RANDOMIZED PHASE I/II TRIAL OF A MACROPHAGE-SPECIFIC IMMUNOMODULATOR (PGG-GLUCAN) IN HIGH-RISK SURGICAL PATIENTS
RANDOMIZED PHASE I/II TRIAL OF A MACROPHAGE-SPECIFIC IMMUNOMODULATOR (PGG-GLUCAN) IN HIGH-RISK SURGICAL PATIENTS
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DOI：
10.1097/00000658-199411000-00002
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发表时间：
1994-11-01
影响因子：
9
通讯作者：
FORSE, RA
中科院分区：
文献类型：
--
作者：
BABINEAU, TJ;MARCELLO, P;FORSE, RA
目的探讨pgg -葡聚糖在胸腹外科术后感染高危患者中的安全性和有效性。最近的研究报道，在接受大手术的患者中，感染并发症发生率为25%至27%，每位感染患者的平均费用为12,000美元。在革兰氏阴性和革兰氏阳性细菌和酵母菌感染的啮齿动物模型中，pgg -葡聚糖预处理在预防败血症中的作用已得到证实。体外研究表明，pgg -葡聚糖给药后，健康志愿者的单核细胞和中性粒细胞杀灭微生物的能力增强。因此，pgg -葡聚糖可能在降低大手术患者感染并发症发生率方面发挥作用。方法采用双盲、安慰剂对照的随机研究方法，对34例接受胸腹大手术的高危患者进行研究。结果pgg -葡聚糖输注无不良反应。接受pgg -葡聚糖治疗的患者感染并发症明显减少（每名感染患者感染3.4次，每名感染患者感染1.4次，p = 0.05），静脉注射抗生素需求减少（10.3天对0.4天，p = 0.04），重症监护病房住院时间缩短（3.3天对0.1天，p = 0.03）。结论pgg -葡聚糖是安全的，在进一步降低大手术的发病率和成本方面是有效的。
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.