BOVINE SURFACTANT THERAPY FOR PATIENTS WITH ACUTE RESPIRATORY-DISTRESS SYNDROME

Lung surfactant is deficient in patients with acute respiratory distre ss syndrome (ARDS). We performed a randomized, prospective, controlled , open-label clinical study of administration of a bovine surfactant t o patients with ARDS to obtain preliminary information about its safet y and efficacy. Patients received either surfactant by endotracheal in stillation in addition to standard therapy or standard therapy only. T hree different groups of patients receiving surfactant were studied: p atients receiving up to eight doses of 50 mg phospholipids/kg, those r eceiving up to eight doses of 100 mg phospholipids/kg, and those recei ving up to four doses of 100 mg phospholipids/kg. Outcome measures inc luded ventilatory support parameters, arterial blood gases, organ syst em failures, bronchoalveolar lavage (BAL) analyses, immunologic analys es, survival, and adverse events during the 28-d study period. Fifty-n ine study patients were evaluable; 43 in the surfactant group and 16 i n the control group. The FIO2 at 120 h after treatment began was signi ficantly decreased only for patients who received up to four doses of 100 mg phospholipids/kg surfactant as compared with control patients ( p = 0.011). Mortality in the same group of patients was 18.8%, as comp ared with 43.8% in the control group (p = 0.075). The surfactant insti llation was generally well tolerated, and no safety concerns were iden tified. This pilot study presents preliminary evidence that surfactant might have therapeutic benefit for patients with ARDS, and provides r ationale for further clinical study of this agent.