Department of Surgery, Juntendo Shizuoka Hospital, Juntendo University School of Medicine, 1129 Izunokuni, Shizuoka, 410-2295, Japan.
Surg Today. 2011 Jun;41(6):754-60. doi: 10.1007/s00595-010-4504-9.
Since direct hemoperfusion with polymyxin B immobilized fiber (PMX-DHP) received its product certification for use in Europe in 1998, several prospective randomized controlled trials (RCTs) have been conducted in European countries. The first RCT, performed in six European academic medical centers in 2005, concluded that PMX-DHP is associated with improved hemodynamic status and cardiac function. Subsequently, a meta-analysis of PMX-DHP was presented in Italy in 2007. This systematic review found positive effects of PMX-DHP on mean arterial pressure and dopamine/ dobutamine use, PaO2/FiO2 ratio, endotoxin removal, and mortality. However, like most trials on extracorporeal therapies, none of the studies was double-blinded. The EUPHAS study, a multicenter RCT performed in ten Italian intensive care units in 2009, found that PMX-DHP improved 28-day survival, blood pressure, vasopressor requirement, and degree of organ failure. However, investigators in Belgium and Canada pointed out that there was no statistical difference in 28-day survival. Two more RCTs, the ABDO-MIX and EUPHRATES studies, the primary end points of which are 28-day mortality, were started in Europe and the United States at the end of 2010. We are hoping that these RCTs will resolve this issue.
自 1998 年聚砜固定化多粘菌素 B （PMX-DHP）在欧洲获得产品认证以来，欧洲国家已经进行了几项前瞻性随机对照试验（RCT）。第一项 RCT 于 2005 年在六个欧洲学术医疗中心进行，结论是 PMX-DHP 可改善血液动力学状态和心功能。随后，2007 年在意大利进行了 PMX-DHP 的荟萃分析。该系统评价发现 PMX-DHP 对平均动脉压和多巴胺/多巴酚丁胺的使用、PaO2/FiO2 比值、内毒素清除率和死亡率有积极影响。然而，与大多数体外治疗试验一样，这些研究均无双盲。EUPHAS 研究是 2009 年在意大利十个重症监护病房进行的一项多中心 RCT，发现 PMX-DHP 改善了 28 天生存率、血压、血管加压药需求和器官衰竭程度。然而，比利时和加拿大的研究人员指出，28 天生存率无统计学差异。另外两项 RCT，即 ABDO-MIX 和 EUPHRATES 研究，其主要终点是 28 天死亡率，已于 2010 年底在欧洲和美国开始。我们希望这些 RCT 能够解决这个问题。
