Martin Erica L, Cruz Dinna N, Monti Gianpaola, Casella Gianpaolo, Vesconi Sergio, Ranieri V Marco, Ronco Claudio, Antonelli Massimo
Contrib Nephrol. 2010;167:119-125. doi: 10.1159/000315926. Epub 2010 Jun 1.
Since 1994, a polystyrene fiber cartridge used for extracorporeal hemoperfusion, to which polymyxin B is bound and immobilized, has been used in septic patients in order to absorb and remove circulating lipopolysaccharide, thereby neutralizing the effects of this endotoxin. This therapy gradually gained acceptance as the amount of evidence increased from initial small clinical studies to a carefully conducted systematic review, and ultimately to the multicentered randomized clinical trial conducted in Italy, entitled the EUPHAS Study (Early Use of Polymyxin B Hemoperfusion in Abdominal Septic Shock). While the conclusions of this initial randomized controlled trial were in agreement with previous studies, it possessed some important limitations, including a slow accrual rate, enrolling only 64 patients between 2004 and 2007, inability to blind treating physicians, and a premature study termination based on the results of the scheduled interim analysis. These limitations resulted in a modest patient sample size, which may have overestimated the true magnitude of the clinical effect. Apart from Japan, Italy is the current primary user of polymyxin B-hemoperfusion in the treatment of sepsis, with about 600 cartridges being used per year. However, no structured collection of data has been attempted, resulting in the an opportunity to understand the effects of polymyxin B-hemoperfusion on a large, diverse sample size. In response, Italian investigators and users of this treatment have designed a new prospective multicentered, collaborative data collection study, entitled EUPHAS 2. The aim of the EUPHAS 2 project is to collect a large database regarding polymyxin B-hemoperfusion treatments in order to better evaluate the efficacy and biological significance of endotoxin removal in clinical practice. Additionally, this study aims to verify the reproducibility of the data currently available in the literature, evaluate the patient population chosen for treatment and identify subpopulations of patients who may benefit from this treatment more than others.
自1994年以来，一种用于体外血液灌流的聚苯乙烯纤维柱已被用于脓毒症患者，该柱结合并固定了多粘菌素B，以吸收和清除循环中的脂多糖，从而中和这种内毒素的作用。随着证据数量从最初的小型临床研究增加到精心开展的系统评价，最终增加到在意大利进行的多中心随机临床试验（名为EUPHAS研究，即腹部脓毒性休克中多粘菌素B血液灌流的早期应用），这种疗法逐渐得到认可。虽然这项初步随机对照试验的结论与先前的研究一致，但它存在一些重要局限性，包括入组率低，在2004年至2007年期间仅招募了64名患者，无法使治疗医生保持盲态，以及根据预定中期分析结果提前终止研究。这些局限性导致患者样本量较小，这可能高估了临床效果的真实程度。除日本外，意大利是目前多粘菌素B血液灌流治疗脓毒症的主要使用者，每年约使用600个柱。然而，尚未尝试进行结构化的数据收集，从而失去了一个了解多粘菌素B血液灌流对大量不同样本影响的机会。作为回应，意大利该治疗方法的研究者和使用者设计了一项新的前瞻性多中心协作数据收集研究，名为EUPHAS 2。EUPHAS 2项目的目的是收集一个关于多粘菌素B血液灌流治疗的大型数据库，以便更好地评估临床实践中内毒素清除的疗效和生物学意义。此外，本研究旨在验证文献中现有数据的可重复性，评估选择接受治疗的患者群体，并识别可能比其他患者更能从该治疗中获益的患者亚群。
