Abstract
To investigate the effects of a recombinant endotoxin-binding protein, bactericidal/permeability-increasing protein (rBPI23), on cytokine release and neutrophil activation in endotoxemia in humans, 8 volunteers were challenged twice with endotoxin and concurrently received either rBPI23 or placebo in a randomized, placebo controlled, double-blind crossover study, rBPI23 treatment significantly lowered circulating endotoxin levels (P = .02) and resulted in a significant reduction in the release of tumor necrosis factor (TNF), soluble TNF receptors p55 and p75, interleukin (IL)-6, IL-8 (P < .01 for each), and IL-10 levels (P = .02) but did not prevent the endotoxin-induced rise in body temperature. The early endotoxin-induced leukopenia was blunted (P = .08), and neutrophil degranulation, as measured by circulating levels of elastase/alpha 1-antitrypsin complexes (P = .03) and lactoferrin (P < .01), was largely prevented by rBPI23. The results of this study indicate that rBPI23 is capable of neutralizing many of the biologic effects of endotoxin in humans.
Publication types
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Clinical Trial
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Antimicrobial Cationic Peptides
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Blood Bactericidal Activity
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Blood Cell Count / drug effects
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Blood Proteins / pharmacokinetics
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Blood Proteins / pharmacology*
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Body Temperature / drug effects
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Cross-Over Studies
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Cytokines / biosynthesis*
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Cytokines / blood
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Double-Blind Method
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Endotoxins / pharmacology*
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Endotoxins / toxicity
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Escherichia coli
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Humans
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Interleukin-10 / biosynthesis
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Interleukin-6 / biosynthesis
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Interleukin-8 / biosynthesis
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Leukocyte Count / drug effects
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Lipopolysaccharides / pharmacology*
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Lipopolysaccharides / toxicity
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Male
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Membrane Proteins*
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Metabolic Clearance Rate
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Neutrophils / drug effects
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Neutrophils / physiology*
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Placebos
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Receptors, Tumor Necrosis Factor / biosynthesis
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Recombinant Proteins / pharmacokinetics
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Recombinant Proteins / pharmacology
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Time Factors
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Tumor Necrosis Factor-alpha / biosynthesis
Substances
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Antimicrobial Cationic Peptides
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Blood Proteins
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Cytokines
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Endotoxins
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Interleukin-6
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Interleukin-8
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Lipopolysaccharides
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Membrane Proteins
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Placebos
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Receptors, Tumor Necrosis Factor
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Recombinant Proteins
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Tumor Necrosis Factor-alpha
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bactericidal permeability increasing protein
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Interleukin-10