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


BACKGROUND
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.
Babineau
T J
TJ
Department of Surgery, Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.
Marcello
P
P
Swails
W
W
Kenler
A
A
Bistrian
B
B
Forse
R A
RA
D000005:Abdomen / Q000601:surgery*; D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000368:Aged; D004311:Double-Blind Method; D005500:Follow-Up Studies; D005936:Glucans / Q000627:therapeutic use*; D006801:Humans; D007239:Infections / Q000628:therapy*; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011292:Premedication; D012307:Risk Factors; D013903:Thoracic Surgery; D047071:beta-Glucans
D000276:Adjuvants, Immunologic; D005936:Glucans; D047071:beta-Glucans; C069894:poly-1-6-glucopyranosyl-1-3-glucopyranose glucan