Randomized phase I/II trial of a macrophage-specific immunomodulator (PGG-glucan) in high-risk surgical patients.

TJ Babineau, P Marcello, W Swails, A Kenler… - Annals of …, 1994 - ncbi.nlm.nih.gov
TJ Babineau, P Marcello, W Swails, A Kenler, B Bistrian, RA Forse
Annals of surgery, 1994ncbi.nlm.nih.gov
OBJECTIVE: The safety and efficacy of PGG-glucan in surgical patients at high risk for
postoperative infection who underwent major thoracic or abdominal surgery were
determined. SUMMARY BACKGROUND DATA: Recent studies have reported a 25% to 27%
infectious complication rate in patients undergoing major surgery with an average cost per
infected patient of $12,000. The efficacy of PGG-glucan pretreatment in prevention of sepsis
has been demonstrated in rodent models for gram-negative and gram-positive bacterial and …
OBJECTIVE
The safety and efficacy of PGG-glucan in surgical patients at high risk for postoperative infection who underwent major thoracic or abdominal surgery were determined.
SUMMARY BACKGROUND DATA
Recent studies have reported a 25% to 27% infectious complication rate in patients undergoing major surgery with an average cost per infected patient of $12,000. The efficacy of PGG-glucan pretreatment in prevention of sepsis has been demonstrated in rodent models for gram-negative and gram-positive bacterial and yeast infections. In vitro studies have demonstrated enhanced microbial killing by monocytes and neutrophils in healthy volunteers after PGG-glucan administration. Thus, PGG-glucan may play a role in decreasing the infectious complication rate in patients undergoing major surgery.
METHODS
A double-blind, placebo-controlled randomized study was performed in 34 high-risk patients undergoing major abdominal or thoracic surgery.
RESULTS
There were no adverse drug experiences associated with PGG-glucan infusion. Patients who received PGG-glucan had significantly fewer infectious complications (3.4 infections per infected patient vs. 1.4 infections per infected patient, p= 0.05), decreased intravenous antibiotic requirement (10.3 days vs. 0.4 days, p= 0.04) and shorter intensive care unit length of stay (3.3 days vs. 0.1 days, p= 0.03).
CONCLUSIONS
PGG-glucan is safe and appears to be effective in the further reduction of the morbidity and cost of major surgery.
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