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

Abstract

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.

• Authors: T J Babineau, P Marcello, W Swails, A Kenler, B Bistrian, R A Forse
• Journal: Annals of surgery (Ann Surg) Vol. 220 Issue 5 Pg. 601-9 (Nov 1994) ISSN: 0003-4932 [Print] United States
• PMID: 7979607 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Adjuvants, Immunologic
• Glucans
• beta-Glucans
• poly-1-6-glucopyranosyl-1-3-glucopyranose glucan

Topics

• Abdomen (surgery)
• Adjuvants, Immunologic (therapeutic use)
• Aged
• Double-Blind Method
• Follow-Up Studies
• Glucans (therapeutic use)
• Humans
• Infections (therapy)
• Middle Aged
• Postoperative Complications (prevention & control)
• Premedication
• Risk Factors
• Thoracic Surgery
• beta-Glucans