Treatment with Metadoxine and its impact on early mortality in patients with severe alcoholic hepatitis
Por:
Higuera-De la Tijera F., Servín-Caamaño A.I., Cruz-Herrera J., Serralde-Zúñiga A.E., Abdo-Francis J.M., Gutiérrez-Reyes G., Pérez-Hernández J.L.
Publicada:
1 may 2014
Categoría:
Hepatology
Resumen:
Background Et Aim. Despite treatment with glucocorticoids, mortality
remains high in patients with severe alcoholic hepatitis. Oxidative
stress and depletion of mitochondrial glutathione are implicated factors
in liver injury. The aim of this study was to evaluate the impact of the
addition of metadoxine, a drug which possesses a multifactorial
mechanism of action, including antioxidant properties, to standard
treatment with glucocorticoids in patients with severe alcoholic
hepatitis. Material and methods. This randomized open label clinical
trial was performed in Mexico's General Hospital (Registry Key
DIC/101107/03/043). We randomized 70 patients with severe alcoholic
hepatitis. The first group received prednisone (40 mg/day), and the
second group received prednisone (40 mg/day) plus metadoxine tablets
(500 mg three times daily). The duration of treatment in both groups was
30 days. Survival at 30 and 90 days, development of complications,
adverse events and response to treatment (Lille model) were assessed.
Results. In the group receiving metadoxine, significant improvements
were observed, as follows: survival at 30 days (74.3 vs. 45.7%, P =
0.02); survival at 90 days (68.6 vs. 20.0%, P = 0.0001). There was less
development or progression of encephalopathy (28.6 vs. 60.0%, P =
0.008) and hepatorenal syndrome (31.4 vs. 54.3%, P = 0.05), and the
response to treatment (Lille model) was higher in the metadoxine group
(0.38 vs. 0.63, P = 0.001; 95% Cl 0.11 to 0.40). There were no
differences between groups regarding the development or progression of
variceal hemorrhage or infection. The incidence of adverse events,
mainly gastrointestinal, was similar in both groups. Conclusions.
Addition of metadoxine to glucocorticoid treatment improves the
short-term survival of patients with severe alcoholic hepatitis and
diminishes the development or progression of encephalopathy and
hepatorenal syndrome.
Filiaciones:
Higuera-De la Tijera F.:
Gastroenterology Department, Hospital General de México, Mexico
Servín-Caamaño A.I.:
Internal Medicine Department, Unit 108, Hospital General de México, Mexico
Cruz-Herrera J.:
Internal Medicine Department, Unit 108, Hospital General de México, Mexico
Serralde-Zúñiga A.E.:
Fundación Mexicana para la Salud A.C., Mexico
Abdo-Francis J.M.:
Gastroenterology Department, Hospital General de México, Mexico
Gutiérrez-Reyes G.:
Univ Nacl Autonoma Mexico, Fac Med, Lab Higado Pancreas & Motilidad HIPAM, Mexico City 04510, DF, Mexico
Pérez-Hernández J.L.:
Gastroenterology Department, Hospital General de México, Mexico
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