Effect of PGG-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations
Effect of PGG-glucan on the rate of serious postoperative infection or death observed after high-risk gastrointestinal operations
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DOI：
10.1001/archsurg.134.9.977
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发表时间：
1999-09-01
影响因子：
--
通讯作者：
Condon, RE
中科院分区：
文献类型：
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作者：
Dellinger, EP;Babineau, TJ;Condon, RE
背景：高风险胃肠道手术后的术后感染仍然很常见。PGG-葡聚糖（Betafectin; Alpha Beta Technology Inc，Worcester，Mass），来源于酵母细胞壁，促进白细胞对细菌病原体的吞噬作用和细胞内杀伤，防止伤口感染动物模型中的感染，并与抗生素协同作用以降低大鼠腹膜炎的死亡率。假设：我们假设这些患者的感染并发症可能通过给予非特异性免疫增强剂而减少。设计：多中心、前瞻性、随机、双盲、安慰剂对照试验，1249例患者前瞻性分为结直肠或非结直肠分层。设置：美国39个医疗中心。患者：年龄18岁或以上，计划进行持续2至8小时的胃肠道手术，有2个或更多确定的风险因素。干预措施：PGG-葡聚糖，0.5 mg/kg或1.0 mg/kg，或安慰剂，术前1次，术后3次。所有患者均接受标准化抗生素预防治疗。主要结果测量：30天内严重感染或死亡。结果：所有随机化患者显示，治疗组与安慰剂组相比，严重感染和死亡无差异（15% vs 14%，P> 0.90）。在前瞻性定义的非结直肠分层（n=391）中，PGG-葡聚糖给药与严重感染和死亡的统计学显著相对减少（39%）相关（安慰剂组，129例中的46例[36%] vs任一PGG-葡聚糖组，132例中的29例[21%]和130例中的28例[22%]，P
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