[血液灌流在麻醉与重症医学中的应用:不同系统的益处、风险及证据]
[Hemoperfusion in anesthesia and intensive care medicine: benefits, risks, and evidence for different systems].
作者信息
Gräfe Caroline, Weidhase Lorenz, Liebchen Uwe, Weigand Markus A, Scharf Christina
机构信息
Klinik für Anaesthesiologie, LMU Klinikum München, Marchioninistr. 15, 81377, München, Deutschland.
Interdisziplinäre internistische Intensivmedizin, Universitätsklinikum Leipzig, Leipzig, Deutschland.
出版信息
Anaesthesiologie. 2023 Dec;72(12):843-851. doi: 10.1007/s00101-023-01341-w. Epub 2023 Sep 14.
BACKGROUND
Hemoperfusion is a technique for the extracorporeal elimination of endogenous and exogenous toxins and harmful mediators by adsorption. It can be used as a stand-alone device, as part of a heart-lung machine or extracorporeal membrane oxygenation (ECMO) or, as is currently the case, integrated into a kidney replacement procedure. In the meantime, various suppliers offer devices with different technologies.
OBJECTIVE
The aim of this work was to evaluate the benefits, risks and evidence of the different systems, how they work and for which indications they are approved in Germany.
METHOD
To achieve this goal, a narrative assessment of the existing literature and guidelines for different indications was performed. The focus was on in vivo studies.
RESULTS
In principle, a distinction must be made in adsorption techniques between pure adsorption and the combination as adsorption and kidney replacement therapy. The adsorbers available in Germany include Cytosorb®, HA-330, Seraph®-100 and Toraymyxin. Combined procedures (adsorption and kidney replacement) are offered with coupled plasma filtration and adsorption (CPFA) and oXiris®. Most adsorbers have been developed for cytokine and endotoxin removal in patients with sepsis; however, to date, no randomized controlled trial (RCT) has demonstrated a survival benefit when using hemoperfusion. Therefore, the S3 guidelines for treatment of sepsis and the surviving sepsis campaign guidelines advise against its routine use. When the corona pandemic began, hemoperfusion was considered as a promising therapeutic approach. Cytosorb®, Seraph®-100, and oXiris® received emergency approval by the FDA to be used in critically ill patients with COVID-19, so questions arose about the appropriateness and importance of its use; however, the data generated did not show positive results, so its use cannot be recommended routinely either. In addition, they are not mentioned as a treatment option in the current guidelines. The use of adsorption procedures in patients with liver failure and rhabdomyolysis has only been rudimentarily studied, so any evidence is currently lacking. The only adsorber that has CE approval in Germany for both applications is Cytosorb®. In the next few years, studies will have to follow that investigate the efficacy and thus either justify or refute the use in clinical routine. Hemoperfusion procedures are used in the heart-lung machine as part of cardiac surgery for either cytokine or anticoagulant adsorption. No congruent data are available to support the use for the elimination of cytokines. If emergency cardiac surgery is required in a patient with pre-existing anticoagulation, hemoperfusion procedures can be used to prevent bleeding complications. Cytosorb® has CE approval for this indication. All available techniques are nonselective adsorption processes, so that adsorption of known and unknown substances can occur. Unintentional adsorption of drugs, such as various anti-infective agents is a relevant risk, especially when used in patients with sepsis.
DISCUSSION
Various adsorption systems can eliminate different known and unknown substances. Currently, there is a lack of evidence for all indications and systems to justify their routine use except in clinical trials. Future clinical trials should evaluate the potential benefits but also dangers, so that in the meantime the routine use can be justified or a recommendation against the use can be given.
背景
血液灌流是一种通过吸附作用体外清除内源性和外源性毒素及有害介质的技术。它可作为独立设备使用,也可作为心肺机或体外膜肺氧合(ECMO)的一部分,或者如目前的情况,集成到肾脏替代程序中。与此同时,各种供应商提供采用不同技术的设备。
目的
这项工作的目的是评估不同系统的益处、风险和证据,它们的工作方式以及在德国获批的适应症。
方法
为实现这一目标,对现有文献和针对不同适应症的指南进行了叙述性评估。重点是体内研究。
结果
原则上,吸附技术必须区分纯吸附以及吸附与肾脏替代疗法的联合应用。德国可用的吸附器包括Cytosorb®、HA - 330、Seraph® - 100和Toraymyxin。联合程序(吸附与肾脏替代)包括耦合血浆滤过吸附(CPFA)和oXiris®。大多数吸附器是为清除脓毒症患者的细胞因子和内毒素而研发的;然而,迄今为止,尚无随机对照试验(RCT)证明使用血液灌流能带来生存获益。因此,脓毒症治疗的S3指南和拯救脓毒症运动指南不建议常规使用。新冠疫情开始时,血液灌流被视为一种有前景的治疗方法。Cytosorb®、Seraph® - 100和oXiris®获得了美国食品药品监督管理局(FDA)的紧急批准,可用于新冠肺炎危重症患者,因此其使用的适当性和重要性引发了疑问;然而,所产生的数据并未显示出阳性结果,所以也不建议常规使用。此外,当前指南未将其列为治疗选择。在肝衰竭和横纹肌溶解患者中使用吸附程序的研究还很初步,因此目前缺乏相关证据。在德国唯一获得这两种应用CE认证的吸附器是Cytosorb®。未来几年,必须开展研究来调查其疗效,从而证明或反驳其在临床常规中的使用合理性。血液灌流程序在心脏手术中作为心肺机的一部分用于细胞因子或抗凝剂吸附。目前尚无一致数据支持用于清除细胞因子。如果已有抗凝治疗的患者需要进行急诊心脏手术,可使用血液灌流程序来预防出血并发症。Cytosorb®获得了该适应症的CE认证。所有可用技术均为非选择性吸附过程,因此可能吸附已知和未知物质。意外吸附药物,如各种抗感染药物,是一个相关风险,尤其是在脓毒症患者中使用时。
讨论
各种吸附系统可清除不同的已知和未知物质。目前,除临床试验外,所有适应症和系统均缺乏证据来证明其常规使用的合理性。未来的临床试验应评估潜在益处和风险,以便在此期间能够证明常规使用的合理性或给出反对使用的建议。