Archives of otolaryngology--head & neck surgery · 2005
Dornase alfa as postoperative therapy in cystic fibrosis sinonasal disease.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Cimmino Mariano, Nardone Massimiliano, Cavaliere Matteo, Plantulli Angela, Sepe Angela, Esposito Valeria, Mazzarella Giuseppina, Raia Valeria
Аннотация
OBJECTIVE: To determine the benefit of nasally inhaled dornase alfa in patients with cystic fibrosis and nasal symptoms.
DESIGN: Double-blind placebo-controlled trial.
SETTING: Cystic Fibrosis Regional Center of Campania at the University of Naples "Federico II."
PATIENTS: A total of 24 patients with cystic fibrosis and chronic sinusitis.
INTERVENTIONS: Patients underwent sinonasal surgery during a 3-year period and received once-daily doses of either dornase alfa (2.5 mg) or hypotonic saline solution (5 mL) beginning 1 month after surgery and for a 12-month period.
MAIN OUTCOME MEASURES: Primary outcomes were nasal-related symptoms and nasal endoscopic appearance; secondary outcomes were forced expiratory volume in 1 second, nasal computed tomography findings, and saccharine clearance test results. Patients were evaluated before and after treatment.
RESULTS: After surgery, all outcomes were significantly improved for each treatment at 1 month (P<.05); primary outcomes were improved at 24 and 48 weeks in the group receiving dornase alfa (P<.05), and at 12 weeks in the group receiving placebo. Secondary outcomes were better in the dornase alfa group (P<.01) than in the placebo group at 12 months except for the saccharine clearance test results. In particular, median relative difference in forced expiratory volume in 1 second between dornase alfa and placebo was significantly improved in the dornase alfa group (P<.01).
CONCLUSIONS: Nasally inhaled dornase alfa can be effective in patients with cystic fibrosis and sinonasal disease who do not respond to conventional therapy after surgical treatment. Further studies should be carried out to determine the long-term effect on sinus disease, recurrence of polyps, and quality of life.
DESIGN: Double-blind placebo-controlled trial.
SETTING: Cystic Fibrosis Regional Center of Campania at the University of Naples "Federico II."
PATIENTS: A total of 24 patients with cystic fibrosis and chronic sinusitis.
INTERVENTIONS: Patients underwent sinonasal surgery during a 3-year period and received once-daily doses of either dornase alfa (2.5 mg) or hypotonic saline solution (5 mL) beginning 1 month after surgery and for a 12-month period.
MAIN OUTCOME MEASURES: Primary outcomes were nasal-related symptoms and nasal endoscopic appearance; secondary outcomes were forced expiratory volume in 1 second, nasal computed tomography findings, and saccharine clearance test results. Patients were evaluated before and after treatment.
RESULTS: After surgery, all outcomes were significantly improved for each treatment at 1 month (P<.05); primary outcomes were improved at 24 and 48 weeks in the group receiving dornase alfa (P<.05), and at 12 weeks in the group receiving placebo. Secondary outcomes were better in the dornase alfa group (P<.01) than in the placebo group at 12 months except for the saccharine clearance test results. In particular, median relative difference in forced expiratory volume in 1 second between dornase alfa and placebo was significantly improved in the dornase alfa group (P<.01).
CONCLUSIONS: Nasally inhaled dornase alfa can be effective in patients with cystic fibrosis and sinonasal disease who do not respond to conventional therapy after surgical treatment. Further studies should be carried out to determine the long-term effect on sinus disease, recurrence of polyps, and quality of life.