Effect of PGG-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations. Betafectin Gastrointestinal Study Group.
BACKGROUND
Postoperative infections remain common after high-risk gastrointestinal procedures. PGG-glucan (Betafectin; Alpha Beta Technology Inc, Worcester, Mass), derived from yeast cell walls, promotes phagocytosis and intracellular killing of bacterial pathogens by leukocytes, prevents infection in an animal model of wound infection, and acts synergistically with antibiotics to reduce mortality in rat peritonitis.


OBJECTIVE
We hypothesized that infectious complications in these patients might be reduced by the administration of a nonspecific immune-enhancing agent.


METHODS
Multicenter, prospective, randomized, double-blind, placebo-controlled trial of 1249 patients prospectively stratified into colorectal or noncolorectal strata.


METHODS
Thirty-nine medical centers throughout the United States.


METHODS
Aged 18 years or older, scheduled for gastrointestinal procedure lasting 2 to 8 hours, with 2 or more defined risk factors.


METHODS
PGG-glucan, 0.5 mg/kg or 1.0 mg/kg, or placebo once preoperatively and 3 times postoperatively. All patients received standardized antibiotic prophylaxis.


METHODS
Serious infection or death within 30 days.


RESULTS
All randomized patients revealed no difference in serious infections and deaths in the treated groups compared with placebo groups (15% vs 14%, P>.90). In the prospectively defined noncolorectal stratum (n = 391), PGG-glucan administration was associated with a statistically significant relative reduction (39%) in serious infections and death (placebo, 46 [36%] of 129 vs either PGG-glucan group, 29 [21%] of 132 and 28 [22%] of 130, P<.02). PGG-glucan reduced postoperative infection or death in malnourished patients having noncolorectal procedures (31 [44%] of 70, placebo group; 16 [24%] of 68, 0.5-mg/kg PGG-glucan group; 12 [17%] of 72, 1.0-mg/kg PGG-glucan group; P<.001). Study drug was stopped owing to adverse effects more frequently for patients receiving PGG-glucan than placebo (2%, 4%, and 7% for the placebo group, 0.5-mg/kg PGG-glucan group, and 1.0-mg/kg PGG-glucan group, respectively, P<.003).


CONCLUSIONS
Perioperative administration of PGG-glucan reduced serious postoperative infections or death by 39% after high-risk noncolorectal operations.
Dellinger
E P
EP
Department of Surgery, University of Washington School of Medicine, Seattle 98195-6410, USA. patch@u.washington.edu
Babineau
T J
TJ
Bleicher
P
P
Kaiser
A B
AB
Seibert
G B
GB
Postier
R G
RG
Vogel
S B
SB
Norman
J
J
Kaufman
D
D
Galandiuk
S
S
Condon
R E
RE
D000276:Adjuvants, Immunologic / Q000494:pharmacology*; D000328:Adult; D001424:Bacterial Infections / Q000401:mortality* / Q000517:prevention & control*; D013505:Digestive System Surgical Procedures; D005936:Glucans / Q000494:pharmacology*; D006801:Humans; D008875:Middle Aged; D011183:Postoperative Complications / Q000401:mortality* / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D047071:beta-Glucans
D000276:Adjuvants, Immunologic; D005936:Glucans; D047071:beta-Glucans; C069894:poly-1-6-glucopyranosyl-1-3-glucopyranose glucan