Traumatic Brain Injury: in-hospital Survival Rates and the Main Predictors of in-hospital Mortality in Northeastern Brazil / Traumatismo cranioencefálico: taxas de sobrevida intrahospitalar e os principais preditores de mortalidade intrahospitalar no nordeste do Brasil

Introduction Upper middle-income countries have epidemiological peculiarities that should be considered to identify the main predictive factors of intrahospital mortality regarding traumatic brain injury (TBI) to address modifiable problems. Objective To assess the in-hospital survival of patients with TBI and to identify the predictors of in-hospital death. Methods This is a retrospective dynamic cohort study of victims of TBI who were admitted to the Hospital de Urgência de Sergipe (HUSE, in the Portuguese acronym) between March 1, 2017 and April 29, 2018. The outcome considered was in-hospital death from any cause. Cox regression was used to assess predictors of in-hospital mortality. Results The sample comprised 596 patients, with a median age of 31.0 (12­94) years old, 504 (84%) of whom were men. Regarding TBI severity, 250 had mild TBI; 121 had moderate TBI; and 225 had severe TBI. The average follow-up was 20.6 4.0 days, with 60 in-hospital deaths and a 30-day mortality of 22.9%. Four independent predictors of in-hospital death were identified: acute subdural hemorrhage (ASDH) (risk ratio [RR] » 1.926; 95% confidence interval [CI] » 1.15­3.22; p » 0.013), swelling (risk ratio [RR] » 3.706; 95%CI » 2.21­6.19; p < 0.001), skull fracture (RR » 2.551; 95%CI » 1.36­ 4.75; p » 0.003), and severe TBI (RR » 2.039; 95%CI » 1.29­4.12; p » 0.005). Conclusions Acute subdural hemorrhage, swelling, skull cap fracture, and a Glasgow Coma Scale score of < 9 at admission were independent predictors of in-hospital mortality in patients with TBI.

Introdução Os países de renda média alta possuem peculiaridades epidemiológicas que devem ser levadas em consideração para identificar os principais fatores preditivos de mortalidade intrahospitalar por traumatismo cranioencefálico (TCE) a fim de abordar problemas modificáveis. Objetivo Avaliar a sobrevida hospitalar de pacientes com TCE e identificar os preditores de óbito hospitalar. Métodos Trata-se de um estudo de coorte dinâmico retrospectivo de vítimas de TCE que deram entrada no Hospital de Urgência de Sergipe (HUSE) entre 1° de março de 2017 e 29 de abril de 2018. O desfecho considerado foi óbito hospitalar por qualquer causa. A regressão de Cox foi usada para avaliar os preditores de mortalidade hospitalar. Resultados A amostra foi composta por 596 pacientes, com idade mediana de 31,0 (12­94) anos, sendo 504 (84%) homens. Em relação à gravidade do TCE, 250 tiveram TCE leve; 121 tiveram TCE moderado, e 225 tiveram TCE grave. O seguimento médio foi de 20,6 4,0 dias, com 60 óbitos hospitalares e mortalidade em 30 dias de 22,9%. Quatro preditores independentes de morte hospitalar foram identificados: hemorragia subdural aguda (ASDH, na sigla em inglês) (risk ratio [RR] » 1,926; intervalo de confiança [IC] 95% » 1,15­3,22; p » 0,013), inchaço (RR » 3,706; IC95% » 2,21­6,19; p < 0,001), fratura de crânio (RR » 2,551; IC95% » 1,36­4,75; p » 0,003) e TCE grave (RR » 2,039, IC95% » 1,29­4,12; p » 0,005). Conclusões Hemorragia subdural aguda, edema, fratura da calota craniana e pontuação na Escala de Coma de Glasgow < 9 na admissão foram preditores independentes de mortalidade hospitalar em pacientes com TCE.

USE OF OFF-LABEL MEDICATIONS IN A NEONATAL INTENSIVE CARE UNIT.

OBJECTIVE: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. METHODS: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). RESULTS: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. CONCLUSIONS: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.

Use of off-label medications in a neonatal intensive care unit / Uso de medicamentos off-label em unidade de terapia intensiva neonatal

ABSTRACT Objective: This paper aims to analyze the use of off label (OL) medicines, according to the National Regulatory Agency, in a neonatal intensive care unit of a high-risk maternity hospital in Northeast Brazil. Methods: A cross-sectional study was carried out, using a convenience sample of newborns that used mechanical ventilation at the Intensive Care Unit. As a reference, OL medications were considered for those without an approval for newborn usage by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária - ANVISA) and by the Food and Drugs Administration (FDA). Results: The sample consisted of 158 newborns, 58.3% male, 87.7% premature, and 70.2% of low or very low birth weight. According to ANVISA, 440 out of the 1,167 prescriptions analyzed were OL, with 98.1% of newborns exposed to at least one of these drugs. According to the FDA, 484 prescriptions were OL, with 75.8% of newborns exposed to at least one of them. Anti-infectives were the most prescribed OL medications. Neonates who presented respiratory failure and pneumonia used these drugs more often; and there was no relation between their use and the number of deaths. Conclusions: Nearly all newborns at the Intensive Care Units, mainly preterm infants, are exposed to at least one off-label (OL) medication during hospital stay, according to the national and international regulatory agencies. No association was found between off-label prescriptions and the frequency of complications or neonatal deaths.

RESUMO Objetivo: Analisar o uso de medicamentos off-label (OL), segundo a agência reguladora nacional, em unidade de terapia intensiva neonatal de uma maternidade de alto risco em Aracaju. Métodos: Foi realizado um estudo transversal, utilizando amostra de conveniência de recém-nascidos (RN) da Unidade Intensiva, que fizeram uso de ventilação mecânica. Consideramos OL o medicamento que não era liberado para uso em RN nos bulários eletrônicos da Agência Nacional de Vigilância Sanitária (ANVISA) e da U.S. Food and Drug Administration (FDA). Resultados: A amostra consistiu de 158 neonatos, sendo 58,3% do sexo masculino, 87,7% prematuros e 70,2% com baixo ou muito baixo peso. De acordo com a ANVISA, das 1.167 prescrições analisadas, 440 foram OL, com 98,1% dos RN expostos a pelo menos um desses medicamentos. Já para a FDA, 484 prescrições foram OL, com 75,8% dos neonatos expostos a pelo menos um deles. As medicações OL mais prescritas foram os anti-infecciosos. Neonatos que apresentaram insuficiência respiratória e pneumonia fizeram mais uso deles e não houve relação entre o seu uso e o número de óbitos. Conclusões: Quase todos os RN internados, principalmente os prematuros, foram expostos a pelo menos um medicamento OL, de acordo com a agência reguladora nacional e internacional, durante a internação. Entretanto, isso não teve relação com a frequência de complicações nem de óbitos neonatais.