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Pharmacokinetics of cyclosporin: a microemulsion in children with idiopathic nephrotic syndrome
Henriques, Luciana dos Santos; Matos, Fabíola de Marcos; Vaisbich, Maria Helena.
  • Henriques, Luciana dos Santos; Universidade de São Paulo. Faculdade de Medicina. Instituto da Criança. São Paulo. BR
  • Matos, Fabíola de Marcos; Universidade de São Paulo. Faculdade de Medicina. Instituto da Criança. São Paulo. BR
  • Vaisbich, Maria Helena; Universidade de São Paulo. Faculdade de Medicina. Instituto da Criança. São Paulo. BR
Clinics ; 67(10): 1197-1202, Oct. 2012. ilus, tab
Artículo en Inglés | LILACS | ID: lil-653484
ABSTRACT

OBJECTIVE:

We present a prospective study of a microemulsion of cyclosporin to treat idiopathic nephrotic syndrome in ten children with normal renal function who presented cyclosporin trough levels between 50 and 150 ng/ml and achieved complete remission with cyclosporin. To compare the pharmacokinetic parameters of cyclosporin in idiopathic nephrotic syndrome during remission and relapse of the nephrotic state.

METHOD:

The pharmacokinetic profile of cyclosporin was evaluated with the 12-hour area under the timeconcentration curve (auc0-12) using seven time-point samples. This procedure was performed on each patient during remission and relapse with the same cyclosporin dose in mg/kg/day. The 12-hour area under the timeconcentration curve was calculated using the trapezoidal rule. All of the pharmacokinetic parameters and the resumed 4-hour area under the time-concentration curve were correlated with the 12-hour area under the timeconcentration curve. ClinicalTrials.govNCT01616446.

RESULTS:

There were no significant differences in any parameters of the pharmacokinetic of cyclosporin during remission and relapse, even when the data were normalized by dose. The best correlation with the 12-hour area under the time-concentration curve was the 4-hour area under the time-concentration curve on remission and relapse of the disease, followed by the 2-hour level after cyclosporin (c2) dosing in both disease states.

CONCLUSIONS:

These data indicate that the same parameters used for cyclosporin therapeutic monitoring estimated during the nephrotic state can also be used during remission. Larger controlled studies are needed to confirm these findings.
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Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Ciclosporina / Inmunosupresores / Síndrome Nefrótico Tipo de estudio: Estudio observacional / Estudio pronóstico Límite: Adolescente / Niño / Child, preschool / Femenino / Humanos / Masculino Idioma: Inglés Revista: Clinics Asunto de la revista: Medicina Año: 2012 Tipo del documento: Artículo / Documento de proyecto País de afiliación: Brasil Institución/País de afiliación: Universidade de São Paulo/BR

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Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Ciclosporina / Inmunosupresores / Síndrome Nefrótico Tipo de estudio: Estudio observacional / Estudio pronóstico Límite: Adolescente / Niño / Child, preschool / Femenino / Humanos / Masculino Idioma: Inglés Revista: Clinics Asunto de la revista: Medicina Año: 2012 Tipo del documento: Artículo / Documento de proyecto País de afiliación: Brasil Institución/País de afiliación: Universidade de São Paulo/BR