A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection
A pilot-controlled study of a polymyxin B-immobilized hemoperfusion cartridge in patients with severe sepsis secondary to intra-abdominal infection
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DOI：
10.1097/01.shk.0000159930.87737.8a
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发表时间：
2005-05-01
期刊：
影响因子：
3.1
通讯作者：
John, S
中科院分区：
文献类型：
--
作者：
Vincent, JL;Laterre, PF;John, S
内毒素是脓毒症的重要致病诱因。在临床前和开放临床研究中，多粘菌素B固定化的内毒素清除血液灌流柱Toraymysin(以下简称PMX)已被证明可以清除内毒素。在欧洲6个学术医学中心的重症监护病房进行的一项多中心、开放、试点、随机、对照研究中，36名术后因腹内感染继发严重败血症或感染性休克的患者被随机分为PMX治疗2小时(n=17)或标准治疗(n=19)。PIVIX耐受性良好，无明显副作用。两组治疗前至治疗后6~8h或治疗后24 h内毒素水平变化差异无统计学意义。治疗前至治疗后6~8h或治疗后24 h，两组患者血清IL-6水平变化差异无统计学意义。与对照组相比，服用PMX的患者心脏指数(CI)(第1天和第2天分别为0.012和0.032)、每搏做功指数(第2天P=0.015)和氧输送指数(DO21 I，第2天P=0.007)均显著增加。进入研究后持续肾脏替代治疗的需要在PIVIX组减少(P=0.043)。根据序贯器官衰竭评估(SOFA)评分，从第0天(基线)到第6天，两组之间的器官功能障碍没有显著差异。使用PIVIX药盒治疗是安全的，可能会改善败血症或感染性休克引起的心和肾功能障碍。需要进一步的研究来证明这一有效性。
Endotoxin is an important pathogenic trigger for sepsis. The polymyxin B-immobilized endotoxin removal hemoperfusion cartridge, Toraymyxin (hereafter PMX), has been shown to remove endotoxin in preclinical and open-label clinical studies. In a multicenter, open-label, pilot, randomized, controlled study conducted in the intensive care unit in six academic medical centers in Europe, 36 postsurgical patients with severe sepsis or septic shock secondary to intra-abdominal infection were randomized to PMX treatment of 2 h (n = 17) or standard therapy (n = 19). PIVIX was well tolerated and showed no significant side effects. There were no statistically significant differences in the change in endotoxin levels from baseline to 6 to 8 h after treatment or to 24 h after treatment between the two groups. There was also no significant difference in the change in interleukin (IL)-6 levels from baseline to 6 to 8 h after treatment or to 24 h after treatment between the two groups. Patients treated with PMX demonstrated significant increases in cardiac index (CI; P = 0.012 and 0.032 at days 1 and 2, respectively), left ventricular stroke work index (LVSWI, P = 0.015 at day 2), and oxygen delivery index (DO2I, P = 0.007 at day 2) compared with the controls. The need for continuous renal replacement therapy (CRRT) after study entry was reduced in the PIVIX group (P = 0.043). There was no significant difference between the groups in organ dysfunction as assessed by the Sequential Organ Failure Assessment (SOFA) scores from day 0 (baseline) to day 6. Treatment using the PIVIX cartridge is safe and may improve cardiac and renal dysfunction due to sepsis or septic shock. Further studies are needed to prove this effectiveness.