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The current document is an update of the recommendations of the Sociedad Argentina de Pediatría based on a bibliographic review of publication from recent years on the use of the monoclonal antibody against respiratory syncytial virus (RSV), palivizumab, in groups of patients at high risk of developing severe respiratory infection. The continuing relevance of RSV as a causative agent of acute lower respiratory infections and hospitalizations are highlighted. The epidemiology of RSV in the country after the COVID-19 pandemic was reviewed. The risk groups in which the use of palivizumab is indicated according to the underlying condition were discussed, as well as aspects of its dosing and future therapeutic options.
El presente documento es la actualización de las recomendaciones de la Sociedad Argentina de Pediatría basadas en la revisión bibliográfica de los últimos años sobre el empleo del anticuerpo monoclonal contra el virus sincicial respiratorio (VSR), palivizumab, en grupos de pacientes con alto riesgo de desarrollar infección respiratoria grave. Se destaca la continua relevancia del VSR como agente causante de infecciones respiratorias agudas bajas e internaciones. Se revisó la epidemiología del VSR en el país tras la pandemia por COVID-19. Se discutieron los grupos de riesgo en los que se indica el uso de palivizumab según la condición de base, así como aspectos sobre su dosificación y futuras opciones terapéuticas.
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AIM: Palivizumab has proven effective in reducing hospitalizations, preventing severe illness, improving health outcomes, and reducing healthcare costs for infants at risk of respiratory syncytial virus (RSV) infection. We aim to assess the value of palivizumab in preventing RSV infection in high-risk infants in Colombia, where RSV poses a significant threat, causing severe respiratory illness and hospitalizations. METHODS: We conducted a decision tree analysis to compare five doses of palivizumab with no palivizumab. The study considered three population groups: preterm neonates (≤ 35 weeks gestational age), infants with bronchopulmonary dysplasia (BPD), and infants with hemodynamically significant congenital heart disease (CHD). We obtained clinical efficacy data from IMpact-RSV and Cardiac Synagis trials, while we derived neonatal hospitalization risks from the SENTINEL-1 study. We based hospitalization and recurrent wheezing management costs on Colombian analyses and validated them by experts. We estimated incremental cost-effectiveness ratios and performed 1,000 Monte Carlo simulations for probabilistic sensitivity analyses. RESULTS: Palivizumab is a dominant strategy for preventing RSV infection in preterm neonates and infants with BPD and CHD. Its high efficacy (78% in preventing RSV in preterm infants), the substantial risk of illness and hospitalization, and the high costs associated with hospitalization, particularly in neonatal intensive care settings, support this finding. The scatter plots and willingness-to-pay curves align with these results. CONCLUSION: Palivizumab is a cost-saving strategy in Colombia, effectively preventing RSV infection in preterm neonates and infants with BPD and CHD by reducing hospitalizations and lowering healthcare costs.
Assuntos
Cardiopatias Congênitas , Infecções por Vírus Respiratório Sincicial , Vírus Sincicial Respiratório Humano , Lactente , Recém-Nascido , Humanos , Palivizumab/uso terapêutico , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Análise Custo-Benefício , Colômbia/epidemiologia , Antivirais/uso terapêutico , Recém-Nascido Prematuro , Anticorpos Monoclonais Humanizados/uso terapêutico , HospitalizaçãoRESUMO
Abstract Objective: Due to the high cost and short term of passive immunization against the respiratory syncytial virus, the main virus causing acute viral bronchiolitis, predicting epidemic regions and epidemic months is extremely important. The objective of this study is to identify both the month when the seasonal peak begins and Brazilian regions and states with the highest incidence of monthly hospitalizations due acute viral bronchiolitis. Methods: Based on data obtained from DATASUS, monthly hospitalization rates due acute viral bronchiolitis were calculated for every 10,000 live births to children under 12 months of age in all Brazilian states and the Federal District between 2000 and 2019. Seasonal autoregressive integrated moving average models were estimated to forecast monthly hospitalization rates in 2020. Results: A higher incidence of hospitalizations was found for male children, especially under six months of age. As for Brazilian regions, between 2000 and 2019, the South region registered the highest incidence of hospitalizations, followed by the Southeast, Midwest, North and Northeast regions, in this order. Considering the seasonal peak, the period between March and July 2020 comprised the highest expected hospitalization rates. Conclusions: Palivizumab is suggested to be started between February/March and June/July for most Brazilian states, with the exception of Rio Grande do Sul, which, in addition to presenting the highest rates of hospitalizations for acute viral bronchiolitis per 10,000 live births, has the longest seasonal peak between May and September.
RESUMO Objetivo: Em razão do alto custo e do curto prazo da imunização passiva contra o vírus sincicial respiratório, principal vírus causador de bronquiolite viral aguda, a previsão das regiões e meses epidêmicos é extremamente importante. Objetiva-se identificar o mês de início do pico sazonal e as regiões e Estados brasileiros de maior incidência de hospitalizações mensais por bronquiolite viral aguda. Métodos: Com dados obtidos no Departamento de Informática do Sistema Único de Saúde do Brasil, foram calculadas as taxas mensais de hospitalizações por bronquiolite viral aguda a cada 10 mil nascidos vivos de crianças com idade inferior a 12 meses, em todos os Estados brasileiros e no Distrito Federal, no período entre 2000 e 2019. Modelos sazonais autorregressivos integrados e de médias móveis foram estimados para a previsão das taxas mensais de hospitalizações em 2020. Resultados: Verificou-se maior incidência de hospitalizações em crianças do sexo masculino, principalmente naquelas com idade inferior a seis meses. Em relação às regiões brasileiras, entre 2000 e 2019, a Região Sul apresentou a maior incidência de hospitalizações, seguida pelas Regiões Sudeste, Centro-Oeste, Norte e Nordeste, respectivamente. Quanto ao pico sazonal, o período entre março e julho de 2020 compreende as maiores taxas de hospitalizações previstas. Conclusões: Sugere-se o início da administração do Palivizumab entre fevereiro/março e junho/julho para a maioria dos Estados brasileiros, com exceção do Rio Grande do Sul, que, além de apresentar as maiores taxas de hospitalizações por bronquiolite viral aguda a cada 10.000 nascidos vivos, possui o pico sazonal de maior duração entre maio e setembro.
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ANTECEDENTES Y OBJETIVO Palivizumab es un medicamento usado como profilaxis del virus respiratorio sincicial en menores de 1 año, prematuros o de bajo peso al nacer. En Chile, este medicamento, por ser de alto costo, se encuentra actualmente cubierto para determinados subgrupos de infantes por la ley N°20.850, también conocida como Ley Ricarte Soto. Es en este contexto con el objetivo de conocer opciones de financiamiento, el Departamento de Coordinación de Garantías y Prestaciones en Salud, de la Subsecretaría de Salud Pública, ha solicitado una síntesis exploratoria sobre las formas de financiamiento de palivizumab en otros países. METODOLOGÍA Para la elaboración de esta síntesis rápida de evidencia, el equipo a cargo formuló estrategias de búsqueda con el fin de ser utilizada en el buscador web Google. De esta manera se recuperaron documentos los cuales fueron filtrados por criterios de tema, y tipo de documento, en donde se priorizaron leyes, documentos elaborados por instituciones gubernamentales y recomendaciones o protocolos de instituciones científicas. Se revisaron las 10 primeras páginas del buscador web Google, la información relevante se estudió a texto completo, además se encontraron referencias a documentos de interés los cuales se recuperaron separadamente. RESULTADOS Se determinaron 9 países por tener sistemas de salud similares a Chile, para explorar sus condiciones de financiamiento, los cuales son: México, Colombia, Italia, Argentina, Brasil, España, Portugal, Reino Unido y Francia. -El financiamiento de palivizumab por parte del sistema de salud se encuentra presente en 8 de 9 países estudiados. -La existencia de un fondo especial para medicamentos de alto costo se encuentra presente en 4 de los 9 países estudiados. -En cuanto si palivizumab posee financiamiento como medicamento de alto costo, 3 de los 9 países presentan esta característica. -Respecto a si restringen el financiamiento de palivizumab por alguna indicación en específico, 7 de los 9 países presentan esta característica.
Assuntos
Recém-Nascido , Lactente , Chile , Financiamento Governamental , Vírus Sinciciais Respiratórios , Sistemas de Saúde , Prática Clínica Baseada em EvidênciasRESUMO
OBJECTIVE: To evaluate the impact of immunoprophylaxis with palivizumab in preterm infants less than 35 weeks in terms of hospitalization rate, intensive care unit requirement, and mortality. METHODS: A prospective cohort study was conducted at six Colombian hospitals. Preterm infants less than 35 weeks who received at least one dose of palivizumab during the first 6 months of life were included. The primary outcome was the hospitalization rate related to respiratory syncytial virus (RSV) infection. RESULTS: A total of 222 newborns participated in the study; 204 (91.8%) completed the 6-month follow-up, and three died during the study. 88.7% received a second dose of palivizumab, 79.7% a third, 34.7% a fourth, and 25.2% a fifth. The nonadjusted incidence rate of RSV infection was 2.4%, and the overall RSV-positive hospitalization rate was 1.9%. The proportion of patients that required Neonatal Intensive Care Unit (NICU) and mechanical ventilation in relation to RSV infection was 1.4%. Discharge with home oxygen, pulmonary dysplasia, and being younger than 6 months were significantly associated with respiratory infection. Furthermore, exposition to cigarette smoke was the only factor associated with increased risk of hospitalization. The group that required hospitalization received fewer doses of palivizumab (p = 0.049). No discontinuation of treatment due to adverse events were reported. No death was judged to be related to palivizumab. CONCLUSION: The hospitalization rate and the need for NICU admission were lower than those reported in the literature. In this real-life setting, palivizumab appears to be effective in preventing serious cases of RSV infection.
Assuntos
Infecções por Vírus Respiratório Sincicial , Anticorpos Monoclonais Humanizados/uso terapêutico , Antivirais/uso terapêutico , Colômbia/epidemiologia , Hospitalização , Hospitais , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Unidades de Terapia Intensiva Neonatal , Oxigênio/uso terapêutico , Palivizumab/uso terapêutico , Estudos Prospectivos , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controleRESUMO
ABSTRACT Objectives: to analyze the occurrence of respiratory complications over the first year of life in preterm infants who did not receive palivizumab monoclonal antibodies. Methods: analytical retrospective cohort study with preterm infants born between 2012 and 2016 in Uberlândia, state of Minas Gerais, Brazil. Data collection occurred from January to November 2018, by consulting hospital and primary healthcare medical records. Data were processed with the Poisson regression model, with p<0.05. Results: of a total of 5,213 preterm births, 504 (9.7%) met the inclusion criteria. The preterm infants in this subset were assisted 2,899 times in primary care, which resulted in 1,098 (37.5%) medical diagnoses, of which 803 (78.5%) involved the respiratory tract. Preterm babies fed on formula milk at hospital discharge had more diagnoses of respiratory diseases. Maternal age (p=0.039), respiratory diagnosis at hospital discharge (p=0.028), and number of sporadic appointments (p<0.001) showed a significant association with bronchiolitis; number of sporadic appointments showed a significant association with occurrence of respiratory diseases; and breastfeeding had a protective effect against the development of bronchiolitis. Conclusions: preterm infants who did not receive palivizumab showed a high percentage of respiratory diseases, and breastfeeding helped protect them against bronchiolitis. It is recommended that these preterm babies be monitored in primary health care.
RESUMEN Objetivos: investigar complicaciones respiratorias en el primer año de vida de prematuros no contemplados con anticuerpo monoclonal palivizumab. Métodos: estudio de cohorte retrospectivo, analítico, con prematuros nacidos entre 2012 y 2016 en Uberlândia, MG. Datos recolectados de enero a noviembre de 2018 en historias clínicas hospitalarias y de atención básica. Se utilizó modelo de regresión de Poisson, considerándose p<0,05. Resultados: de 5.513 nacimientos prematuros, 504 (9,7%) atendieron criterios; estos prematuros recibieron 2.899 consultas en atención básica; 1.098 (37,5%) con diagnóstico médico; 803 (78,5%) del tracto respiratorio. Prematuros con fórmula láctea al alta hospitalaria recibieron más diagnósticos de enfermedades respiratorias. Edad materna (p=0,039), diagnóstico respiratorio al alta (p=0,028), cantidad de consultas eventuales (p<0,001) mostraron asociación significativa con bronquiolitis. Conclusiones: prematuros sin palivizumab mostraron elevado porcentaje de enfermedades respiratorias; se observó efecto protector de la lactancia materna. Se recomienda el seguimiento de dichos prematuros en atención primaria.
RESUMO Objetivos: investigar intercorrências respiratórias no primeiro ano de vida de prematuros não contemplados com anticorpo monoclonal palivizumabe. Métodos: estudo de coorte retrospectivo, analítico, com prematuros nascidos entre 2012 e 2016, em Uberlândia, MG. Coleta realizada de janeiro a novembro de 2018, em prontuários hospitalar e da atenção básica. Utilizou-se modelo de regressão de Poisson; considerou-se p<0.05. Resultados: de 5.213 nascimentos prematuros, 504 (9,7%) atenderam os critérios; esses prematuros tiveram 2.899 atendimentos na atenção básica; 1.098 (37,5%) com diagnóstico médico, 803 (78,5%) do trato respiratório. Prematuros com fórmula láctea na alta hospitalar tiveram mais diagnósticos de doenças respiratórias. Idade materna (p=0,039), diagnóstico respiratório na alta (p=0,028), número de consultas eventuais (p<0,001) apresentaram associação significativa com bronquiolite. Consultas eventuais foram significantes para doenças respiratórias; o aleitamento materno mostrou-se protetor para bronquiolite. Conclusões: prematuros sem palivizumabe apresentaram elevado percentual de doenças respiratórias; observou-se efeito protetor do aleitamento materno. Recomenda-se vigilância desses prematuros na atenção primária.
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INTRODUCTION: Respiratory syncytial virus (RSV) is one of the most important childhood infections. OBJECTIVE: To evaluate the effectiveness and safety of palivizumab immunoprophylaxis in preterm infants at a high risk of severe respiratory syncytial virus infection during the RSV season in Colombia. METHODOLOGY: A prospective observational non-comparative multicenter study in six Colombian cities. At the beginning of the RSV infection season, palivizumab prophylaxis, up to five doses, was administered to infants born at ≤32 weeks of gestation, infants younger than six months, infants under one year of age with bronchopulmonary dysplasia (BPD), infants one year or less of age with hemodynamically significant acyanotic and non-acyanotic congenital heart disease (CHD), and with follow-up during the immunoprophylaxis until one month after the last dose. RESULTS: The study enrolled 600 patients, 91.8% of which were born at ≤ 32 weeks of gestation. BPD was observed in 54.9% of infants. 49% were born at < 32 weeks gestation and presented BPD. 6.9% had hemodynamically significant acyanotic and non-acyanotic CHD 53.3% received three or more doses of palivizumab. The mean interval between doses was 39.6 days. 1.8% of patients were hospitalized due to a confirmed RSV infection. Overall mortality was 1.2%, whereas the mortality by RSV in infants undergoing prophylaxis was 0.2%. CONCLUSIONS: Palivizumab was a clinically effective, well-tolerated treatment in the Colombian population. The safety profile of palivizumab reflects the findings from previous studies in developed countries.
Assuntos
Antivirais/administração & dosagem , Palivizumab/administração & dosagem , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Colômbia , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Profilaxia Pós-Exposição/métodos , Estudos Prospectivos , Infecções por Vírus Respiratório Sincicial/epidemiologia , Vírus Sincicial Respiratório Humano/imunologiaRESUMO
ABSTRACT Objective: To determine the prevalence of recurrent wheezing (RW) in preterm infants who received prophylaxis against severe infection with respiratory syncytial virus (RSV) and to identify genetic susceptibility (atopy or asthma) and risk factors for RW. Methods: This was a cross-sectional study involving preterm infants who received prophylaxis with palivizumab at a referral center in Brazil during the first two years of age. A structured questionnaire was administered in a face-to-face interview with parents or legal guardians. Results: The study included 410 preterm infants (median age = 9 months [0-24 months]). In the sample as a whole, 111 children (27.1%; [95% CI, 22.9-31.5]) had RW. The univariate analysis between the groups with and without RW showed no differences regarding the following variables: sex, ethnicity, maternal level of education, gestational age, birth weight, breastfeeding, number of children in the household, day care center attendance, pets in the household, and smoking caregiver. The prevalence of RW was twice as high among children with bronchopulmonary dysplasia (adjusted OR = 2.08; 95% CI, 1.11-3.89; p = 0.022) and almost five times as high among those with a personal/family history of atopy (adjusted OR = 4.96; 95% CI, 2.62-9.39; p < 0.001) as among those without these conditions. Conclusions: Preterm infants who received prophylaxis with palivizumab but have a personal/family history of atopy or bronchopulmonary dysplasia are more likely to have RW than do those without these conditions.
RESUMO Objetivo: Determinar a prevalência de sibilância recorrente (SR) em crianças pré-termo que receberam profilaxia contra infecção grave pelo vírus sincicial respiratório (VSR) e identificar susceptibilidade genética (atopia ou asma) e fatores de risco para SR. Métodos: Estudo transversal envolvendo crianças pré-termo que receberam profilaxia com palivizumabe em um centro de referência no Brasil durante os primeiros dois anos de vida. Um questionário estruturado foi aplicado em entrevista presencial com os pais ou responsáveis. Resultados: O estudo incluiu 410 crianças pré-termo (mediana de idade = 9 meses [0-24 meses]). Na amostra total, 111 crianças (27,1%; IC95%: 22,9-31,5) apresentavam SR. A análise univariada entre os grupos com e sem SR não mostrou diferenças em relação às seguintes variáveis: sexo, etnia, escolaridade materna, idade gestacional, peso ao nascer, aleitamento materno, número de crianças no domicílio, frequência em creche, presença de animais de estimação no domicílio e cuidador tabagista. A prevalência de SR foi duas vezes maior entre crianças com displasia broncopulmonar (OR ajustada = 2,08; IC95%: 1,11-3,89; p = 0,022) e quase cinco vezes maior entre aquelas com história pessoal/familiar de atopia (OR ajustada = 4,96; IC95%: 2,62-9,39; p < 0,001) do que entre aquelas sem essas condições. Conclusões: Crianças pré-termo que receberam profilaxia com palivizumabe, mas apresentam história pessoal/familiar de atopia ou displasia broncopulmonar, têm maior probabilidade de apresentar SR do que aquelas sem essas condições.
Assuntos
Humanos , Recém-Nascido , Lactente , Sons Respiratórios , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Infecções por Vírus Respiratório Sincicial/epidemiologia , Antivirais/uso terapêutico , Recém-Nascido Prematuro , Estudos Transversais , Fatores de Risco , Palivizumab/uso terapêutico , HospitalizaçãoRESUMO
Resumen Antecedentes: La bronquiolitis es la infección del tracto respiratorio inferior más frecuente en lactantes. El virus respiratorio sincicial es el principal agente y responde hasta por un 85 % de los casos. Los principales factores de riesgo asociados son: sexo masculino; lactantes menores; prematuros; patologías médicas de fondo como: cardiopatía congénita, displasia broncopulmonar, síndrome de Down y enfermedades neuromusculares; así como otros factores ambientales y sociales. El objetivo de este estudio fue caracterizar los prematuros, el tratamiento utilizado, el perfil de la inmunofluorescencia viral, las complicaciones, el uso de palivizumab y los costos de hospitalización en pacientes hospitalizados por bronquiolitis durante enero de 2011 y diciembre de 2011. Pacientes y métodos: Estudio observacional, descriptivo, basado en la revisión retrospectiva de expedientes clínicos de una serie de pacientes hospitalizados en el Hospital Nacional de Niños de la Caja Costarricense de Seguro Social. Se incluyeron todos los pacientes menores de 2 años egresados con el diagnóstico de bronquiolitis durante 2011, con el antecedente de prematuridad (menor de 37 semanas de edad gestacional). Resultados: Se incluyó un total de 141 pacientes; un 63 % (n=89) de sexo masculino, promedio de edad 5,7 meses (rango 0-24). Un 43 % (n=61) de los pacientes manifestó bronquiolitis antes de los 3 meses de edad. Con respecto a la edad gestacional, se obtuvo que el 35,46 % de los pacientes eran de 32 a 35 semanas, de 35 a 37 semanas un 31,2 %, de 30 a 32 semanas un 19,86 % y el resto menores de las 29 semanas. En 93 niños (66 %) se anotó el antecedente de tabaquismo en el entorno del hogar; de forma específica, en 17 % de estos pacientes se presentó el antecedente de tabaquismo pasivo, al reportarse que el padre o el abuelo eran los fumadores activos. El antecedente heredofamiliar de asma fue positivo en el 41,8 %. Con respecto al tratamiento recibido durante su hospitalización, el 100 % ameritó oxígeno suplementario y un 61 % recibió nebulizaciones con salbutamol; los esteroides sistémicos se utilizaron en el 33 % de los pacientes y solo en un 29 % se utilizó la terapia antibiótica. Un 28 % de la población estudiada presentó complicaciones, de los cuales 28 (19,86 %) prematuros ameritaron soporte ventilatorio. El hallazgo de atelectasia en la radiografía de tórax se evidenció en el 7,8 % de los pacientes. Únicamente un 4,25 % de los pacientes tuvo una sobreinfección bacteriana. Debido a la dificultad de los accesos venosos de este grupo de niños, 14 (9,93 %) ameritaron la colocación de catéter venoso central. El rango de estancia hospitalaria fue de 1 a 31 días, con un promedio de 7; la hospitalización en la Unidad de Cuidados Intensivos alcanzó un rango de 5 a 18 días, con un promedio de 10, y el promedio de la necesidad de ventilación mecánica asistida fue de 8,2 días, y de cánula de alto flujo de 2,8 días. Únicamente un 6,38 % (n=9) tenía el antecedente de haber recibido profilaxis con palivizumab: la mayoría había recibido más de dos dosis y ninguno de los pacientes había completado el esquema de las 5 dosis. Durante 2011, el Hospital reportó que el costo promedio diario fue de ¢ 766 476. Con un total de 1001 días de hospitalización acumulada, se estimó un costo directo de ¢ 767 242 142, equivalente a $ 1 522 306 (dólares estadounidenses). Conclusión: El perfil de los prematuros en este estudio es muy similar a lo reportado internacionalmente, por ser un grupo de prematuros con prevalencia más elevada de complicaciones que la población pediátrica general. Dado el costo que implica el internamiento de estos pacientes, es necesario evaluar la aplicación de intervenciones como el palivizumab para prevenir la hospitalización y disminuir otros costos al sistema de salud solidario.
Abstract Background: Bronchiolitis is the most common lower respiratory tract infection in infants. Respiratory Syncytial Virus is the main agent and responds in up to 85% of cases. The main associated risk factors are: male sex, young infants, premature infants, underlying medical conditions such as: congenital heart disease, bronchopulmonary dysplasia, Down syndrome and neuromuscular diseases; as well as other environmental and social factors. The objective of this study was to characterize preterm infants, the treatment used, the viral immunofluorescence profile, complications, the use of palivizumab, and hospitalization costs in patients hospitalized for bronchiolitis during January 2011 and December 2011. Methods: An observational, descriptive study, based on a retrospective review of clinical records of a series of hospitalized patients at the National Children's Hospital (HNN) of the Costa Rican Social Security Fund. All patients under 2 years of age who were discharged with a diagnosis of bronchiolitis during 2011, with a history of prematurity (less than 37 weeks gestational age) were included. Results: A total of 141 patients were included, 63% (n = 89) were male, with an average age of 5.7 months (range 0-24). 43% (n = 61) of patients with Bronchiolitis manifested before 3 months of age. With regard to gestational age, it was found that 35.46% of the patients were between 32 and 35 weeks, 31.2% from 35 to 37 weeks, 19.86% from 30 to 32 weeks and the rest were under 29 weeks. In 93 children (66%) a history of smoking was noted in the home environment; specifically, 17% of these patients had a history of passive smoking as the father or grandfather was reported as active smokers. In relation to the hereditary family history of asthma, it was positive in 41.8%. Regarding the treatment received during their hospitalization, 100% required supplemental oxygen and 61% received nebulizations with salbutamol; systemic steroids were used in 33% of patients and antibiotic therapy was used in only 29%. 28% of the population studied presented complications, of which 28 (19.86%) premature babies required ventilatory support. The finding of atelectasis on the chest X-ray occurred in 7.8% of the patients. Only 4.25% of the patients had a bacterial superinfection. Due to the difficulty of the venous access in this group of children, 14 (9.93%) of them required the placement of a central venous catheter. The range of hospital stay was from 1 to 31 days with an average of 7 days, hospitalization in the Intensive Care Unit reached a range of 5 to 18 days with an average of 10 days and the average need for assisted mechanical ventilation It was 8.2 days and the high-flow cannula was 2.8 days. Only 6.38% (n = 9) had a history of having received prophylaxis with Palivizumab, the majority had received more than two doses, and none of the patients had completed the 5-dose schedule. During that year 2011, the hospital reported that the average daily cost was ¢ 766 476; With a total of 1001 cumulative hospitalization days, a total direct cost of ¢ 767 242 142 was estimated, equivalent to $ 1 522 306 (US dollars). Conclusion: The profile of the characteristics of premature infants in this study is very similar to that reported internationally, as it is a group of premature infants with a higher prevalence of complications than the general pediatric population. Given the cost involved in the hospitalization of these patients, it is necessary to evaluate the application of interventions such as palivizumab to prevent hospitalization and reduce other costs to the solidarity health system.
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Humanos , Recém-Nascido , Bronquiolite/diagnóstico , Bronquiolite/economia , Recém-Nascido PrematuroRESUMO
Resumen Objetivo Estimar la eficiencia mediante el análisis costo-efectividad incremental de la terapia con Palivizumab contra la práctica clínica habitual en el período 2010-2017. Materiales y Métodos Se realizó una evaluación económica completa del tipo costo-efectividad y el horizonte temporal fue de un año (sin tasa de descuento). El estudio considero la perspectiva de la Seguridad Social, se incluyeron siete hospitales y las variables de efectividad se seleccionaron a partir de la información disponible en la literatura científica. Los costos se expresaron en dólares americanos para cada año. Se hizo el análisis árbol de decisiones con los datos agrupados y el análisis costo-efectividad medio e incremental de sensibilidad al considerar la edad gestacional como variable clasificadora. Se consideraron los principios éticos pertinentes. Resultados Se encontraron datos de 200 prematuros con Palivizumab y 206 sin la administración del tratamiento. El análisis del árbol de decisiones mostró un costo efectividad incremental de US$1,799.00. El costo-efectividad medio fue más alto en prematuros con Palivizumab y el costo-efectividad incremental en el sub grupo de 32 a 35 semanas resultó el de más costo-efectivo. Al intervalo de confianza del 90 y 95%, el rango del valor promedio del costo total del tratamiento es amplio por lo que el costo es sensible al cambio. Conclusiones El Palivizumab es mayor en costo-efectivo en prematuros de 32 a 35 semanas de edad gestacional.
Abstract Objective To estimate the efficiency by incremental cost effectiveness analysis of palivizumab therapy against the usual clinical practice in 2010-2017 period. Materials and methods A complete economic evaluation of the cost effectiveness type was carried out and the time horizon was one year, without discount rate, the study was carried out from the perspective of Social Security, seven hospitals were included and the effectiveness variables were selected from the available information in the literature scientifically, the costs were expressed in US dollars for each year. The decision tree analysis was carried out with the grouped data and the average and incremental cost effectiveness and sensitivity analysis when considering gestational age as a classification variable. Relevant ethical principles were considered. Results Data of 200 premature infants were found with palivizumab and 206 without the administration of this treatment. The decision tree analysis showed an incremental cost effectiveness of US $ 1,799. The average cost effectiveness was higher in premature infants with palivizumab and the incremental cost effectiveness in the subgroup 32-35 weeks was the most effective cost. At the 90 and 95% confidence interval, the range of the average value of the total treatment cost is wide, so the cost is sensitive to change. Conclusions Palivizumab is more effective cost in premature of 32-35 weeks of gestational age.
Resumo Objetivo Estimar a eficiência através da análise de custo-efetividade incremental da terapia com Palivizumab em relação à prática clínica habitual no período 2010-2017. Materiais e Métodos Foi realizada uma avaliação econômica completa do tipo custo-efetividade e o horizonte temporal foi de um ano (sem taxa de desconto). O estudo considerou a perspectiva da Previdência Social, sete hospitais e as variáveis de efetividade foram incluídas foram selecionados a partir das informações disponíveis na literatura científica. Os custos foram expressos em dólares americanos para cada ano. A análise da árvore de decisão foi feita com os dados agrupados e a análise de custo-efetividade média e incremental da sensibilidade a considere a idade gestacional como uma variável classificatória. Princípios éticos relevantes foram considerados. Resultados Foram encontrados dados de 200 bebês prematuros com Palivizumab e 206 sem administração do tratamento. A análise da árvore de decisão mostrou um custo incremental de $1.799,00. O custo-benefício médio foi maior em prematuros com Palivizumab, e o custo-efetividade incremental no subgrupo de 32 a 35 semanas foi o mais econômico. No intervalo de confiança de 90 e 95%, a faixa do valor médio do custo total do tratamento é ampla, tornando o custo sensível à mudança. Conclusões O palivizumabe é mais econômico em prematuros de 32 a 35 semanas de idade gestacional.
Résumé Objectif Estimer l'efficience, au moyen de l'analyse coût-efficacité incrémental, du traitement par Palivizumab par rapport à la pratique clinique habituelle au cours de la période 2010-2017. Méthodologie Une évaluation économique complète de type coût-efficacité a été réalisée sur un horizon temporel d'un an (sans taux d'actualisation). L'étude a été réalisée dans le contexte de la Sécurité Sociale. Sept hôpitaux ont été inclus et les variables d'efficacité ont été sélectionnées sur la base des informations disponibles dans la littérature scientifique. Les coûts ont été exprimés en dollars américains par an. L'analyse de l'arbre de décisions a été réalisée avec les données groupées, ainsi que l'analyse du rapport coût-efficacité moyen et incrémental de sensibilité en considérant l'âge gestationnel comme variable de classification. Les principes éthiques pertinents ont été appliqués. Résultats Des données concernant 200 nourrissons prématurés traités avec Palivizumab et 206 sans ce traitement ont été réunies. L'analyse de l'arbre de décisions a montré un coût-efficacité incrémental de 1 799 $ US. Le rapport coût-efficacité moyen a été plus élevé chez les nourrissons prématurés avec Palivizumab et le coût-efficacité incrémental dans le sous-groupe de 32 à 35 semaines a été le plus rentable. Avec un intervalle de confiance de 90 et 95%, la fourchette de la valeur moyenne du coût total du traitement est large, de sorte que le coût est sensible au changement. Conclusions Le Palivizumab est plus rentable chez les bébés prématurés de 32 à 35 semaines d'âge gestationnel.
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OBJECTIVE: To describe the viruses involved, seasonality and coinfection in hospitalised children with suspected bronchiolitis. METHODS: Over the period 1/07/2007 to 31/12/2008, all children hospitalised for bronchiolitis in the paediatric ward were prospectively included, and had respiratory syncytial virus (RSV) screenings. We retrospectively tested all samples for RSVA, RSVB, rhinovirus (RV), human metapneumovirus, parainfluenza 1, 2, 3, 4, influenza A and influenza B. RESULTS: 198 children were tested, and 23% were negative for all viruses. RSVA was predominant in 2008 (64% of all viruses) and RSVB in 2007 (66% of all viruses). RV was frequent during both seasons (24% of all viruses). Flu was not found during the study period. Virus distribution was similar regardless of season or age, and identical to typical patterns in temperate countries. Coinfections were less frequent than in temperate regions because respiratory virus seasons seem to be better separated. The bronchiolitis season started in August and finished in December with a peak in October. CONCLUSION: The specific seasonality of bronchiolitis infection requires palivizumab prophylaxis starting in early July for high-risk infants.
OBJECTIF: Décrire les virus impliqués, la saisonnalité et la coinfection chez les enfants hospitalisés avec une suspicion de bronchiolite. MÉTHODES: Au cours de la période du 01/07/2007 au 31/12/2008, tous les enfants hospitalisés pour bronchiolite dans le service de pédiatrie ont été prospectivement inclus et soumis à un dépistage du virus respiratoire syncytial (VRS). Nous avons testé rétrospectivement tous les échantillons pour RSVA, RSVB, rhinovirus (RV), métapneumovirus humain, Parainfluenza 1, 2, 3, 4, Influenza A, et Influenza B. RÉSULTATS: 198 enfants ont été testés et 23% étaient négatifs pour tous les virus. RSVA était prédominant en 2008 (64% de tous les virus) et RSVB en 2007 (66% de tous les virus). RV était fréquent pendant les deux saisons (24% de tous les virus). La grippe n'a pas été trouvée pendant la période d'étude. La distribution des virus était similaire quelle que soit la saison ou l'âge, et identique aux modèles typiques dans les pays tempérés. Les coinfections étaient moins fréquentes que dans les régions tempérées car les saisons virales respiratoires semblent mieux séparées. La saison des bronchiolites a commencé en août et s'est terminée en décembre avec un pic en octobre. CONCLUSION: La saisonnalité spécifique de l'infection bronchiolite nécessite une prophylaxie au palivizumab débutant en juillet pour les nourrissons à haut risque.
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Bronquiolite/epidemiologia , Resfriado Comum/epidemiologia , Infecções por Vírus Respiratório Sincicial/epidemiologia , Vírus Sincicial Respiratório Humano/isolamento & purificação , Rhinovirus/isolamento & purificação , Antivirais/administração & dosagem , Antivirais/uso terapêutico , Bronquiolite/prevenção & controle , Bronquiolite/virologia , Criança , Criança Hospitalizada , Pré-Escolar , Coinfecção , Resfriado Comum/prevenção & controle , Resfriado Comum/virologia , Feminino , Humanos , Lactente , Recém-Nascido , Estudos Longitudinais , Masculino , Martinica/epidemiologia , Palivizumab/administração & dosagem , Palivizumab/uso terapêutico , Estudos Prospectivos , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Infecções por Vírus Respiratório Sincicial/virologia , Estudos Retrospectivos , Estações do Ano , Clima TropicalRESUMO
OBJECTIVE: To measure the real-world effectiveness of palivizumab immunoprophylaxis against respiratory syncytial virus (RSV)-confirmed infection before age 2 years in a population-cohort of high-risk infants. STUDY DESIGN: Palivizumab is funded for high-risk infants in Western Australia. We used probabilistically linked administrative data encompassing RSV laboratory-confirmed infections, hospital admissions, and palivizumab dispensing records for a cohort of 24 329 high-risk infants admitted to neonatal intensive care units, born 2002-2013 with follow-up to 2015. We used a traditional cohort method with Cox proportional hazards regression and a self-controlled case series analysis to assess effectiveness of palivizumab in reducing RSV-confirmed infection by number of doses. RESULTS: From the cohort of 24 329 infants, 271 (1.1%) received at least 1 dose of palivizumab and 1506 (6.2%) had at least 1 RSV-confirmed infection before age 2 years. Using the traditional cohort approach, we found no protective association of palivizumab receipt with RSV detection (adjusted hazard ratio = 0.99 [95% CI 0.5, 1.9] for 1 dose). However, using a self-controlled case series to eliminate confounding by indication, a protective association was seen with a 74% lower RSV incidence (relative incidence = 0.26; 95% CI 0.11, 0.67) following any dose of palivizumab compared with control (nonexposed) periods. CONCLUSIONS: After accounting for confounding by indication through a self-controlled analysis, palivizumab appeared effective for reducing virologically confirmed RSV in this high-risk cohort.
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Palivizumab/administração & dosagem , Infecções por Vírus Respiratório Sincicial/tratamento farmacológico , Vírus Sincicial Respiratório Humano/genética , Antivirais/administração & dosagem , Pré-Escolar , DNA Viral/análise , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Incidência , Lactente , Recém-Nascido , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Masculino , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/virologia , Estudos Retrospectivos , Fatores de Risco , Austrália Ocidental/epidemiologiaRESUMO
BACKGROUND: Palivizumab prophylaxis for the human respiratory syncytial virus (HRSV) has been reported to reduce the risk of hospital admissions related to HRSV in children with congenital heart disease (CHD). These children are at high risk of developing severe lower respiratory tract infection (LRTI) due to HRSV infection. Our goal was to evaluate the incidence of HRSV infection in children with CHD after being submitted to immunoprophylaxis with palivizumab in Pará state, North region of Brazil. METHODS: A prospective and observational cohort study was performed in children ≤2 years of age with CHD who received palivizumab immunoprophylaxis between January 1 and June 31, 2016. A questionnaire about basic non-medical care measures was applied to parents/legal representatives. Data on patients' demographic characteristics, household environment, and respiratory infections were evaluated. HRSV infection was determined by qPCR. RESULTS: There were 104 children enrolled in this investigation and the results showed a mean age of 10.6 months, an average weight of 7.3 kg and 3.5 doses of palivizumab per children during seasonality of HRSV. Respiratory infection was observed in 27.9% of cases, of which 9.6% were LRTI. No case of children who received palivizumab immunoprophylaxis and developed influenza-like symptoms tested positive for HRSV. CONCLUSION: Although the lack of a control group doesn't allow to affirm the effectiveness of HRSV passive immunization, the immunoprophylaxis with palivizumab appeared to be totally efficient in preventing respiratory infection by HRSV in children up to two years of age with CHD.
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Antivirais/uso terapêutico , Cardiopatias Congênitas/epidemiologia , Palivizumab/uso terapêutico , Infecções por Vírus Respiratório Sincicial/epidemiologia , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Brasil/epidemiologia , Feminino , Humanos , Imunização , Incidência , Lactente , Recém-Nascido , Masculino , Estudos ProspectivosRESUMO
OBJECTIVES: To evaluate the impact of the American Academy of Pediatrics revised recommendations (2014) for palivizumab prophylaxis on respiratory syncytial virus (RSV) admissions and severity of illness among children ≥29 weeks and <35 weeks of gestational age. STUDY DESIGN: We evaluated patients hospitalized with RSV infection from October 1, 2012, through April 30, 2017. RSV hospitalizations, community RSV activity, duration of hospitalization, disease severity, and mortality were reviewed. Data were compared before and after implementation of the guideline changes. RESULTS: A total of 91 patients were born at ≥29 weeks and <35 weeks of gestational age and hospitalized within the first year of life during the evaluation period. Gestational age, birth weight, age at diagnosis, and sex remained constant over the seasons evaluated. RSV hospitalizations and activity in the community were unchanged over 5 years. Duration of hospitalization increased. There was no difference in need for intensive care, supplemental oxygen, or mechanical ventilation or mortality. CONCLUSIONS: Implementation of the 2014 American Academy of Pediatrics guidelines regarding eligibility for palivizumab prophylaxis in older infants born preterm did not increase RSV hospitalizations or disease severity among children hospitalized for RSV at our hospital. Our data support continued adherence to the guidelines.
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Antivirais/uso terapêutico , Palivizumab/uso terapêutico , Guias de Prática Clínica como Assunto , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Academias e Institutos , Feminino , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Masculino , Admissão do Paciente/estatística & dados numéricos , Pediatria , Estudos Retrospectivos , Índice de Gravidade de DoençaRESUMO
A bronquiolite, causada pelo vírus sincicial respiratório (VSR), é a doença mais frequente do trato respiratório inferior em prematuros e a primeira causa de hospitalização de recémnascidos (RN) no mundo. Sem uma vacina contra o VSR para uso populacional, o Palivizumabe (PVZ), um anticorpo monoclonal, tem sido indicado para profilaxia da doença grave por VSR. Beneficiam-se com PVZ crianças menores de um ano de idade, nascidas prematuras com Idade Gestacional (IG) menor ou igual a 28 semanas e crianças com até dois anos de idade com doença pulmonar crônica ou doença cardíaca congênita com repercussão hemodinâmica demonstrada. Este estudo de coorte retrospectivo, analítico, objetivou analisar o adoecimento de crianças prematuras, por complicações respiratórias, nascidas entre 2012 e 2016 em Uberlândia, MG e que não foram contempladas com PVZ. Extraíram-se dados dos prontuários de 504 crianças, tanto no Hospital de Clínicas da Universidade Federal quanto nas Unidades de Saúde do município. A média de idade materna foi de 26,1 anos, 281(55,9%) tinham ensino médio e 274 (55,1%) eram de cor não branca. Tiveram gestações anteriores, 306 (60,7%) mães que realizaram, na gestação atual, média de 7,8 consultas de pré-natal. Maior prevalência (371;73,6%) para parto cesáreo, 255 (50,7%) crianças do sexo masculino; IG média de 34,2 semanas e 385 (76,4%) com baixo peso ao nascer. Identificaram-se 270 (54%) RN com internação em Unidade de Terapia Intensiva (UTI); 284 (58,7%) bebês com, pelo menos, um diagnóstico respiratório na internação e 267 (53,3%) receberam alta hospitalar após sete ou mais dias. Na alta, 186 (36,6%) RN estavam em aleitamento materno exclusivo. Ao longo do primeiro ano de vida, identificaram-se 2.899 atendimentos de rotina e eventuais; média de 5,75 consultas para cada criança. Em 1.437 atendimentos foram diagnosticadas doenças com maior frequência para doenças do trato respiratório 803(55,8%), seguidas das doenças do aparelho digestivo 141(9,8%), doenças nutricionais e metabólicas 73(5%) e doenças do ouvido 72 (5%), respectivamente. Dos 561 episódios de doenças do trato respiratório superior (DTRS), as Infecções das Vias Aéreas Superiores (IVAS) e a nasofaringite aguda (resfriado comum) corresponderam a 477 (85%) episódios. Em relação aos 242 episódios de doenças respiratórias do trato respiratório inferior (DRTI) 105 (29,5%) crianças foram acometidas com 147 (60,7%) episódios de bronquiolite, média de 0,43 episódios. Em 44 (3,33%) atendimentos, houve necessidade de hospitalização, sendo três (0,14%) em UTI. Verificou-se correlação entre o número de consultas eventuais (NCE) e o número de episódios de doenças respiratórias. Crianças com somente fórmula láctea na alta hospitalar tiveram um número médio maior de episódios de doenças respiratórias no primeiro ano de vida. A idade da mãe, o diagnóstico respiratório na alta hospitalar e o NCE apresentaram associação significativa com adoecimento por bronquiolite. As DTRS foram mais frequentes nessa coorte, com média de 2,16 episódios de doença respiratória por criança no primeiro ano de vida. O NCE foi significante para doenças respiratórias e o aleitamento materno mostrou-se como fator protetor para este desfecho. Da análise do adoecimento das crianças prematuras, a ocorrência de bronquiolite revela a importância de atender estas crianças em tempo oportuno para evitar desfechos desfavoráveis como hospitalização. Evidencia-se também a importância de rastrear crianças com diagnóstico respiratório em uso de fórmula na alta hospitalar para orientar medidas preventivas de doenças respiratórias
Bronchiolitis, caused by the respiratory syncytial virus (RSV), is the most common disease of the lower respiratory tract in premature infants and the leading cause of hospitalization of newborns (NB) in the world. Without a RSV vaccine for population use, Palivizumab (PVZ), a monoclonal antibody, has been indicated for the prophylaxis of severe RSV disease. Children under one year of age, premature babies with gestational age (GA) less than or equal to 28 weeks and children up to two years of age with chronic lung disease or congenital heart disease with demonstrated hemodynamic repercussion benefit from PVZ. This retrospective, analytical cohort study aimed to analyze the illness of premature children, due to respiratory complications, born between 2012 and 2016 in Uberlândia, MG and who were not treated with PVZ. Data was extracted from the medical records of 504 children, both at the Clinical Hospital of the Federal University and in the Health Units of the municipality. The mean maternal age was 26.1 years, 281 (55.9%) had high school and 274 (55.1%) were non-white. There were previous pregnancies, 306 (60.7%) mothers who had, in the current pregnancy, an average of 7.8 prenatal consultations. Higher prevalence (371; 73.6%) for cesarean delivery, 255 (50.7%) male children; Mean IG of 34.2 weeks and 385 (76.4%) with low birth weight. 270 (54%) NB with admission to the Intensive Care Unit (ICU) were identified; 284 (58.7%) babies with at least one respiratory diagnosis on admission and 267 (53.3%) were discharged after seven or more days. At discharge, 186 (36.6%) NBs were exclusively breastfed. During the first year of life, 2,899 routine and occasional visits were identified; average of 5.75 consultations for each child. In 1,437 visits, diseases were diagnosed more frequently for diseases of the respiratory tract 803 (55.8%), followed by diseases of the digestive system 141 (9.8%), nutritional and metabolic diseases 73 (5%) and diseases of the ear 72 (5%), respectively. Of the 561 episodes of upper respiratory tract disease (URTD), Upper Airway Infections (UAI) and acute nasopharyngitis (common cold) corresponded to 477 (85%) episodes. Regarding the 242 episodes of respiratory diseases of the lower respiratory tract (LRTD) 105 (29.5%) children were affected with 147 (60.7%) episodes of bronchiolitis, average of 0.43 episodes. In 44 (3.33%) visits, there was a need for hospitalization, three (0.14%) in the ICU. There was a correlation between the number of occasional visits (NOV) and the number of episodes of respiratory diseases. Children with milk formula only at hospital discharge had a higher average number of episodes of respiratory diseases in the first year of life. The mother's age, the respiratory diagnosis at hospital discharge and the NOV showed a significant association with illness from bronchiolitis. URTD were more frequent in this cohort, with an average of 2.16 episodes of respiratory disease per child in the first year of life. NOV was significant for respiratory diseases and breastfeeding was shown to be a protective factor for this outcome. From the analysis of the illness of premature children, the occurrence of bronchiolitis reveals the importance of attending these children in a timely manner to avoid unfavorable outcomes such as hospitalization. It also highlights the importance of screening children with respiratory diagnosis using formula at hospital discharge to guide preventive measures against respiratory diseases
Assuntos
Humanos , Recém-Nascido , Lactente , Vírus Sinciciais Respiratórios , Recém-Nascido Prematuro , Bronquiolite/virologia , PalivizumabRESUMO
El Palivizumab es una terapia biológica perteneciente a la familia de los anticuerpos monoclonales IgG, indicado para la prevención de enfermedad respiratoria inferior grave causada por el Virus Sincitial Respiratorio (VSR) en neonatos prematuros con factores de riesgo. Los recién nacidos pretérminos (RNPT) se consideran los más susceptibles a dichas enfermedades en comparación con los recién nacidos a términos (RNT) sanos, lo que se traduce en mayores ingresos a Unidades De Cuidados intensivos Neonatales (UCIN), mayores costos hospitalarios y mayor morbi-mortalidad. La profilaxis con Palivizumab según la última actualización de la Academia Americana de Pediatría (AAP) se puede administrar a los recién nacidos ≥ 29 semanas y 0 días de gestación que son menores de 12 meses en el inicio de la temporada del VSR o sean dados de alta durante ella. Para los recién nacidos durante la estación del VSR, se necesitarán al menos 5 dosis. Dada la controversia que existe actualmente en el uso de Palivizumab, por sus altos costos y discrepancias en las indicaciones relacionadas con la edad gestacional decidimos hacer una revisión bibliográfica del uso de Palivizumab en RNPT...(AU)
Assuntos
Humanos , Masculino , Recém-Nascido , Palivizumab/uso terapêutico , Anticorpos Monoclonais/classificação , Doenças Respiratórias , Vírus Sincicial Respiratório HumanoRESUMO
OBJECTIVE: To analyze the efficacy of a novel palivizumab protocol for hemodynamically significant congenital heart disease (hsCHD) in subtropical areas without clear respiratory syncytial virus seasonality. STUDY DESIGN: Since July 2013, the National Health Insurance program has provided reimbursement for palivizumab prophylaxis with a novel monthly protocol in selected patients with hsCHD under 1 year of age. We performed a multicenter study to assess the trend of respiratory syncytial virus hospitalizations in patients with hsCHD from 2010 to 2016 during the prepalivizumab, transition, and postpalivizumab periods, and compared treatment and propensity-matched control groups. RESULTS: A total of 747 patients were enrolled in the study group and 809 in the control group. The male:female was 836:720. Cyanotic CHD was observed in 42.9% of patients. The mean age at diagnosis of CHD was 32.9 days. After 516 685 patient-days of follow-up and a mean of 3.9 doses of palivizumab in the treatment group, respiratory syncytial virus hospitalization rates decreased by 53% and 49% before and after match compared with the control group (P = .009 and .029, respectively). Hospitalization days and intensive care unit admission rate also decreased similarly in the treatment group. The efficacy of this protocol was more prominent in patients with cyanotic hsCHD. The annual respiratory syncytial virus-associated hospitalization rates also decreased significantly from the prepalivizumab to the palivizumab period (from 4.8% to 2.0%; P = .038). CONCLUSION: Palivizumab prophylaxis through the novel monthly protocol for patients with hsCHD is effective in reducing respiratory syncytial virus-related hospitalizations.
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Antivirais/uso terapêutico , Cardiopatias Congênitas/complicações , Hospitalização/estatística & dados numéricos , Palivizumab/uso terapêutico , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Estudos de Casos e Controles , Feminino , Humanos , Lactente , Masculino , Taiwan , Clima TropicalRESUMO
O objetivo deste estudo foi avaliar o programa de uso da imunoglobulina palivizumabe no Estado de São Paulo, Brasil. Adotou-se o referencial de avaliação proposto por Donabedian, e os dados foram discutidos com base nas recomendações da Portaria que regulamenta o uso da palivizumabe em rede nacional e no Manual de Normas e Procedimentos para Vacinação. Foram incluídos os 16 locais de aplicação do estado, bem como 693 crianças/mães inscritas no programa em 2014 (85,1% da população elegível). Para avaliação da estrutura e processo foram criados escores que permitiram classificar os locais de aplicação em adequado, parcialmente adequado e inadequado, quando havia até 10%, de 11-20% e superior a 20% de desconformidades, respectivamente. Para a avaliação de resultado, buscou-se associação entre falha na tomada da palivizumabe e a necessidade de hospitalização por doença/sintomatologia respiratória, baseando-se em odds ratio pontual e intervalar, com intervalo de 95% de confiança e valor de p crítico < 0,05. Dos 11 postos de aplicação que tiveram estrutura classificada como adequada, apenas dois apresentaram processo adequado, quatro apresentaram processo inadequado e cinco parcialmente adequados. O risco de hospitalização em UTI por doença/sintomatologia respiratória aumentou em média 30% a cada falha (p = 0,003; OR = 1,30; IC95%: 1,09-1,55). Conclui-se que ter estrutura do programa de uso da imunoglobulina no Estado de São Paulo favorável não resultou, necessariamente, em processo adequado. Em geral, a situação da estrutura foi melhor do que a de processo. Mostrou-se relevante a aplicação de todas as doses da imunoglobulina para a prevenção de internação por doença/sintomatologia respiratória.
This study aimed to assess the program for use of the monoclonal antibody palivizumab in São Paulo State, Brazil. The evaluation adopted the frame of reference proposed by Donabedian, and the data were discussed on the basis of the guidelines from the Ruling on the use of palivizumab in the national network and in the Manual on Standards and Procedures for Vaccination. Sixteen application services in the state were included, with 693 children/mothers enrolled in the program in 2014 (85.1% of the eligible population). For the structure and process evaluation, scores were created that allowed classifying the application services as adequate, partially adequate, and inadequate (non-compliance rates were ≤ 10%, 11-20%, and > 20%, respectively). Results were evaluated according to the association between failure to administer palivizumab and need for hospitalization due to respiratory disease/symptoms, based on the point and interval odds ratios, with 95% confidence interval and critical p-value < 0.05. Of the 11 application services whose structure was classified as adequate, only two showed adequate process, four showed inadequate process, and five partially adequate process. Risk of ICU admission due to respiratory disease/symptoms increased on average by 30% for each failure (p = 0.003; OR = 1.30; 95%CI: 1.09-1.55). In conclusion, having a favorable structure for the program for use of palivizumab in São Paulo State did not necessarily result in an adequate process. In general, the situation with the structure was better than the process. All doses of the monoclonal antibody need to be administered in order to prevent hospitalization from respiratory disease/symptoms.
El objetivo de este estudio fue evaluar el programa de uso de la inmunoglobulina palivizumab en el Estado de São Paulo, Brasil. Se adoptó el sistema referencial de evaluación propuesto por Donabedian, donde los datos se discutieron en base a las recomendaciones del decreto que regula el uso del palivizumab en la red nacional y en el Manual de Normas y Procedimientos para la Vacunación. Se incluyeron 16 espacios de aplicación en el estado, así como a 693 niños/madres inscritas en el programa en 2014 (85,1% de la población elegible). Para la evaluación de la estructura y proceso se crearon marcadores que permitieron clasificar los lugares de aplicación como: adecuado, parcialmente adecuado e inadecuado, cuando había hasta un 10%, de 11-20% y superior al 20% de discordancias, respectivamente. Para la evaluación del resultado, se buscó la asociación entre el fallo en la toma del palivizumab y la necesidad de hospitalización por enfermedad/sintomatología respiratoria, basándose en la razón de probabilidades puntual y con intervalos, con un intervalo del 95% de confianza y valor de p crítico < 0,05. De los 11 puestos de aplicación que contaron con una estructura clasificada como adecuada, solamente dos presentaron un proceso adecuado, cuatro presentaron proceso inadecuado y cinco parcialmente adecuados. El riesgo de hospitalización en la UTI por enfermedad/sintomatología respiratoria aumentó de media un 30% con cada fallo (p = 0,003; OR = 1,30; IC95%: 1,09-1,55). Se concluye que contar con una estructura del programa de uso de la inmunoglobulina en el Estado de São Paulo no resultó favorable, necesariamente, en un proceso adecuado. En general, la situación de la estructura fue mejor que la del proceso. Se mostró relevante la aplicación de todas las dosis de inmunoglobulina para la prevención del internamiento por enfermedad/sintomatología respiratoria.
Assuntos
Humanos , Masculino , Feminino , Lactente , Adulto , Adulto Jovem , Avaliação de Programas e Projetos de Saúde , Palivizumab/administração & dosagem , Hospitalização/estatística & dados numéricos , Erros de Medicação/estatística & dados numéricos , Anticorpos Monoclonais/administração & dosagem , Padrões de Referência , Infecções Respiratórias/prevenção & controle , Estações do Ano , Brasil , Fatores de Risco , Imunização Passiva/normas , Medição de RiscoRESUMO
Abstract Objective: This study aims to describe real world palivizumab use and effectiveness in high-risk Latin American infants and young children. Method: Prospective, multicenter observational study with infants at risk for severe RSV infection who received palivizumab according to routine clinical practice. Subjects were followed for one year with monthly visits after the first dose of palivizumab. An infant was considered adherent if receiving all the expected injections or five or fewer injections within appropriate inter-dose intervals. Annual incidence rates and risk factors of lower respiratory tract infection (LRTI) hospitalization were determined through Poisson regression models (α = 0.05). Results: The study enrolled 458 children from seven countries in Latin America, from February 2011 to September 2012. The majority (98%) were born <36 weeks gestation. Overall, patients received 83.7% of their expected injections and 86.7% completed one year of follow-up. Of the 61 LRTI hospitalizations, 12 episodes were due to RSV infection. The RSV-associated hospitalization rate was 2.9 per 100 patient-years. Bronchopulmonary dysplasia was identified as an independent risk factor for LRTI hospitalization. A total of 1165 adverse events were recorded during one year of follow-up. One hundred and two patients (22.3%) had a total of 135 serious adverse events, but no events were considered to be related to palivizumab. Conclusions: The rate of RSV hospitalization in high-risk infants in Latin America was low and aligned with those observed in randomized control trials and observational studies. Palivizumab prophylaxis appeared effective and had a good safety profile in this population.
Resumo Objetivo: Descrever o uso e a eficácia do palivizumabe no mundo real em neonatos e jovens crianças de alto risco latino-americanas. Método: Estudo observacional prospectivo multicêntrico com neonatos em risco devido a infecção grave por VSR que receberam palivizumabe de acordo com a prática clínica de rotina. Os indivíduos foram acompanhados por um ano, com visitas mensais após a primeira dose de palivizumabe. Um neonato foi considerado adepto se recebeu todas as injeções esperadas ou ≤ 5 injeções nos intervalos entre doses adequados. As taxas de incidência anuais e os fatores de risco de internação por infecção do trato respiratório inferior (ITRI) foram determinados por meio dos modelos de regressão de Poisson (α = 0,05). Resultados: O estudo inscreveu 458 crianças de sete países da América Latina, de fevereiro de 2011 a setembro de 2012. A maioria (98%) nasceu com < 36 semanas. Em geral, os pacientes receberam 83,7% de suas injeções esperadas e 86,7% completaram um ano de acompanhamento. Das 61 internações por ITRI, 12 episódios foram devidos a infecção por VSR. A taxa de internação associada ao VSR foi de 2,9 em cada 100 pacientes-ano. A displasia broncopulmonar foi identificada como um fator de risco independente da internação por ITRI. Foram registrados 1.165 eventos adversos durante um ano de acompanhamento; 122 (22,3%) apresentaram 135 eventos adversos graves, porém nenhum deles foi considerado relacionado ao palivizumabe. Conclusões: A taxa de internação por VSR em neonatos de alto risco na América Latina foi baixa e em linha com as observadas em ensaios clínicos controlados randomizados e estudos observacionais. A profilaxia com palivizumabe pareceu eficaz e com bom perfil de segurança nessa população.
Assuntos
Humanos , Masculino , Feminino , Lactente , Pré-Escolar , Antivirais/uso terapêutico , Infecções por Vírus Respiratório Sincicial/prevenção & controle , Palivizumab/uso terapêutico , Antivirais/efeitos adversos , Fatores de Tempo , Estudos Prospectivos , Fatores de Risco , Palivizumab/efeitos adversos , América LatinaRESUMO
Respiratory syncytial virus (RSV) infection can cause lower respiratory tract disease and mortality in pediatric hematopoietic stem cell transplant (HSCT) recipients. We report two children who underwent HSCT and developed RSV infection simultaneously at the Bone Marrow Transplant Unit. The treatment with intravenous palivizumab was provided and sequential viral loads were measured in nasopharyngeal (NP) and whole blood samples. To our knowledge, this is the first report where RSV loads were measured in parallel (NP and blood), before and after palivizumab, in correlation with a favorable clinical outcome in both cases.