Introdução: A lavagem nasal com budesonida em solução salina de alto volume (BAV) tem sido utilizada no tratamento de rinossinusite crônica (RSC). Atualmente, não existem evidências de superioridade da BAV sobre o placebo (PLA). Objetivo: O estudo avalia a eficácia da lavagem nasal com BAV na RSC com polipose nasossinusal de difícil controle e asma brônquica. Métodos: Os indivíduos foram prospectivamente recrutados e randomizados em dois grupos: budesonida (1mg/dia) ou placebo, diluídos em 250mL de Soro Fisiológico a 0,9%, e orientados para aplicar 125mL dessa solução em cada narina de 12 em 12 horas, por 12 semanas. Os pacientes foram avaliados quanto a: qualidade de vida doença-específica (SNOT-20, NOSE), endoscopia nasossinusal (Lund-Kennedy) e olfato (UPSIT). Efeitos adversos foram avaliados por meio do cortisol sérico e urinário, feita a avaliação da opacidade do cristalino e teste de sobrecarga hídrica para aferição da pressão ocular. Resultados: Trinta e oito pacientes foram randomizados: 20 no grupo budesonida e 18 no grupo placebo; 3 pacientes do grupo placebo não concluíram o tratamento. O grupo BAV apresentou melhora estatisticamente significativa evidenciada nos questionários NOSE e Lund-Kennedy, enquanto no SNOT observou-se melhora em ambos os grupos. Não houve diferença estatisticamente significativa na comparação entre os grupos em nenhum parâmetro. Entretanto, o grupo BAV mostrou uma redução maior da obstrução nasal (NOSE), comparado ao grupo PLA, cuja análise dos dados apresentou uma tendência para significância estatística (p=0,0593) que poderia ter sido evidenciada caso houvesse um tamanho amostral maior. Pacientes com doença respiratória exacerbada por aspirina no grupo BAV apresentaram melhora mais importante da obstrução nasal (NOSE) quando comparada ao placebo (p=0,0030). Não ocorreu aumento significativo dos eventos adversos após os tratamentos. Conclusão: A lavagem nasal com budesonida em alto volume de solução salina na rinossinusite crônica com polipose nasossinusal de difícil controle e asma brônquica não mostrou ser eficaz na melhora da qualidade de vida doença-específica para rinossinusite (SNOT-20) quando comparada ao placebo, mas uma tendência para melhora significativa da obstrução nasal (NOSE) foi observada / Introduction: Nasal irrigation with high-volume budesonide (HVB) in saline solution has been utilized in the treatment of chronic rhinosinusitis (CRS). Currently, there is no evidence of the superiority of HVB over placebo (PLA). The efficacy and safety of this treatment in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and asthma still needs to be better established. Objective: This study evaluated the efficacy of nasal irrigation with HVB in patients with difficult-to-control CRS with nasal polyposis and bronchial asthma. Methods: Subjects were prospectively recruited and randomized into two groups: budesonide (1 mg/day) or placebo, diluted in 250 mL of 0.9% saline solution. Patients were instructed to irrigate each nostril with 125 mL of this solution every 12 hours for 12 weeks. Patients were evaluated for disease-specific quality of life (SNOT-20, NOSE) and underwent sinonasal endoscopy (Lund-Kennedy score) and an olfactory test (UPSIT). Adverse effects were evaluated by measurement of serum and urinary cortisol levels, assessment of lens opacity, and a water-drinking test for measurement of intraocular pressure. Results: Thirty-eight patients were randomized: 20 to the budesonide and 18 to the placebo group. Three patients in the placebo group did not complete treatment. The HVB group exhibited statistically significant improvement in NOSE and Lund-Kennedy scores, while improvement in NOSE scores was observed in both groups. There were no statistically significant differences in any parameter on between-group comparison. However, the HVB group exhibited a greater reduction in nasal obstruction scores (NOSE) as compared to the PLA group, with data analysis showing a trend toward statistical significance (p=0.0593) if the sample size had been larger. Patients with aspirin-exacerbated respiratory disease in the HVB group exhibited greater improvement in nasal obstruction (NOSE) than those in the placebo group (p=0.0030). There was no increase in adverse effects after treatment. Conclusion: In patients with difficult-to-control chronic rhinosinusitis with nasal polyposis and bronchial asthma, nasal irrigation with high-volume saline solution plus budesonide was not effective in improving disease-specific quality of life (SNOT-20) as compared with placebo, but was associated with a trend toward significant improvement in nasal obstruction (NOSE)

Introdução: A lavagem nasal com budesonida em solução salina de alto volume (BAV) tem sido utilizada no tratamento de rinossinusite crônica (RSC). Atualmente, não existem evidências de superioridade da BAV sobre o placebo (PLA). Objetivo: O estudo avalia a eficácia da lavagem nasal com BAV na RSC com polipose nasossinusal de difícil controle e asma brônquica. Métodos: Os indivíduos foram prospectivamente recrutados e randomizados em dois grupos: budesonida (1mg/dia) ou placebo, diluídos em 250mL de Soro Fisiológico a 0,9%, e orientados para aplicar 125mL dessa solução em cada narina de 12 em 12 horas, por 12 semanas. Os pacientes foram avaliados quanto a: qualidade de vida doença-específica (SNOT-20, NOSE), endoscopia nasossinusal (Lund-Kennedy) e olfato (UPSIT). Efeitos adversos foram avaliados por meio do cortisol sérico e urinário, feita a avaliação da opacidade do cristalino e teste de sobrecarga hídrica para aferição da pressão ocular. Resultados: Trinta e oito pacientes foram randomizados: 20 no grupo budesonida e 18 no grupo placebo; 3 pacientes do grupo placebo não concluíram o tratamento. O grupo BAV apresentou melhora estatisticamente significativa evidenciada nos questionários NOSE e Lund-Kennedy, enquanto no SNOT observou-se melhora em ambos os grupos. Não houve diferença estatisticamente significativa na comparação entre os grupos em nenhum parâmetro. Entretanto, o grupo BAV mostrou uma redução maior da obstrução nasal (NOSE), comparado ao grupo PLA, cuja análise dos dados apresentou uma tendência para significância estatística (p=0,0593) que poderia ter sido evidenciada caso houvesse um tamanho amostral maior. Pacientes com doença respiratória exacerbada por aspirina no grupo BAV apresentaram melhora mais importante da obstrução nasal (NOSE) quando comparada ao placebo (p=0,0030). Não ocorreu aumento significativo dos eventos adversos após os tratamentos. Conclusão: A lavagem nasal com budesonida em alto volume de solução salina na rinossinusite crônica com polipose nasossinusal de difícil controle e asma brônquica não mostrou ser eficaz na melhora da qualidade de vida doença-específica para rinossinusite (SNOT-20) quando comparada ao placebo, mas uma tendência para melhora significativa da obstrução nasal (NOSE) foi observada / Introduction: Nasal irrigation with high-volume budesonide (HVB) in saline solution has been utilized in the treatment of chronic rhinosinusitis (CRS). Currently, there is no evidence of the superiority of HVB over placebo (PLA). The efficacy and safety of this treatment in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) and asthma still needs to be better established. Objective: This study evaluated the efficacy of nasal irrigation with HVB in patients with difficult-to-control CRS with nasal polyposis and bronchial asthma. Methods: Subjects were prospectively recruited and randomized into two groups: budesonide (1 mg/day) or placebo, diluted in 250 mL of 0.9% saline solution. Patients were instructed to irrigate each nostril with 125 mL of this solution every 12 hours for 12 weeks. Patients were evaluated for disease-specific quality of life (SNOT-20, NOSE) and underwent sinonasal endoscopy (Lund-Kennedy score) and an olfactory test (UPSIT). Adverse effects were evaluated by measurement of serum and urinary cortisol levels, assessment of lens opacity, and a water-drinking test for measurement of intraocular pressure. Results: Thirty-eight patients were randomized: 20 to the budesonide and 18 to the placebo group. Three patients in the placebo group did not complete treatment. The HVB group exhibited statistically significant improvement in NOSE and Lund-Kennedy scores, while improvement in NOSE scores was observed in both groups. There were no statistically significant differences in any parameter on between-group comparison. However, the HVB group exhibited a greater reduction in nasal obstruction scores (NOSE) as compared to the PLA group, with data analysis showing a trend toward statistical significance (p=0.0593) if the sample size had been larger. Patients with aspirin-exacerbated respiratory disease in the HVB group exhibited greater improvement in nasal obstruction (NOSE) than those in the placebo group (p=0.0030). There was no increase in adverse effects after treatment. Conclusion: In patients with difficult-to-control chronic rhinosinusitis with nasal polyposis and bronchial asthma, nasal irrigation with high-volume saline solution plus budesonide was not effective in improving disease-specific quality of life (SNOT-20) as compared with placebo, but was associated with a trend toward significant improvement in nasal obstruction (NOSE)

Ο άξονας Υποθάλαμος – Υπόφυση – Επινεφρίδια και το συμπαθητικό νευρικό σύστημα είναι τα περιφερικά σκέλη του συστήματος απάντησης στο στρες, με στόχο τη διατήρηση της ομοιόστασης του οργανισμού. Ανεπάρκεια ανταπόκρισης των επινεφριδίων στη σοβαρή νόσο μπορεί να παρουσιαστεί χωρίς προφανή βλάβη στον άξονα ΥΥΕ. Σε πολλούς ασθενείς με σοβαρή νόσο, τα επίπεδα κορτιζόλης παρά το ότι είναι αυξημένα, δεν είναι αρκετά ώστε να εκδηλώσουν επαρκή επινεφριδιακή απάντηση σε σχέση με τη σοβαρότητα της νόσου. Η βέλτιστη απάντηση του άξονα ΥΥΕ σε καταστάσεις νόσου παραμένει υπό αμφισβήτηση. Η διάγνωση της πιθανής σχετικής με τη νόσο παροδικής επινεφριδιακής ανεπάρκειας και η ανάγκη για χορήγηση κορτικοστεροειδών είναι ακόμη υπό συζήτηση. Σκοπός της μελέτης αυτής είναι η εκτίμηση της επινεφριδιακής απάντησης ανάλογα με τη σοβαρότητα της νόσου στην οξεία φάση της νόσου και η μελέτη του άξονα ΥΥΕ τόσο στην οξεία φάση, όσο και στην ανάρρωση. Για το σκοπό αυτό μελετήθηκαν 56 νοσηλευόμενοι ασθενείς με διαφορετικής βαρύτητας νόσημα (ΑΕΕ, ήπια νόσο, σήψη και σοβαρή σήψη), καθώς και 15 υγιή άτομα – μάρτυρες. Σε όλους τους συμμετέχοντες, κατά την εισαγωγή τους (1η ημέρα), μετρήθηκε η κορτιζόλη και η ACTH. Κατόπιν εφαρμόστηκε η δοκιμασία με χαμηλή δόση (1μg) κορτικοτροπίνης και δύο ώρες αργότερα η δοκιμασία με τη συνήθη δόση (250μg) κορτικοτροπίνης. Τη δεύτερη ημέρα νοσηλείας στους ασθενείς μετρήθηκε η ημερήσια διακύμανση της κορτιζόλης. Κατά την 5η -6η ημέρα νοσηλείας (φάση ανάρρωσης) έγινε επανάληψη των δοκιμασιών σε 15 ασθενείς (7 με σήψη και 8 με σοβαρή σήψη). Από την επεξεργασία των αποτελεσμάτων, στην ομάδα των ΑΕΕ και της σοβαρής σήψης παρατηρούνται οι υψηλότερες τιμές κορτιζόλης, καθώς επίσης και εξάλειψη της ημερήσιας διακύμανσης της κορτιζόλης. Παράλληλα, σε όλους τους ασθενείς παρατηρείται διαχωρισμός των επιπέδων κορτιζόλης και ACTH. Η αύξηση της κορτιζόλης (Δmax κορτιζόλης) μετά από διέγερση με 1 μg κορτικοτροπίνης δεν διέφερε μεταξύ των ομάδων νόσου, ενώ η Δmax κορτιζόλης μετά από διέγερση με 250μg κορτικοτροπίνης παρουσίασε οριακά σημαντική διαφορά με μια τάση να είναι υψηλότερη στην ομάδα των υγιών μαρτύρων. Η συχνότητα της απάντησης ή μη στη συνήθη δοκιμασία με βάση το κριτήριο Δmax κορτιζόλης <9 δεν διέφερε μεταξύ των υγιών και των ομάδων ασθενών, ενώ όλοι οι ασθενείς επιβίωσαν χωρίς τη χορήγηση κορτικοειδών, ανεξάρτητα από την απάντηση ή μη στις δοκιμασίες με ACTH. Στους ασθενείς με σήψη, η Δmax κορτιζόλης μετά από διέγερση με 250 μg κορτικοτροπίνης ήταν υψηλότερη στη φάση ανάρρωσης σε σχέση με την οξεία φάση, ενώ στους ασθενείς με σοβαρή σήψη η αντίστοιχη διαφορά δεν ανεδείχθη σε σημαντικό βαθμό. Η βασική κορτιζόλη ήταν υψηλότερη στην οξεία φάση σε σχέση με τη φάση ανάρρωσης και στις δύο ομάδες νόσου. Συμπερασματικά, διαπιστώνονται ήπιες αλλαγές στον άξονα ΥΥΕ, ανάλογα με τη σοβαρότητα του νοσήματος. Παρόλα αυτά, δεν επιβεβαιώνεται η ύπαρξη σχετικής επινεφριδιακής ανεπάρκειας σε μη βαριά νοσούντες ασθενείς. / Relative corticosteroid insufficiency maybe is common in critically ill patients, associated with poor outcome; however it is not known the response of the hypothalamic-pituitary-adrenal (HPA) axis in nursed patients. Our aim was to evaluate the response of HPA axis in non-critically ill nursed (NCIN) patients. Fifty -six nursed patients, divided into four groups (stroke, mild disease, sepsis and severe sepsis) as well as a control group (n=15) were studied. At admission (day 1), cortisol and ACTH measured and a low - dose (1mug ) corticotropin test was performed, followed two hours later by a standard-dose (250 mug). Diurnal variation of cortisol was obtained on day 2. A second identical set of low and standard set of corticotropin tests were performed on day 5 or 6 (recovery phase). In patients with stroke and severe sepsis cortisol had the highest values and its diurnal variation was abolished. Dissociation of ACTH and cortisol was found in all patients. The Deltamax of cortisol after the 1 mug corticotropin test did not differ among the groups while after the 250 mug corticotropin test was borderline higher in controls. The ratio of responders (Deltamax of cortisol >/= 9 mug/dL) to non-responders after 1 mug or 250 mug corticotrophin tests did not differ among patients and controls. All patients had a good outcome without glucocorticoid treatment. In conclusion, mild alterations of the HPA axis, depending on the severity of illness occurred. However, relative corticosteroid insufficiency in non-critically ill nursed patients did not confirm.