| Autor: |
Greenman, R L, Schein, R M, Martin, M A, Wenzel, R P, MacIntyre, N R, Emmanuel, G, Chmel, H, Kohler, R B, McCarthy, M, Plouffe, J |
| Předmět: |
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| Zdroj: |
JAMA: Journal of the American Medical Association; 8/28/91, Vol. 266 Issue 8, p1097-1102, 6p |
| Abstrakt: |
Objective: To assess the efficacy of adjunctive monoclonal antibody antiendotoxin immunotherapy in patients with gram-negative sepsis.Design: Double-blind, randomized, placebo-controlled trial.Setting: Thirty-three university-affiliated centers, including Veterans Affairs, community, and municipal hospitals.Patients: Hospitalized adults with signs of gram-negative infection and a systemic septic response.Intervention: Patients were assigned to receive either 2 mg/kg of a murine monoclonal antibody directed against gram-negative endotoxin (E5) or placebo. A second infusion was administered 24 hours later.Main Outcome Measures: Mortality over the 30-day study period, resolution of organ failures, and safety.Results: Four hundred eighty-six patients were enrolled. Three hundred sixteen had confirmed gram-negative sepsis (54% bacteremic, 46% nonbacteremic). The survival difference was not statistically significant for all patients. Among patients with gram-negative sepsis who were not in shock at study entry (n = 137), E5 treatment resulted in significantly greater survival (relative risk, 2.3; P = .01). Resolution of individual organ failures was more frequent among these patients, occurring in 19 (54%) of 35 patients in the E5 group vs eight (30%) of 27 in the placebo group (P = .05). Four reversible allergic reactions occurred among 247 patients (1.6%) receiving E5. No other toxicity was identified.Conclusions: Treatment with E5 antiendotoxin antibody appears safe. It reduces mortality and enhances the resolution of organ failure among patients with gram-negative sepsis who are not in shock when treated. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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