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A Phase II Multicenter, Double-blind, Randomized, Placebo-Controlled Study of Three Dosages of an Immunomodulator (PGG-Glucan) in High-Risk Surgical Patients

Timothy J. Babineau, MD; Alan Hackford, MD; Andrew Kenler, MD; Bruce Bistrian, MD, PhD; R. Armour Forse, MD, PhD; Patrick G. Fairchild, MD; Stephen Heard, MD; Mark Keroack, MD; Philip Caushaj, MD; Peter Benotti, MD
Arch Surg. 1994;129(11):1204-1210. doi:10.1001/archsurg.1994.01420350102014.
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Objective:  To examine the safety and efficacy of multiple doses of PGG-glucan (poly- [ 1-6]-B-Dglucopyranosyl-[ 1-3]-B-D-glucopyranose) in high-risk patients undergoing major thoracic or abdominal surgery.

Design:  An interventional, multicenter, double-blind, randomized, placebo-controlled study.

Setting:  Four university-affiliated medical centers.

Patients:  Sixty-seven high-risk patients undergoing major thoracic or abdominal surgery.

Intervention:  Patients were randomized in a 1:1:1:1 ratio to receive saline placebo or PGG-glucan at a dose of 0.1 mg/kg, 0.5 mg/kg, and 1.0 mg/kg or 2.0 mg/kg. One dose was administered before surgery and three doses were administered after surgery.

Main Outcome Measures:  To examine the safety and efficacy of PGG-glucan infusion and to identify potentially important factors for a planned phase III study.

Results:  A dose-response trend with regard to infection incidence among patients who received PGG-glucan was observed. Serious infections occurred in four patients who received placebo and in three patients who received PGG-glucan at a dose of 0.1 mg/kg. However, only one patient who received PGG-glucan at a high dose had a serious infection. The incidence and severity of adverse events was comparable in all groups.

Conclusions:  PGG-glucan was generally safe and well tolerated, may decrease postoperative infection rates, and warrants further investigation in a planned phase III trial.(Arch Surg. 1994;129:1204-1210)

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