TORAYMYXIN PMX-20R
Este área contiene información dirigida exclusivamente a profesionales sanitarios capacitados para prescribir o dispensar medicamentos.

    TORAYMYXIN PMX-20R

    TORAY

    Sepsis

    TORAYMYXIN PMX-20R es un cartucho de hemoperfusión extracorpórea diseñado para la extracción selectiva de endotoxinas de la sangre circulante a través de la hemoperfusión directa.1
    El cartucho PMX contiene fibras elaboradas con derivados de poliestireno, en cuya superficie se ha inmovilizado polimixina B que adsorbe y extrae las endotoxinas de la sangre circulante del paciente.1
    TORAYMYXIN PMX-20R está indicado para el tratamiento de pacientes con sepsis o shock séptico por bacterias gram negativas.1


    Criterios de selección de pacientes 2,3,4,5,6

    • Shock séptico de origen abdominal, biliar y urológico (probable Gram negativo).
    • Actividad de endotoxina (EAA)> 0,6 EU/ml (no imprescindible).
    • Ausencia de mejora o empeoramiento después de 6 horas de correcto tratamiento intensivo.
    • Fallo multiorgánico persistente después de 6 horas de tratamiento inicial adecuado (2 o más órganos afectados).
    • Tiempo de evolución dle shock séptico no superior a 12h (inicio del tratamiento de 6-12h desde el ingreso en críticos).

    Este producto cumple con la normativa de productos sanitarios.
    Marcado CE 0123.

    Ver instrucciones de uso

    Solicitar información

    Información adicional

    El cartucho TORAYMYXIN PMX-20R consiste en un conducto perforado de polipropileno envuelto por un filtro de tejido de polipropileno-poliestireno, ambos contenidos en una carcasa de polipropileno.

    La circulación sanguínea penetra por el conducto perforado, sigue una trayectoria radial a través del filtro de tejido y se recoge periféricamente en el espacio interior de la carcasa, que la conduce hasta el orificio de salida.

    El tejido del filtro está hecho de fibras de polipropileno-poliestireno, y el poliestireno está modificado (poliestireno alfacloroacetato amidometilado) para poder fijar en su superficie polimixina B.

    La polimixina B está inmovilizada sobre el poliestireno por un extremo de su molécula, y el extremo que queda libre tiene una alta capacidad química para adsorber la endotoxina de la sangre circulante. Con ello se consigue que la endotoxina quede fijada al filtro y se depure la sangre (Shoji y cols. 1998; 2003).

    Forma de administración

    El tratamiento se realiza por hemoperfusión extracorpórea directa, acoplando TORAYMYXIN PMX-20R a un sistema de circulación extracorpórea adecuado (para más detalles, ver Instrucciones de uso).1

    La duración de la hemoperfusión extracorpórea directa es de dos horas (2 h) por cada cartucho de TORAYMYXIN PMX-20R.1

    Habitualmente se realizan 2 ciclos de hemoperfusión extracorpórea directa, de dos horas (2 h) cada uno, separados 24 h, por lo que se utilizan 2 cartuchos de TORAYMYXIN PMX-20R por paciente. Si el tratamiento con 3 cartuchos por ciclo no resulta efectivo, deberá aplicarse otro tipo de tratamiento.1

    Instrucciones de uso

     

    Referencias

    1 Instrucciones de uso.
    Candel FJ et al. La depuración de endotoxina como tratamiento coadyuvante en la sepsis grave por microorganismos gramnegativos. Rev Esp Quimioter. 2010(3):115-21.
    3 Ronco C, Klein DJ. Polymyxin B hemoperfusion: a mechanistic perspective. Crit. Care Med. 2013;41(9):2209-20.
    4 Monti G et al. Rescue Therapy with Polymyxin B hemoperfusion in high-dose vasopressor therapy refractory septic shock. Minerva Anestesiologica 2015:81.
    Maynar J, Martínez-Sagasti F, Herrera-Gutiérrez M, Martí F, Candel FJ, Belda J, Castaño S, Sanchez-Izquierdo JA. Direct hemoperfusion with polymyxin-B immobilized cartridge in severe sepsis due to intestinal perforation: hemodynamic findings and clinical considerations in anticoagulation therapy. Rev Esp Quimioter 2013;26(2):151-8.
    Navarro R, Guerrero M, González M, Quecedo L, García A, Ramasco F. Descripción de los efectos hemodinámicos y respiratorios del tratamiento mediante hemoperfusión con polimixina B en pacientes con shock séptico de origen abdominal. Rev Esp Anestesiol Reanim 2013;60(6):344-7.

    La depuración de endotoxina como tratamiento coadyuvante en la sepsis grave por microorganismos gramnegativos

    The mortality rate of severe sepsis and septic shock remains still high. Within the last years a better knowledge of its physiopathology and the implementation of a group of measures addressed to a fast identification and early treatment of the septic patients have proved to reduce mortality rate. Likewise, it continues being investigated in modulating the inflammatory response and limiting the harmful action of the bacterial products on the immune system. As a result of this research some endotoxin adsorber devices have been designed to control one of the most important targets that start the inflammatory cascade when gram negative microorganisms are involved.The usefulness that these endotoxin removal devices might have as adjuvant treatment in the Septic Syndrome and its applicability are reviewed in this paper. Likewise a profile of patient that might be to the benefit of this therapy is suggested according to the current knowledge.

    Candel FJ, Martínez-Sagasti F, Borges M, Maseda E, Herrera-Gutiérrez M, Garnacho-Montero J, Maynar FJ, Zaragoza R et al.
    Rev Esp Quimioter 2010;23(3):115-121
    01/2010
    Immunomodulation in sepsis: the role of endotoxin removal by polymyxin B-immobilized cartridge

    Severe sepsis results in high morbidity and mortality. Immunomodulation strategies could be an adjunctive therapy to treat sepsis. Endotoxin is a component of gram-negative bacteria and plays an important role in the pathogenesis of septic shock when it is recognized by immune cells. Removal of endotoxin could be an effective adjunctive approach to the management of sepsis. Devices to adsorb endotoxin or inflammatory cytokines have been designed as a strategy to treat severe sepsis, especially sepsis caused by gram-negative bacteria. Polymyxin B-immobilized cartridge has been successfully used to treat patients with sepsis of abdominal origin. Although this cartridge was conceived to adsorb endotoxin, several other immunological mechanisms have been elucidated, and this device has also yielded promising results in patients with nonseptic respiratory failure. In this paper, we summarize the immune modulation actions of Polymyxin B-immobilized cartridge to explore its potential usefulness beyond endotoxin elimination.

    Esteban E, Ferrer R, Alsina L, Artigas A.
    Mediators Inflamm. 2013;2013:507539.
    12/2013
    Direct hemoperfusion with polymyxin B-immobilized cartridge in severe sepsis due to intestinal perforation: hemodynamic findings and clinical considerations in anticoagulation therapy

    BACKGROUND: High levels of endotoxin have been reported as a risk factor for mortality in critical patients. Toraymyxin® is a column designed to remove circulating blood endotoxin by direct hemoperfusion widely used in Japan.

    OBJECTIVES: To evaluate the effect of direct hemoperfusion with Toraymyxin® (DHP-PMX) as an adjuvant treatment in patients with severe sepsis due to intestinal perforation in terms of hemodynamic function and coagulation abnormalities.

    METHODS: Prospective cohort study with a historical control group. Cohort 1: prospective cohort undergoing two sessions of DHP-PMX (n=14). Cohort 2: retrospective historical cohort (n=7). The anticoagulation regime was used according to the protocol of each centre and to the special conditions of each patient.

    RESULTS: Mean norepinephrine dose was significantly reduced (0.9 ± 0.5 μg/kg/min pre-first DHP-PMX vs 0.3 ± 0.4 μg/kg/min post-second DHP-PMX treatment, p<0.05). Central venous pressure (CVP) and stroke volume variation (SVV) remained without significant changes during the study, as well as cardiac index (CI) in patients with initial CI ≥ 2.5 L/min/m2. CI significantly increased in patients with initial CI<2.5 L/min/m2 (2.1 ± 0.4 pre-first DHP-PMX vs 3.4 ± 0.4 pre-second DHP-PMX session, p=0.01). Mean platelet count pre-first and post-second DHP-PMX decreased significantly (213.9 x 10(3) ± 138.5 x 10(3) platelets/mm3 vs 91.0 x 10(3) ± 53.5 x 10(3) platelets/mm3, p=0.03), without significant changes during each DHP-PMX treatment. Patients did not experience bleeding nor complications derived from DHP-PMX treatments. Survival rates at 28 and 56 days did not differ significantly between cohort 1 and 2 (21.4% vs 42.9%; 42.9% vs 57.1%; respectively).

    CONCLUSIONS: Performing two sessions of DHP-PMX treatment in a cohort of patients with abdominal sepsis is a feasible adjuvant therapeutic approach, safe in terms of coagulation abnormalities, can be done with different anticoagulation protocols, improves hemodynamic status and may impact on survival.

    Maynar J, Martínez-Sagasti F, Herrera-Gutiérrez M, Martí F, Candel FJ, Belda J, Castaño S, Sanchez-Izquierdo JA.
    Rev Esp Quimioter. 2013 Jun;26(2):151-8.
    01/2013
    Descripción de los efectos hemodinámicos y respiratorios del tratamiento mediante hemoperfusión con polimixina B en pacientes con shock séptico de origen abdominal

    The objective of this study is to describe the hemodynamic effects, inotropic and vasoactive drug dependence, and to analyze the PO2/FiO2 ratio in 13 patients with septic shock of abdominal origin after hemoperfusion treatment with polymyxin-B. Treatment with polymyxin hemoperfusion therapy is indicated for patients with severe sepsis/septic shock of abdominal origin who do not respond adequately to conventional therapy. Two complete cycles with polymyxin cartridge were performed on 11 of the 13 patients, and a single cycle on the other O2. After treatment, the mean airway pressure (MAP) was increased (P=.003), the need for norepinephrine decreased (P=.003), and the PO2/FiO2 ratio increased (P=.02). The use of polymyxin hemoperfusion in patients with septic shock of intra-abdominal origin can significantly improve hemodynamic and respiratory functions.

    Navarro R, Guerrero M, González M, Quecedo L, García A, Ramasco F.
    Rev Esp Anestesiol Reanim. 2013 Jun;60(6):344-7.
    01/2013
    Utilidad de la hemoperfusión en el tratamiento del paciente séptico grave

    Haemoperfusion is an extracorporeal technique that removes endotoxin and/or inflammatory mediators by means of an adsorptive mechanism during the passage of the blood through a porous filter. Most of the studies in the literature use polymyxin B as the adsorptive agent. This treatment is based on the assumption that the removal of endotoxin and inflammatory mediators from the circulation attenuates the inflammatory response in sepsis. This review summarizes the theoretical basis, and the experimental and clinical results published to date with the use of haemoperfusion. Although most of the studies show positive results, some doubts have arisen about the suitability of the methods described (small number of cases, low quality of the experimental design, and excessive mortality in the control groups). There are also some inconsistencies regarding the theoretical basis of its use (lack of positive effects after the removal of endotoxin from the circulation using alternative mechanisms, discrepancies regarding the best moment to initiate the therapy, unexplained beneficial effects in the absence of increased endotoxin levels). It is the opinion of the authors that haemoperfusion represents a promising therapy for the treatment of sepsis, but consider that its usefulness requires confirmation in well designed studies before being included in protocols.

    Pestaña D, Ojeda N, Padrón OM, Higuera E, Rey T, Aldecoa C.
    Rev Esp Anestesiol Reanim. 2013 Jun;60(6):336-43.
    01/2013
    Polymyxin B hemoperfusion: a mechanistic perspective

    Direct hemoperfusion therapy with polymyxin B immobilized fiber cartridge (PMX-DHP) is an established strategy in the treatment of septic shock in Japan and parts of Western Europe. PMX-DHP is currently the subject of a pivotal North American randomized controlled trial (EUPHRATES) in patients with septic shock and confirmed endotoxemia, as measured by the endotoxin activity assay. The major mechanism of action of this therapy is the removal of circulating endotoxin. High affinity binding of circulating endotoxin by the PMX-DHP column may decrease circulating endotoxin levels by up to 90% after two standard treatments. Basic research has shown reductions in circulating cytokine levels and in renal tubular apoptosis. Clinical research has shown that PMX-DHP therapy results in hemodynamic improvements, improvements in oxygenation, renal function, and reductions in mortality. Further research is needed to further define additional patient populations with endotoxemia that may benefit from PMX-DHP therapy as well as to further elucidate dosing, timing, and additional information on mechanisms of action. This review will present the mechanistic rationale for this targeted strategy of endotoxin removal using PMX-DHP in endotoxemic septic patients, highlighting both the specific effects of the therapy and the evidence accumulated so far of clinical improvement following this therapy in terms of recovery of organ function.

    Ronco C, Klein DJ.
    Crit. Care Med. 2013;41(9):2209-20.
    01/2013
    Blood purification and mortality in sepsis: a meta-analysis of randomized trials

    OBJECTIVES: Although blood purification improves outcomes in animal studies of sepsis, results of clinical trials have been mixed. We conducted a systematic review and meta-analysis of randomized trials to determine the association between various blood purification techniques and all-cause mortality in humans with sepsis.

    DATA SOURCES: We searched for relevant studies in MEDLINE, EMBASE, and the Cochrane Library database from January 1966 to May 2012.

    STUDY SELECTION: Inclusion required a diagnosis of sepsis and comparison of blood purification techniques including hemofiltration, hemoperfusion, plasma exchange, or hemodialysis with no blood purification (control group).

    DATA EXTRACTION: Two authors independently selected studies and extracted data. Summary statistics, risk ratios, and CIs were calculated using random-effects modeling. Study quality was assessed using Jadad score, and publication bias was assessed using funnel plots and Egger's statistic.

    DATA SYNTHESIS: Overall, blood purification decreased mortality compared with no blood purification (35.7% vs 50.1%; risk ratio, 0.69 [95% CI, 0.56-0.84]; p<0.001; 16 trials, n=827). However, these results were driven mainly by hemoperfusion (risk ratio, 0.63 [95% CI, 0.50-0.80]; p<0.001; 10 trials, n=557) and plasma exchange (risk ratio, 0.63 [95% CI, 0.42-0.96]; p=0.03; two trials, n=128). Pooling of all trials of blood purification for treatment of sepsis was no longer associated with lower mortality (risk ratio, 0.89 [95% CI, 0.71-1.13]; p=0.36; eight trials, n=457) after excluding trials using polymyxin B hemoperfusion.

    CONCLUSIONS: Blood purification techniques including hemoperfusion, plasma exchange, and hemofiltration with hemoperfusion were associated with lower mortality in patients with sepsis. These results were mainly influenced by studies using polymyxin B hemoperfusion from Japan.

    Zhou F, Peng Z, Murugan R, Kellum JA.
    Crit Care Med. 2013 Sep;41(9):2209-20.
    01/2013

    Registro EUPHAS-2

    El objetivo de este proyecto es recopilar una gran base de datos sobre tratamientos de hemoperfusión con Toraymyxin, a fin de evaluar la eficacia e importancia biológica de la eliminación de endotoxina en la práctica clínica.

    Además, este proyecto tiene como objetivo verificar la reproductibilidad de los datos actualmente disponibles en la literatura, evaluar la población de pacientes elegidos para el tratamiento e identificar las subpoblaciones de pacientes que pueden beneficiarse de este tratamiento más que otros.

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    SEMICYUC

    Los profesionales del enfermo crítico

    GTIPO

    Grupo de Trabajo en Infecciones Perioperatorias

    SEDAR

    Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

    Euphas2 Project

    50 Preguntas Clave en SEPSIS

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    SEPSIS. Casos clínicos I

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    SEPSIS. Casos clínicos II

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    SEPSIS. Casos clínicos III

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    Protocolo montaje TORAYMYXIN-Prismaflex

    Procedimiento de montaje, aclarado y cebado del cartucho de Toraymyxin en la máquina Primaflex de Hospal

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    Protocolo montaje TORAYMYXIN-Fresenius

    Procedimiento de montaje, aclarado y cebado del cartucho de Toraymyxin en la máquina de Fresenius

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    2017

    LII Congreso Nacional SEMICYUC, 18-21 Junio 2017

    Profesionales del enfermo crítico.

    Madrid
     

    XXXIII Congreso Nacional de la SEDAR, 4-6 Mayo 2017

    SEDAR. Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

    Alicante
     

    27th European Congress ECCMID, 22-25 Abril 2017

    ESCMID. European Society of Clinical Microbiology and Infectious Diseases.

    Viena, Austria
     

    37th International Symposium on Intensive Care and Emergency Medicine, 21-24 Marzo 2017

    SIZ. Belgian Society of Intensive Care and Emergency Medicine.

    Bruselas, Bélgica
     

    22nd International Symposium on Infections in the Critically III Patient, 8-10 Febrero 2017

    ESCMID. European Society of Clinical Microbiology and Infectious Diseases.

    Porto, Portugal
     

    2015

    XXVI Reunión del Grupo de Trabajo de Enfermedades Infecciosas y Sepsis, 19-20 Noviembre 2015

    Puntos críticos en la gestión del paciente séptico.

    Málaga
     

    XXXII Congreso Nacional de la SEDAR15-17 Octubre 2015

    SEDAR. Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor.

    Santander
     

    L Congreso Nacional SEMICYUC, 14-17 Junio 2015

    Profesionales del enfermo crítico.

    San Sebastián
     

    35th International Symposium on Intensive Care and Emergency Medicine, 17-20 Marzo 2015

    Categories like Medical, Emergency, Medicine, Emergency Medicine, Intensive Care, Health Care and Treatment.

    Bruselas
     

    EMPaCI (Enfoque multidisciplinar del paciente crítico infectado), 12-13 Febrero 2015

    Enfoque multidisciplinar del paciente crítico infectado.

    Madrid
     

    20th Symposium on Infections in the Critically III Patient , 6-7 Febrero 2015

    ESCMID. European Society of Clinical Microbiology and Infectious Diseases.

    Barcelona

    Noticias

    Última modificación: 02/12/2016