Binary option expert review of neurotherapeutics

Intervenção de um Programa de Reminiscência para Melhorar a Qualidade de Vida de Residentes de Cuidados de Longo Prazo com Doença de Alzheimer. A Randomized Controlled Trial Intervenção com um programa de reminiscência para melhorar a qualidade de vida de residentes com Alzheimer com cuidados prolongados. Ensaio controlado randomizado Os links de autores abrem o painel de sobreposição. Os números correspondem à lista de afiliações que podem ser expostos usando o link show more. Faculdade de Psicologia. Departamento de Psicobiologia. Objetivo: Um ensaio controlado randomizado, de grupos paralelos (intervenção, grupo de controle ativo e passivo), com uma única cegueira (ECA) ) Foi escolhido para investigar se um programa específico de reminiscência está associado a níveis mais altos de qualidade de vida em residentes de idosos com demência. Métodos . A intervenção utilizou uma abordagem de história de vida, enquanto os grupos de controle participaram de discussões casuais. A Escala de Engajamento Social (SES) ea Escala de Qualidade de Vida Auto-Reportada (SRQoL) foram utilizadas como medidas de resultado, que foram examinadas no início do estudo (T0), 12 semanas (T1) e seis meses (T2) após a intervenção. A amostra final tinha 135 indivíduos (grupo de controlo activo 45 grupo de controlo passivo 45 grupo de intervenção 45). Resultados . O teste de Wilcoxon mostrou diferenças significativas no grupo de intervenção entre T2 e T0, e entre T1 e T0 no SES, e houve diferenças significativas entre T0 e T1 (efeito efeito intervenção 0,267) e T1 e T2 (efeito intervenção tamanho 0,450) em O SRQoL. Os escores de regressão logística univariada mostraram que os preditores de mudança no SRQoL estavam associados a menos sintomas de ansiedade basais e menores escores de depressão. Conclusões. A intervenção conduziu a diferenças significativas entre os três grupos ao longo do tempo, mostrando melhora significativa na qualidade de vida e envolvimento dos moradores no grupo de intervenção. Objetivo: Elegeu-se um ensaio aleatorizado controlado simples cego, com grupos paralelos (interveno, comparao e controle) para pesquisar se um programa especfico de reminiscncia associa-se com maiores nveis de qualidade de vida em residentes com demncia com cuidados prolongados. Mtodo. No grupo de intervenção usou-se o enfoque da história de vida, enquanto o grupo de controle conversas amistosas. A Escala de Compromisso Social (SES) e uma escala auto-referência de qualidade de vida (SRQoL) foram como medidas de resultados, examinados na linha de base, doze semanas e seis meses aps um interveno. A mostra final teve 135 sujeitos (controle n 45 comparao n 45 interveno n 45). Resultados. Teste de Wilcoxon no grupo intervencional comparando os resultados entre T1 e T0, T2 e T1, e T2 e T0 mostraram diferenças significativas entre T2 e T0 (tamanho do efeito de intervenção 0,460) e T0 SES e entre T0 e T1 (tamanho do efeito de intervenção 0,267) e T1 e T2 (tamanho do efeito de intervenção 0,450) no SRQoL no grupo de interveno. Como pontuaes de regresso logstica univariada mostraram que os preditores de mudana estão associados a menores níveis de ansiedade basal e menores são de depresin. Conclusões. Um interveno produziu diferenças significativas entre os grupos ao longo do tempo, demonstrando uma melhoria na qualidade de vida e compromisso dos residentes no grupo de intervenção. Demência Reminiscência Vida-História Livro Aleatório Ensaio Controlado Enfermagem Cuidados Domiciliares Demncia Reminiscência Livro de História de Vida Ensaio controlado randomizado Cuidados prolongados Outros usuários também visualizaram estes artigosResearch in bipolar disorder (BD) implica fronto-limbic-striatal disfunção durante face emoção processamento, mas é Com a ressonância magnética funcional (IRMf), 181 participantes, incluindo 62 BD (36 crianças e 26 adultos) e 119 indivíduos saudáveis ​​de comparação (HC) (57 crianças e 62 Adultos), envolvidos no processamento constrangido e sem restrições de faces emocionais (raivosos, temerosos, felizes) e não emocionais (neutros). Durante o processamento restrito, os sujeitos responderam a perguntas focando sua atenção no rosto, que foi processado de forma implícita (avaliação da largura do nariz) ou explicitamente (classificações de medo subjetivo de hostilidade). Processamento sem restrição consistia em visualização passiva. BD pediátrico classificava as faces neutras como mais hostis do que outros grupos. Em pacientes BD, as análises de região de interesse corrigidas por erro familiar (FWE) revelaram disfunção na amígdala, giro frontal inferior (IFG), córtex cingulado anterior (ACC) e putamen. Os pacientes com BD mostraram hiperativação da amígdala durante o processamento explícito (classificações de hostilidade) de rostos temerosos e visão passiva de rostos irritados e neutros, mas a hipoativação de IFG durante o processamento implícito de rostos neutros e felizes. No ACC e estriado, a direção da disfunção variou de acordo com a demanda por tarefa: BD demonstrou hiperativação durante o processamento sem restrições de faces irritadas ou neutras, mas hipoativação durante o processamento restrito (implícito ou explícito) de faces zangadas, neutras ou felizes. Findings sugerem hiperativação da amígdala em BD Enquanto processam faces negativamente validadas e neutras, independentemente da condição atencional, e hipoactivação de BD IFG durante o processamento implícito. No circuito de controle cognitivo envolvendo o ACC eo putamen, a disfunção neural de BD foi sensível às demandas da tarefa. Disfunção fronto-límbico-estriada em pacientes pediátricos e adultos com transtorno bipolar: impacto da emoção facial e demandas atencionais. Citações BioEntities Artigos Relacionados Ligações externas Psychol Med. Autor do manuscrito disponível no PMC 2015 1 de junho. Publicado na forma final editada como: Disfunção fronto-límbico-estriada em pacientes pediátricos e adultos com transtorno bipolar: impacto da emoção facial e demandas atencionais 1 Ramo de Emoção e Desenvolvimento, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde Mental, Instituto Nacional de Saúde e Serviços Humanos, Saúde, Departamento de Saúde e Serviços Humanos, Bethesda, MD, EUA Endereço para correspondência: MA Brotman, Ph. D. Building 10, Room B1D43C, 10 Center Drive, Bethesda, MD 20892, EUA. (E-mail: vog. hin. liammnamtorb) Antecedentes Investigação em transtorno bipolar (BD) implica fronto-límbico-disfunção estriatal durante processamento de emoção face, mas é desconhecido como tal disfunção varia de acordo com as demandas da tarefa, emoção rosto e idade do paciente. Durante a imagem de ressonância magnética funcional (fMRI), 181 participantes, incluindo 62 BD (36 crianças e 26 adultos) e 119 indivíduos saudáveis ​​(57 crianças e 62 adultos), envolveram-se no processamento constrangido e sem restrições de emocional , Felizes) e não emocionais (neutros). Durante o processamento restrito, os sujeitos responderam a perguntas focando sua atenção no rosto, que foi processado de forma implícita (avaliação da largura do nariz) ou explicitamente (classificações de medo subjetivo de hostilidade). Processamento sem restrição consistia em visualização passiva. BD pediátrica classificou as faces neutras como mais hostis do que os outros grupos. Em pacientes BD, as análises de região de interesse corrigidas por erro familiar (FWE) revelaram disfunção na amígdala, giro frontal inferior (IFG), córtex cingulado anterior (ACC) e putamen. Os pacientes com BD mostraram hiperativação da amígdala durante o processamento explícito (classificações de hostilidade) de rostos temerosos e visão passiva de rostos irritados e neutros, mas a hipoativação de IFG durante o processamento implícito de rostos neutros e felizes. No ACC e no estriado, a direção da disfunção variou por demanda de tarefa: BD demonstrou hiperativação durante o processamento sem restrições de faces irritadas ou neutras, mas hipoativação durante o processamento restrito (implícito ou explícito) de faces zangadas, neutras ou felizes. Conclusões Os achados sugerem hiperativação da amígdala em BD ao processar faces negativamente validadas e neutras, independentemente da condição atencional, e hipoativação de BD IFG durante o processamento implícito. No circuito de controle cognitivo envolvendo o ACC eo putamen, a disfunção neural de BD foi sensível às demandas da tarefa. Introdução A pesquisa em transtorno bipolar (BD) envolve a disfunção fronto-límbico-estriada, com metanálises geralmente sugerindo hipoativação do córtex pré-frontal (PFC) e limbic (limbic-striatal disfunção) Hiper-ativação durante paradigmas de processamento de emoções faciais (Chen et al., 2011) 2012). No entanto, a natureza precisa da disfunção varia diferentes demandas de tarefas e emoções rosto são utilizados em todos os estudos e podem contribuir para discrepâncias na literatura. Além disso, há uma pesquisa limitada sobre como as anormalidades diferem no desenvolvimento, isto é, em pacientes pediátricos versus adultos (Kim et al., 2012). Relatamos dados de uma amostra relativamente grande 62 BD, 119 comparações saudáveis ​​(HC) em que comparamos a atividade neural em diferentes condições de atenção e emoções de rosto, usando um paradigma que foi breve o suficiente para ser tolerado por crianças e adultos afetados. Na tarefa atual de visualização do rosto emocional, como em outras tarefas, existem três tipos de condições atencionais: (1) implícita, (2) visão passiva e (3) explícita. Durante paradigmas implícitos, os sujeitos focalizam um recurso de estímulo diferente da emoção de face. A hiperatividade da amígdala tem sido relatada de forma consistente tanto em pacientes pediátricos quanto em adultos BD durante essas tarefas, incluindo a marcação de gênero (Kim et al., 2004). 2012 Thomas et al., 2013), rótulo de idade facial (Pavuluri et al., 2009) e rótulo de cor de imagem facial (Chen et al., 2006). No entanto, a direção precisa da disfunção no PFC e no estriado durante o processamento da emoção de face implícita tem sido variável, com alguns relatos indicando hiperativação em BD (Lawrence et al., 2004), Surguladze et al. 2010 Ladouceur et al., 2011) e outros relatando hipoativação (Lawrence et al., 2009). Enquanto alguns pesquisadores incluíram a visão passiva como uma forma de processamento implícito de face, a atenção dos sujeitos durante a visão passiva é completamente sem restrições e as demandas cognitivas não são claras. Como nos paradigmas implícitos, a hiperativação da amígdala tem sido relatada em BD durante a visão passiva (Blumberg et al., 2005), embora a hipoativação da amígdala também tenha sido observada (Blumberg et al., 2005). Do mesmo modo, tanto o PFC como a hiperactivação estriatal (Pavuluri et al., 2007) e a hipoactivação (Blumberg et al., 2005, Pavuluri et al., 2007 Killgore et al., 2008) foram relatados em paradigmas passivos de observação. Os paradigmas explícitos de processamento de emoções faciais, nos quais a tarefa dirige a atenção para a emoção de face, também provocaram hiperatividade da amígdala em BD (Yurgelun-Todd et al., 2000, Rich et al., 2006, Chen et al 2010 Versace et al., 2010), embora alguns encontrem hipoativação (Lennox et al., 2004). Esses achados mistos em BD são consistentes com meta-análises em adultos saudáveis ​​(Sergerie et al., 2008), sugerindo que o processamento explícito de emoção de face pode sondar a amígdala de forma menos efetiva do que os paradigmas passivos de observação e pode mesmo estar associado à diminuição da ativação da amígdala Costafreda et al., 2008). No BD, assim como nas tarefas de visualização implícita e passiva, os achados no PFC e no estriado incluem tanto a hiperatividade quanto a hipoatividade (Rich et al., 2006). Yurgelun-Todd et al., 2000 Lennox et al., 2004 Altshuler et al., 2008 Foland-Ross et al., 2008 Foland et al., 2012). Dessa forma, é difícil determinar o impacto das demandas atencionais sobre a disfunção neural do BD porque as conclusões da literatura são baseadas em achados em estudos que utilizam diferentes paradigmas. Os estudos têm ainda de incluir condições de atenção múltiplas, incluindo condicionantes (implícitas e explícitas) e não restringidas (observação passiva) dentro de uma tarefa. Em ambos os paradigmas atencionais limitados e não-limitados, uma ampla gama de emoções faciais provocou disfunção neural na BD. Essas emoções são felizes (Lawrence et al., 2004, Lennox et al., 2004, Blumberg et al., 2005, Hulle et al. 2010 Versace et al., 2010 Colar e outros (2012) e Garrett (2012), coléricos (Pavuluri et al., 2007) Altshuler et al. 2008 Passarotti et al., 2011 Perlenman et al., 2012 Thomas et al., 2012), triste (Lawrence et al., 2004 Lennox et al., 2004 Chen et al., 2006 Jogia et al., 2008 Almeida Et al., 2010), Garrett et al., 2012), e outros, de acordo com a invenção, Al.2012) e temeroso (Yurgelun-Todd et al., 2000, 2004). 2010 Keener et al. 2012 Perlman et al. 2012 Thomas et al. 2012). No entanto, semelhante às conclusões tiradas sobre disfunção BD em diferentes condições de atenção, é difícil determinar o impacto de emoções rosto específico sobre a função neural em BD porque a maioria dos estudos utilizam apenas uma emoção rosto ou análise de colapso em emoções rosto. Até o momento, nenhum estudo incluiu emoções de face múltiplas e estados de atenção (incluindo condições implícitas e explícitas e visão passiva) em um modelo estatístico. Examinamos a disfunção neural durante o processamento da emoção facial em várias emoções e estados de atenção em pacientes pediátricos e adultos. Utilizamos um paradigma de processamento emocional de face porque os déficits comportamentais na rotulação de emoção facial foram encontrados em pacientes com BD, independentemente da idade de início (Kohler et al., 2011). Os défices de processamento de face também estão presentes durante a eutímia (Schenkel et al., 2007, Rich et al., 2008), representando um endofenótipo potencial da doença (Brotman et al., 2008) Olsavsky et al. No entanto, não está claro se os correlatos neurais de tais déficits comportamentais diferem em BD pediátricos e adultos. Meta-análises relatam que a diminuição do volume de amígdala é encontrada de forma mais consistente na juventude do que em adultos com BD (Pfeifer et al., 2008 Chen et al., 2011), sugerindo que anormalidades funcionais da amígdala podem ser mais proeminentes em jovens BD do que em adultos Al., 2012). Utilizamos um paradigma que incluiu avaliações implícitas (largura do nariz) e avaliações explícitas (hostilidade, medo subjetivo), além de uma condição de atenção sem restrições (visão passiva). A tarefa incluiu várias emoções face (irritado, feliz, temeroso, neutro). Foram selecionadas quatro regiões de interesse (ROIs), incluindo a amígdala, o córtex cingulado anterior (ACC), o giro frontal inferior (IFG) e o putamen, estas regiões têm sido consistentemente implicadas em BD (Chen et al., 2011 Houenou et al. Al., 2011). Nossas principais análises de ROI incluíram, em um modelo estatístico, todas as condições de atenção, emoção de face, idade do sujeito e diagnóstico. Esperávamos que as diferenças de diagnóstico entre grupos surgissem em todos os ROIs. Também foram analisados ​​os principais efeitos do diagnóstico e diagnóstico por interações de grupos etários. Especificamente, dada a literatura relativamente consistente sobre a hiperactivação da amígdala na BD através das emoções faciais, hipotetizamos que, em relação ao HC , Tanto os pacientes BD adultos quanto os pediátricos demonstrariam um aumento da atividade da amígdala em tarefas de atenção restrita (avaliação implícita, explícita) e não restrita (observação passiva) em todas as emoções de face (raivoso, temeroso, feliz e neutro). Consistente com um estudo recente usando um paradigma de identificação de gênero (Kim et al., 2012), esperávamos que a disfunção da amígdala fosse mais acentuada em jovens BD do que adultos BD, particularmente durante a tarefa implícita. Com base em metanálises (Chen et al., 2011, Delvecchio et al., 2012 Houenou et al., 2011), também anteciparam a hipoativação de BD IFG. Finalmente, esperávamos que a disfunção no circuito de controle cognitivo composto do ACC e estriado fosse sensível às demandas atencionais. Utilizaram-se dados de ressonância magnética funcional (fMRI) obtidos de 181 participantes, incluindo 36 BD pediátricos (9x0201318 anos), 26 BD adultos (24x0201358 anos), 57 crianças HC (9x0201318 anos) e 62 adultos HC (20x0201353 anos) ). Destes 181 indivíduos, dados de 101 foram publicados anteriormente, incluindo 32 pacientes pediátricos de BD (Rich et al., 2006), 56 crianças de HC (Rich et al., 2006, Guyer et al., 2008 Beesdo et al., 2009 Olsavsky et al., 2012) e 13 adultos de HC (Guyer et al., 2008). Os dados BD adultos (n 26) e dados de 54 outros sujeitos (quatro BD pediátrica, uma criança HC, 49 adultos HC) não foram publicados anteriormente. Pacientes BD pediátricos foram avaliados utilizando a Tabela de Perturbações Afectivas e Esquizofrenia para Crianças em idade escolar x02013 Presente e versão Lifetime (K-SADS-PL Kaufman et al., 1997). Para avaliar o estado de espírito, os médicos administraram a Escala de Depressão da Childx02019s (CDRS Poznanski et al., 1984) ea Escala de Avaliação da Mania Nova (YMRS Young et al., 1978) ao pai e à criança dentro de 48 horas de varredura. O BD adulto (BD-I ou BD-II) foi avaliado utilizando a Entrevista Clínica Estruturada para a Edição do Paciente do DSM-IV-TR Axis I x02013 (SCID-I / P First et al., 2002) ou a Entrevista Diagnóstica para Estudos Genéticos DIGS Nurnberger et al., 1994). O Guia de Entrevistas Estruturado para a Escala de Avaliação da Depressão de Hamilton, a versão Seasonal Affective Disorders (SIGH-SAD Williams, 1988) e o YMRS (Young et al., 1978) foram usados ​​para avaliar o estado de humor em adultos BD. Os critérios de exclusão incluíram: IQx0003c70, história de traumatismo craniano, distúrbio neurológico, transtorno invasivo do desenvolvimento, doença médica instável ou abuso / dependência de substâncias nos últimos 3 meses. Foram incluídos pacientes medicados. Para obter detalhes, consulte Material Suplementar on-line. Paradigma comportamental Para detalhes de tarefas, ver Material Complementar e Rich et al. 2006 Guyer et al. 2008 Beesdo et al. 2009 Brotman et al. 2010 Olsavsky et al. 2012. Em resumo, os indivíduos viram rostos adultos exibindo expressões felizes, temerosas, zangadas ou neutras. As condições de atenção incluíam um implícito (x02018Como grande é o nosex02019), dois explícitos (x02018How hostil é o carax02019 x02018Como medo são youx02019) e uma condição de visualização passiva. Análise de dados comportamentais Utilizou-se um grupo de 2 (diagnóstico: BD, HC) x000d72 (grupo etário: criança, adulto) x000d74 (face emoção: zangado, feliz, temeroso, neutro) x000d7 3 (estado de atenção: medo, hostilidade, largura do nariz) Greenhousex02013Geisser - ANOVA de medidas repetidas corrigidas, com emoção de face e estado de atenção como variáveis ​​dentro do sujeito. Para entender as interações significativas, foram utilizados ANOVA pós-hoc 2 (diagnóstico) x000d73 (estado de atenção) e 2 (diagnóstico) x000d74 (face emotion). Foram utilizados testes t para decompor ainda mais estas análises pós-hoc e as correlações de Pearson para avaliar as relações entre as avaliações de humor e o desempenho comportamental. Para aquisição de varredura e pré-processamento, consulte Material Suplementar. Realizou-se análise de ROI esquerda e direita com uma correção de pequeno volume (SVC), utilizando-se a correção de erros familiares (FWE) em um limite estatístico de p x0003c0,05. A análise primária consistiu numa ANOVA 2 de quatro vias (diagnóstico) x000d72 (grupo etário) x000d74 (emoção face) x000d7 4 (estado de atenção). Não houve voxels supra-limiar em nenhum dos ROIs na ANOVA de quatro vias (ver Material Suplementar para uma tendência). Dado nosso interesse principal nas diferenças entre BD e HC, as análises então focalizaram as interações tridimensionais significativas que incluíam o diagnóstico. A interação de três vias ANOVA 2 (diagnóstico) x000d74 (emoção facial) x000d7 4 (estado de atenção) produziu o maior número de agrupamentos significativos. Nenhuma outra interação de três vias significativa (isto é, diagnóstico x000d7age grupox000d7 estado de atenção e diagnósticox000d7age grupox000d7face emoção) em qualquer um dos ROI sobreviveu correção FWE. Também examinamos as interações bidirecionais do grupo de diagnóstico x000d7age e os principais efeitos do diagnóstico em cada ROI. Nas análises pós-hoc, a idade, as avaliações comportamentais eo tempo de reação foram incluídos como covariáveis. Realizou-se uma ANCOVA de 2 (diagnóstico) x000d74 (face emotion) x000d74 (estado de atenção) repetidas medidas, com idade como covariate contínua a 2 (diagnóstico) x000d74 (face emotion) x000d74 (Avaliações de hostilidade de faces neutras) como uma covariável e um 2 (diagnóstico) x000d74 (face emoção) x000d74 (atenção estado) repetidas medidas ANCOVA, com tempo de reação como covariável. Para testar os efeitos de variáveis ​​potencialmente confundidoras em nossos resultados (ver Material Complementar), os testes t post-hoc compararam: (1) pacientes eutímicos (n 36) versus não eutímicos (n 24), (2) ) Versus sem diagnóstico co-mórbido (n 28) e (3) pacientes não medicados (n 12) versus pacientes medicados (n 47). Finalmente, foram utilizadas correlações de Pearson para examinar as associações entre ativação neural e humor, juntamente com ativação neural e medicamentos psicotrópicos. Além das análises de ROI, realizou-se uma análise exploratória de todo o cérebro, utilizando um limiar estatístico de p x0003c0.001, não corrigido, limite de extensão de voxel de k x0226520 (Lieberman x00026 Cunningham, 2009). Obtivemos resultados consistentes com as análises de ROI (ver Material Suplementar e Tabela S4). Características clínicas e demográficas Comparação de Lorazepam, Diazepam e Placebo para o Tratamento de Epilepticus fora do Hospital Epilepticus Nós realizamos um estudo randomizado, duplo-cego para avaliar benzodiazepinas intravenosas administradas por paramédicos para o tratamento de estado fora do hospital epilepticus . Adultos com crises convulsivas generalizadas prolongadas (com duração de cinco minutos ou mais) ou repetitivas receberam diazepam (5 mg), lorazepam (2 mg) ou placebo por via intravenosa. Foi administrada uma segunda injecção idêntica, se necessário. Dos 205 pacientes inscritos, 66 receberam lorazepam, 68 receberam diazepam e 71 receberam placebo. O estado epiléptico tinha sido terminado à chegada ao serviço de emergência em mais doentes tratados com lorazepam (59,1 por cento) ou diazepam (42,6 por cento) do que os doentes tratados com placebo (21,1 por cento) (P0,001). Após ajuste para covariáveis, o odds ratio para o término do status epilepticus no momento da chegada no grupo lorazepam comparado com o grupo placebo foi de 4,8 (intervalo de confiança de 95%, 1,9 a 13,0). O índice de chance foi de 1,9 (intervalo de confiança de 95 por cento, 0,8 a 4,4) no grupo de lorazepam em comparação com o grupo diazepam e 2,3 (intervalo de confiança de 95 por cento, 1,0 a 5,9) no grupo diazepam em comparação com o grupo placebo. As taxas de complicações respiratórias ou circulatórias após o tratamento do estudo foram administradas foram 10,6 por cento para o grupo lorazepam, 10,3 por cento para o grupo diazepam e 22,5 por cento para o grupo placebo (P0,08). Conclusões Os benzodiazepínicos são seguros e eficazes quando administrados por paramédicos para o estado epiléptico fora do hospital em adultos. Lorazepam é provável ser uma terapia melhor do que o diazepam. Artigo Atividade O estado epiléptico convulsivo generalizado é uma condição de convulsões prolongadas ou repetidas que requerem tratamento rápido. As benzodiazepinas são as drogas de escolha para o tratamento inicial porque são rápidas e eficazes. 1,2 Vários estudos randomizados de tratamento medicamentoso para o status epilepticus em pacientes hospitalizados foram conduzidos. No entanto, os pacientes com crises convulsivas e status epilepticus são comumente encontrados fora do hospital por pessoal de serviços de emergência médica. Tradicionalmente, estes pacientes foram transportados rapidamente para os serviços de emergência para tratamento. Nos últimos anos, muitos sistemas de serviços de emergência médica têm implementado protocolos que permitem a administração intravenosa de benzodiazepinas (principalmente diazepam) por paramédicos. No entanto, os riscos e benefícios do tratamento com benzodiazepínicos fora do hospital não foram estudados. Os benefícios potenciais incluem a prevenção de seqüelas sistêmicas e neurológicas de convulsões convulsivas prolongadas. Os riscos potenciais incluem depressão respiratória e comprometimento cardiovascular associado a benzodiazepinas e diagnósticos errados que levam a um tratamento inadequado. 2 Realizou-se um estudo randomizado, duplo-cego, controlado com placebo para determinar se a administração de benzodiazepínicos por paramédicos é um tratamento fora do hospital eficaz e seguro para o status epilepticus e para determinar se o lorazepam é superior ao diazepam. Inscrição Os métodos de estudo são descritos em pormenor noutros locais. 5 Entre 4 de janeiro de 1994 e 31 de janeiro de 1999, os pacientes foram matriculados e tratados por paramédicos do Departamento de Saúde Pública de São Francisco. Durante esse período, o sistema de serviços médicos de emergência consistia de um hospital base com base em médicos e nove hospitais de destino. Os paramédicos treinados no protocolo do estudo estabeleceram contato por rádio com o hospital de base e foram autorizados por um médico para inscrever os pacientes após revisão dos critérios de inclusão e exclusão. Design do Estudo Os adultos (18 anos de idade ou mais) com diagnóstico de estado epiléptico fora do hospital foram randomizados para receber 5 mg de diazepam, 2 mg de lorazepam ou placebo por injecção intravenosa (durante um período de um a dois minutos). O status epilepticus foi definido como atividade de convulsão contínua ou repetida por mais de cinco minutos sem recuperação da consciência. O fármaco do estudo foi administrado por paramédicos somente durante a atividade de convulsão tonicclônica generalizada. Se as crises recidivaram ou continuaram quatro minutos ou mais após a primeira injecção, então foi administrada uma segunda injecção idêntica. Assim, os pacientes receberam um máximo de 10 mg de diazepam ou 4 mg de lorazepam. Foram excluídos pacientes com pulso inferior a 60 batimentos por minuto, pressão arterial sistólica inferior a 100 mmHg, bloqueio atrioventricular de segundo ou terceiro graus, taquiarritmia ventricular sustentada, asma ou doença pulmonar obstrutiva crônica, história de Uso prolongado de benzodiazepínicos, ou sensibilidade aos benzodiazepínicos. Os doentes também foram excluídos se estivessem grávidas, se o acesso intravenoso não pudesse ser estabelecido, ou se tivessem sido transportados por uma empresa de ambulância privada ou estivessem sob custódia policial. Diazepam aberto foi imediatamente disponível no caso de uma difícil ou inseguro extrication de um paciente ou se um paciente foi considerado como sendo de alto risco de uma complicação com risco de vida. Os paramédicos documentaram atividade de convulsões, estado respiratório, função cardiovascular e nível de consciência a cada cinco minutos. O tratamento padronizado para pacientes que permaneceram em status epilepticus no momento da chegada ao hospital não foi requerido. No entanto, um protocolo de tratamento sugerido foi dado ao pessoal do estudo e apresentado por paramédicos em forma escrita aos médicos quando o paciente chegou ao departamento de emergência. 2 Oversight, Central Review e Consent O estudo foi aprovado pela Secção de Serviços de Emergência Médica do Departamento de Saúde Pública de San Francisco, pela Agência de Serviços de Emergência Médica da Califórnia e pelos conselhos de revisão institucionais da Universidade da Califórnia em São Francisco e no destino participante Hospitais. A supervisão foi prestada por um comitê consultivo externo, composto por quatro pessoas com experiência em epilepsia e medicina de emergência que não estavam afiliadas ao estudo. Este grupo reviu o estudo anualmente e foi responsável pelas decisões sobre a continuação ou término antecipado do estudo com base em análises de segurança provisórias. A supervisão adicional foi prestada por um órgão de segurança de dados e monitoramento dos Institutos Nacionais de Saúde, que independentemente realizou uma revisão anual do progresso do estudo e determinou se o estudo poderia continuar com base nas análises de segurança provisórias. Todos os eventos adversos e óbitos foram relatados prontamente aos conselhos de revisão institucional dos hospitais de destino, ao comitê consultivo externo e ao conselho de segurança e monitoramento de dados. Os dados demográficos foram determinados a partir do registro dos pacientes que o grupo étnico ou racial foi designado pelos pesquisadores. Devido à natureza de emergência do status epilepticus e ao estado inconsciente do paciente, a inscrição ocorreu sob uma renúncia do consentimento informado de acordo com regulamentos federais. O raciocínio da renúncia foi que diazepam, lorazepam ou nenhum benzodiazepínicos foram utilizados por vários sistemas de serviços médicos de emergência para a gestão do status epilepticus no momento do estudo e que os dados insuficientes estavam disponíveis para determinar o ótimo out-of - Tratamento hospitalar para esta condição. Tratamento de Drogas e Aleatorização Os kits de estudo codificados continham duas seringas de vidro colorido de 2,5 ml. As seringas num único kit de estudo tinham um conteúdo idêntico: uma solução de 1,0 ml de 5 mg de diazepam (Schein, Florham Park, NJ e ElkinsSinn, Cherry Hill, NJ) ou 2 mg de lorazepam (Ativan, WyethAyerst, Philadelphia) ou Uma solução placebo (20 por cento de propileno glicol vol / vol em 0,9 por cento de cloreto de sódio) formulada para imitar a viscosidade dos fármacos activos. Os códigos numéricos e o conteúdo das seringas foram determinados com a utilização de uma sequência gerada por computador de números aleatórios. Os kits foram armazenados em ambulâncias em uma caixa à prova de luz, fechada sem refrigeração e foram reabastecidos a cada 60 dias. 6 Resultados e Medidas A medida de resultado primária foi o término do estado epiléptico no momento da chegada ao serviço de emergência. Considerou-se que o status epilepticus terminou quando as convulsões cessaram se o paciente recuperasse a consciência. Status epilepticus was considered to be ongoing when seizures were clinically evident, when clinical seizures ended but the patient remained comatose and an electroencephalogram indicated ongoing electrical seizure activity, or when a patient remained unconscious and subsequently had a convulsive seizure requiring treatment with an antiseizure drug. Five outcome measures were selected as secondary study end points: out-of-hospital complications, complications at transfer, the duration of status epilepticus before arrival at the hospital, the neurologic outcome at discharge, and the disposition of the patient from the emergency department. Out-of-hospital complications were defined by the occurrence of a respiratory or cardiovascular complication after the administration of the study drug. Standardized criteria for hypotension and cardiac dysrhythmias were applied. 5 A respiratory complication was considered to be present if the patient received bag valve-mask ventilation or if intubation was attempted. Complications at transfer were defined by the presence of cardiorespiratory complications at the time the care of the patient was transferred from paramedics to emergency-department personnel. 5 The duration of status epilepticus before arrival at the hospital was defined as the interval between administration of the study drug and the termination of status epilepticus. Times were censored on arrival at the emergency department (if seizures were ongoing) or when out-of-hospital open-label drug treatment was administered (as occurred with two patients in the placebo group and two patients in the diazepam group). The neurologic outcome at hospital discharge was evaluated relative to the base-line condition of the patient and categorized as an unchanged condition, a condition characterized by new neurologic deficits, or death. The location to which the patient was transferred from the emergency department or the discharge or death of the patient was also selected as a secondary end point. Since previous studies have shown that the cause of status epilepticus is an important determinant of outcome, we assigned patients into three prognostic groups (good, intermediate, and poor) according to the cause of status epilepticus. 7,8 Interim Safety Analyses Interim safety analyses were performed after the enrollment of 25, 50, 100, and 150 patients. The OBrienFleming procedure was applied to each of the comparisons of active treatments and placebo with the use of a two-tailed alpha level of 0.025. 9 Secondary analyses were performed with adjustment for covariates. The interim analyses conducted when 150 subjects had been enrolled yielded one significantly different pairwise comparison for the rate of termination of status epilepticus on arrival at the emergency department. However, the data safety and monitoring board and external advisory committee both concluded that the data as a whole did not support early termination. Statistical Analysis The target sample size of 210 patients was based on estimated response rates (for the primary outcome) of 75 percent for lorazepam, 50 percent for diazepam, and 25 percent for placebo, with 80 percent power and a two-sided significance level of 5 percent. Some patients were enrolled more than once. Patients who received the study drug were included in all analyses of the primary and secondary outcomes. Logistic-regression analysis was used to estimate the effects of treatment on the primary outcome and to adjust for the potential confounding effects of covariates (the intervals from the onset of status epilepticus to treatment and from treatment to arrival at the emergency department and the cause of status epilepticus). 10 We compared the treatment groups with regard to the covariates using analysis of variance for continuous covariates and chi-square tests for categorical covariates. The logistic models included potentially confounding covariates as well as those with significantly different distributions among the study groups. The fit of the logistic model was assessed with use of HosmerLemeshow tests, and there was no evidence of lack of fit. We calculated simultaneous 95 percent confidence intervals using the Bonferroni method 11 for the comparisons of lorazepam with the other study treatments that is, we calculated 97.5 percent confidence intervals. We also calculated 97.5 percent confidence intervals for the comparisons of diazepam with placebo. Differences in the duration of status epilepticus before arrival at the hospital among the treatment groups were examined with the use of proportional-hazards models. 12 Initially, the distributions of durations were compared with the use of KaplanMeier curves and a log-rank test. Adjustments for potential confounders were made with the use of proportional-hazards models and covariates. A total of 567 events met the study definition of status epilepticus. After exclusions (Figure 1 Figure 1 Study Population. ), the study population consisted of 258 enrollments, representing 205 patients. We report only data from the first enrollment of each patient. Patients in the three treatment groups did not differ significantly with regard to age, sex, history of seizures, cause of status epilepticus, or interval from treatment to arrival at the emergency department however, the racial and ethnic groups of study patients were unevenly distributed (Table 1 Table 1 Characteristics of the 205 Patients Enrolled in the Study. ). Race or ethnic group was added to subsequent regression analyses, but the effect was minimal. The interval from the onset of status epilepticus to administration of the study treatment was significantly longer in the placebo group than in the active-treatment groups (P0.001) but was not significantly associated with outcome. This variable was added to subsequent regression analyses. Out-of-Hospital Treatment and Response Status epilepticus was terminated by the time of arrival at the emergency department in 59.1 percent of patients given lorazepam, 42.6 percent of patients given diazepam, and 21.1 percent of patients given placebo (P0.001) (Table 2 Table 2 Status Epilepticus at the Time of Arrival at the Emergency Department. ). The odds ratios indicated that termination of status epilepticus was more likely with lorazepam than placebo (odds ratio, 5.4 95 percent confidence interval, 2.3 to 13.2) and with diazepam than placebo (odds ratio, 2.8 95 percent confidence interval, 1.2 to 6.7). The odds ratio favored lorazepam over diazepam, but the difference was not significant (odds ratio, 1.9 95 percent confidence interval, 0.9 to 4.3). We obtained similar results using a logistic-regression model for the binary variable of the presence or absence of status epilepticus on arrival at the emergency department and adjusting for covariates. The odds of termination of status epilepticus on arrival at the emergency department were 4.8 times as high for the lorazepam group as for the placebo group (95 percent confidence interval, 1.9 to 13.0), 1.9 times as high for the lorazepam group as for the diazepam group (95 percent confidence interval, 0.8 to 4.4), and 2.3 times as high for the diazepam group as for the placebo group (95 percent confidence interval, 1.0 to 5.9). Figure 2 Figure 2 KaplanMeier Curves Comparing the Durations of Out-of-Hospital Status Epilepticus after Treatment with Lorazepam, Diazepam, or Placebo. presents KaplanMeier curves for the distribution of duration of status epilepticus before arrival at the hospital in the three groups. These curves were significantly different by the log-rank test (Plt0.001). When we used a proportional-hazards model and adjusted for covariates, the times were significantly shorter in the lorazepam group than in the placebo group (relative hazard of ongoing status epilepticus, 0.34 95 percent confidence interval, 0.17 to 0.71). Times were shorter for patients in the lorazepam group than for those in the diazepam group (adjusted relative hazard, 0.65 95 percent confidence interval, 0.36 to 1.17), but the difference was not significant. Out-of-Hospital and Transfer Complications An out-of-hospital complication (hypotension, cardiac dysrhythmia, or respiratory intervention) occurred in 7 (10.6 percent) of the patients treated with lorazepam, 7 (10.3 percent) of the patients treated with diazepam, and 16 (22.5 percent) of the patients given placebo (P0.08). The most common complication was a change in respiratory status requiring ventilation assistance by bag valve-mask or an attempt at intubation (7 patients given lorazepam, 6 given diazepam, and 11 given placebo). Cardiorespiratory complications that persisted to the time when patients were transferred to emergency-department personnel (complications at transfer) occurred in 13 patients (7.0 percent), with no significant differences between groups (P0.39). Hospital Care and Outcome After arrival at an emergency department, active (open-label) antiseizure-drug treatment was used at the discretion of the treating physician for each patient. For patients still in status epilepticus, the interval from arrival at the emergency department to the termination of status epilepticus did not differ significantly among the three treatment groups. There were no significant differences among the groups in the rate of occurrence of new cardiorespiratory complications in the emergency department. The transfer location, discharge, or death of patients after treatment in the emergency department and the neurologic outcome of patients at hospital discharge did not differ significantly among the treatment groups (Table 3 Table 3 Outcome of Patients after Leaving the Emergency Department and Neurologic Outcome at Hospital Discharge. ). Regardless of treatment, patients in status epilepticus on arrival at the emergency department were more likely to require admission to the intensive care unit than those whose seizures were terminated before arrival at the hospital (73 percent vs. 32 percent, likelihood-ratio chi-square lt0.001). When these two groups of patients were compared according to the cause of the episode (prognosis group), no significant differences were found. Thus, it is likely that the higher rate of admission to the intensive care unit among patients remaining in status epilepticus on arrival at the emergency department was related to ongoing seizures rather than to the severity of underlying neurologic or medical disease. At hospital discharge, 150 patients (74.3 percent) had returned to their base-line neurologic condition and 33 patients (16.3 percent) had new neurologic deficits. Nineteen patients (9.4 percent) died between enrollment and discharge from the hospital. No patients died before reaching the hospital. Calculated with the use of contingency-table analysis, the differences in death rates among the treatment groups were not significant (P0.08 by Fishers exact test). The small numbers of deaths precluded adjustment for potentially confounding covariates. Severe underlying illnesses were the probable causes of death in most patients. Discussion We found clear evidence that intravenous benzodiazepines are safe and effective when administered by paramedics for the treatment of out-of-hospital status epilepticus in adults. At the doses we used, lorazepam and diazepam were more effective than placebo, and there was a trend favoring lorazepam over diazepam. The rates of response (59 percent for 2 to 4 mg of lorazepam and 43 percent for 5 to 10 mg of diazepam) are slightly lower than those reported in in-hospital studies of status epilepticus. 3,13 However, unlike in-hospital studies that assess response at a defined time after treatment, we assessed the rate of termination of status epilepticus at the time of arrival at the emergency department. The interval between the study treatment and the assessment of response varied among patients. This factor may partially explain the differences in response rates between our study and previous reports. Cardiorespiratory complications before arrival at the hospital and at the time of transfer were important secondary outcomes that relate to the safety of out-of-hospital therapy with intravenous benzodiazepines. Despite concern regarding the adverse effects of these agents, we found a trend toward lower rates of out-of-hospital complications (primarily respiratory compromise) in the active-treatment groups than in the placebo group. This suggests that respiratory complications associated with prolonged seizures may be more pronounced than those caused by intravenous lorazepam and diazepam given at relatively low doses. The lower rate of complications at transfer than of out-of-hospital complications among patients in all groups suggests that the paramedics effectively managed the care of these patients. Although San Francisco paramedics received training on the clinical recognition of status epilepticus, in addition to study procedures, the education was relatively basic. Thus, we believe that our results are likely to be applicable to other emergency-medical-services systems that employ paramedics. We used multiple levels of regulatory review and interim safety analyses to ensure that the study was appropriate in design and was not continued unnecessarily. Given the potential cardiorespiratory complications of intravenous benzodiazepines, and the difficulty of monitoring for these complications during transport in an ambulance, we believed that the placebo comparison was justified. Although the use of intravenous diazepam before arrival at the hospital has been reported in children, 14 it has also been discouraged because of an unacceptable rate of respiratory depression and intubation-related aspiration and trauma. 15 Also, paramedics receive limited training in the recognition of status epilepticus, and their ability to identify this condition accurately is unknown. Misdiagnosis may expose patients to unnecessary risks associated with treatment. Furthermore, the interval from the time the paramedics reach the patient to the time of arrival at an emergency department (where additional diagnostic and support measures are available) is short in our emergency-medical-services system (approximately 15 minutes). Finally, relatively few out-of-hospital interventions have been evaluated in randomized controlled trials, 16 and when they have been evaluated carefully, therapies with intuitive appeal have often been found either to lack benefit or to cause harm to patients. 17-20 On the basis of these results, and given the preference for lorazepam as in-hospital therapy, 2 we recommend lorazepam as out-of-hospital therapy for adults in status epilepticus. One practical concern is that refrigerated storage is recommended for lorazepam but not for diazepam. In a previous study, we found that lorazepam retained 90 percent of its original concentration for five months while stored in ambulances without refrigeration. However, lorazepam was less stable at 37C and during the warmer months in San Francisco. 6 We recommend that ambulances carrying lorazepam be restocked every 60 days when ambient temperatures are 30C or more. In warmer climates, less frequent restocking or refrigerated storage is necessary. Despite the beneficial outcomes associated with intravenous lorazepam and diazepam, 41 to 57 percent of patients who received active treatment were still in status epilepticus at the time of arrival at the emergency department. These patients were more than twice as likely to require intensive medical care as those whose seizures ended outside the hospital. Differences in the causes of the episodes of status epilepticus are unlikely to account for this difference. These observations, coupled with the favorable riskbenefit profile associated with lorazepam and diazepam in this trial, suggest that higher doses should be studied to define the optimal therapy for patients with out-of-hospital status epilepticus. Supported by a grant (R01 31403) from the National Institutes of Health. We are indebted to the paramedics of the San Francisco Fire Department and to the physicians and nurses of the Department of Emergency Services at San Francisco General Hospital and at the various destination hospitals for their care of the patients enrolled in this study, and to Scott Fields, Pharm. D. and the members of the external advisory committee David M. Treiman, M. D. (chair), Robert J. DeLorenzo, M. D. Ph. D. M. P.H. Robert W. Derlet, M. D. and Michael Taigman, E. M.T.-P. for their invaluable help. Source Information From the Departments of Clinical Pharmacy (B. K.A. M. D.G.), Neurology (B. K.A. F. A. D. H.L.), Surgery (S. 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