<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0028-3746</journal-id>
<journal-title><![CDATA[Neumología y cirugía de tórax]]></journal-title>
<abbrev-journal-title><![CDATA[Neumol. cir. torax]]></abbrev-journal-title>
<issn>0028-3746</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Mexicana de Neumología y Cirugía de Tórax; Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas; Sociedad Cubana de Neumología; Sociedad Paraguaya de Neumología; Sociedad Boliviana de Neumología.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0028-37462019000300296</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Evaluación de la seguridad del uso poscomercial del surfactante cubano, SURFACEN®, en el tratamiento del síndrome de dificultad respiratoria aguda del adulto]]></article-title>
<article-title xml:lang="en"><![CDATA[Safety&#8217;s evaluation the post-commercial use of Cuban surfactant, SURFACEN®, in the treatment of acute respiratory distress syndrome in adults]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Barrese Pérez]]></surname>
<given-names><![CDATA[Yinet]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Lim Alonso]]></surname>
<given-names><![CDATA[Nora]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Díaz Casañas]]></surname>
<given-names><![CDATA[Elaine]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Uranga Piña]]></surname>
<given-names><![CDATA[Rolando]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ávila Albuerne]]></surname>
<given-names><![CDATA[Yisel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional Coordinador de Ensayos Clínicos  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Hospital Hermanos Ameijeiras  ]]></institution>
<addr-line><![CDATA[La Habana ]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Centro Nacional de Sanidad Agropecuaria  ]]></institution>
<addr-line><![CDATA[San José de las Lajas Mayabeque]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>09</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>09</month>
<year>2019</year>
</pub-date>
<volume>78</volume>
<numero>3</numero>
<fpage>296</fpage>
<lpage>303</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S0028-37462019000300296&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S0028-37462019000300296&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S0028-37462019000300296&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen:  Objetivo: Corroborar la seguridad del tratamiento combinado del SURFACEN® con la terapia estándar de oxigenación y ventilación mecánica en el tratamiento del síndrome de dificultad respiratoria aguda del adulto.  Material y métodos: Pacientes adultos con síndrome de dificultad respiratoria aguda del adulto (141) incluidos en un ensayo clínico fase IV, multicéntrico, no controlado, ni aleatorizado, abierto, en el que se les indicó la instilación endotraqueal de 100 mg SURFACEN® cada 8 horas durante tres días en combinación con la terapia convencional de oxigenación y ventilación mecánica. Se identificaron y cuantificaron los eventos adversos que se clasificaron de acuerdo a la gravedad, seriedad y relación de causalidad con respecto a la instilación del surfactante y se analizó la mortalidad al día 28 de haber sido incluidos a los pacientes en el estudio.  Resultados:  Predominaron los eventos adversos no graves/no serios (57.60%), de intensidad no severa (26.72% leves y 42.89% moderados), no relacionados con la instilación del surfactante (66.67%), reversibles (87.75%) y que no provocaron cambios en el tratamiento (95.02%). La fiebre y la hipotensión arterial fueron los eventos adversos que se reportaron con mayor frecuencia.  Conclusión:  El tratamiento del síndrome de dificultad respiratoria aguda del adulto con SURFACEN® en combinación con la oxigenación y la ventilación mecánica es seguro.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract:  Objective: To corroborate the safety of the combined treatment of Surfacen® with standard oxygenation and mechanical ventilation therapy in the treatment of acute respiratory distress syndrome in adults.  Material and methods: Adult patients with acute respiratory distress syndrome (141) included in a phase IV clinical trial, multicenter, uncontrolled, not randomized, open, in which the endotracheal instillation of 100 mg SURFACEN® was indicated every 8 hours for three days in combination with conventional oxygenation and mechanical ventilation therapy. Adverse events were identified and quantified, which were classified according to severity, seriousness and causality with respect to the instillation of the surfactant and mortality was analyzed at day 28 after the patients had been included in the study.  Results: Non-serious adverse events (57.60%) predominated, non-severe intensity (26.72% mild and 42.89% moderate), unrelated to surfactant instillation (66.67%), predominated. reversible (87.75%) and that did not cause changes in the treatment (95.02%). Fever and hypotension were the most frequently reported adverse events.  Conclusion: The treatment of acute respiratory distress syndrome with SURFACEN® in combination with oxygenation and mechanical ventilation is safe.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Adultos]]></kwd>
<kwd lng="es"><![CDATA[síndrome de dificultad respiratoria aguda del adulto]]></kwd>
<kwd lng="es"><![CDATA[seguridad]]></kwd>
<kwd lng="es"><![CDATA[surfactante]]></kwd>
<kwd lng="en"><![CDATA[Adults]]></kwd>
<kwd lng="en"><![CDATA[acute respiratory distress syndrome]]></kwd>
<kwd lng="en"><![CDATA[security]]></kwd>
<kwd lng="en"><![CDATA[surfactant]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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