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

Ann Surg. 1994 Nov;220(5):601-9. doi: 10.1097/00000658-199411000-00002.


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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Randomized Controlled Trial

MeSH terms

  • 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*


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