Abstract

BARRESE PEREZ, Yinet et al. Safety of the treatment with pulmonary surfactant in adults with acute respiratory distress syndrome. AMC [online]. 2015, vol.19, n.6, pp.551-558. ISSN 1025-0255.

Introduction: acute respiratory distress syndrome is a nosologic disease associated to a high mortality and morbidity. Objective: to determine the adverse events associated to the therapy with pulmonary surfactant (SURFACEN^®) in adults with acute respiratory distress syndrome. Methods: a randomized and multicentric clinical trial stage II was conducted in 48 adult patients between 18 and 75 years old. The group A, that included 24 patients, received doses of 100 total milligrams of pulmonary surfactant every eight hours for three days, along with the standard treatment (oxygenation and mechanical ventilation). The group B, also with 24 patients, received the standard treatment. The appearance of adverse events was identified and quantified, as well as the seriousness and the causality regarding the medicine from the inclusion of the patient in the study to the discharge from the intensive care unit. Results: the 56, 25 % of the patients included in the study presented an adverse event: 14 (29, 17 %) in the group A and 13 (27, 08 %) in the group B. The 42, 37 % of these adverse events appeared with moderate intensity; the 39, 39 % were reversible and the 92, 59 % had a remote causality regarding the surfactant. Fever was the most frequent adverse event reported. Conclusions: pulmonary surfactant (SURFACEN^®), along with the standard treatment in adults with acute respiratory distress syndrome, is safe

Keywords : RESPIRATORY DISTRESS SYNDROME, ADULT; PULMONARY SURFACTANTS; TREATMENT OUTCOME [therapeutic use]; ADULT; CLINICAL TRIAL, PHASE II.

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