Abstract

ROMERO MALDONADO, Silvia et al. Efectiveness of ursodeoxycholic acid versus phenobarbital for the treatment of neonatal cholestasis: a cross-randomizad clinical trial. Bol. Med. Hosp. Infant. Mex. [online]. 2010, vol.67, n.5, pp.422-429. ISSN 1665-1146.

Background. The prevalence of neonatal cholestasis varies from 7-57%. Part of the treatment includes ursodeoxycholic acid (UDCA) and phenobarbital, both with little supporting evidence in the literature. We undertook this study to compare the effectiveness of phenobarbital vs. UDCA in reducing the direct serum bilirubin levels in patients with cholestasis and weighing from 1 000 to 2 000 g. Methods. Using a cross-randomized clinical trial, 18 patients were included with 36 treatments. Each subject randomly received one of the two interventions: UDCA (10 mg/kg/day) every 12 h or phenobarbital (3 mg/kg/day, every 24 h for 7 days) continuing with 7 days of wash-out to return to their initial state, and to subsequently receive the other treatment. At the beginning and at the end of the administration of each medication, bilirubin concentrations and hepatic test functions were measured. Central tendency and dispersion measurements were applied according to the type of variable. For hypothesis confirmation, paired t-test was carried out. Results. The obtained results indicate that with UDCA at a dose of 10 mg/kg/day every 12 h for 7 days, serum bilirubin levels decreased to 2.7 mg/dL (p <0.01). Phenobarbital had no effect in reducing bilirubin concentration. Conclusion. Use of UDCA is recommended at a dose of 10 mg/kg/dose every 12 h (PO) as a coadjuvant in the treatment of neonatal cholestasis.

Keywords : cholestasis; direct hyperbilirubinemia; ursodeoxycholic acid; phenobarbital.