Am. J. Respir. Crit. Care Med., Vol 155, No. 4, Apr 1997, 1309-1315.
Bovine surfactant therapy for patients with acute respiratory distress syndrome
TJ Gregory, KP Steinberg, R Spragg, JE Gadek, TM Hyers, WJ Longmore, MA Moxley, GZ Cai, RD Hite, RM Smith, LD Hudson, C Crim, P Newton, BR Mitchell and AJ Gold
Department of Internal Medicine, Ohio State University Hospital, Columbus, USA.
Lung surfactant is deficient in patients with acute respiratory distress
syndrome (ARDS). We performed a randomized, prospective, controlled,
open-label clinical study of administration of a bovine surfactant to
patients with ARDS to obtain preliminary information about its safety and
efficacy. Patients received either surfactant by endotracheal instillation
in addition to standard therapy or standard therapy only. Three different
groups of patients receiving surfactant were studied: patients receiving up
to eight doses of 50 mg phospholipids/kg, those receiving up to eight doses
of 100 mg phospholipids/kg, and those receiving up to four doses of 100 mg
phospholipids/kg. Outcome measures included ventilatory support parameters,
arterial blood gases, organ system failures, bronchoalveolar lavage (BAL)
analyses, immunologic analyses, survival, and adverse events during the
28-d study period. Fifty-nine study patients were evaluable; 43 in the
surfactant group and 16 in the control group. The FI(O2) at 120 h after
treatment began was significantly 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 compared with 43.8% in the control group (p = 0.075). The
surfactant instillation was generally well tolerated, and no safety
concerns were identified. This pilot study presents preliminary evidence
that surfactant might have therapeutic benefit for patients with ARDS, and
provides rationale for further clinical study of this agent.
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V. BALARAMAN, J. MEISTER, T. L. KU, S. L. SOOD, E. TAM, J. KILLEEN, C. F. T. UYEHARA, E. EGAN, and D. EASA
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D. HAFNER, P.-G. GERMANN, and D. HAUSCHKE
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T. F. Fok, M. Al-Essa, M. Dolovich, F. Rasid, and H. Kirpalani
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Copyright © 1997 American Thoracic Society
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