Irrigação nasal com corticosteroide em pacientes com rinossinusite crônica com pólipos nasais no pós-operatório tardio: ensaio clínico randomizado
Data
2024-05-02
Autores
Marchetti, Erika Cabernite 
Orientadores
Kosugi, Eduardo Macoto
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Introdução: O tratamento da rinossinusite crônica (RSC) atualmente baseia-se principalmente no uso de corticosteroides (CE) tópicos nasais em spray e a irrigação nasal com solução salina. Porém, na prática clínica, as falhas são notórias e por esta razão, começou-se a preconizar o uso de corticosteroides diluídos em soro fisiológico para irrigação nasal em alto volume (INCE), aliando-se o melhor medicamento disponível no momento à melhor técnica para penetração sinusal das soluções. Objetivo: Comparar o método de irrigação nasal com corticosteroide em relação ao spray nasal com corticosteroide, na melhora da qualidade de vida, sintomas e endoscopia nasal de pacientes com rinossinusite crônica com pólipos nasais no período pós-operatório tardio. Método: Trata-se de um ensaio clínico randomizado duplo cego de pacientes com rinossinusite crônica com pólipos nasais (RSCcPN) submetidos a cirurgia endoscópica nasossinusal há no mínimo 4 meses e que apresentem falha em atingir o controle clínico da doença com o uso de CE em spray. É composto por 2 tratamentos distintos: “Irrigação CE + Spray placebo” e “Irrigação placebo + Spray CE”, que foram realizados por 3 meses, com um período de wash out de 2 semanas e crossing over dos tratamentos. Os seguintes parâmetros foram avaliados: questionário SNOT-22, escore endoscópico Lund-Kennedy modificado (EEKm), Classificação do controle clínico da doença, avaliação subjetiva do paciente sobre o estado atual da doença, avaliação sobre o número de agudizações e necessidade de nova cirurgia. Resultados: Na fase de tratamento da INCE, houve diferença estatisticamente significante entre o pré-tratamento e 3 meses no SNOT-22 total (36,0-26,6; p = < 0,001) e nos domínios nasal (17,8-14,1; p = 0,02) e sono (5,1-3,9; p = 0,03). Enquanto na fase de tratamento Spray CE, foi observado significância na diferença de todas as médias: SNOT-22 total (38,4-24,3; p = < 0,01), domínio nasal (17,9-13,4; p = 0,003), otológico (6,4-4,3; p = 0,04), psicológico (7,5-3,2; p = 0,004) e sono (6,7-3,4; p = 0,03). Em relação ao parâmetro endoscópico, na fase de tratamento Spray CE, houve diminuição do domínio edema entre o pré-tratamento e após 1 mês (3,4-3,0; p = 0,04) e 3 meses de tratamento (3,4-2,9; p = 0,04). No controle da doença segundo NOSE, no tratamento Spray CE houve redução do número de pacientes descontrolados da doença para um aumento dos parcialmente controlados. Nas demais variáveis avaliadas não houve diferença nos tratamentos avaliados. Conclusão: Concluímos que em pacientes com RSCcPN operados, a INCE e o Spray CE são capazes de melhorar os sintomas e a qualidade de vida destes doentes, porém sem superioridade de um método em relação ao outro. O Spray CE reduziu significantemente o domínio edema e teve melhor controle clínico objetivo segundo o NOSE porém sem concordância entre os tratamentos. Nenhum dos tratamentos demonstrou diferença em prevenir as reagudizações da doença e em evitar a necessidade de reabordagem cirúrgica. Na análise dos fenótipos clínicos, os pacientes com RSCe apresentaram resultado semelhante a amostra geral enquanto a RSCne não obteve resultados significantes.
Introduction: The treatment of chronic rhinosinusitis (CRS) is mainly based on the use of topical nasal spray corticosteroids (CE) and nasal irrigation with saline solution. However, in clinical practice, failures are notorious and for this reason, the use of corticosteroids diluted in saline solution for highvolume nasal irrigation (CE) began to be recommended, combining the best medication available at the time with the best technique for sinus penetration. Objective: To compare the method of nasal irrigation with corticosteroids in relation to nasal sprays with corticosteroids, in improving quality of life, symptoms and nasal endoscopy of patients with chronic rhinosinusitis and nasal polyps in the late postoperative period. Methods: This is a doubleblind randomized clinical trial of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who underwent endoscopic sinus surgery for at least 4 months and who failed to achieve clinical control of the disease with the use of CE in spray. It consists of 2 different treatments: “CE Irrigation + Placebo Spray” and “Placebo Irrigation + CE Spray”, for 3 months each, with a wash out period of 2 weeks and crossing over of treatments. The following parameters were evaluated: SNOT22 questionnaire, modified LundKennedy endoscopic score, Classification of clinical control of the disease, subjective assessment of the patient on the current state of the disease, assessment of the number of exacerbations and need for new surgery. Results: In the CE Irrigation treatment phase, there was a statistical difference between pretreatment and 3 months in the total SNOT22 (36.026.6; p = < 0.001) and in the nasal domains (17.814. 1; p = 0.02) and sleep (5.13.9; p = 0.03). While in the CE Spray treatment phase, significance was observed in the difference of all means: total SNOT22 (38.424.3; p = < 0.01), nasal domain (17.913.4; p = 0.003), otological (6.44.3; p = 0.04), psychological (7.53.2; p = 0.004) and sleep (6.73.4; p = 0 .03). Regarding the endoscopic parameter, in the Spray CE treatment phase, there was a decrease in the edema domain between pretreatment and 1 month (3.43.0; p = 0.04) and 3 months (3.42, 9; p = 0.04). In controlling the disease according to NOSE, in the CE Spray treatment there was a reduction in the number of patients with uncontrolled disease and an increase in partially controlled ones. In the other variables evaluated, there was no difference in the treatments evaluated. Conclusions: We concluded that in patients with CRSwNP who underwent surgery, CE Irrigation and CE Spray are capable of improving the symptoms and quality of life of these patients, but without superiority of one method over the other. CE Spray significantly reduced the edema domain and had better objective clinical control according to NOSE, but without agreement between treatments. None of the treatments demonstrated a difference in preventing recurrences of the disease and in avoiding the need for surgical reapproach. In the analysis of clinical phenotypes, patients with eCRS showed similar results to general sample, while noneCRS did not obtain significant results.
Introduction: The treatment of chronic rhinosinusitis (CRS) is mainly based on the use of topical nasal spray corticosteroids (CE) and nasal irrigation with saline solution. However, in clinical practice, failures are notorious and for this reason, the use of corticosteroids diluted in saline solution for highvolume nasal irrigation (CE) began to be recommended, combining the best medication available at the time with the best technique for sinus penetration. Objective: To compare the method of nasal irrigation with corticosteroids in relation to nasal sprays with corticosteroids, in improving quality of life, symptoms and nasal endoscopy of patients with chronic rhinosinusitis and nasal polyps in the late postoperative period. Methods: This is a doubleblind randomized clinical trial of patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who underwent endoscopic sinus surgery for at least 4 months and who failed to achieve clinical control of the disease with the use of CE in spray. It consists of 2 different treatments: “CE Irrigation + Placebo Spray” and “Placebo Irrigation + CE Spray”, for 3 months each, with a wash out period of 2 weeks and crossing over of treatments. The following parameters were evaluated: SNOT22 questionnaire, modified LundKennedy endoscopic score, Classification of clinical control of the disease, subjective assessment of the patient on the current state of the disease, assessment of the number of exacerbations and need for new surgery. Results: In the CE Irrigation treatment phase, there was a statistical difference between pretreatment and 3 months in the total SNOT22 (36.026.6; p = < 0.001) and in the nasal domains (17.814. 1; p = 0.02) and sleep (5.13.9; p = 0.03). While in the CE Spray treatment phase, significance was observed in the difference of all means: total SNOT22 (38.424.3; p = < 0.01), nasal domain (17.913.4; p = 0.003), otological (6.44.3; p = 0.04), psychological (7.53.2; p = 0.004) and sleep (6.73.4; p = 0 .03). Regarding the endoscopic parameter, in the Spray CE treatment phase, there was a decrease in the edema domain between pretreatment and 1 month (3.43.0; p = 0.04) and 3 months (3.42, 9; p = 0.04). In controlling the disease according to NOSE, in the CE Spray treatment there was a reduction in the number of patients with uncontrolled disease and an increase in partially controlled ones. In the other variables evaluated, there was no difference in the treatments evaluated. Conclusions: We concluded that in patients with CRSwNP who underwent surgery, CE Irrigation and CE Spray are capable of improving the symptoms and quality of life of these patients, but without superiority of one method over the other. CE Spray significantly reduced the edema domain and had better objective clinical control according to NOSE, but without agreement between treatments. None of the treatments demonstrated a difference in preventing recurrences of the disease and in avoiding the need for surgical reapproach. In the analysis of clinical phenotypes, patients with eCRS showed similar results to general sample, while noneCRS did not obtain significant results.
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Citação
MARCHETTI, Erika Cabernite. Irrigação nasal com corticosteroide em pacientes com rinossinusite crônica com pólipos nasais no pós-operatório tardio: ensaio clínico randomizado. 2024. 108 f. Tese (Doutorado em Otorrinolaringologia) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP). São Paulo, 2024.