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革兰氏阴性菌败血症中的一种新型内毒素吸附装置:使用固定化白蛋白的MATISSE吸附器。

A new endotoxin adsorption device in Gram-negative sepsis: use of immobilized albumin with the MATISSE adsorber.

作者信息

Staubach Karl-Hermann, Boehme Marc, Zimmermann Michael, Otto Veit

机构信息

Department of Surgery, University Hospital of Leubeck, Ratzeburger Allee 160, 23538 Lübeck, Germany.

出版信息

Transfus Apher Sci. 2003 Aug;29(1):93-8. doi: 10.1016/s1473-0502(03)00100-9.

Abstract

MATISSE is a new endotoxin (ET) adsorption system. It comprises the FRESENIUS hemoadsorption machine 4008 ADS to maintain the extracorporeal circuits and disposables including the MATISSE-adsorber based on macroporous beads immobilized with human serum albumin. In vivo and in vitro experiments with this new compound had shown favourable ET elimination properties. In a first study 19 healthy volunteers were included for the safety and tolerability of the endotoxin adsorber system. One single veno-venous hemoperfusion with this system was performed. Apheresis treatment with the human albumin immobilized adsorber seems to be safe and well tolerable in healthy volunteers. A slight decrease in platelet count as well as insulin level was observed. No serious adverse events were mentioned. Similar findings were made in an open uncontrolled trial in six patients with suspected Gram-negative sepsis. Here endotoxin adsorption seems to be safe and well tolerated without adsorber related major adverse events. In the last clinical trial including 145 patients mainly peritonitis patients (104), again no safety concerns were found during the apheresis. Trends in improvement of morbidity and organ dysfunction were found as well as efficient LPS removal in peritonitis patients. LPS whole blood immunoadsorption is a promising new method. No relevant side effects were observed so far. A large controlled study to prove clinical efficacy in patients with severe sepsis and confirmed endotoxemia (e.g. peritonitis) should be necessary.

摘要

MATISSE是一种新型内毒素吸附系统。它包括费森尤斯血液吸附机4008 ADS,用于维持体外循环,以及一次性用品,包括基于固定有人血清白蛋白的大孔珠的MATISSE吸附器。对这种新化合物进行的体内和体外实验已显示出良好的内毒素清除特性。在第一项研究中,纳入了19名健康志愿者以评估内毒素吸附系统的安全性和耐受性。使用该系统进行了一次单针静脉-静脉血液灌流。在健康志愿者中,用人白蛋白固定吸附器进行的血液成分单采治疗似乎是安全且耐受性良好的。观察到血小板计数和胰岛素水平略有下降。未提及严重不良事件。在一项针对6例疑似革兰氏阴性菌败血症患者的开放非对照试验中也有类似发现。在内毒素吸附似乎是安全且耐受性良好的,未出现与吸附器相关的重大不良事件。在最后一项临床试验中,纳入了145例患者,主要是腹膜炎患者(104例),在血液成分单采过程中同样未发现安全问题。发现了发病率和器官功能障碍改善的趋势,以及腹膜炎患者中脂多糖的有效清除。脂多糖全血免疫吸附是一种有前景的新方法。到目前为止,未观察到相关副作用。有必要进行一项大型对照研究,以证明该方法对严重脓毒症和确诊内毒素血症(如腹膜炎)患者的临床疗效。

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