuficiência Renal Crônica/terapia , Diálise Renal/efeitos adversosRESUMO
INTRODUCTION: In the cognitive sphere, alterations have been found in up to 65% of patients with multiple sclerosis (MS). Study of the P300 wave is a positive component of long latency related to cognitive function: amplitude with attention, and latency with the ability to process information. OBJECTIVE: To assess a study of the P300 wave in a group of patients with MS. PATIENTS AND METHODS: The P300 wave was studied in 26 patients, 22 women and 4 men, with definite clinical MS (on criteria of Poser et al), with normal motor and sensory conduction velocity studies. All patients had a battery of multi-modal evoked potentials (MEP), nuclear magnetic resonance imaging and immunological study of the cerebrospinal fluid. Seventeen patients had the exacerbation-remission (ER) and nine the primary progressive (PP) clinical forms of the disorder. RESULTS: The most markedly altered MEP were the visual and somatosensory evoked potentials (SSEP) of the patients with MS. When the types of clinical course were compared, the SSEP were statistically significant in the PP form, which may be explained by the greater spinal involvement of these patients. Comparative analysis of the P300 wave was done for 26 healthy patients of similar age and sex to that of the patients, and significant differences were found in P300 latency and amplitude between the MS and control groups. The patients who had had the disease for longer had significantly greater anomalies in the P300 waves. CONCLUSION: Study of the evolution of the P300 wave, which is cheap and easy to do, may be valuable in the evolutional assessment of cognitive changes in patients with MS.