Overprescription of short-acting β2 agonists: reflections from the SABINA study in Brazil / Prescrição excessiva de β2-agonistas de curta duração: reflexões a partir do estudo SABINA no Brasil

ABSTRACT Objective: To assess prescription patterns for short-acting b2 agonists (SABAs) and other asthma medications in asthma patients treated by specialists and participating in the SABA use IN Asthma (SABINA) study in Brazil. Methods: This was an observational, cross-sectional study conducted at five sites in different regions of Brazil. The primary endpoints were to record SABA prescriptions and obtain data on over-the-counter (OTC) SABA purchases at the pharmacy. Results: Data on 218 asthma patients were analyzed. Of those 218 patients, 80.3% were prescribed SABAs in addition to their maintenance therapy, with a mean of 11.2 SABA canisters in the previous 12 months. Of those patients, 71.4% were prescribed ≥ 3 canisters and 42.2% were prescribed ≥ 10 canisters. None of the patients were prescribed SABA monotherapy. A total of 14.2% of the patients reported purchasing SABAs OTC at a pharmacy without a prescription. Of those, 48.4% purchased ≥ 3 SABA canisters. A fixed-dose combination of an inhaled corticosteroid and a long-acting b2 agonist was prescribed to 95.0% of the patients. In the year before the study visit, 45.0% of the patients received at least one course of oral corticosteroid burst treatment. Asthma was well controlled in 43.1% of the patients, partly controlled in 34.9%, and uncontrolled in 22.0%. Patients reported a mean of 1.1 severe asthma exacerbations, with 49.1% experiencing 1 or more severe exacerbations. Conclusions: Overprescription and OTC purchases of SABAs are common in Brazil, possibly leading to the need for courses of oral corticosteroids. The health care community should collaborate to implement evidence-based recommendations and promote health education to improve asthma management in Brazil.

RESUMO Objetivo: Avaliar os padrões de prescrição de short-acting b2 agonists (SABAs, b2-agonistas de curta duração) e outros medicamentos para asma em pacientes tratados por especialistas e participantes do estudo SABA use IN Asthma (SABINA) no Brasil. Métodos: Trata-se de um estudo transversal observacional realizado em cinco locais em diferentes regiões do Brasil. Os desfechos primários foram registrar as prescrições de SABAs e obter dados a respeito da compra de SABAs sem receita médica na farmácia. Resultados: Foram analisados dados a respeito de 218 pacientes com asma. Dos 218 pacientes, 80,3% receberam prescrição de SABA além da terapia de manutenção, com uma média de 11,2 frascos de SABA nos 12 meses anteriores. Destes, 71,4% receberam prescrição de ≥ 3 frascos e 42,2% receberam prescrição de ≥ 10 frascos. Nenhum dos pacientes recebeu prescrição de monoterapia com SABA. Do total de pacientes, 14,2% relataram que compraram SABAs sem receita médica na farmácia. Destes, 48,4% compraram ≥ 3 frascos de SABA. Foram prescritas doses fixas combinadas de corticosteroide inalatório e b2-agonista de longa duração para 95,0% dos pacientes. No ano anterior à visita do estudo, 45,0% dos pacientes receberam pelo menos um ciclo de tratamento de curta duração com corticosteroide oral. A asma estava bem controlada em 43,1% dos pacientes, parcialmente controlada em 34,9% e não controlada em 22,0%. Os pacientes relataram uma média de 1,1 exacerbações graves da asma, sendo que 49,1% apresentaram uma ou mais exacerbações graves. Conclusões: A prescrição excessiva e a compra de SABAs sem receita médica são comuns no Brasil e possivelmente levam à necessidade de uso de corticosteroides orais. A comunidade de profissionais de saúde deve colaborar para implantar recomendações baseadas em evidências e promover a educação em saúde para melhorar o manejo da asma no Brasil.

Uso de inhaladores para la enfermedad pulmonar obstructiva crónica en un grupo de pacientes colombianos

Introducción: En Colombia son escasos los datos sobre el uso de los inhaladores en pacientes con EPOC. Objetivo: Describir la técnica de uso de inhaladores de dosis medida y polvo seco en pacientes de un hospital colombiano. Materiales y métodos: Estudio descriptivo en pacientes mayores de 40 años con EPOC atendidos en un hospital en La Virginia, Risaralda, Colombia, entre el 1 de septiembre de 2019 al 31 de enero de 2020. La unidad de análisis fueron los pacientes. Se incluyeron variables sociodemográficas, clínicas y lista de chequeo para uso de inhaladores. Se aplicaron frecuencias y proporciones para variables discretas, estadísticas de tendencia central y dispersión para variables continuas. Resultados: Se incluyeron 104 pacientes con edad media de 73,6 ± 10,1 años; 57 eran mujeres (54,8 %). Además, 48 pacientes estaban clasificados como GOLD-D (46,2 %). Igualmente, 89 pacientes manifestaron haber recibido educación sobre el uso de broncodilatadores (85,6 %). Los más frecuentes fueron los inhaladores de dosis medida (DM) en 95 casos (91,3 %), seguido de los de polvo seco unidosis (7,7 %). Así mismo, 37 pacientes que usaron DM sin inhalocámara (35,6 %) no cumplieron los pasos de la lista de chequeo. En el sistema multidosis, el más realizado fue cerrar de manera adecuada el inhalador y el menos ejecutado, expulsar el aire lentamente evitando hacerlo cerca del inhalador (n = 6; 5,7 %). Discusión: Se lograron describir las características de la técnica de uso de los inhaladores en pacientes con EPOC. A pesar de que ningún paciente logró utilizar el inhalador de forma "perfecta", la mayoría han recibido educación por parte de los profesionales de la salud. Conclusión: Un alto porcentaje de pacientes usa inadecuadamente los dispositivos para suministrar los broncodilatadores. Esto puede impactar negativamente en el control de la enfermedad.

Introduction: In Colombia, there is limited data on the use of inhalers in patients with COPD. Objective: The objective was to describe the technique of using metered-dose inhalers and dry powder in patients in a Colombian hospital. Methods: Observational, descriptive study of patients over 40 years of age with COPD, treated in a hospital in La Virginia, Risaralda, Colombia, between September 1st, 2019 and January 31st, 2020. The unit of analysis were patients in consultation. Sociodemographic and clinical variables, and a checklist for use of inhalers were included. Frequencies and proportions were applied for discrete variables, statistics of central tendency and dispersion for continuous variables. Results: A total of 104 patients with an average age of 73.6 ± 10.1 years were included; 57 were women (54.8%). In addition, 48 patients were classified as GOLD-D (46.2%). Similarly, 89 patients reported having received education on the use of bronchodilators (85.6%). The most common were metered-dose (MD) inhalers in 95 cases (91.3%), followed by single-dose dry powder inhalers in eight patients (7.7%). Likewise, 37 patients who used DM without inhalochamber (35.6%) did not comply with the steps of the checklist. In the multidose system, the most performed was to properly close the inhaler and the least performed was to expel the air slowly, avoiding doing so near the inhaler (n=6; 5.7%). Discussion: The characteristics of the technique of using inhalers in patients with COPD were described. Although no patient was able to use the inhaler "perfectly", most have received education from health professionals. Conclusion: A high percentage of patients misuse the devices to deliver bronchodilators. This can negatively impact the control of the disease.

Effects of nebulization with high-dose budesonide combined with ipratropium bromide on airway remodeling and mucus secretion in patients with AECOPD / 中国基层医药

Objective:To investigate the effects of nebulization with high-dose budesonide (BUD) combined with ipratropium bromide (IB) on airway remodeling and mucus secretion in patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD).Methods:Ninety patients with AECOPD who received treatment in Wenling Hospital of Traditional Chinese Medicine between January 2020 and June 2021 were included in this study. They were assigned to the conventional-dose group ( n = 45, odd number) and high-dose group ( n = 45, even number) according to the number of admission. In the conventional-dose group, nebulization with IB (0.5 mg administered within 20 minutes, three times daily) and BUD (2 mg administered within 20 minutes, twice daily) was performed. In the high-dose group, nebulization with IB (0.5 mg administered within 20 minutes, three times daily) and BUD (4 mg administered within 20 minutes, twice daily) was performed. After nebulization, a mouthwash was required in each group. After 7 days of treatment, clinical efficacy was compared between the two groups. Before and 7 days after treatment, airway remodeling level (matrix metalloproteinase-9 and interleukin-8), airway mucus secretion (mucin-5ac and neutrophil elastase) and the incidence of adverse reactions were compared between the two groups. Results:Total response rate in the high-dose group was significantly higher than that in the conventional-dose group [95.56% (43/45) vs. 82.22% (37/45), χ2 = 4.05, P < 0.05]. After 7 days of treatment, serum matrix metalloproteinase-9 and interleukin-8 levels in the high-dose group were (416.96 ± 30.96) μg/L and (6.33 ± 1.03) μg/L, respectively, which were significantly lower than those in the conventional-dose group [(452.25 ± 32.16) μg/L, (7.85 ± 1.24) μg/L, t = 5.30, 6.32, both P < 0.001)]. After 7 days of treatment, serum mucin-5ac and neutrophil elastase levels in the high-dose group were (1.33 ± 0.21) μg/L and (4.06 ± 1.03) μg/L, respectively, which were significantly lower than those in the conventional-dose group [(1.58 ± 0.23) μg/L, (5.11 ± 1.14) μg/L, t = 5.38, 4.58, both P < 0.001]. There was no significant difference in incidence of adverse reactions between high-dose and conventional-dose groups [8.89% (4/45) vs. 4.44% (2/45), χ2 = 0.71, P > 0.05). Conclusion:Nebulization with high-dose BUD combined with IB for treatment of AECOPD can improve airway remodeling, reduce airway mucus hypersecretion and has definite therapeutic effects. Findings from this study are of great innovation and science.

Eficácia e segurança de tripla terapia broncodilatadora comparada à dupla terapia em DPOC grave: revisão rápida de evidências / Effectiveness and safety of triple bronchodilator therapy compared to dual therapy in severe COPD: rapid response review of evidence

Tecnologia: Tripla terapia broncodilatadora (vilanterol/ umeclidínio/ fluticasona, formoterol/ glicopirrônio/ beclometasona) e dupla terapia. Indicação: Tratamento de doença pulmonar obstrutiva crônica (DPOC), formas grave e muito grave. Pergunta: Há diferenças de efeito nos principais desfechos de eficácia e segurança entre a tripla terapia broncodilatadora e as duplas terapias no tratamento de pacientes com DPOC, formas grave e muito grave? Métodos: Revisão rápida de evidências (overview) de revisões sistemáticas, com levantamento bibliográfico realizado na base de dados PUBMED, utilizando estratégia estruturada de busca. A qualidade metodológica das revisões sistemáticas foi avaliada com AMSTAR-2 (Assessing the Methodological Quality of Systematic Reviews). Resultados: Foram selecionadas e incluídas 2 revisões sistemáticas. Conclusão: A tripla terapia broncodilatadora era mais eficaz que a dupla terapia para reduzir a taxa anual de exacerbações moderadas a severas, mas não tinha superioridade para obter ganhos clínicos em outros desfechos (volume expiratório forçado no primeiro segundo, qualidade de vida, índice de dispneia, mortalidade geral, mortalidade respiratória), exceto que a tripla terapia era superior à dupla terapia com agonistas beta-2/ antagonistas antimuscarínicos e similar à dupla terapia com agonistas beta-2/ corticoesteróides inalatórios para reduzir mortalidade. A tripla terapia tinha perfil de segurança similar à dupla terapia, com mesmo risco para eventos adversos e eventos adversos graves. A tripla terapia tinha maior risco para pneumonias que a dupla terapia com agonistas beta-2/ antagonistas antimuscarínicos

Technology: Triple bronchodilator therapy (vilanterol/ umeclidinium/ fluticasone, formoterol/ glycopyrronium/ beclomethasone) and dual therapy. Indication: Treatment of chronic obstructive pulmonary disease (COPD), severe and very severe forms. Question: Are there differences in effects of efficacy and safety outcomes between triple bronchodilator therapy and dual therapies in treating patients with severe and very severe forms of COPD? Methods: Rapid review of evidence (overview) from systematic reviews, with a bibliographic search in the PUBMED database, using a structured strategy. The methodological quality of systematic reviews was assessed with AMSTAR-2 (Methodological Quality Assessment of Systematic Reviews). Results: Two systematic reviews were selected and included. Conclusion: Triple bronchodilator therapy was more effective than dual therapy in reducing the annual rate of moderate to severe exacerbations, but had no superiority for clinical gains in other outcomes (forced expiratory volume in first second, quality of life, dyspnea index, general mortality, respiratory mortality), except that, for reducing mortality, triple therapy was superior to dual therapy with beta-2 agonists/ antimuscarinic antimuscarinics and similar to dual therapy with beta 2 agonists/ inhaled corticosteroids. The triple therapy had a similar safety profile to dual therapy, with the same risk for adverse events and serious adverse events. The triple therapy had a higher risk for pneumonia than a dual therapy with beta-2 agonists/ antimuscarinic antagonists

Association between beta-2 adrenergic receptor variants and clinical outcomes in children and adolescents with acute asthma

ABSTRACT Objective To investigate whether different genotypes of p.Arg16Gly, p.Gln27Glu, p.Arg19Cys and p.Thr164Ile variants interfere in response to treatment in children and adolescents with moderate to severe acute asthma. Methods This sample comprised patients aged 2 to 17 years with a history of at least two wheezing episodes and current moderate to severe asthma exacerbation. All patients received multiple doses of albuterol and ipratropium bromide delivered via pressurized metered-dose inhaler with holding chamber and systemic corticosteroids. Hospital admission was defined as the primary outcome. Secondary outcomes were changes in forced expiratory volume in the first second after 1 hour of treatment, and for outpatients, length of stay in the emergency room. Variants were genotyped by sequencing. Results A total of 60 patients were evaluated. Hospital admission rates were significantly higher in carriers of the genotype AA relative to those with genotype AG or GG, within the p.Arg16Gly variant (p=0.03, test χ2, alpha=0.05). Secondary outcomes did not differ between genotypes. Conclusion Hospital admission rates were significantly higher among carriers of the genotype AA within the p.Arg16Gly variant. Trial registration: ClinicalTrials.gov: NCT01323010

Utilização da porcentagem e escore Z para avaliar resposta broncodilatadora em crianças asmáticas de idade pré-escolar / Use of percentage and Z-score to evaluate bronchodilator response in preschool asthmatic children

Introdução: A resposta ao broncodilatador (RBD) é frequentemente utilizada no apoio diagnóstico e na tomada de decisões terapêuticas em crianças com sintomas respiratórios. Entretanto, não há um consenso do ponto de corte da RBD em crianças pré-escolares. Objetivo: Avaliar RBD através da porcentagem e do deslocamento do escore Z do volume expiratório forçado em relação ao tempo (VEFt) de crianças asmáticas pré-escolares e propor novos pontos de corte. Métodos: Estudo transversal com 174 espirometrias de crianças asmáticas do ambulatório de alergia/imunologia de hospital de referência nacional no Rio de Janeiro (RJ), realizadas antes e após 15 minutos do uso do broncodilatador, expressas em escore Z e classificadas com padrão obstrutivo quando VEF1/capacidade vital (CV) < -1,645. O poder discriminatório para a RBD dos parâmetros espirométricos foi analisado por curvas ROC, e novos pontos de corte de RBD positiva foram calculados. Resultados: 23,4% apresentou padrão obstrutivo. O índice de Tiffeneau em crianças asmáticas com 3 anos é significativamente menor do que em crianças de 4-6 anos (p = 0,040). VEF0,75 apresentou maior poder discriminatório para RBD (variação > 11% e acurácia > 90%). Os pontos de corte encontrados para as variações percentuais na resposta positiva ao RBD foram 9,5 (VEF1); 13,8 (VEF0,75); 0,6 (escore Z VEF1) e 0,8 (escore Z VEF0,75). Tais pontos de corte refletem altos valores de sensibilidade e especificidade, com valores preditivos positivo e negativo variando em 90%. A conclusão pode ser estendida às variações nos escores Z de VEFt. Conclusões: O VEF0,75 > 11% apresentou melhor discriminação para RBD, demonstrando ser bom parâmetro para a clínica. Os valores encontrados no deslocamento do escore Z após o broncodilatador corroboram com a percepção de que seja um novo recurso para a interpretação da RBD.

Introduction: Bronchodilator response (BDR) is often used to support diagnostic and therapeutic decision-making in children with respiratory symptoms. However, there is no consensus on the BDR cutoff in preschool children. Objective: To evaluate BDR through the percentage and displacement of Z-scores for forced expiratory volume over time (FEVt) of preschool asthmatic children and to propose new cutoff points. Methods: Crosssectional study with 174 spirometry tests of asthmatic children from the allergy/immunology outpatient clinic of a national reference hospital in Rio de Janeiro, Brazil, performed before and after 15 min of bronchodilator use, expressed as Z-score and classified as obstructive pattern when forced expiratory volume in 1 minute (FEV1)/vital capacity (VC) < -1,645. The discriminatory power of spirometric parameters to assess BDR was analyzed by receiver operating characteristics (ROC) curves and new positive BDR cutoff points were calculated. Results: 23.4% presented obstructive pattern. The Tiffeneau index in asthmatic children aged 3 years is significantly lower than that found in children aged 4-6 years (p = 0.040). FEV0.75 presented higher discriminatory power for BDR (variation > 11% and accuracy > 90%). The cutoff points found for percentage changes in positive BDR were 9.5 (FEV1); 13.8 (FEV0.75); 0.6 (FEV1 Z-score) and 0.8 (FEV0.75 Z-score). Such cutoff points reflect high sensitivity and specificity values, with positive and negative predictive values ranging by 90%. The conclusion can be expanded to variations in FEVt Z-scores. Conclusions: FEV0.75 > 11% presented better discrimination for BDR, proving to be a good parameter for clinic practice. The values found in the Z-score displacement after use of bronchodilator corroborate the perception that it is a new resource for the interpretation of BDR.

Beta-2 agonistas para el tratamiento de bronquiolitis / Beta-2 agonists for the treatment of bronchiolitis

INTRODUCCIÓN La bronquiolitis es la inflamación aguda de las vías aéreas de pequeño calibre, teniendo como causa principal las infecciones virales. Es altamente frecuente en menores de dos años, sobretodo en menores de 12 meses. Existe gran controversia sobre el manejo de esta patología, siendo especialmente cuestionable el uso de beta-2 agonistas de corta acción tanto en el ámbito ambulatorio como hospitalario. MÉTODOS Para responder esta pregunta utilizamos Epistemonikos, la mayor base de datos de revisiones sistemáticas en salud a nivel mundial, la cual es mantenida mediante búsquedas en múltiples fuentes de información, incluyendo MEDLINE, EMBASE, Cochrane, entre otras. Extrajimos los datos desde las revisiones identificadas, reanalizamos los datos de los estudios primarios, realizamos un metanálisis, y preparamos una tabla de resumen de los resultados utilizando el método GRADE. RESULTADOS Y CONCLUSIONES Identificamos siete revisiones sistemáticas que en conjunto incluyen 47 estudios primarios, de los cuales 44 corresponden a ensayos aleatorizados. Concluimos que el uso de beta-2 agonistas podría no tener ningún beneficio en el manejo de la bronquiolitis, en términos de necesidad de hospitalización y/o duración de la misma. Por otra parte, podría aumentar efectos adversos como arritmias, sin embargo, la certeza de esta evidencia es baja

Bronchodilator test in extreme old age: Adverse effects of short-acting beta-2 adrenergic agonists with clinical repercussion and bronchodilator response

SUMMARY OBJECTIVE: To evaluate chronological age as a limiting factor to perform the bronchodilator test, determine significant adverse effects of short-acting beta 2 agonists with clinical repercussions, and assess bronchodilator response in extreme-old-age patients who undergo the spirometry test. METHODS: This is a cross-sectional and retrospective study. The sample was extracted from the database (spirometer and respiratory questionnaire) of a pulmonary function service. Patients over 90 years old were included in the research, and we evaluated their bronchodilator response and its significant adverse effects that may have clinical repercussions related to the bronchodilator. RESULTS: A sample of 25 patients aged 92.12 ± 2.22 years (95% CI, 91.20 - 93.04), with a minimum age of 90 years and a maximum of 97 years and a predominance of females with 72% (18/25). The bronchodilator test was performed in 84% (21/25) of the patients. The bronchodilator response was evaluated in 19 of the 21 patients (90.47%) who underwent the bronchodilator test. Two tests did not meet the criteria of acceptability and reproducibility. No clinical adverse effects were observed with the bronchodilator medication (salbutamol) during or after the exam. CONCLUSIONS: Chronological age is not a limiting factor for the bronchodilator test, short-acting beta-2 agonists did not present adverse effects with significant clinical repercussion and were useful in the diagnosis and therapeutic guidance of extreme-old-age patients.

RESUMO OBJETIVOS: Avaliar se idade cronológica é um fator limitante para realizar prova broncodilatadora, determinar efeitos adversos significativos com repercussão clínica dos beta-2 agonistas de curta ação e avaliar a resposta broncodilatadora na espirometria, na velhice extrema. MÉTODOS: Estudo transversal, retrospectivo. Amostra extraída do banco de dados (espirômetro e questionário respiratório) de um serviço de função pulmonar. Incluídos na pesquisa pacientes com ≥90 anos, sendo avaliados a resposta broncodilatadora e efeitos adversos significativos com repercussão clínica ao broncodilatador. RESULTADOS: Amostra de 25 pacientes com idade de 92,12 ± 2,22 anos (IC 95%; 91,20 - 93,04), idade mínima de 90 anos e máxima de 97 anos, predominando o sexo feminino, com 72% (18/25). A prova broncodilatadora foi realizada em 84% (21/25) dos pacientes. A avaliação da resposta ao broncodilatador foi feita em 19 dos 21 pacientes (90,47%) que realizaram a prova broncodilatadora, uma vez que dois desses exames não preencheram os critérios de aceitabilidade e reprodutibilidade. A resposta broncodilatadora foi significativa em 10,52% (2/19) dos pacientes, ambos portadores de pneumopatia obstrutiva. Não foram observados efeitos adversos com repercussão clínica da medicação broncodilatadora (salbutamol) durante ou após sua realização. CONCLUSÕES: A idade cronológica não é um fator limitante para a realização da prova broncodilatadora, os beta-2 agonistas de curta ação não apresentaram efeitos adversos com repercussão clínica significativa e foram bastante úteis para auxiliar no diagnóstico e orientação terapêutica na velhice extrema.

Tratamiento farmacológico y no farmacológico de la enfermedad pulmonar obstructiva crónica / Pharmacologic and non-pharmacologic treatment of chronic obstructive pulmonary disease / Tratamento farmacológico e não farmacológico da doença pulmonar obstrutiva crônica

Introducción. La enfermedad pulmonar obstructiva crónica (EPOC), caracterizada por limitación del flujo aéreo, constituye una patología con alta prevalencia y mortalidad a nivel mundial, representada por exacerbaciones que requieren escalonar el tratamiento; el abordaje se realiza por medio de medidas farmacológicas y no farmacológicas.Objetivo. Sintetizar los aspectos relevantes de las principales guías de manejo y de los artículos cientí-ficos acerca del tratamiento farmacológico y no farmacológico de la enfermedad pulmonar obstructiva crónica.Método. Revisión descriptiva sobre el tratamiento farmacológico y no farmacológico de la enferme-dad pulmonar obstructiva crónica, a partir de la búsqueda de literatura publicada en bases de datos electrónicas especializadas en salud. Se encontraron 265 documentos, entre artículos y guías, que cumplían con los criterios de búsqueda, se seleccionaron 118, se excluyeron 60 y se analizaron 58 referencias.Conclusión. La enfermedad pulmonar obstructiva crónica tiene alta prevalencia y mortalidad a nivel mundial, por esto hay que diagnosticarla bajo los parámetros de la guía de referencia mundial Global Initiative for Chronic Obstructive Lung Disease y de acuerdo con esto, abordar al paciente de forma integral e instaurándole un manejo farmacológico y no farmacológico individualizado con el fin de aumentar la adherencia al tratamiento, disminuir los síntomas y las exacerbaciones y, por consiguien-te, mejorar la calidad de vida.

Introduction. Chronic obstructive pulmonary disease (COPD) is characterized by airflow limitation, this disease presents a high prevalence and mortality rateworldwide. It is represented by exacerba-tions requiring step therapy. The treatment approach is performed by means of pharmacological and non-pharmacological measures.Objective. To synthesize the most relevant aspects of the main management guidelines and scientific articles about the pharmacological and non-pharmacological treatment of chronic obstructive pul-monary disease.Method. Descriptive review of pharmacological and non-pharmacological treatment of chronic obs-tructive pulmonary disease, by means of a search of literature published by electronic databases spe-cialized in health sciences. 265 documents were found, including articles and guides, which met the search criteria, 118 were selected, 60 were excluded and 58 references were analyzed.Conclusion. Chronic obstructive pulmonary disease has a high prevalence and mortality rate world-wide, thus, it is necessary to diagnose it by following the parameters set by the worldwide reference guide: Global Initiative for Chronic Obstructive Lung Disease.According to these guidelines it is ne-cessary to treat the patient holistically and establish a pharmacological and non-pharmacological individualized management in order to increase adherence to the treatment, reduce symptoms and exacerbations, and thereby, improve the quality of life.

Introdução. A doença pulmonar obstrutiva crônica (DPOC), caracterizada pela limitação do fluxo aéreo, representa uma patologia com alta prevalência e mortalidade em todo o mundo, sendo repre-sentada por exacerbações que requerem um escalonamento do tratamento; a abordagem é realizada por meio de medidas farmacológicas e não farmacológicas.Objetivo. Sintetizar os aspectos relevantes dos principais guias de gestão e artigos científicos sobre o tratamento farmacológico e não farmacológico da doença pulmonar obstrutiva crônica.Método. Revisão descritiva do tratamento farmacológico e não farmacológico da doença pulmonar obstrutiva crônica, baseado na busca bibliográfica de artigos e guias publicados em bases de dados eletrônicas especializadas em saúde. Foram obtidos 265 artigos e guias que preenchiam os critérios de busca, 118 foram selecionados, 60 foram excluídos e 58 referências foram analisadas.Conclusão. A doença pulmonar obstrutiva crônica tem alta prevalência e mortalidade em todo o mundo, por isso deve ser diagnosticada sob os parâmetros da Global Initiative for Chronic Obstructive Lung Disease e de acordo com isso, abordar o paciente de forma integral e instalando um manejo far-macológico e não farmacológico individualizado, a fim de aumentar a adesão ao tratamento, diminuir os sintomas e as exacerbações e, portanto, melhorar a qualidade de vida.

Efficacy and safety of tiotropium bromide in chronic obstructive pulmonary disease: a systematic review of randomized clinical trials / Eficácia e segurança do brometo de tiotrópio na doença pulmonar obstrutiva crônica. Revisão sistemática de ensaios clínicos randomizados

Chronic obstructive pulmonary disease (COPD) is among the most prevalent pulmonary diseases. This study aimed at assessing the efficacy and safety of anticholinergic tiotropium bromide (TB) in Chronic obstructive pulmonary disease patients. This is a systematic review of randomized clinical trials performed in the Brazilian Cochrane Center. Electronic database searched: Cochrane library, Medline, LILACS, Pubmed. There were no language, date or other restrictions. Participants: Patients with Chronic obstructive pulmonary disease. Intervention: tiotropium bromide. Comparison: Other bronchodilators or placebo. Outcomes: Mortality, Chronic obstructive pulmonary disease exacerbation, hospitalizations, adverse effects. Results: 14 studies were included in this systematic review. Mortality was lower in the tiotropium bromide group when compared with the salmeterol group [statistical significance: relative risk (RR) 0.16, confidence interval 95% (CI) 0.03 to 0.89, number needed to treat (NNT) of 100]. There was not a statistical difference in the mortality outcome in the comparison between tiotropium bromide and placebo groups (RR 0.88, CI 0.74 to 1.06). Chronic obstructive pulmonary disease exacerbation decreases significantly in the tiotropium bromide group when compared to placebo (statistical significance: RR 0.85, CI 0.77 to 0.93, NNT 25), but in comparison to the salmeterol group there was no statistical difference (RR 0.93, CI 0.80 to 1.08). The number of hospitalizations was lower in the tiotropium bromide group than in the placebo group (statistical significance:RR 0.77, CI 0.59 to 0.99, NNT 50). The results indicate that tiotropium bromide is an effective once-daily bronchodilator. Tiotropium bromide was associated with consistent health benefits, including reduced chronic obstructive pulmonary disease exacerbations, hospitalizations and even mortality when compared with salmeterol.(AU)

A doença pulmonar obstrutiva crônica está entre as doenças pulmonares mais prevalentes. O objetivo deste estudo foi verificar a eficácia e segurança do brometo de tiotrópio em pacientes com doença pulmonar obstrutiva crônica. Trata-se de revisão sistemática de ensaios clínicos randomizados realizada no Centro Cochrane do Brasil. A estratégia de busca eletrônica foi realizada nos nas bases LILACS, MEDLINE, Biblioteca Cochrane, PubMed. Não houve restrições à linguagem e nem à data. Participaram pacientes com doença pulmonar obstrutiva crônica. A intervenção foi o uso de brometo de tiotrópio comparado a outros broncodilatadores ou placebo. Os desfechos analisados foram mortalidade, exacerbações da doença pulmonar obstrutiva crônica, hospitalização e efeitos adversos. A mortalidade foi menor no grupo brometo de tiotrópio quando comparado com o grupo salmeterol (significância estatística: risco relativo de 0,16; intervalo de confiança de 95% de 0,03-0,89, número necessário para tratar de 100). Não houve diferença estatística no desfecho mortalidade na comparação entre os grupos brometo de tiotrópio e placebo (risco relativo de 0,88; intervalo de confiança de 95% de 0,74-1,06). As exacerbações da doença pulmonar obstrutiva crônica diminuíram significantemente no grupo brometo de tiotrópio quando comparado ao placebo (significância estatística: risco relativo de 0,85; intervalo de confiança de 95% de 0,77-0,93; número necessário para tratar de 25), porém, quando comparado ao salmeterol não obteve significância estatística (risco relativo de 0,93; intervalo de confiança de 95% 0,80-1,08). O número de hospitalizações foi menor no grupo brometo de tiotrópio do que no grupo placebo (significância estatística: risco relativo de 0,77; intervalo de confiança de 95% 0,59-0,99; número necessário para tratar de 50). Os resultados indicam que o brometo de tiotrópio é um broncodilatador eficaz em dose única diária. O brometo de tiotrópio traz benefícios à saúde com resultados consistentes, incluindo redução de exacerbações da doença pulmonar obstrutiva crônica, internações e até mesmo a mortalidade quando comparados com salmeterol.(AU)

Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysis / Antagonistas muscarínicos de longa duração vs. β 2 -agonistas de longa duração em exacerbações da DPOC: revisão sistemática e meta-análise

ABSTRACT Objective: To determine whether long-acting muscarinic antagonists (LAMAs) provide superior therapeutic effects over long-acting β2 agonists (LABAs) for preventing COPD exacerbations. Methods: This was a systematic review and meta-analysis of randomized clinical trials involving patients with stable, moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease criteria, treated with a LAMA (i.e., tiotropium bromide, aclidinium, or glycopyrronium), followed for at least 12 weeks and compared with controls using a LABA in isolation or in combination with a corticosteroid. Results: A total of 2,622 studies were analyzed for possible inclusion on the basis of their title and abstract; 9 studies (17,120 participants) were included in the analysis. In comparison with LABAs, LAMAs led to a greater decrease in the exacerbation rate ratio (relative risk [RR] = 0.88; 95% CI: 0.84-0.93]; a lower proportion of patients who experienced at least one exacerbation (RR = 0.90; 95% CI: 0.87-0.94; p < 0.00001); a lower risk of exacerbation-related hospitalizations (RR = 0.78; 95% CI: 0.69-0.87; p < 0.0001); and a lower number of serious adverse events (RR = 0.81; 95% CI: 0.67-0.96; p = 0.0002). The overall quality of evidence was moderate for all outcomes. Conclusions: The major findings of this systematic review and meta-analysis were that LAMAs significantly reduced the exacerbation rate (exacerbation episodes/year), as well as the number of exacerbation episodes, of hospitalizations, and of serious adverse events.

RESUMO Objetivo: Determinar se long-acting muscarinic antagonists (LAMAs, antagonistas muscarínicos de longa duração) são superiores a long-acting β2 agonists (LABAs, β2-agonistas de longa duração) na prevenção de exacerbações da DPOC. Métodos: Revisão sistemática e meta-análise de ensaios clínicos controlados aleatórios com pacientes com DPOC estável, de moderada a grave, conforme os critérios da Global Initiative for Chronic Obstructive Lung Disease, tratados com LAMA (brometo de tiotrópio, aclidínio ou glicopirrônio), acompanhados durante pelo menos 12 semanas e comparados a controles que usaram LABA isoladamente ou com um corticosteroide. Resultados: Foram analisados 2.622 estudos para possível inclusão com base em seu título e resumo; 9 estudos (17.120 participantes) foram incluídos na análise. Em comparação com LABAs, LAMAs resultaram em maior diminuição da razão da taxa de exacerbações [risco relativo (RR) = 0,88; IC95%: 0,84-0,93]; menor proporção de pacientes que apresentaram pelo menos uma exacerbação (RR = 0,90; IC95%: 0,87-0,94; p < 0,00001); menor risco de hospitalizações em virtude de exacerbação da doença (RR = 0,78; IC95%: 0,69-0,87; p < 0,0001) e menor número de eventos adversos sérios (RR = 0,81; IC95%: 0,67-0,96; p = 0,0002). A qualidade geral das evidências foi moderada para todos os desfechos. Conclusões: O principal achado desta revisão sistemática e meta-análise foi que LAMAs reduziram significativamente a taxa de exacerbações (episódios de exacerbação/ano), os episódios de exacerbação, as hospitalizações e os eventos adversos sérios.

Safety and Effectiveness of Indacaterol in Chronic Obstructive Pulmonary Disease Patients in South Korea / 결핵및호흡기질환

BACKGROUND: Inhaled indacaterol (Onbrez Breezhaler), a long-acting β₂-agonist, is approved in over 100 countries, including South Korea, as a once-daily bronchodilator for maintenance and treatment of chronic obstructive pulmonary disease (COPD). Here, we present an interim analysis of a post-marketing surveillance study conducted to evaluate the real-world safety and effectiveness of indacaterol in the Korean population. METHODS: This was an open-label, observational, prospective study in which COPD patients, who were newly prescribed with indacaterol (150 or 300 µg), were evaluated for 12 or 24 weeks. Safety was assessed based on the incidence rates of adverse events (AEs) and serious adverse events (SAEs). Effectiveness was evaluated based on physician's assessment by considering changes in symptoms and lung function, if the values of forced expiratory volume in 1 second were available. RESULTS: Safety data were analyzed in 1,016 patients of the 1,043 enrolled COPD patients receiving indacaterol, and 784 patients were included for the effectiveness analysis. AEs were reported in 228 (22.44%) patients, while 98 (9.65%) patients reported SAEs. The COPD condition improved in 348 patients (44.4%), while the condition was maintained in 396 patients (50.5%), and only 40 patients (5.1%) exhibited worsening of ailment as compared with baseline. During the treatment period, 90 patients were hospitalized while nine patients died. All deaths were assessed to be not related to the study drug by the investigator. CONCLUSION: In real-life clinical practice in South Korea, indacaterol was well tolerated in COPD patients, and can be regarded as an effective option for their maintenance treatment.

Spirometry and Bronchodilator Test / 결핵및호흡기질환

Spirometry is a physiological test for assessing the functional aspect of the lungs using an objective indicator to measure the maximum amount of air that a patient can inhale and exhale. Acceptable spirometry testing needs to be conducted three times by an acceptable and reproducible method for determining forced vital capacity (FVC). Until the results of three tests meet the criteria of reproducibility, the test should be repeated up to eight times. Interpretation of spirometry should be clear, concise, and informative. Additionally, spirometry should guarantee optimal quality prior to the interpreting spirometry results. Our guideline adopts a fixed normal predictive value instead of the lower limit of normal as the reference value because fixed value is more convenient and also accepts FVC instead of vital capacity (VC) because measurement of VC using a spirometer is impossible. The bronchodilator test is a method for measuring the changes in lung capacity after inhaling a short-acting β-agonist that dilates the airway. When an obstructive ventilatory defect is observed, this test helps to diagnose and evaluate asthma and chronic obstructive pulmonary disease by measuring reversibility with the use of an inhaled bronchodilator. A positive response to a bronchodilator is generally defined as an increase of ≥12% and ≥200 mL as an absolute value compared with a baseline in either forced expiratory volume at 1 second or FVC.

Effects of indacaterol versus tiotropium on exercise tolerance in patients with moderate COPD: a pilot randomized crossover study / Efeitos do indacaterol versus tiotrópio na tolerância ao exercício em pacientes com DPOC moderada: estudo cruzado randomizado piloto

Abstract Objective: To compare a once-daily long-acting β2 agonist (indacaterol 150 µg) with a once-daily long-acting anticholinergic (tiotropium 5 µg) in terms of their effects on exercise endurance (limit of tolerance, Tlim) in patients with moderate COPD. Secondary endpoints were their effects on lung hyperinflation, exercise-related dyspnea, and daily-life dyspnea. Methods: This was a randomized, single-blind, crossover pilot study involving 20 patients (mean age, 60.9 ± 10.0 years; mean FEV1, 69 ± 7% of predicted). Spirometric parameters, Transition Dyspnea Index scores, Tlim, and exertional dyspnea were compared after three weeks of each treatment (with a one-week washout period between treatments). Results: Nineteen patients completed the study (one having been excluded because of COPD exacerbation). Improvement in Tlim from baseline tended to be greater after treatment with tiotropium than after treatment with indacaterol (96 ± 163 s vs. 8 ± 82 s; p = 0.06). Tlim significantly improved from baseline after treatment with tiotropium (having increased from 396 ± 319 s to 493 ± 347 s; p = 0.010) but not after treatment with indacaterol (having increased from 393 ± 246 to 401 ± 254 s; p = 0.678). There were no differences between the two treatments regarding improvements in Borg dyspnea scores and lung hyperinflation at "isotime" and peak exercise. There were also no significant differences between treatments regarding Transition Dyspnea Index scores (1.5 ± 2.1 vs. 0.9 ± 2.3; p = 0.39). Conclusions: In patients with moderate COPD, tiotropium tends to improve Tlim in comparison with indacaterol. No significant differences were observed between the two treatments regarding their effects on lung hyperinflation, exercise-related dyspnea, and daily-life dyspnea. Future studies, including a larger number of patients, are required in order to confirm our findings and explore mechanistic explanations. (ClinicalTrials.gov identifier: ...

RESUMO Objetivo: Comparar um β2-agonista de longa duração administrado uma vez por dia (indacaterol 150 µg) a um anticolinérgico de longa duração administrado uma vez por dia (tiotrópio 5 µg) quanto a seus efeitos na resistência ao exercício (limite de tolerância, Tlim) em pacientes com DPOC moderada. Os desfechos secundários foram seus efeitos na hiperinsuflação pulmonar, na dispneia causada pelo exercício e na dispneia na vida diária. Métodos: Estudo piloto randomizado cruzado e simples cego com 20 pacientes (média de idade: 60,9 ± 10,0 anos; média do VEF1: 69 ± 7% do previsto). Parâmetros espirométricos, pontuação no Transition Dyspnea Index, Tlim e dispneia aos esforços foram comparados após três semanas de cada tratamento (com uma semana de intervalo entre os tratamentos). Resultados: Dezenove pacientes completaram o estudo - um foi excluído por causa de exacerbação da DPOC. A melhora no Tlim tendeu a ser maior com tiotrópio do que com indacaterol (96 ± 163 s vs. 8 ± 82 s; p = 0,06). Em comparação com os valores basais, o Tlim melhorou significativamente com tiotrópio (aumentando de 396 ± 319 s para 493 ± 347 s; p = 0,010), mas não com indacaterol (aumentando de 393 ± 246 para 401 ± 254 s; p = 0,678). Não houve diferença entre os tratamentos quanto à melhora na pontuação na escala de dispneia de Borg e na insuflação pulmonar no "isotempo" e no pico do exercício. Também não houve diferenças significativas entre os tratamentos quanto à pontuação no Transition Dyspnea Index (1,5 ± 2,1 vs. 0,9 ± 2,3; p = 0,39). Conclusões: Em pacientes com DPOC moderada, o tiotrópio tende a melhorar o Tlim em comparação com o indacaterol. Não houve diferenças significativas entre os tratamentos quanto a seus efeitos na insuflação pulmonar, na dispneia durante o exercício e na dispneia na vida diária. São necessários mais estudos, com um número maior de pacientes, para confirmar nossos achados e explorar explicações mecanicistas. (ClinicalTrials.gov ...

Bronchodilator response cut-off points and FEV 0. 75 reference values for spirometry in preschoolers / Pontos de corte da resposta ao broncodilatador e valores de referência para VEF 0. 75 em espirometria de pré-escolares

ABSTRACT Objective: To determine the cut-off points for FEV1, FEV0.75, FEV0.5, and FEF25-75% bronchodilator responses in healthy preschool children and to generate reference values for FEV0.75. Methods: This was a cross-sectional community-based study involving children 3-5 years of age. Healthy preschool children were selected by a standardized questionnaire. Spirometry was performed before and after bronchodilator use. The cut-off point of the response was defined as the 95th percentile of the change in each parameter. Results: We recruited 266 children, 160 (60%) of whom were able to perform acceptable, reproducible expiratory maneuvers before and after bronchodilator use. The mean age and height were 57.78 ± 7.86 months and 106.56 ± 6.43 cm, respectively. The success rate for FEV0.5 was 35%, 68%, and 70% in the 3-, 4-, and 5-year-olds, respectively. The 95th percentile of the change in the percentage of the predicted value in response to bronchodilator use was 11.6%, 16.0%, 8.5%, and 35.5% for FEV1, FEV0.75, FEV0.5, and FEF25-75%, respectively. Conclusions: Our results provide cut-off points for bronchodilator responsiveness for FEV1, FEV0.75, FEV0.5, and FEF25-75% in healthy preschool children. In addition, we proposed gender-specific reference equations for FEV0.75. Our findings could improve the physiological assessment of respiratory function in preschool children.

RESUMO Objetivo: Determinar os pontos de corte de resposta ao broncodilatador do VEF1, VEF0,75, VEF0,5 e FEF25-75% em crianças pré-escolares saudáveis e gerar valores de referência para o VEF0,75. Métodos: Foi realizado um estudo transversal de base comunitária em crianças de 3-5 anos de idade. Pré-escolares saudáveis foram selecionados por um questionário padronizado. Foi realizada espirometria antes e depois do uso de broncodilatador. Foram definidos os pontos de corte dessa resposta como o percentil 95 de variação em cada parâmetro. Resultados: Foram recrutadas 266 crianças, e 160 (60,0%) foram capazes de gerar manobras expiratórias aceitáveis e reprodutíveis antes e depois do uso de broncodilatador. As médias de idade e estatura dos participantes foram 57,78 ± 7,86 meses e 106,56 ± 6,43 cm, respectivamente. A taxa de sucesso para o VEF0,5 foi de 35%, 68% e 70%, respectivamente, nos participantes com 3, 4 e 5 anos de idade. O percentil 95 de variação percentual do valor previsto na resposta ao broncodilatador foram, respectivamente, de 11,6%, 16,0%, 8,5% e 35,5%, para VEF1, VEF0,75, VEF0,5 e FEF25-75%. Conclusões: Nossos resultados definiram pontos de corte de resposta ao broncodilatador para o VEF1, VEF0,75, VEF0,5 e FEF25-75 em crianças pré-escolares saudáveis. Adicionalmente, foram propostas equações de referência para o VEF0,75, separadas por sexo. Os achados deste estudo podem melhorar a avaliação fisiológica da função respiratória em pré-escolares.

Evaluating bronchodilator response in pediatric patients with post-infectious bronchiolitis obliterans: use of different criteria for identifying airway reversibility / Avaliação da resposta ao broncodilatador em pacientes pediátricos com bronquiolite obliterante pós-infecciosa: uso de diferentes critérios de identificação de reversibilidade das vias aéreas

ABSTRACT Objective: Post-infectious bronchiolitis obliterans (PIBO) is a clinical entity that has been classified as constrictive, fixed obstruction of the lumen by fibrotic tissue. However, recent studies using impulse oscillometry have reported bronchodilator responses in PIBO patients. The objective of this study was to evaluate bronchodilator responses in pediatric PIBO patients, comparing different criteria to define the response. Methods: We evaluated pediatric patients diagnosed with PIBO and treated at one of two pediatric pulmonology outpatient clinics in the city of Porto Alegre, Brazil. Spirometric parameters were measured in accordance with international recommendations. Results: We included a total of 72 pediatric PIBO patients. The mean pre- and post-bronchodilator values were clearly lower than the reference values for all parameters, especially FEF25-75%. There were post-bronchodilator improvements. When measured as mean percent increases, FEV1 and FEF25-75%, improved by 11% and 20%, respectively. However, when the absolute values were calculated, the mean FEV1 and FEF25-75% both increased by only 0.1 L. We found that age at viral aggression, a family history of asthma, and allergy had no significant effects on bronchodilator responses. Conclusions: Pediatric patients with PIBO have peripheral airway obstruction that is responsive to treatment but is not completely reversible with a bronchodilator. The concept of PIBO as fixed, irreversible obstruction does not seem to apply to this population. Our data suggest that airway obstruction is variable in PIBO patients, a finding that could have major clinical implications.

RESUMO Objetivo: A bronquiolite obliterante pós-infecciosa (BOPI) é uma entidade clínica que tem sido classificada como obstrução fixa e constritiva do lúmen por tecido fibrótico. Entretanto, estudos recentes utilizando oscilometria de impulso relataram resposta ao broncodilatador em pacientes com BOPI. O objetivo deste estudo foi avaliar a resposta broncodilatadora em pacientes pediátricos com BOPI, comparando critérios diferentes para a definição da resposta. Métodos: Foram avaliados pacientes pediátricos com diagnóstico de BOPI tratados em um de dois ambulatórios de pneumologia pediátrica na cidade de Porto Alegre (RS). Parâmetros espirométricos foram medidos de acordo com recomendações internacionais. Resultados: Foram incluídos 72 pacientes pediátricos com BOPI no estudo. As médias dos valores pré- e pós-broncodilatador foram claramente inferiores aos valores de referência para todos os parâmetros, especialmente FEF25-75%. Houve uma melhora pós-broncodilatador. Quando medidos como aumentos percentuais médios, VEF1 e FEF25-75% melhoraram em 11% e 20%, respectivamente. Entretanto, quando os valores absolutos foram calculados, as médias de VEF1 e FEF25-75% aumentaram somente em 0,1 l. Verificamos que a idade da agressão viral, história familiar de asma e alergia não tiveram efeitos significativos na resposta ao broncodilatador. Conclusões: Pacientes pediátricos com BOPI têm uma obstrução das vias aéreas periféricas que responde ao tratamento, mas não uma reversão completa com o broncodilatador. O conceito de BOPI como obstrução fixa e irreversível parece não se aplicar a essa população. Nossos dados sugerem que a obstrução de vias aéreas em pacientes com BOPI é variável, e esse achado pode ter importantes implicações clínicas.

Atualizações no tratamento de bronquiolite viral aguda / Updates on acute bronchiolitis treatment

Bronquiolite viral aguda consiste em uma afecção viral que acomete lactentes com idade inferior a dois anos, sendo o pico de incidência abaixo de seis meses de vida. O quadro clínico consiste em sintomas de infecção de vias aéreas superiores, que evolui após dois a quatro dias com cansaço, dispneia, taquipneia, além de esforço respiratório. Febre e redução da aceitação da dieta também podem ocorrer. Apneia tem sido relatada em casos graves ou em prematuros. O diagnóstico baseia-se na história clínica e no exame físico, sendo exames complementares reservados quando há suspeita de outros diagnósticos ou de complicações. O tratamento é suportivo, sendo a oxigenoterapia indicada para pacientes com saturação de oxigênio abaixo de 90%. Atualmente, o corticoide oral não tem indicação no tratamento. Broncodilatadores não são indicados de rotina e o uso da salina hipertônica é controverso. O antiviral, ribavirina, tem indicação em casos específicos, devido aos efeitos adversos e ao alto custo. A profilaxia da BVA é fundamental, sendo a lavagem das mãos e o uso de álcool, de máscaras e de luvas essenciais para prevenção da doença. Como medicação profilática, o palivizumabe é indicado apenas em casos selecionados.(AU)

Acute bronchiolitis consists of a viral infection that affects children younger than 2 years old, with the peak of incidence under 6 months. The clinical disease has symptoms of infection of the upper airway, which develops after 2-4 days with fatigue, dyspnea, tachypnea, and respiratory effort. Fever and reduction of dietary compliance, may also occur. Apnea has been reported in severe cases or premature. The diagnosis is based on clinical history and physical examination, reserved additional tests when there is a suspicion of other diagnoses or complications. Treatment is supportive, the oxygen therapy is indicated for patients with oxygen saturation under 90%. Currently, oral corticosteroids has no indication for the treatment. The use of bronchodilators is not routinely indicated and the use of hypertonic saline is controversial. The use of the antiviral ribavirin is indicated in specific cases because there are adverse effects and high costs. Prophylaxis of bronchiolitis is fundamental, and hand-washing, use of alcohol, use of masks and gloves are essential for disease prevention. The use of palivizumab is indicated in selected cases.(AU)

Perfil epidemiológico-clínico de pacientes con enfermedad pulmonar obstructiva crónica en el Centro de Salud Jardinillos / Clinical-epidemiological profile of patients with chronic obstructive pulmonary disease in Jardinillos Health Center

FUNDAMENTO: la enfermedad pulmonar obstructiva crónica, se caracteriza esencialmente por una limitación crónica al flujo aéreo poco reversible, conocerla facilita brindarles una mejor calidad de vida a los que la padecen. OBJETIVO: estudiar el perfil clínico y epidemiológico del enfermo en el Centro de Salud Jardinillos del área de Palencia, para brindarles una mejor calidad de vida. MÉTODOS: se realizó un estudio observacional descriptivo transversal en 228 pacientes con diagnóstico de enfermedad pulmonar obstructiva crónica desde enero a diciembre de 2013. Para conocer el perfil epidemiológico y clínico, se utilizó un formulario de recolección de datos previamente estructurado y codificado. Se revisaron las historias clínicas y epidemiológicas de cada uno de los pacientes y se analizaron los datos a través del programa Excel donde se incluyeron los pacientes confirmados. RESULTADOS: existió predominio del sexo masculino con una edad aproximada entre 71 y 80 años. Las comorbilidades más señaladas fueron la hipertensión arterial y la diabetes mellitus, un 61, 8 % de los pacientes eran fumadores. Con respecto a la vacunación un 65, 8 % del total estaban vacunados contra la gripe y neumococo. Confirmaron enolismo negativo el 86 % de los pacientes estudiados. Presentaron exacerbaciones de enfermedad obstructiva crónica un 85, 96 % que requirieron cambio de tratamiento o ingreso hospitalario. La mayoría pertenecían al fenotipo agudizador con bronquitis crónica. El tratamiento más utilizado con los broncodilatadores de acción prolongada. CONCLUSIONES: la mayoría de los pacientes eran del sexo masculino, con edad avanzada. La comorbilidad más frecuente fue la hipertensión arterial y la diabetes mellitus y un 61, 8 % de pacientes eran fumadores. El fenotipo agudizador con bronquitis crónica fue el más identificado, el tratamiento más utilizado fueron los broncodilatadores de acción prolongada.

BACKGROUND: chronic obstructive pulmonary disease is mainly characterized by a chronic limitation to little-reversible air flow. Knowing this disease facilitates giving the patients a better quality of life. Objective: to study the clinical-epidemiological profile of patients in Jardinillos Health Center, in Palencia area, to give them a better quality of life. METHODS: a cross-sectional, descriptive, observational study was conducted in 228 patients with the diagnosis of chronic obstructive pulmonary disease from January to December, 2013. A previously structured and codified form for collecting data was used to know the clinical-epidemiological profile. The clinical and epidemiological histories of each patient were revised. Data were analyzed by means of Excel program and the confirmed patients were included. RESULTS: male patients between 71 and 80 years old predominated. The most seen comorbidity was hypertension and diabetes mellitus; a 61, 8 % of the patients were smokers. Regarding vaccination, a 65, 8 % of the patients were vaccinated against influenza and pneumococcus. The 86 % of the studied patients were negative to alcoholism. The 85, 96 % of the patients presented exacerbation of chronic obstructive disease and required a change in the treatment or admission in the hospital. Most of the patients belonged to the acuter phenotype with chronic bronchitis. The treatment with long-acting bronchodilators was the most used one. CONCLUSIONS: most of the patients were male and of advanced years. The most frequent comorbidity was hypertension and diabetes mellitus and a 61, 8 % of the patients were smokers. The acuter phenotype with chronic bronchitis was the most identified. The treatment with long-acting bronchodilators was the most used one.

Efficacy and safety of the single-capsule combination of fluticasone/formoterol in patients with persistent asthma: a non-inferiority trial / Eficácia e segurança da associação fluticasona/formoterol em cápsula única em pacientes com asma persistente: estudo de não inferioridade

OBJECTIVE: Fluticasone and formoterol are effective in the treatment of asthma. When a corticosteroid alone fails to control asthma, combination therapy is the treatment of choice. The objective of this study was to compare the efficacy and safety of formulations containing budesonide/formoterol (BUD/FOR), fluticasone alone (FLU), and the single-capsule combination of fluticasone/formoterol (FLU/FOR) on lung function in patients with mild-to-moderate persistent asthma. METHODS: This was a randomized, multicenter, open phase III trial conducted in Brazil. The primary efficacy analysis was the assessment of non-inferiority between FLU/FOR and BUD/FOR combinations regarding FEV1 (in L) at the final visit. The secondary analyses were PEF, level of asthma control, serum cortisol levels, frequency of adverse events, adherence to treatment, and appropriate inhaler use. RESULTS: We randomized 243 patients to three groups: FLU/FOR (n = 79), BUD/FOR (n = 83), and FLU (n = 81). In terms of the mean FEV1 after 12 weeks of treatment, the difference between the FLU/FOR and BUD/FOR groups was 0.22 L (95% CI: −0.06 to 0.49), whereas the difference between the FLU/FOR and FLU groups was 0.26 L (95% CI: −0.002 to 0.52). Non-inferiority was demonstrated by the difference between the lower limits of the two 95% CIs (−0.06 vs. −0.002). The level of asthma control and PEF were significantly greater in the FLU/FOR and BUD/FOR groups than in the FLU group. There were no significant differences among the groups regarding patient adherence, patient inhaler use, or safety profile of the formulations. CONCLUSIONS: The single-capsule combination of FLU/FOR showed non-inferiority to the BUD/FOR and FLU formulations regarding efficacy and ...

OBJETIVO: A fluticasona e o formoterol são efetivos no tratamento da asma. A terapia combinada é o tratamento de escolha quando o corticosteroide isolado não controla a asma. O objetivo deste estudo foi comparar a eficácia e segurança de formulações contendo budesonida/formoterol (BUD/FOR), fluticasona (FLU) e fluticasona/formoterol (FLU/FOR) em cápsula única sobre a função pulmonar em pacientes com asma persistente leve e moderada. MÉTODOS: Estudo de fase III multicêntrico brasileiro, aleatorizado e aberto. A análise primária de eficácia foi a avaliação de não inferioridade da combinação FLU/FOR perante a combinação BUD/FOR em relação ao VEF1 (em L) na visita final. As análises secundárias foram PFE, nível de controle da asma, nível de cortisol sérico, frequência de eventos adversos, aderência ao tratamento e uso adequado do inalador. RESULTADOS: Foram randomizados 243 pacientes nos grupos FLU/FOR (n = 79), BUD/FOR (n = 83) e FLU (n = 81). Após 12 semanas de tratamento, a média da diferença do VEF1 foi de 0,22 L (IC95%: −0,06 a 0,49) entre os grupos FLU/FOR e BUD/FOR e de 0,26 L (IC95%: −0,002 a 0,52) entre os grupos FLU/FOR e FLU. A não inferioridade ficou demonstrada pela diferença de limite inferior do IC95% (−0,06 vs. −0,002). O nível de controle da asma e o PFE foram significativamente maiores nos grupos FLU/FOR e BUD/FOR em comparação com o grupo FLU. Não houve diferenças significativas em relação a adesão, uso do inalador e perfil de segurança entre os grupos. CONCLUSÕES: ...

Can bronchodilators improve exercise tolerance in COPD patients without dynamic hyperinflation? / Os broncodilatadores podem melhorar a tolerância ao exercício na ausência de hiperinsuflação dinâmica em pacientes com DPOC?

OBJECTIVE: To investigate the modulatory effects that dynamic hyperinflation (DH), defined as a reduction in inspiratory capacity (IC), has on exercise tolerance after bronchodilator in patients with COPD. METHODS: An experimental, randomized study involving 30 COPD patients without severe hypoxemia. At baseline, the patients underwent clinical assessment, spirometry, and incremental cardiopulmonary exercise testing (CPET). On two subsequent visits, the patients were randomized to receive a combination of inhaled fenoterol/ipratropium or placebo. All patients then underwent spirometry and submaximal CPET at constant speed up to the limit of tolerance (Tlim). The patients who showed ΔIC(peak-rest) < 0 were considered to present with DH (DH+). RESULTS: In this sample, 21 patients (70%) had DH. The DH+ patients had higher airflow obstruction and lower Tlim than did the patients without DH (DH-). Despite equivalent improvement in FEV1 after bronchodilator, the DH- group showed higher ΔIC(bronchodilator-placebo) at rest in relation to the DH+ group (p < 0.05). However, this was not found in relation to ΔIC at peak exercise between DH+ and DH- groups (0.19 ± 0.17 L vs. 0.17 ± 0.15 L, p > 0.05). In addition, both groups showed similar improvements in Tlim after bronchodilator (median [interquartile range]: 22% [3-60%] vs. 10% [3-53%]; p > 0.05). CONCLUSIONS: Improvement in TLim was associated with an increase in IC at rest after bronchodilator in HD- patients with COPD. However, even without that improvement, COPD patients can present with greater exercise tolerance after bronchodilator provided that they develop DH during exercise. .

OBJETIVO: Investigar os efeitos moduladores da hiperinsuflação dinâmica (HD), definida pela redução da capacidade inspiratória (CI), na tolerância ao exercício após broncodilatador em pacientes com DPOC. MÉTODOS: Estudo experimental e randomizado com 30 pacientes com DPOC sem hipoxemia grave. Na visita inicial, os pacientes realizaram avaliação clínica, espirometria e teste de exercício cardiopulmonar (TECP) incremental. Em duas visitas subsequentes, os pacientes foram randomizados para receber uma combinação de fenoterol/ipratrópio ou placebo e, em seguida, realizaram espirometria e TECP com velocidade constante até o limite da tolerância (Tlim). Os pacientes com ΔCI(pico-repouso) < 0 foram considerados com HD (HD+). RESULTADOS: Nesta amostra, 21 pacientes (70%) apresentaram HD. Os pacientes HD+ apresentaram maior obstrução ao fluxo aéreo e menor Tlim do que os pacientes sem HD (HD-). Apesar de ganhos equivalentes de VEF1 após broncodilatador, o grupo HD- apresentou maior ΔCI(broncodilatador-placebo) em repouso em relação ao grupo HD+ (p < 0,05). Entretanto, isso não ocorreu com a ΔCI no pico do exercício entre os grupos HD+ e HD- (0,19 ± 0,17 L vs. 0,17 ± 0,15 L; p > 0,05). Similarmente, ambos os grupos apresentaram melhoras equivalentes do Tlim após broncodilatador (mediana [intervalo interquartílico]: 22% [3-60%] e 10% [3-53%]; p > 0,05). CONCLUSÕES: A melhora da CI em repouso após broncodilatador associou-se com ganho de tolerância ao esforço mesmo nos pacientes com DPOC que não apresentem HD. Por outro lado, pacientes sem melhora da CI em repouso ainda podem obter beneficio funcional com o broncodilatador desde que apresentem HD no exercício. .