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

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. Recent studies have reported a 25% to 27% infectious complication rate in patients undergoing major surgery with an average cost per...

Full description

Saved in:
Bibliographic Details
Published in:Annals of surgery 1994-11, Vol.220 (5), p.601-609
Main Authors: BABINEAU, T. J, MARCELLO, P, SWAILS, W, KENLER, A, BISTRIAN, B, FORSE, R. A
Format: Article
Language:English
Subjects:
Abdomen - surgery
Adjuvants, Immunologic - therapeutic use
Aged
beta-Glucans
Biological and medical sciences
Double-Blind Method
Follow-Up Studies
Glucans - therapeutic use
Humans
Immunomodulators
Infection - therapy
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Postoperative Complications - prevention & control
Premedication
Risk Factors
Thoracic Surgery
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. A double-blind, placebo-controlled randomized study was performed in 34 high-risk patients undergoing major abdominal or thoracic surgery. 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). PGG-glucan is safe and appears to be effective in the further reduction of the morbidity and cost of major surgery.
ISSN:0003-4932
1528-1140
DOI:10.1097/00000658-199411000-00002