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

T J Babineau1, P Marcello, W Swails

  • 1Department of Surgery, Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.

Annals of Surgery
|November 1, 1994
PubMed
Abstract

Insights

PGG-glucan is safe and effective for reducing postoperative infections in high-risk surgical patients. This immunotherapy significantly decreased infectious complications, antibiotic use, and ICU stays, lowering overall morbidity and costs.

Area of Science:

  • Immunology
  • Surgical Infectious Diseases

Background:

  • High-risk surgical patients face significant infectious complication rates (25-27%) and associated costs ($12,000 per patient).
  • Preclinical studies show PGG-glucan's efficacy in preventing sepsis and enhancing immune cell function against various pathogens.
  • PGG-glucan demonstrates potential for reducing surgical infectious complications.

Purpose of the Study:

  • To determine the safety and efficacy of PGG-glucan in high-risk patients undergoing major thoracic or abdominal surgery.
  • To evaluate PGG-glucan's impact on postoperative infection rates and associated clinical outcomes.

Main Methods:

  • A double-blind, placebo-controlled, randomized study was conducted.
  • 34 high-risk patients undergoing major abdominal or thoracic surgery were enrolled.

Main Results:

  • No adverse drug experiences were reported with PGG-glucan infusion.
  • Patients receiving PGG-glucan experienced significantly fewer infectious complications (1.4 vs. 3.4 infections per patient, p=0.05).
  • PGG-glucan treatment led to decreased antibiotic requirements (0.4 vs. 10.3 days, p=0.04) and shorter ICU stays (0.1 vs. 3.3 days, p=0.03).

Conclusions:

  • PGG-glucan is safe for use in high-risk surgical patients.
  • PGG-glucan appears effective in further reducing morbidity and costs associated with major surgery.

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