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临床实践中多粘菌素吸附柱内毒素清除:EUPHAS试验结果

PMX endotoxin removal in the clinical practice: results from the EUPHAS trial.

作者信息

Antonelli Massimo, Fumagalli Roberto, Cruz Dinna N, Brienza Nicola, Giunta Francesco

出版信息

Contrib Nephrol. 2010;167:83-90. doi: 10.1159/000315922. Epub 2010 Jun 1.

Abstract

Polymyxin B fiber column is a medical device designed to reduce blood endotoxin levels in sepsis. Gram-negative-induced abdominal sepsis is likely to be associated with high circulating endotoxin. In June 2009, the EUPHAS study (Early Use of Polymyxin B Hemoperfusion in Abdominal Sepsis) was published in JAMA. Sixty-four patients who underwent emergency surgery for intra-abdominal infection between December 2004 and December 2007 were enrolled with severe sepsis or septic shock. Intervention patients were randomized to either conventional therapy (n = 30) or conventional therapy plus two sessions of polymyxin B hemoperfusion (n = 34). The main outcome measures were change in mean arterial pressure (MAP) and vasopressor requirement, and secondary outcomes were the PaO(2)/FiO(2) (fraction of inspired oxygen) ratio, change in organ dysfunction measured using sequential organ failure assessment (SOFA) scores, and 28-day mortality. At 72 h, MAP increased (76 to 84 mm Hg; p = 0.001) and the vasopressor requirement decreased (inotropic score: 29.9 to 6.8; p = 0.001) in the polymyxin B group, but not in the conventional therapy group (MAP: 74 to 77 mm Hg; p = 0.37; inotropic score: 28.6 to 22.4; p = 0.14). The PaO(2)/FiO(2) ratio increased slightly (235 to 264; p = 0.049) in the polymyxin B group, but not in the conventional therapy group (217 to 228; p = 0.79). SOFA scores improved in the polymyxin B group, but not in the conventional therapy group (change in SOFA: -3.4 vs. -0.1; p = 0.001), and 28-day mortality was 32% (11/34 patients) in the polymyxin B group and 53% (16/30 patients) in the conventional therapy group (unadjusted HR: 0.43, 95% CI: 0.20-0.94; adjusted HR: 0.36, 95% CI:0.16-0.80). The study demonstrated how polymyxin B hemoperfusion added to conventional therapy significantly improved hemodynamics and organ dysfunction and reduced 28-day mortality in a targeted population with severe sepsis and/or septic shock from intra-abdominal Gram-negative infections.

摘要

多黏菌素B纤维柱是一种旨在降低脓毒症患者血液内毒素水平的医疗器械。革兰氏阴性菌引起的腹部脓毒症可能与循环内毒素水平升高有关。2009年6月,EUPHAS研究(腹部脓毒症中多黏菌素B血液灌流的早期应用)发表于《美国医学会杂志》。2004年12月至2007年12月期间因腹腔内感染接受急诊手术的64例严重脓毒症或脓毒性休克患者被纳入研究。干预组患者被随机分为接受传统治疗组(n = 30)或传统治疗加两次多黏菌素B血液灌流组(n = 34)。主要观察指标为平均动脉压(MAP)变化和血管升压药使用需求,次要观察指标为动脉血氧分压/吸入氧分数(PaO₂/FiO₂)比值、使用序贯器官衰竭评估(SOFA)评分衡量的器官功能障碍变化以及28天死亡率。72小时时,多黏菌素B组的MAP升高(从76毫米汞柱升至84毫米汞柱;p = 0.⁰⁰¹)且血管升压药使用需求降低(肌力评分:从29.9降至6.8;p = 0.⁰⁰¹),而传统治疗组则无变化(MAP:从74毫米汞柱升至77毫米汞柱;p = 0.37;肌力评分:从28.6降至22.4;p = 0.14)。多黏菌素B组的PaO₂/FiO₂比值略有升高(从235升至264;p = 0.⁰⁴⁹),传统治疗组则无变化(从217升至228;p = 0.79)。多黏菌素B组的SOFA评分有所改善,传统治疗组则无变化(SOFA评分变化:-3.4对-0.1;p = 0.⁰⁰¹),多黏菌素B组的28天死亡率为32%(11/34例患者),传统治疗组为53%(16/30例患者)(未调整的风险比:0.43,95%置信区间:0.20 - 0.94;调整后的风险比:0.36,95%置信区间:0.16 - 0.80)。该研究表明,在传统治疗基础上加用多黏菌素B血液灌流可显著改善血流动力学和器官功能障碍,并降低腹腔革兰氏阴性菌感染所致严重脓毒症和/或脓毒性休克目标人群的28天死亡率。

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