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. 1994 Nov;220(5):601–609. doi: 10.1097/00000658-199411000-00002

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

T J Babineau 1, P Marcello 1, W Swails 1, A Kenler 1, B Bistrian 1, R A Forse 1
PMCID: PMC1234447  PMID: 7979607

Abstract

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.

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Selected References

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  1. Browder W., Williams D., Pretus H., Olivero G., Enrichens F., Mao P., Franchello A. Beneficial effect of enhanced macrophage function in the trauma patient. Ann Surg. 1990 May;211(5):605–613. [PMC free article] [PubMed] [Google Scholar]
  2. Czop J. K., Puglisi A. V., Miorandi D. Z., Austen K. F. Perturbation of beta-glucan receptors on human neutrophils initiates phagocytosis and leukotriene B4 production. J Immunol. 1988 Nov 1;141(9):3170–3176. [PubMed] [Google Scholar]
  3. Daly J. M., Lieberman M. D., Goldfine J., Shou J., Weintraub F., Rosato E. F., Lavin P. Enteral nutrition with supplemental arginine, RNA, and omega-3 fatty acids in patients after operation: immunologic, metabolic, and clinical outcome. Surgery. 1992 Jul;112(1):56–67. [PubMed] [Google Scholar]
  4. Finkler S. A. The distinction between cost and charges. Ann Intern Med. 1982 Jan;96(1):102–109. doi: 10.7326/0003-4819-96-1-102. [DOI] [PubMed] [Google Scholar]
  5. Janusz M. J., Austen K. F., Czop J. K. Isolation of soluble yeast beta-glucans that inhibit human monocyte phagocytosis mediated by beta-glucan receptors. J Immunol. 1986 Nov 15;137(10):3270–3276. [PubMed] [Google Scholar]
  6. Knaus W. A., Draper E. A., Wagner D. P., Zimmerman J. E. An evaluation of outcome from intensive care in major medical centers. Ann Intern Med. 1986 Mar;104(3):410–418. doi: 10.7326/0003-4819-104-3-410. [DOI] [PubMed] [Google Scholar]
  7. Mellors J. W., Kelly J. J., Gusberg R. J., Horwitz S. M., Horwitz R. I. A simple index to estimate the likelihood of bacterial infection in patients developing fever after abdominal surgery. Am Surg. 1988 Sep;54(9):558–564. [PubMed] [Google Scholar]
  8. Shulkin D. J., Kinosian B., Glick H., Glen-Puschett C., Daly J., Eisenberg J. M. The economic impact of infections. An analysis of hospital costs and charges in surgical patients with cancer. Arch Surg. 1993 Apr;128(4):449–452. doi: 10.1001/archsurg.1993.01420160091015. [DOI] [PubMed] [Google Scholar]
  9. Wakefield D. S., Helms C. M., Massanari R. M., Mori M., Pfaller M. Cost of nosocomial infection: relative contributions of laboratory, antibiotic, and per diem costs in serious Staphylococcus aureus infections. Am J Infect Control. 1988 Oct;16(5):185–192. doi: 10.1016/0196-6553(88)90058-2. [DOI] [PubMed] [Google Scholar]
  10. de Felippe Júnior J., da Rocha e Silva Júnior M., Maciel F. M., Soares A. de M., Mendes N. F. Infection prevention in patients with severe multiple trauma with the immunomodulator beta 1-3 polyglucose (glucan). Surg Gynecol Obstet. 1993 Oct;177(4):383–388. [PubMed] [Google Scholar]
  11. von der Kammer H., Krauhs E., Aumüller G., Scheit K. H. Characterization of a monoclonal antibody specific for prostatic secretory protein of 94 amino acids (PSP94) and development of a two-site binding enzyme immunoassay for PSP94. Clin Chim Acta. 1990 Mar 15;187(3):207–219. doi: 10.1016/0009-8981(90)90106-3. [DOI] [PubMed] [Google Scholar]

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