Effect of interferon gamma on infection-related death in patients with severe injuries. A randomized, double-blind, placebo-controlled trial
D. J. Dries, G. J. Jurkovich, R. V. Maier, T. P. Clemmer, S. N. Struve, J. A. Weigelt, G. G. Stanford, D. L. Herr, H. R. Champion, F. R. Lewis and al. et
Department of Surgery and Shock Trauma Institute, Loyola University Medical Center, Maywood, Ill.
OBJECTIVE: To assess the efficacy of interferon gamma in reducing infection
and death in patients sustaining severe injury. DESIGN: Multicenter,
randomized, double-blind, placebo-controlled trial with observation for 60
days and until discharge for patients with major infection on day 60.
SETTING: Nine university-affiliated level 1 trauma centers. PATIENTS: Four
hundred sixteen patients with severe injuries, assessed by Injury Severity
Score and degree of contamination. INTERVENTION: Recombinant human
interferon gamma, 100 micrograms, was administered subcutaneously once
daily for 21 days (or until patient discharge if prior to 21 days) as an
adjunct to standard antibiotic and supportive therapy. MAIN OUTCOME
MEASURES: Incidence of major infection, death related to infection, and
death. RESULTS: Infection rates were similar in both treatment groups;
however, patients treated with interferon gamma experienced fewer deaths
related to infection (seven [3%] vs 18 [9%]; P = .008) and fewer overall
deaths (21 [10%] vs 30 [14%]; P = .17). While 12 early deaths (days 1
through 7) occurred in each treatment group, late death occurred in 18
placebo-treated patients and nine in interferon gamma-treated patients. The
results were dominated by findings at one center, which had the highest
enrollment and higher infection and death rates. Statistical analysis did
not eliminate the possibility of an unidentified imbalance between arms as
an explanation for the results. CONCLUSION: Further evaluation is required
to determine the validity of the observed reduction in infection-related
deaths in patients treated with interferon gamma.
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