evaluation and invention of endotoxin detoxifying material for clinical application

1)PMX-F的性能评价及临床应用：在本基金资助之前，PMX-F已经在犬和小鼠的内毒素灌注休克模型上被证明在循环动力学和存活率方面有效。然后，这种治疗也在大肠杆菌输注的感染性休克狗模型上得到了证实。PMX-F对水和血清（含蛋白质溶液）中的内毒素有吸附作用。肿瘤坏死因子也有较好的吸附作用。2）但血中内毒素的测定不可靠。所有商业化的测量试剂盒都不能相信。为此，我们进行了新的方法和样品前处理的探索.现在，新方法几乎已被存档。通过这种新的方法，PMX-F吸附患者血液中的内毒素。3）在确定了PMX-F柱的大小和灭菌方法后，在福利部的许可下开始了临床试验。并对10例感染性休克患者进行了治疗。该治疗的有效性和安全性至少在人类病例中得到了证实。1方案;病例：脓毒症患者柱：170 ml/体积的PMX-F用于DHP流速：60 - 200 ml/min抗凝剂：肝素或甲磺酸萘氨司他持续时间：2小时治疗：胃肠道气体，循环动力学因素（Swan-Swanz）血液化学因素，代谢因素，4）PMX-F对感染性休克疗效的相关机制：血液中内毒素的减少难以证明，因为内毒素的测量方法无法令人信服。强调了新的概念，即输注的内毒素在循环血液中停留的时间比认为它立即消失的时间长。内毒素的毒性作用也仍然存在。另一方面，血浆的内毒素解毒能力得到了证实，但不是那么多。从血液中去除内毒素是治疗内毒素休克的有效方法。

1) Evaluation of the capacities of PMX-F and clinical application: Until this Grant, PMX-F was already proofed efficient in circulatory dynamics and survival rate on the endotoxin infused shock models of the dogs and mice. And then this treatment was certified also on the E.coli infused septic shock model of dogs. PMX-F could adsorb endotoxin from water and serum (protein contained solution. Tumor necrosis factor was also adsorbed well.2) But measurement of endotoxin in the blood was found to be unreliable. All the commercialized measurement kits could not be believed. So we have tried and invent new method and pretreatment of the sample. Now new method is almost archived. By this new method, PMX-F adsorb endotoxin from the blood of patients.3) After establishments of size and the method of sterilization of PMX-F colomn for human, clinical trial was started under the permission by the Welfare Ministry. And 10 patients with septic shock were treated by this column with DHP. The efficacies and safety of this treatment were certified in the human cases at the least.1 Protocol; Case :septic patients Column:170ml/volume of PMX-F for DHP Flow rate:60 - 200ml/min Anticoagulant:Heparin or Nafamstat mesilate Duration: 2 hours Monitors: glood gases, circulatory dynamic factors(Swan-Gantz) chemical factors of blood, metabolic factors,4) Mechanism related to the efficacy on septic shock by PMX-F: The reduction of endotoxin in the blood was difficult to certify, because the measurement method of endotoxin could not be believed. New concepts was stressed that the infused endotoxin stayed in the circulating blood so long time than that it was thought to disappear from immediately. And toxic effects of endotoxin also remains. On the other hand the endotoxin detoxifying abilities by plasma was certified but not so much. Endotoxin removal from the blood had the right as an effective treatment for endotoxin shock.