O papel da irrigação nasal com corticosteroide no controle da rinossinusite crônica em pacientes sem cirurgia nasossinusal: ensaio clínico randomizado
Data
2023-12-13
Autores
Matsumoto, Gabriela Ricci Lima Luz 
Orientadores
Kosugi, Eduardo Macoto
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivo: Comparar a eficácia do corticosteroide nasal em altas doses via irrigação em alto volume e via spray em pacientes com rinossinusite crônica, sem cirurgia nasossinusal prévia. Método: Ensaio clínico randomizado duplo cego composto por 2 grupos que receberam a dose de 1000 µg/dia de budesonida nasal de duas formas distintas durante 3 meses: via Irrigação e via Spray. Foram incluídos pacientes com rinossinusite crônica nunca operados com indicação de tratamento cirúrgico devido à falha ao tratamento clínico apropriado, em fila de espera para cirurgia endoscópica nasossinusal em serviço público de saúde. Desfechos primários incluíram mudança nos questionários de controle clínico e SNOT-22 e no escore endoscópico de Lund-Kennedy e desfechos secundários incluíram melhora subjetiva, diminuição no número de exacerbações e cirurgias. As análises comparativas foram realizadas para a amostra total, presença ou ausência de pólipos e de acordo com os novos fenótipos da RSC primária difusa. Resultados: Total de 67 pacientes completaram o estudo (34 no grupo Irrigação e 33 no grupo Spray). Pacientes com pólipos nasais foram maioria na amostra total, correspondendo a 80,6% dos casos. Em relação aos novos fenótipos da rinossinusite crônica, 28,4% da amostra foi classificada como doença atópica do compartimento central, 35,8% como rinossinusite crônica eosinofílica e 35,8% como rinossinusite crônica não eosinofílica. O grupo Spray foi superior em melhorar o Lund-Kennedy na amostra total (p=0,030), nos pacientes com pólipos (p=0,037) e na doença atópica do compartimento central (p=0,037). Houve melhora significante no SNOT-22 em ambos os grupos de tratamento para a amostra total e em quase todos os fenótipos, porém não houve superioridade entre os tratamentos. O grupo Spray também foi superior em diminuir o número de descontrolados pelo questionário de controle clínico EPOS 2020 na amostra total (p=0,046) e nos pacientes com pólipos (p=0,020). Conclusão: O spray nasal com corticosteroide em altas doses foi superior à irrigação nasal com corticosteroide em alto volume em melhorar a endoscopia nasal na amostra total, nos pacientes com pólipos nasais e na doença atópica do compartimento central, além de reduzir significantemente o número de descontrolados na amostra total e nos pacientes com pólipos nasais.
Objectives: To compare the efficacy of high-dose nasal corticosteroids via high-volume irrigation and via spray in non-operated chronic rhinosinusitis patients. Methods: Randomized double-blind clinical trial consisting of 2 groups that received a dose of 1000µg/day of nasal budesonide in two different ways for 3 months: via Irrigation and via Spray. Non-operated chronic rhinosinusitis patients who failed routine initial medical and needed surgical intervention, on the waiting list for endoscopic sinus surgery in a public hospital, were included. Primary outcomes measure was changes in specific quality of life questionnaire and clinical control questionnaires and Lund-Kennedy endoscopic score. Secondary outcomes measure was subjective improvement and number of exacerbations and need for surgery. Comparative analyses were performed for a total sample, presence or absence of polyps and according to the new phenotypes of chronic rhinosinusitis. Results: Total of 67 patients completed the study (34 in the Irrigation group and 33 in the Spray group). Patients with nasal polyps were the majority in the sample, corresponding to 80,6% of cases. Regarding the new phenotypes of chronic rhinosinusitis, 28,4% was classified as central compartment atopic disease. 35,8% as eosinophilic chronic rhinosinusitis and 35,8% as non-eosinophilic chronic rhinosinusitis. The spray group was superior in improving Lund-Kennedy in the total sample (p=0,030), in patients with polyps (p=0,037) and in central compartment atopic disease (p=0,037). There was a significant improvement in quality-of-life questionnaire (SNOT-22) in both treatment groups for the total sample and in almost all phenotypes, but there wasn’t superiority between treatments. The Spray group was also superior in reducing the number of uncontrolled patients in clinical control questionnaire (EPOS 2020) in the total sample (p=0,046) and in patients with polyps (p=0,020). Conclusion: High-dose corticosteroid nasal spray was superior to high-volume corticosteroid nasal irrigation in improving nasal endoscopy in the total sample, in patients with nasal polyps and in central compartment atopic disease and significantly reduced the number of uncontrolled patients in the sample total and in patients with nasal polyps.
Objectives: To compare the efficacy of high-dose nasal corticosteroids via high-volume irrigation and via spray in non-operated chronic rhinosinusitis patients. Methods: Randomized double-blind clinical trial consisting of 2 groups that received a dose of 1000µg/day of nasal budesonide in two different ways for 3 months: via Irrigation and via Spray. Non-operated chronic rhinosinusitis patients who failed routine initial medical and needed surgical intervention, on the waiting list for endoscopic sinus surgery in a public hospital, were included. Primary outcomes measure was changes in specific quality of life questionnaire and clinical control questionnaires and Lund-Kennedy endoscopic score. Secondary outcomes measure was subjective improvement and number of exacerbations and need for surgery. Comparative analyses were performed for a total sample, presence or absence of polyps and according to the new phenotypes of chronic rhinosinusitis. Results: Total of 67 patients completed the study (34 in the Irrigation group and 33 in the Spray group). Patients with nasal polyps were the majority in the sample, corresponding to 80,6% of cases. Regarding the new phenotypes of chronic rhinosinusitis, 28,4% was classified as central compartment atopic disease. 35,8% as eosinophilic chronic rhinosinusitis and 35,8% as non-eosinophilic chronic rhinosinusitis. The spray group was superior in improving Lund-Kennedy in the total sample (p=0,030), in patients with polyps (p=0,037) and in central compartment atopic disease (p=0,037). There was a significant improvement in quality-of-life questionnaire (SNOT-22) in both treatment groups for the total sample and in almost all phenotypes, but there wasn’t superiority between treatments. The Spray group was also superior in reducing the number of uncontrolled patients in clinical control questionnaire (EPOS 2020) in the total sample (p=0,046) and in patients with polyps (p=0,020). Conclusion: High-dose corticosteroid nasal spray was superior to high-volume corticosteroid nasal irrigation in improving nasal endoscopy in the total sample, in patients with nasal polyps and in central compartment atopic disease and significantly reduced the number of uncontrolled patients in the sample total and in patients with nasal polyps.
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Citação
MATSUMOTO, Gabriela Ricci Lima Luz. O papel da irrigação nasal com corticosteroide no controle da rinossinusite crônica em pacientes sem cirurgia nasossinusal: ensaio clínico randomizado. 2023. 127. Tese (Doutorado em Otorrinolaringologia) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP). São Paulo, 2023.