Safety and effectiveness of Surfacen in hyaline membrane disease treatment.

E Diáz-Casaña1, A Morilla2, O Fernández1, AI Martin1, O Blanco1. 1Centro Nacional de Sanidad Agropecuaria, Producciones Biologicas, Cuba, 2Hospital Pediátrico Angel A. Aballi, Unidad de Cuidados Intensivos, Cuba

The hyaline membrane disease (HMD) is caused by the lack of endogenous lung surfactant due to the incapacity of pneomocytes type II of synthesizing it. Thus, the administration of the endogenous lung surfactant has become the habitual treatment in newborns. In Cuba, there is a natural lung surfactant produced at the National Center for Animal and Plant Health (CENSA) registered as SURFACEN. Such product has been evaluated and approved for its commercialization taking into account all the national and international regulations established for this kind of drug. After 15 years of having SURFACEN in the market, there has been a pharmacosurveillance study having as objectives to evaluate the effectiveness and safety of this drug for the hyaline membrane disease, as well as to identify the behavior of some hospitable indicators. For this aim, a descriptive and prospective study was carried out for 2 years in 17 neonatology services in the country. Two hundred fifty nine newborns under 37 weeks of gestational age which fulfilled the criteria were included. SURFACEN was instilled by an endotracheal probe in doses of 100 mg/kg weight. PaO2/FiO2, mortality, presence of complications and mechanical ventilation times were the response variables evaluated in the Intensive Care Units (ICUs); and all side events were recorded. Response to treatment immediately reached values permanently above 200 in the first hour of application. Surviving was of 80%; the 13.72% of dead children had the HMD as main cause of death, the rest was due to other causes. The most frequent complications were: late pneumonia, reopening of the arterial duct and pneumothorax. Mechanical ventilation days and stays in the ICUs were similar to those of phase III clinical trials. There was some adverse event in the 47% of the patients; the most frequent were: hyperoxia and hypocapnia. SURFACEN shows a safety pattern similar to the rest of the surfactants commercialized in the international market. The results obtained under the habitual practical-clinical conditions of the neonatology services in Cuba enrich the existent data about the use of SURFACEN.