Rachoin Jean-Sebastien, Foster Debra, Dellinger R Phillip
Contrib Nephrol. 2010;167:111-118. doi: 10.1159/000315925. Epub 2010 Jun 1.
There is a large amount of support for the safety of polymyxin-B (PMX-B) hemoperfusion in the treatment of septic shock from Japan and Europe. There is also support for potential efficacy, although randomized controlled trials are few and conflicting. PMX-B hemoperfusion represents a promising new treatment that could significantly improve survival. Previous clinical trials of PMX-B have been criticized for methodological issues, such as the absence of blinding, the use of surrogate outcomes and lack of longer term mortality outcomes. The variability in the number of treatment cartridges used, the selection of subjects based on likelihood of endotoxin presence without endotoxin measurement, and small sample sizes in mainly single-center trials have also been cited. The newly designed EUPHRATES trial (Evaluating Use of Polymyxin Hemoperfusion in a Randomized Controlled Trial of Adults treated for Endotoxemia and Septic Shock) addresses many of the methodological issues and represents a significant opportunity to test for clinical efficacy of endotoxin removal in the critically ill septic patient.
来自日本和欧洲的大量研究支持多粘菌素B(PMX - B)血液灌流治疗感染性休克的安全性。尽管随机对照试验较少且结果相互矛盾,但也有研究支持其潜在疗效。PMX - B血液灌流是一种有前景的新疗法,有望显著提高生存率。此前PMX - B的临床试验因方法学问题受到批评,如缺乏盲法、使用替代结局以及缺乏长期死亡率结局。还提到了治疗柱使用数量的变异性、在未测量内毒素的情况下根据内毒素存在可能性选择受试者,以及主要在单中心试验中的小样本量。新设计的EUPHRATES试验(在成人内毒素血症和感染性休克治疗的随机对照试验中评估多粘菌素血液灌流的应用)解决了许多方法学问题,为测试重症感染患者内毒素清除的临床疗效提供了重要契机。