TY  - JOUR
T1  - EFfect of pgg-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations
AU  - Dellinger E, Babineau TJ, Bleicher P, et al
Y1  - 1999/09/01
N1  - 10.1001/archsurg.134.9.977
JO  - Archives of Surgery
SP  - 977
EP  - 983
VL  - 134
IS  - 9
N2  - 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.Hypothesis 
    We hypothesized that infectious complications in these patients might be reduced by the administration of a nonspecific immune-enhancing agent.Design 
    Multicenter, prospective, randomized, double-blind, placebo-controlled trial of 1249 patients prospectively stratified into colorectal or noncolorectal strata.Setting 
    Thirty-nine medical centers throughout the United States.Patients 
    Aged 18 years or older, scheduled for gastrointestinal procedure lasting 2 to 8 hours, with 2 or more defined risk factors.Interventions 
    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.Main Outcome Measures 
    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).Conclusion 
    Perioperative administration of PGG-glucan reduced serious postoperative infections or death by 39% after high-risk noncolorectal operations.
SN  - 0004-0010
M3  - doi: 10.1001/archsurg.134.9.977
UR  - http://dx.doi.org/10.1001/archsurg.134.9.977
ER  -