J Pharm Pharmacogn Res 3(suppl. 1): S27, 2015
Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015 September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.
OC-09: EFFICACY AND SAFETY OF SURFACEN® IN THE TREATMENT OF CHILDREN WITH RESPIRATORY DISTRESS SYNDROME (RDS)
Díaz E, Blanco O, Rodríguez VS, Morilla A, Barrese Y, Ávila Y, Uranga R, Machado MC, Castro BL, Fernández O.
Introduction: The RDS in newborns (NRDS) has high incidence. The mortality has decreased by the use of protective ventilation and exogenous surfactants. However, the Acute Respiratory Distress Syndrome in pediatric ages does not have high incidence, but high rate of mortality. Objective: to demonstrate the efficacy, effectiveness in newborns, and security of SURFACEN® in the treatment of the SDR in children. Material and Methods: Clinical phase III (pediatrics) multicentric, open, controlled and randomized with two treatment groups, SURFACEN® and control. Clinical trial phase IV (neonatology), multicentric, open. Clinical ventilatory and gasometric variables were evaluated, the mortality a day 28 of the treatment and in general, as well as those related with the security and hospital outcomes. Results: It was demonstrated in both clinical trials that SURFACEN® treatment, significantly improves oxygenation and lung images, and the patients had a satisfactory evolution. In the study of pediatric age, the mortality at day 28 of inclusion decreased (P=0.0074) in the treated patients with SURFACEN® (20.0%) with regard to the controls (62.0%). In the newborn, ones the answer to the treatment was of 74.22%, (IC 95%, 68 – 80%), those that responded showed decreased length of ventilation necessity (P <0.0001) and low frequency of secondary complications due to ventilation in the preterm newborns (P <0.0001), as well as the days at the intensive care neonates unit. The administration of this medication did not provoke adverse severe/serious irreversible events related with the product. Conclusions: SURFACEN® demonstrated to be an effective medication in children in pediatric age as well as in newborn, besides having good security.
Citation Format: Díaz E, Blanco O, Rodríguez VS, Morilla A, Barrese Y, Ávila Y, Uranga R, Machado MC, Castro BL, Fernández O (2015) Efficacy and safety of Surfacen® in the treatment of children with respiratory distress syndrome (RDS). [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S27. Abstract nr OC-09.