The efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia / 소아과
Korean Journal of Pediatrics
; : 347-353, 2015.
Article
en En
| WPRIM
| ID: wpr-42543
Biblioteca responsable:
WPRO
ABSTRACT
PURPOSE:
The purpose of this study was to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonarydysplasia (BPD).METHODS:
The Interventional study was designed as a multicenter, prospective, and randomized trial, with open labeled and parallel-experimental groups, 66 infants were enrolled and allocated to either the case group (n=30) or the control group (n=36) based on gestational age (GA). Infants in the case group were given Montelukast sodium (Singulair) based on their body weight (BW). Zero week was defined as the start time of the study.RESULTS:
The incidence of moderate to severe BPD was not different between the groups (case group 13 of 30 [43.3%] vs. control group 19 of 36 [52.8%], P=0.912). Additionally, secondary outcomes such as ventilation index, mean airway pressure and resort to systemic steroids were not significantly different. There were no serious adverse drug reactions in either group, and furthermore the rate of occurrence of mild drug related-events were not significantly different (case group 10 of 42 [23.8%] vs. control group 6 of 48 (15.8%), P=0.414).CONCLUSION:
Montelukast was not effective in reducing moderate or severe BPD. There were no significant adverse drug events associated with Montelukast treatment.Palabras clave
Texto completo:
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Índice:
WPRIM
Asunto principal:
Sodio
/
Esteroides
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Ventilación
/
Peso Corporal
/
Displasia Broncopulmonar
/
Recien Nacido Prematuro
/
Farmacocinética
/
Incidencia
/
Estudios Prospectivos
/
Edad Gestacional
Tipo de estudio:
Clinical_trials
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
Límite:
Humans
/
Infant
/
Newborn
Idioma:
En
Revista:
Korean Journal of Pediatrics
Año:
2015
Tipo del documento:
Article