PGG-葡聚糖对高危胃肠道手术后严重术后感染率或死亡率的影响。倍他菌素胃肠道研究组。

Effect of PGG-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations. Betafectin Gastrointestinal Study Group.

作者信息

Dellinger E P, Babineau T J, Bleicher P, Kaiser A B, Seibert G B, Postier R G, Vogel S B, Norman J, Kaufman D, Galandiuk S, Condon R E

机构信息

Department of Surgery, University of Washington School of Medicine, Seattle 98195-6410, USA.

出版信息

Arch Surg. 1999 Sep;134(9):977-83. doi: 10.1001/archsurg.134.9.977.

DOI:10.1001/archsurg.134.9.977

PMID:10487593

Abstract

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.

摘要

背景

高风险胃肠道手术后，术后感染仍然很常见。从酵母细胞壁提取的PGG-葡聚糖（β-葡聚糖；马萨诸塞州伍斯特市的阿尔法贝塔科技公司）可促进白细胞对细菌病原体的吞噬作用和细胞内杀伤，在伤口感染动物模型中预防感染，并与抗生素协同作用降低大鼠腹膜炎的死亡率。

假设

我们假设给予非特异性免疫增强剂可能会减少这些患者的感染并发症。

设计

一项多中心、前瞻性、随机、双盲、安慰剂对照试验，对1249例患者进行前瞻性分层，分为结直肠或非结直肠层。

地点

美国各地的39个医疗中心。

患者

年龄在18岁及以上，计划进行持续2至8小时的胃肠道手术，有2个或更多明确的风险因素。

干预措施

术前一次、术后3次给予0.5mg/kg或1.0mg/kg的PGG-葡聚糖或安慰剂。所有患者均接受标准化抗生素预防。

主要观察指标

30天内的严重感染或死亡。

结果

与安慰剂组相比，所有随机分组患者的治疗组在严重感染和死亡方面无差异（15%对14%，P>.90）。在预先定义的非结直肠层（n = 391）中，给予PGG-葡聚糖与严重感染和死亡的统计学显著相对降低（39%）相关（安慰剂组，129例中有46例[36%]；PGG-葡聚糖组，132例中有29例[21%]，130例中有28例[22%]，P<.02）。PGG-葡聚糖降低了接受非结直肠手术的营养不良患者的术后感染或死亡风险（安慰剂组，70例中有31例[44%]；0．5mg/kg PGG-葡聚糖组，68例中有16例[24%]；1.0mg/kg PGG-葡聚糖组，72例中有12例[17%]；P<.001）。与安慰剂组相比，接受PGG-葡聚糖的患者因不良反应更频繁地停止研究药物治疗（安慰剂组、0.5mg/kg PGG-葡聚糖组和1.0mg/kg PGG-葡聚糖组分别为2%、4%和7%，P<.003）。