The use of surfactant preparations in the absence of primary deficiency: publications, legal and regulatory framework

Abstract

Pulmonary surfactant (Sf) reduces surface tension thus facilitating the widening of collapsed alveoli. Preparations of St are used in respiratory distress syndrome of the newborn — a condition with a primary deficiency of Sf. It was reported in some publications about successful use of Sf preparations in conditions without its primary deficiency: acute respiratory distress syndrome in children and adults, tuberculosis and others. Bronchoscopy was applied in some studies as a delivery method. It is argued here that some published data are theoretically unconvincing and not generally confirmed in the international literature. Further studies using different experimental models, adequately planned and performed to be reproducible, are necessary.