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Métodos Terapéuticos y Terapias MTCI
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1.
Antimicrob Agents Chemother ; 57(5): 2127-33, 2013 May.
Artículo en Inglés | MEDLINE | ID: mdl-23439637

RESUMEN

Ureaplasma respiratory tract colonization is associated with bronchopulmonary dysplasia (BPD) in preterm infants. Previously, we demonstrated that a single intravenous (i.v.) dose of azithromycin (10 mg/kg of body weight) is safe but inadequate to eradicate Ureaplasma spp. in preterm infants. We performed a nonrandomized, single-arm open-label study of the pharmacokinetics (PK) and safety of intravenous 20-mg/kg single-dose azithromycin in 13 mechanically ventilated neonates with a gestational age between 24 weeks 0 days and 28 weeks 6 days. Pharmacokinetic data from 25 neonates (12 dosed with 10 mg/kg i.v. and 13 dosed with 20 mg/kg i.v.) were analyzed using a population modeling approach. Using a two-compartment model with allometric scaling of parameters on body weight (WT), the population PK parameter estimates were as follows: clearance, 0.21 liter/h × WT(kg)(0.75) [WT(kg)(0.75) indicates that clearance was allometrically scaled on body weight (in kilograms) with a fixed exponent of 0.75]; intercompartmental clearance, 2.1 liters/h × WT(kg)(0.75); central volume of distribution (V), 1.97 liters × WT (kg); and peripheral V, 17.9 liters × WT (kg). There was no evidence of departure from dose proportionality in azithromycin exposure over the tested dose range. The calculated area under the concentration-time curve over 24 h in the steady state divided by the MIC90 (AUC24/MIC90) for the single dose of azithromycin (20 mg/kg) was 7.5 h. Simulations suggest that 20 mg/kg for 3 days will maintain azithromycin concentrations of >MIC50 of 1 µg/ml for this group of Ureaplasma isolates for ≥ 96 h after the first dose. Azithromycin was well tolerated with no drug-related adverse events. One of seven (14%) Ureaplasma-positive subjects and three of six (50%) Ureaplasma-negative subjects developed physiologic BPD. Ureaplasma was eradicated in all treated Ureaplasma-positive subjects. Simulations suggest that a multiple-dose regimen may be efficacious for microbial clearance, but the effect on BPD remains to be determined.


Asunto(s)
Antibacterianos/uso terapéutico , Azitromicina/uso terapéutico , Displasia Broncopulmonar/tratamiento farmacológico , Recien Nacido Prematuro , Modelos Estadísticos , Sistema Respiratorio/efectos de los fármacos , Ureaplasma/efectos de los fármacos , Antibacterianos/farmacocinética , Área Bajo la Curva , Azitromicina/farmacocinética , Peso Corporal , Displasia Broncopulmonar/microbiología , Displasia Broncopulmonar/patología , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Edad Gestacional , Humanos , Recién Nacido , Inyecciones Intravenosas , Masculino , Pruebas de Sensibilidad Microbiana , Sistema Respiratorio/microbiología , Sistema Respiratorio/patología , Resultado del Tratamiento , Ureaplasma/crecimiento & desarrollo
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