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2.
Stroke ; 44(10): 2681-7, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23963331

RESUMO

BACKGROUND AND PURPOSE: Granulocyte colony-stimulating factor (G-CSF; AX200; Filgrastim) is a stroke drug candidate with excellent preclinical evidence for efficacy. A previous phase IIa dose-escalation study suggested potential efficacy in humans. The present large phase IIb trial was powered to detect clinical efficacy in acute ischemic stroke patients. METHODS: G-CSF (135 µg/kg body weight intravenous over 72 hours) was tested against placebo in 328 patients in a multinational, multicenter, randomized, and placebo-controlled trial (NCT00927836; www.clinicaltrial.gov). Main inclusion criteria were ≤9-hour time window after stroke onset, infarct localization in the middle cerebral artery territory, baseline National Institutes of Health Stroke Scale score range of 6 to 22, and baseline diffusion-weighted imaging lesion size ≥15 mL. Primary and secondary end points were the modified Rankin scale score and the National Institutes of Health Stroke Scale score at day 90, respectively. Data were analyzed using a prespecified model that adjusted for age, National Institutes of Health Stroke Scale score at baseline, and initial infarct volume (diffusion-weighted imaging). RESULTS: G-CSF treatment failed to meet the primary and secondary end points of the trial. For additional end points such as mortality, Barthel index, or infarct size at day 30, G-CSF did not show efficacy either. There was, however, a trend for reduced infarct growth in the G-CSF group. G-CSF showed the expected peripheral pharmacokinetic and pharmacodynamic profiles, with a strong increase in leukocytes and monocytes. In parallel, the cytokine profile showed a significant decrease of interleukin-1. CONCLUSIONS: G-CSF, a novel and promising drug candidate with a comprehensive preclinical and clinical package, did not provide any significant benefit with respect to either clinical outcome or imaging biomarkers. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00927836.


Assuntos
Infarto Encefálico , Fator Estimulador de Colônias de Granulócitos , Acidente Vascular Cerebral , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Infarto Encefálico/diagnóstico por imagem , Infarto Encefálico/tratamento farmacológico , Infarto Encefálico/metabolismo , Imagem de Difusão por Ressonância Magnética/métodos , Feminino , Filgrastim , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/efeitos adversos , Fator Estimulador de Colônias de Granulócitos/farmacocinética , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Proteínas Recombinantes/farmacocinética , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/metabolismo , Fatores de Tempo
5.
Rev Esp Cardiol ; 60(7): 753-69, 2007 Jul.
Artigo em Espanhol | MEDLINE | ID: mdl-17663860

RESUMO

Stroke is the second cause of death and the first cause of disability with an important economical cost. Thrombolysis and stroke units are the major contribution to stroke treatment of the last years changing a nihilist therapeutic attitude towards an active attitude, stroke is a medical emergency. Treatment with rtPA has shown to be effective in the first 3 hours following stroke and the FDA and the European Medical Agency (EMEA) have approved its use. A protocolised management of the acute phase to treat physiological complications is the mainstone of stroke units showing a reduction in mortality and disability. Multiple strategies are under development in order to treat more patients, drugs with a longer therapeutic window, intravenous thrombolysis followed by intrarterial thrombolysis, selection of patients with mismatch with new neuroimaging techniques and neuroprotective therapies. Preventive treatment has also experienced a change due to a better knowledge of the ethiopathogeny, the role of vascular risk factors and the development of new preventive drugs. Knowledge of cerebrovascular diseases is today's clue for the best treatment of our patients.


Assuntos
Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Humanos , Acidente Vascular Cerebral/tratamento farmacológico
6.
Rev. esp. cardiol. (Ed. impr.) ; 60(7): 753-769, jul. 2007. ilus, tab
Artigo em Es | IBECS | ID: ibc-058065

RESUMO

En nuestro medio, el ictus es la segunda causa de muerte y la primera de discapacidad, con un gran impacto económico. La trombolisis y las unidades de ictus son la mayor contribución al tratamiento del ictus de los últimos años y han cambiado una actitud nihilista por una actitud activa, ya que el ictus es una emergencia médica. El activador tisular del plasminógeno recombinante es eficaz en las primeras 3 h del inicio del ictus y la Food and Drug Administration y la Agencia Europea del Medicamento han aprobado su uso. La actuación protocolizada durante la fase aguda para corregir alteraciones fisiológicas es el fundamento de las unidades de ictus, y muestra una reducción de la mortalidad y la discapacidad. Se están desarrollando múltiples estrategias para tratar a un mayor número de pacientes, como los fármacos con mayor ventana terapéutica, la trombolisis intravenosa combinada con intraarterial, la identificación de pacientes con penumbra isquémica mediante nuevas técnicas de neuroimagen y los tratamientos neuroprotectores para evitar mayor daño cerebral. El tratamiento preventivo también ha experimentado un cambio por el mejor conocimiento de la etiopatogenia, el papel de los factores de riesgo vascular y el desarrollo de nuevos fármacos. El conocimiento de la enfermedad cerebrovascular y su adecuado tratamiento es hoy día imprescindible para el mejor tratamiento de los pacientes con ictus (AU)


Stroke is the second cause of death and the first cause of disability with an important economical cost. Thrombolysis and stroke units are the major contribution to stroke treatment of the last years changing a nihilist therapeutic attitude towards an active attitude, stroke is a medical emergency. Treatment with rtPA has shown to be effective in the first 3 hours following stroke and the FDA and the European Medical Agency (EMEA) have approved its use. A protocolised management of the acute phase to treat physiological complications is the mainstone of stroke units showing a reduction in mortality and disability. Multiple strategies are under development in order to treat more patients, drugs with a longer therapeutic window, intravenous thrombolysis followed by intrarterial thrombolysis, selection of patients with mismatch with new neuroimaging techniques and neuroprotective therapies. Preventive treatment has also experienced a change due to a better knowledge of the ethiopathogeny, the role of vascular risk factors and the development of new preventive drugs. Knowledge of cerebrovascular diseases is today's clue for the best treatment of our patients (AU)


Assuntos
Humanos , Acidente Vascular Cerebral/diagnóstico , Técnicas de Diagnóstico Cardiovascular , Acidente Vascular Cerebral/classificação , Acidente Vascular Cerebral/prevenção & controle , Acidente Vascular Cerebral/terapia , Terapia Trombolítica/métodos , Angioplastia Coronária com Balão/métodos , Risco , Prevenção Primária , Anticoagulantes/uso terapêutico
7.
Rev. Rol enferm ; 25(2): 98-104, feb. 2002. ilus, tab
Artigo em Es | IBECS | ID: ibc-26116

RESUMO

Tras una breve introducción sobre qué es una Unidad de Ictus, se describe el proyecto de la Unidad de Ictus del Hospital Universitario Dr. Josep Trueta de Gerona. Posteriormente se analizan su desarrollo y los resultados obtenidos en el tiempo. Se concluye un considerable aumento de beneficios para los pacientes, al tratarlos con nuevas pautas terapéuticas en una unidad especializada y la posibilidad de desarrollar nuevas líneas de investigación, tanto para los médicos como para enfermería (AU)


Assuntos
Idoso , Feminino , Masculino , Humanos , Acidente Vascular Cerebral/enfermagem , Unidades de Terapia Intensiva/organização & administração , Instituições de Cuidados Especializados de Enfermagem/organização & administração , Cuidados de Enfermagem/métodos
8.
Rev. Rol enferm ; 25(2): 106-110, feb. 2002.
Artigo em Es | IBECS | ID: ibc-26123

RESUMO

El manejo del ictus requiere un esfuerzo urgente, coordinado y multidisciplinario. El tratamiento farmacológico en la fase aguda del mismo es un paso más en el tratamiento integrado de nuestros pacientes. Nos centraremos en los fármacos específicamente indicados en el caso del ictus agudo, sin entrar en el manejo estándar de soporte ni en el abordaje de las complicaciones más habituales (AU)


Assuntos
Humanos , Acidente Vascular Cerebral/tratamento farmacológico , Cuidados Críticos/métodos , Cuidados de Enfermagem/métodos , Terapia Trombolítica/métodos , Fármacos Neuroprotetores/uso terapêutico , Aspirina/uso terapêutico , Heparina/uso terapêutico , Corticosteroides , Manitol
9.
Rev Enferm ; 25(2): 18-24, 2002 Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-13677777

RESUMO

After a brief introduction about what an lctus Word is, the authors describe the project for an lctus Ward at the Dr. Josep Trueta University Hospital in Girona. Afterwards, the authors analyze its development and its results during its existence. The authors conclude that there has been a significant increase in benefits for patients since they have received new therapeutic treatments in a specialized ward, furthermore, both doctors and nurses have had the opportunity to develop new research projects.


Assuntos
Unidades Hospitalares/organização & administração , Neurologia , Acidente Vascular Cerebral/terapia , Hospitais Universitários , Humanos , Espanha
10.
Rev Enferm ; 25(2): 26-30, 2002 Feb.
Artigo em Espanhol | MEDLINE | ID: mdl-13677778

RESUMO

Ictus treatment requires an urgent, coordinated, multidisciplinary effort be carried out. Pharmacological treatment of an acute phase of Ictus is another step in an integrated treatment of our patients. The author will concentrate on the specific pharmacological treatment indicated to care for acute Ictus without dealing with the standard support care nor with the treatment of the most usual complications.


Assuntos
Acidente Vascular Cerebral/tratamento farmacológico , Doença Aguda , Humanos , Terapia Trombolítica
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