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mientras que est&#225;n demostrados los efectos del tocilizumab como anticuerpo monoclonal humano recombinante antagonizando el receptor de la IL-6<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Durante esta pandemia&#44; un gran n&#250;mero de pacientes han recibido una gran variedad de terapias en todo tipo de combinaciones&#46; Dentro de estas combinaciones&#44; basados en las premisas descritas&#44; se ha producido el empleo combinado de tocilizumab y corticoides&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">En este contexto&#44; hemos querido analizar el impacto de la terapia combinada de tocilizumab y corticoideo&#44; en la supervivencia a corto plazo &#40;28 d&#237;as&#41;&#44; de los enfermos ingresados en una unidad de cuidados intensivos &#40;UCI&#41; por SARS-CoV-2&#46; Para ello&#44; realizamos un estudio retrospectivo de todos los casos hospitalizados por infecci&#243;n por SARS-CoV-2&#44; ingresados entre el 15 de marzo y el 5 de diciembre de 2020&#46; Se clasific&#243; a los enfermos en 4 grupos atendiendo a las diferentes combinaciones&#58; grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Se consider&#243; el uso de tocilizumab en aquellos enfermos con progresi&#243;n cl&#237;nica con PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>300 y dimero D<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>1&#46;500<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;o en aumento progresivo&#41; o IL-6<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>40<span class="elsevierStyleHsp" style=""></span>pg&#47;ml o ferritina elevada&#46; La dosis administrada fue&#44; en pacientes con peso<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>75<span class="elsevierStyleHsp" style=""></span>kg&#58; una dosis &#250;nica de 600<span class="elsevierStyleHsp" style=""></span>mg&#59; y en pacientes con<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>74<span class="elsevierStyleHsp" style=""></span>kg&#58; una dosis &#250;nica de 400<span class="elsevierStyleHsp" style=""></span>mg&#46; Cinco enfermos recibieron una segunda dosis de tocilizumab&#44; 6 enfermos recibieron 3 dosis de tocilizumab y 2 enfermos recibieron 4 dosis de tocilizumab&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Se registr&#243; el uso de corticoide como una variable binaria &#40;S&#237; o No&#41; si al menos los pacientes recib&#237;an 40<span class="elsevierStyleHsp" style=""></span>mg de metilprednisolona&#44; o su equivalencia&#44; durante un per&#237;odo de al menos 3 d&#237;as con el fin de tratar la inflamaci&#243;n asociada con la neumon&#237;a viral&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Se realiz&#243; inicialmente un an&#225;lisis descriptivo de la muestra y posteriormente una regresi&#243;n de Cox y un an&#225;lisis de supervivencia a 28 d&#237;as con el m&#233;todo de Kaplan-Meier para la variable de tiempo de muerte&#46; Las curvas de supervivencia se compararon mediante el test de log-rank&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">En el periodo estudiado&#44; ingresaron un total de 254 enfermos&#46; Fueron excluidos del an&#225;lisis 46 pacientes por falta de datos o no confirmaci&#243;n de la presencia de SARS-CoV-2&#46; Se analizaron 208 enfermos&#46; Las principales caracter&#237;sticas de los 4 grupos de pacientes se muestran en la <a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0045" class="elsevierStylePara elsevierViewall">Mediante un an&#225;lisis de regresi&#243;n de Cox &#40;m&#233;todo&#58; intro&#59; estado&#58; fallecimiento en UCI&#59; utilizando como covariables&#58; la edad&#44; el sexo&#44; las comorbilidades de los pacientes&#44; las terapias implicadas en el tratamiento&#44; la escala SOFA&#44; la PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span> al ingreso&#44; los valores anal&#237;ticos y las terapias de soporte ventilatorio&#41;&#44; la PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span> al ingreso en UCI se comport&#243; como un factor protector frente a mortalidad &#40;HR&#58; 0&#44;98&#59; IC95&#37;&#58; 0&#44;97-0&#44;99&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;01&#41;&#46; De las terapias evaluadas&#44; el uso combinado de corticoides y tocilizumab se asoci&#243; con una mejora en la supervivencia en la UCI &#40;HR&#58; 9&#46;623&#59; IC95&#37;&#58; 2&#44;39-38&#44;69&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46; No se encontraron asociaciones significativas con el resto de variables analizadas&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">En el an&#225;lisis de supervivencia a 28 d&#237;as&#44; el grupo de terapia combinada de tocilizumab y corticoide mostr&#243; una mayor probabilidad significativa de sobrevivir a los 28 d&#237;as &#40;OR&#58; 2&#44;83&#59; IC95&#37;&#58; 1&#44;24-6&#44;44&#41; frente a no recibir tocilizumab y corticoide&#46; No se observ&#243; esta diferencia significativa en la comparaci&#243;n con los otros 2 grupos analizados&#58; OR&#58; 1&#44;26&#59; IC95&#37;&#58; 0&#44;54-2&#44;94 frente al tratamiento con tocilizumab&#59; OR&#58; 1&#44;31&#59; IC95&#37;&#58; 0&#44;57-3&#44;01 frente al tratamiento corticoideo &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0055" class="elsevierStylePara elsevierViewall">Actualmente&#44; los estudios m&#225;s consistentes y recientes que evaluaron el tocilizumab en monoterapia en la COVID-19 no revelaron ning&#250;n efecto beneficioso<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">5&#8211;7</span></a>&#46; Estos datos pueden demostrar que bloquear una sola citoquina no es suficiente para tener un impacto cl&#237;nico significativo en estos pacientes&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Del mismo modo&#44; podr&#237;a interpretarse que usar una dosis fija de esteroides independientemente de la gravedad de la enfermedad&#44; de la tormenta de citoquinas desarrollada o de la presencia de s&#237;ndrome de dificultad respiratoria aguda&#44; resultar&#237;a insuficiente en muchos de estos enfermos<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Nuestros resultados se encuentran en consonancia con los datos del estudio REMAP-CAP<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">9</span></a> que evalu&#243; el empleo de tocilizumab entre una poblaci&#243;n de pacientes que ingresaron en la UCI para soporte org&#225;nico&#46; En el mismo&#44; se evidenci&#243; que la adici&#243;n de tocilizumab al empleo de dexametasona mejoraba la mortalidad de la muestra&#46; En la misma l&#237;nea&#44; el trabajo de Mikulska et al&#46; mostr&#243; que el impacto negativo de la respuesta inmunitaria en COVID-19 podr&#237;a mitigarse mediante la administraci&#243;n temprana de tratamiento corticoideo m&#225;s tocilizumab<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Por otro lado&#44; queremos destacar c&#243;mo en el grupo que &#250;nicamente recibi&#243; tratamiento con tocilizumab presentaban peor oxigenaci&#243;n al ingreso&#44; desarrollaron mayor necesidad de vasopresores y terapias de reemplazo renal durante su ingreso en UCI&#44; as&#237; como desarrollaron m&#225;s sobreinfecci&#243;n nosocomial&#44; entre ellos traqueobronquitis y neumon&#237;as asociadas a ventilaci&#243;n mec&#225;nica &#40;TAVM&#47;NAVM&#41;&#46; En este sentido es un hecho constatado en la bibliograf&#237;a que las infecciones de las v&#237;as respiratorias altas son los efectos adversos m&#225;s conocidos del tocilizumab<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">11&#44;12</span></a>&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Nuestro estudio presenta varias limitaciones&#58; es una serie relativamente peque&#241;a de pacientes procedentes de un solo hospital&#46; Por otro lado&#44; son resultados obtenidos en plena pandemia con saturaci&#243;n de los servicios y en ocasiones con personal m&#233;dico y de enfermer&#237;a frecuentemente no experto&#46; Ninguno de los tratamientos se aplic&#243; de forma aleatorizada&#44; sino en el mejor criterio de los profesionales&#46; Recordando adem&#225;s que existen contraindicaciones espec&#237;ficas para el uso del tocilizumab&#44; como la presencia de fallo hep&#225;tico o infecciones previas que pueden incidir en un sesgo de selecci&#243;n de los pacientes a priori&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Actualmente podr&#237;a considerarse prematura la indicaci&#243;n de la terapia combinada de tocilizumab m&#225;s corticoides&#44; siendo necesarios nuevos estudios aleatorizados para establecer las mejores opciones de tratamiento&#44; duraci&#243;n y limitaciones&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financiaci&#243;n</span><p id="par0085" class="elsevierStylePara elsevierViewall">El presente manuscrito no ha recibido financiaci&#243;n alguna&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicto de intereses</span><p id="par0090" class="elsevierStylePara elsevierViewall">Todos los autores reconocen no presentar conflicto de intereses en la realizaci&#243;n del presente trabajo&#46;</p></span></span>"
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          "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">An&#225;lisis de supervivencia &#40;Kaplan-Meier&#41; referido a la supervivencia a los 28 d&#237;as en los 4 grupos establecidos&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">CK&#58; creatin quinasa&#59; DD&#58; d&#237;mero D&#59; DM&#58; diabetes mellitus&#59; ECMO&#58; circuito de oxigenaci&#243;n extracorp&#243;rea&#59; HFNO&#58; High Flow Nasal Oxygen&#59; HTA&#58; hipertensi&#243;n arterial&#59; IL-6&#58; interleucina 6&#59; iNO&#58; &#243;xido n&#237;trico inhalado&#59; LDH&#58; lactato deshidrogenasa&#59; NAVM&#58; neumon&#237;a asociada a ventilaci&#243;n mec&#225;nica&#59; PCR&#58; prote&#237;na C reactiva&#59; SAMR&#58; <span class="elsevierStyleItalic">Staphylococcus aureus</span> meticil&#237;n resistente&#59; TAVM&#58; traqueobronquitis asociada a ventilaci&#243;n mec&#225;nica&#59; TRR&#58; terapias de reemplazo renal&#59; VMI&#58; ventilaci&#243;n mec&#225;nica invasiva&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Valores de referencia&#58; CK &#40;46-171<span class="elsevierStyleHsp" style=""></span>U&#47;l&#41;&#59; DD &#40;0-500 &#40;ng&#47;ml&#41;&#59; IL6 &#40;&#60;<span class="elsevierStyleHsp" style=""></span>5<span class="elsevierStyleHsp" style=""></span>pg&#47;l&#41;&#59; PCR &#40;&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;5<span class="elsevierStyleHsp" style=""></span>g&#47;dl&#41;&#59; LDH &#40;120-246<span class="elsevierStyleHsp" style=""></span>U&#47;l&#41;&#59; ferritina &#40;22-322<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#41;&#46;</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">La tabla muestra los valores de OR con su intervalo de confianza al 95&#37;&#46;</p>"
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Dislipidemia&#44; n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">SOFA score&#44; media &#40;DE&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">PaO</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">&#47;FiO</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">al ingreso en UCI&#44; media &#40;DE&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">Datos de laboratorio al ingreso en UCI</span></td></tr><tr title="table-row"><td class="td-with-role" title="\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>DD&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>IL-6&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>PCR&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>LDH&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">469 &#40;512&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Ferritina&#44; media&#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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Carta científica
Terapia combinada de tocilizumab y corticoides en la enfermedad grave por SARS-CoV-2
Combined therapy of tocilizumab and corticosteroids in severe SARS-CoV-2 disease
A. González-Castro
Autor para correspondencia
e409@humv.es

Autor para correspondencia.
, E. Cuenca Fito, A. Fernandez, P. Escudero Acha, J.C. Rodríguez Borregán, Y. Peñasco
Servicio de Medicina Intensiva, Hospital Universitario Marqués de Valdecilla, Santander, España
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mientras que est&#225;n demostrados los efectos del tocilizumab como anticuerpo monoclonal humano recombinante antagonizando el receptor de la IL-6<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">4</span></a>&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Durante esta pandemia&#44; un gran n&#250;mero de pacientes han recibido una gran variedad de terapias en todo tipo de combinaciones&#46; Dentro de estas combinaciones&#44; basados en las premisas descritas&#44; se ha producido el empleo combinado de tocilizumab y corticoides&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">En este contexto&#44; hemos querido analizar el impacto de la terapia combinada de tocilizumab y corticoideo&#44; en la supervivencia a corto plazo &#40;28 d&#237;as&#41;&#44; de los enfermos ingresados en una unidad de cuidados intensivos &#40;UCI&#41; por SARS-CoV-2&#46; Para ello&#44; realizamos un estudio retrospectivo de todos los casos hospitalizados por infecci&#243;n por SARS-CoV-2&#44; ingresados entre el 15 de marzo y el 5 de diciembre de 2020&#46; Se clasific&#243; a los enfermos en 4 grupos atendiendo a las diferentes combinaciones&#58; grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Se consider&#243; el uso de tocilizumab en aquellos enfermos con progresi&#243;n cl&#237;nica con PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>300 y dimero D<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>1&#46;500<span class="elsevierStyleHsp" style=""></span>ng&#47;ml &#40;o en aumento progresivo&#41; o IL-6<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>40<span class="elsevierStyleHsp" style=""></span>pg&#47;ml o ferritina elevada&#46; La dosis administrada fue&#44; en pacientes con peso<span class="elsevierStyleHsp" style=""></span>&#62;<span class="elsevierStyleHsp" style=""></span>75<span class="elsevierStyleHsp" style=""></span>kg&#58; una dosis &#250;nica de 600<span class="elsevierStyleHsp" style=""></span>mg&#59; y en pacientes con<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>74<span class="elsevierStyleHsp" style=""></span>kg&#58; una dosis &#250;nica de 400<span class="elsevierStyleHsp" style=""></span>mg&#46; Cinco enfermos recibieron una segunda dosis de tocilizumab&#44; 6 enfermos recibieron 3 dosis de tocilizumab y 2 enfermos recibieron 4 dosis de tocilizumab&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Se registr&#243; el uso de corticoide como una variable binaria &#40;S&#237; o No&#41; si al menos los pacientes recib&#237;an 40<span class="elsevierStyleHsp" style=""></span>mg de metilprednisolona&#44; o su equivalencia&#44; durante un per&#237;odo de al menos 3 d&#237;as con el fin de tratar la inflamaci&#243;n asociada con la neumon&#237;a viral&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">Se realiz&#243; inicialmente un an&#225;lisis descriptivo de la muestra y posteriormente una regresi&#243;n de Cox y un an&#225;lisis de supervivencia a 28 d&#237;as con el m&#233;todo de Kaplan-Meier para la variable de tiempo de muerte&#46; Las curvas de supervivencia se compararon mediante el test de log-rank&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">En el periodo estudiado&#44; ingresaron un total de 254 enfermos&#46; Fueron excluidos del an&#225;lisis 46 pacientes por falta de datos o no confirmaci&#243;n de la presencia de SARS-CoV-2&#46; Se analizaron 208 enfermos&#46; Las principales caracter&#237;sticas de los 4 grupos de pacientes se muestran en la <a class="elsevierStyleCrossRef" href="#tbl0005">tabla 1</a>&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0045" class="elsevierStylePara elsevierViewall">Mediante un an&#225;lisis de regresi&#243;n de Cox &#40;m&#233;todo&#58; intro&#59; estado&#58; fallecimiento en UCI&#59; utilizando como covariables&#58; la edad&#44; el sexo&#44; las comorbilidades de los pacientes&#44; las terapias implicadas en el tratamiento&#44; la escala SOFA&#44; la PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span> al ingreso&#44; los valores anal&#237;ticos y las terapias de soporte ventilatorio&#41;&#44; la PaO<span class="elsevierStyleInf">2</span>&#47;FiO<span class="elsevierStyleInf">2</span> al ingreso en UCI se comport&#243; como un factor protector frente a mortalidad &#40;HR&#58; 0&#44;98&#59; IC95&#37;&#58; 0&#44;97-0&#44;99&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;01&#41;&#46; De las terapias evaluadas&#44; el uso combinado de corticoides y tocilizumab se asoci&#243; con una mejora en la supervivencia en la UCI &#40;HR&#58; 9&#46;623&#59; IC95&#37;&#58; 2&#44;39-38&#44;69&#59; p<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>0&#44;001&#41;&#46; No se encontraron asociaciones significativas con el resto de variables analizadas&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">En el an&#225;lisis de supervivencia a 28 d&#237;as&#44; el grupo de terapia combinada de tocilizumab y corticoide mostr&#243; una mayor probabilidad significativa de sobrevivir a los 28 d&#237;as &#40;OR&#58; 2&#44;83&#59; IC95&#37;&#58; 1&#44;24-6&#44;44&#41; frente a no recibir tocilizumab y corticoide&#46; No se observ&#243; esta diferencia significativa en la comparaci&#243;n con los otros 2 grupos analizados&#58; OR&#58; 1&#44;26&#59; IC95&#37;&#58; 0&#44;54-2&#44;94 frente al tratamiento con tocilizumab&#59; OR&#58; 1&#44;31&#59; IC95&#37;&#58; 0&#44;57-3&#44;01 frente al tratamiento corticoideo &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>&#41;&#46;</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0055" class="elsevierStylePara elsevierViewall">Actualmente&#44; los estudios m&#225;s consistentes y recientes que evaluaron el tocilizumab en monoterapia en la COVID-19 no revelaron ning&#250;n efecto beneficioso<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">5&#8211;7</span></a>&#46; Estos datos pueden demostrar que bloquear una sola citoquina no es suficiente para tener un impacto cl&#237;nico significativo en estos pacientes&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Del mismo modo&#44; podr&#237;a interpretarse que usar una dosis fija de esteroides independientemente de la gravedad de la enfermedad&#44; de la tormenta de citoquinas desarrollada o de la presencia de s&#237;ndrome de dificultad respiratoria aguda&#44; resultar&#237;a insuficiente en muchos de estos enfermos<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">8</span></a>&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">Nuestros resultados se encuentran en consonancia con los datos del estudio REMAP-CAP<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">9</span></a> que evalu&#243; el empleo de tocilizumab entre una poblaci&#243;n de pacientes que ingresaron en la UCI para soporte org&#225;nico&#46; En el mismo&#44; se evidenci&#243; que la adici&#243;n de tocilizumab al empleo de dexametasona mejoraba la mortalidad de la muestra&#46; En la misma l&#237;nea&#44; el trabajo de Mikulska et al&#46; mostr&#243; que el impacto negativo de la respuesta inmunitaria en COVID-19 podr&#237;a mitigarse mediante la administraci&#243;n temprana de tratamiento corticoideo m&#225;s tocilizumab<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">10</span></a>&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Por otro lado&#44; queremos destacar c&#243;mo en el grupo que &#250;nicamente recibi&#243; tratamiento con tocilizumab presentaban peor oxigenaci&#243;n al ingreso&#44; desarrollaron mayor necesidad de vasopresores y terapias de reemplazo renal durante su ingreso en UCI&#44; as&#237; como desarrollaron m&#225;s sobreinfecci&#243;n nosocomial&#44; entre ellos traqueobronquitis y neumon&#237;as asociadas a ventilaci&#243;n mec&#225;nica &#40;TAVM&#47;NAVM&#41;&#46; En este sentido es un hecho constatado en la bibliograf&#237;a que las infecciones de las v&#237;as respiratorias altas son los efectos adversos m&#225;s conocidos del tocilizumab<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">11&#44;12</span></a>&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">Nuestro estudio presenta varias limitaciones&#58; es una serie relativamente peque&#241;a de pacientes procedentes de un solo hospital&#46; Por otro lado&#44; son resultados obtenidos en plena pandemia con saturaci&#243;n de los servicios y en ocasiones con personal m&#233;dico y de enfermer&#237;a frecuentemente no experto&#46; Ninguno de los tratamientos se aplic&#243; de forma aleatorizada&#44; sino en el mejor criterio de los profesionales&#46; Recordando adem&#225;s que existen contraindicaciones espec&#237;ficas para el uso del tocilizumab&#44; como la presencia de fallo hep&#225;tico o infecciones previas que pueden incidir en un sesgo de selecci&#243;n de los pacientes a priori&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">Actualmente podr&#237;a considerarse prematura la indicaci&#243;n de la terapia combinada de tocilizumab m&#225;s corticoides&#44; siendo necesarios nuevos estudios aleatorizados para establecer las mejores opciones de tratamiento&#44; duraci&#243;n y limitaciones&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Financiaci&#243;n</span><p id="par0085" class="elsevierStylePara elsevierViewall">El presente manuscrito no ha recibido financiaci&#243;n alguna&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicto de intereses</span><p id="par0090" class="elsevierStylePara elsevierViewall">Todos los autores reconocen no presentar conflicto de intereses en la realizaci&#243;n del presente trabajo&#46;</p></span></span>"
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          "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">An&#225;lisis de supervivencia &#40;Kaplan-Meier&#41; referido a la supervivencia a los 28 d&#237;as en los 4 grupos establecidos&#46;</p> <p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">CK&#58; creatin quinasa&#59; DD&#58; d&#237;mero D&#59; DM&#58; diabetes mellitus&#59; ECMO&#58; circuito de oxigenaci&#243;n extracorp&#243;rea&#59; HFNO&#58; High Flow Nasal Oxygen&#59; HTA&#58; hipertensi&#243;n arterial&#59; IL-6&#58; interleucina 6&#59; iNO&#58; &#243;xido n&#237;trico inhalado&#59; LDH&#58; lactato deshidrogenasa&#59; NAVM&#58; neumon&#237;a asociada a ventilaci&#243;n mec&#225;nica&#59; PCR&#58; prote&#237;na C reactiva&#59; SAMR&#58; <span class="elsevierStyleItalic">Staphylococcus aureus</span> meticil&#237;n resistente&#59; TAVM&#58; traqueobronquitis asociada a ventilaci&#243;n mec&#225;nica&#59; TRR&#58; terapias de reemplazo renal&#59; VMI&#58; ventilaci&#243;n mec&#225;nica invasiva&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Grupo A&#58; no recibieron ni tratamiento corticoideo ni tocilizumab&#59; grupo B&#58; recibieron terapia combinada con corticoide y tocilizumab&#59; grupo C&#58; &#250;nicamente recibieron tocilizumab&#59; grupo D&#58; &#250;nicamente recibieron corticoide&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Valores de referencia&#58; CK &#40;46-171<span class="elsevierStyleHsp" style=""></span>U&#47;l&#41;&#59; DD &#40;0-500 &#40;ng&#47;ml&#41;&#59; IL6 &#40;&#60;<span class="elsevierStyleHsp" style=""></span>5<span class="elsevierStyleHsp" style=""></span>pg&#47;l&#41;&#59; PCR &#40;&#60;<span class="elsevierStyleHsp" style=""></span>0&#44;5<span class="elsevierStyleHsp" style=""></span>g&#47;dl&#41;&#59; LDH &#40;120-246<span class="elsevierStyleHsp" style=""></span>U&#47;l&#41;&#59; ferritina &#40;22-322<span class="elsevierStyleHsp" style=""></span>ng&#47;ml&#41;&#46;</p><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">La tabla muestra los valores de OR con su intervalo de confianza al 95&#37;&#46;</p>"
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>Dislipidemia&#44; n &#40;&#37;&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">SOFA score&#44; media &#40;DE&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleItalic">PaO</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">&#47;FiO</span><span class="elsevierStyleInf"><span class="elsevierStyleItalic">2</span></span><span class="elsevierStyleItalic">al ingreso en UCI&#44; media &#40;DE&#41;</span>&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>DD&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>IL-6&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t"><span class="elsevierStyleHsp" style=""></span>PCR&#44; media &#40;DE&#41;&nbsp;\t\t\t\t\t\t\n
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