<?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>1025-0255</journal-id>
<journal-title><![CDATA[Revista Archivo Médico de Camagüey]]></journal-title>
<abbrev-journal-title><![CDATA[AMC]]></abbrev-journal-title>
<issn>1025-0255</issn>
<publisher>
<publisher-name><![CDATA[Universidad de Ciencias Médicas de Camagüey]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S1025-02552019000400455</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Estrategia de desarrollo clínico para la evaluación de la eficacia y seguridad de SURFACEN(]]></article-title>
<article-title xml:lang="en"><![CDATA[Clinical development strategy for the evaluation of the efficacy and safety of SURFACEN (]]></article-title>
</title-group>
<contrib-group>
<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[Morilla-Guzmán]]></surname>
<given-names><![CDATA[Andrés Armando]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Rodríguez-Moya]]></surname>
<given-names><![CDATA[Valentín Santiago]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<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-group>
<aff id="Af1">
<institution><![CDATA[,Centro Nacional de Sanidad Agropecuaria (CENSA) de Mayabeque  ]]></institution>
<addr-line><![CDATA[ Mayabeque]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad de Ciencias Médicas de La Habana Hospital Materno Infantil Dr. Ángel Arturo Aballí Servicio de Neonatología]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Universidad de Ciencias Médicas de Camagüey Hospital General Docente Martín Chang Puga de Nuevitas Servicio de Pediatría]]></institution>
<addr-line><![CDATA[ Camagüey]]></addr-line>
<country>Cuba</country>
</aff>
<aff id="Af4">
<institution><![CDATA[,Centro Nacional Coordinador de Ensayos Clínicos  ]]></institution>
<addr-line><![CDATA[ La Habana]]></addr-line>
<country>Cuba</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2019</year>
</pub-date>
<volume>23</volume>
<numero>4</numero>
<fpage>455</fpage>
<lpage>463</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_arttext&amp;pid=S1025-02552019000400455&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_abstract&amp;pid=S1025-02552019000400455&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.sld.cu/scielo.php?script=sci_pdf&amp;pid=S1025-02552019000400455&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN  Fundamento:  el primer reporte de la eficacia de un surfactante pulmonar exógeno en el tratamiento de la enfermedad de membrana hialina data de 1980. A partir de ese hallazgo diferentes grupos de investigadores en todo el mundo dedican sus esfuerzos al desarrollo de surfactantes pulmonares ya sean naturales o sintéticos.  Objetivo:  desarrollar una estrategia para la evaluación de la eficacia y seguridad de Surfacen® en el tratamiento, que permitiera su registro e introducción a la práctica habitual.  Métodos:  para demostrar la eficacia y seguridad de Surfacen® en el tratamiento del síndrome de dificultad respiratoria en recién nacidos pretérmino, se realizaron ensayos clínicos y la fármaco-vigilancia. En otras indicaciones como el síndrome de dificultad respiratoria aguda en niños y adultos; se ejecutaron ensayos clínicos (fase II, III y IV). En todos los ensayos se siguió la metodología establecida para cada fase.  Resultados:  el Surfacen® demostró su eficacia al mejorar la oxigenación, las variables ventilatorias, las radiográficas, la evolución clínica que contribuyó a reducir la mortalidad en recién nacidos pretérmino, con un perfil de seguridad similar al resto de surfactantes pulmonares comercializados a nivel internacional. La terapia con Surfacen® fue eficaz al reducir la mortalidad en niños (esta última no en adultos), demostró ser bien tolerada y segura al notificarse un número reducido de eventos adversos relacionados con su administración. Los días de estancia en las unidades de cuidados intensivos y días de ventilación mecánica no se modificaron con el esquema de tratamiento evaluado.  Conclusiones:  se registró Surfacen® para las indicaciones terapéuticas estudiadas y se introdujo en la práctica clínica habitual al contribuir a reducir la mortalidad en niños.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT  Background:  the first report of the efficacy of an exogenous pulmonary surfactant in the treatment of the membrane hyaline illness dates back to 1980. From this finding, different groups of investigators worldwide dedicate their efforts to the development of pulmonary surfactants either natural or synthetic.  Objective:  to develop a strategy for the evaluation of the efficacy and safety of Surfacen® in the treatment of respiratory distress syndrome that would allow its registration and introduction to normal practice.  Methods:  to demonstrate the efficacy and safety of Surfacen® in the treatment of RDS in preterm infants, clinical trials and the pharmaco-vigilance were conducted. In other indications such as acute RDS in children and adults; clinical trials (phase II, III and IV) were conducted. In all the trials, the methodology established for each phase was followed.  Results:  Surfacen® demonstrated its efficacy by improving oxygenation, ventilation variables, radiographic ones, clinical evolution and contributed to reduce mortality in preterm infants, with a safety profile similar to the rest of commercially available pulmonary surfactants internationally. Surfacen® therapy proved to be effective in improving oxygenation, ventilation variables, radiographic, clinical evolution, contributed to reduce mortality in children, (the latter not in adults) and proved to be well tolerated and safe to notify a reduced number of adverse events related to its administration. The days of stay in the intensive care units and days of mechanical ventilation were not modified with the treatment scheme evaluated.  Conclusions:  Surfacen® was registered for the therapeutic indications studied and introduced in routine clinical practice contributing to reduce mortality in children.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[SURFACTANTES PULMONARES/administración &amp; dosificación]]></kwd>
<kwd lng="es"><![CDATA[SURFACTANTES PULMONARES/uso terapéutico]]></kwd>
<kwd lng="es"><![CDATA[SÍNDROME DE DIFICULTAD RESPIRATORIA DEL RECIÉN NACIDO/tratamiento farmacológico]]></kwd>
<kwd lng="es"><![CDATA[RECIÉN NACIDO PREMATURO]]></kwd>
<kwd lng="es"><![CDATA[ENSAYO CLÍNICO]]></kwd>
<kwd lng="en"><![CDATA[PULMONARY SURFACTANTS/administration &amp; dosage]]></kwd>
<kwd lng="en"><![CDATA[PULMONARY SURFACTANTS/therapeutic use]]></kwd>
<kwd lng="en"><![CDATA[RESPIRATORY DISTRESS SYNDROME]]></kwd>
<kwd lng="en"><![CDATA[NEWBORN/drug therapy]]></kwd>
<kwd lng="en"><![CDATA[INFANT]]></kwd>
<kwd lng="en"><![CDATA[PREMATURE]]></kwd>
<kwd lng="en"><![CDATA[CLINICAL TRIAL]]></kwd>
</kwd-group>
</article-meta>
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