Imunoprofilaxia do vírus sincicial respiratório com palivizumabe em crianças em hospital da zona sul de São Paulo / Immunoprophylaxis of respiratory syncytial virus with palivizumab in children at a hospital in the southern zone of São Paulo

As infecções agudas do trato respiratório inferior (IATRIs) são a primeiras causas de mortes nos países de baixa renda e a quarta nos países de média renda, que incluem o Brasil. O vírus sincicial respiratório (VSR) é o principal agente de infecções agudas do trato respiratório inferior, a causa mais conhecida bronquiolite, entre lactentes e jovens crianças. O palivizumabe é um anticorpo monoclonal imunoglobulina G subclasse 1 (IgG1) humanizado indicado para infecções do trato respiratório causado pelo VSR. Desenvolvimento de protocolo de imunização, e monitoramento do uso do palivizumabe em pacientes pediátricos de alto risco; verificando se a profilaxia com o palivizumabe reduz as taxas de internações e de mortalidade por VSR. O farmacêutico é parte fundamental no desenvolvimento dos protocolos clínicos, pois realiza um importante trabalho no seguimento farmacoterapêutico. Estudo observacional, prospectivo, em crianças com o risco de infecção grave por VSR que receberam palivizumabe de acordo com os critérios clínicos estabelecidos no Protocolo Federal da Portaria nº 522 de 13/05/2013. Os indivíduos foram seguidos por meio de visitas mensais. Implantação do protocolo de uso do palivizumabe dentro da instituição de saúde, nele foram estabelecidos, parâmetros e padrões, visando uma maior agilidade e eficiência dos processos. Foram acompanhados 14 neonatos e jovens crianças, 42,8% foram prematuros, 28,5% apresentavam displasia broncopulmonar e 28,5% cardiopatia congênita. Três óbitos (21,4%) foram registrados durante o acompanhamento. Os resultados mostraram que a imunização passiva com o palivizumabe é uma ferramenta importante na prevenção de infecções pelo VSR

Acute lower respiratory tract infections (IATRIs) are the main cause of death in low-income countries and the fourth in middle-income countries, which include Brazil. Respiratory syncytial virus (RSV) is the main agent of acute lower respiratory tract infections, the most well known cause of bronchiolitis, among infants and young children. Palivizumab is a humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody indicated for respiratory tract infections caused by RSV. The pharmacist is a fundamental part in the development of clinical protocols, as it performs an important work in the pharmacotherapeutic follow-up. Development of an immunization protocol and monitoring the use of palivizumab in high-risk pediatric patients; verifying whether prophylaxis with palivizumab reduces hospitalization rates and RSV mortality. Observational prospective study in children at risk of severe RSV infection who received palivizumab according to the clinical criteria established in the Federal Protocol of Administrative Rule nº 522 of 05/13/2013. Children were followed through monthly visits. Implementation of the protocol for the use of palivizumab on the health institution, in which parameters, standards and parameters were established, aim at greater agility and efficiency of the processes.14 neonates and young children were followed, 42.8% were premature, 28.5% had bronchopulmonary dysplasia and 28.5% had congenital heart disease. Three deaths (21.4%) were recorded during follow-up. The results showed that passive immunization with palivizumab are an important tool in the prevention of RSV infections

Recomendaciones de la Sociedad Española de Neonatología para la utilización de palivizumab como profilaxis de las infecciones graves por el virus respiratorio sincitial en lactantes de alto riesgo, actualización / An update of the recommendations of the Spanish Neonatology Society for the use of palivizumab as prophylaxis for severe infections due to syncytial respiratory virus in high risk infants

No disponible

Cost effectiveness of a protocol using palivizumab in preterm infants / Eficiencia de un protocolo de uso de palivizumab en pacientes prematuros

Objective: The main objective was to evaluate the cost-effectiveness of protocol use of palivizumab in premature established by consensus in our Hospital comparing it based on the recommendations of various Scientific Societies. As a secondary objective risk factors and severity of hospitalized patients attending the established protocol in our Hospital were analyzed. Methods: The study period was 4 seasons with the expanded protocol (retrospective data) versus 2 with restricted or agreed protocol (prospective data). The perspective of the study was the Health System, including the costs of hospitalization and palivizumab our center. The calculation of the effectiveness was determined with the admission rate of premature patients stratified by weeks of gestational age <29, <32; and < 35. For the analysis of risk factors and severity in patients admitted seasons with the new protocol are collected prospectively clinical data and environmental and social factors. Results: In the range of gestational age< 29 years old and < 32 greater effectiveness of the extended protocol was not demonstrated against the consensus. Only more effective for EG < 35 35 in the accumulated data and comparing seasons 12/13 and 08/09 to 13/14 for individual data was observed. This range has an associated incremental cost effectiveness ratio of €53250,07 (range: €14793,39 to €90446,47 for singles data and €50525,53 (€28688.22 to €211575,65) for accumulated. The establishment of this protocol in our center meant an average saving per season €169911,51. A cost-effectiveness of the extended protocol appropriate relationship is found if the cost of palivizumab per patient was less than €1206,67 (calculated for maximum use of the vial) and a higher rate of hospitalization of 9.21%. Children entering the season with the new protocol (season 12/13 and 13/14) are 63.4% in children under 3 months and 90% are term infants who do not belong to any population at risk, while many of them have associated risk factors you vary as have school-age siblings, rural residence, parental smoking, poor educational background of parents, lack of artificial feeding and family history of allergy. Conclusions: The consensus protocol has not been a significant increase in hospitalization rates in preterm infants (AU)

Objetivo: El objetivo principal fue evaluar el coste-efectividad del protocolo de uso de palivizumab en prematuros instaurado por consenso en nuestro hospital comparándolo con el basado en las recomendaciones de diferentes sociedades científicas. Como objetivo secundario se analizaron los factores de riesgo y gravedad de los pacientes hospitalizados atendiendo al protocolo establecido en nuestro centro. Material y métodos: El periodo de estudio fue de cuatro temporadas con el protocolo ampliado (datos retrospectivos) frente a dos con el protocolo restringido o consensuado (datos prospectivos). La perspectiva del estudio fue la del sistema sanitario, incluyendo los costes de hospitalización y del palivizumab en nuestro centro. El cálculo de la efectividad se determinó con la tasa de ingresos de pacientes prematuros estratificados por semanas de edad gestacional: < de 29, <32 y < 35. Para el análisis de los factores de riesgo y gravedad en pacientes ingresados en las temporadas con el nuevo protocolo se recogen, de forma prospectiva, datos clínicos y factores ambientales y sociales. Resultados: En los estratos de edad gestacional <29 y <32 no se demostró una mayor efectividad del protocolo ampliado frente al consensuado. Solamente se objetivó una mayor efectividad para EG <35 en los datos acumulados y al comparar las temporadas 08/09 con la 12/13 y 13/14 para datos individuales. Este estrato lleva asociado un cociente coste eficacia incremental de 53.250,07€ (rango: 14.793,39€ a 90.446,47€ para los datos individuales y 50.525,53€ (28.688,22€ a 211.575,65€) para los acumulados. La instauración de este protocolo en nuestro centro supuso un ahorro medio por temporada de 169.911,51€. Se constata una relación coste-efectividad adecuada del protocolo ampliado si el coste del palivizumab por paciente fuese menor de 1.206,67€ (calculados para el máximo aprovechamiento del vial) y para una tasa de hospitalización mayor de 9,21%. Los niños que ingresan en las temporadas con el nuevo protocolo (temporada 12/13 y 13/14) son en un 63,4% niños menores de 3 meses y el 90% son neonatos a término que no pertenecen a ninguna población de riesgo, mientras que muchos de ellos tienen asociados varías factores de riesgo como tener hermanos en edad escolar, residencia rural, padres fumadores, escasa formación académica de los progenitores, ausencia de lactancia artificial e historia familiar de alergia. Conclusiones: El protocolo consensuado no ha supuesto un aumento significativo en las tasas de hospitalización en los pacientes prematuros < 32 semanas de EG. En aquellos <35 se ha observado una mayor tasa de hospitalización, con una relación coste-efectividad muy desfavorable para todos los escenarios clínicos valorados (AU)