International forum of allergy & rhinology · 2014
RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Han Joseph K, Forwith Keith D, Smith Timothy L, Kern Robert C, Brown William J, Miller Steven K, Ow Randall A, Poetker David M, Karanfilov Boris, Matheny Keith E, Stambaugh James, Gawlicka Anna K
Аннотация
BACKGROUND: Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid-eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency.
METHODS: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes.
RESULTS: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation.
CONCLUSION: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.
METHODS: This was a randomized, controlled, blinded study including 100 patients chronic rhinosinusitis with nasal polyposis (CRSwNP) refractory to medical therapy and considered candidates for revision ESS. Follow-up included endoscopic grading by investigators and patient-reported outcomes.
RESULTS: Treated patients (n = 53; age as mean ± standard deviation [SD] 47.8 ± 12.6 years; 55% male) underwent in-office bilateral placement. Control patients (n = 47; age 51.6 ± 13.1 years; 66% male) underwent a sham procedure. At 3 months, treated patients experienced a significant reduction in bilateral polyp grade (p = 0.0269) and ethmoid sinus obstruction (p = 0.0001) compared to controls. Treated patients also experienced a 2-fold improvement in the mean nasal obstruction/congestion score (-1.33 ± 1.47 vs -0.67 ± 1.45; p = 0.1365). This improvement reached statistical significance (p = 0.025) in patients with greater polyp burden (grade ≥2 bilaterally; n = 74). At 3 months, 53% of treated patients compared to only 23% of controls were no longer indicated for repeat ESS. There was no serious adverse event or clinically significant increases in intraocular pressure or cataract formation.
CONCLUSION: The symptomatic improvement and statistically significant reduction in polyp grade and ethmoid sinus obstruction supported the efficacy of the steroid-eluting implant for in-office treatment of CRS patient with recurrent polyposis after ESS. The study results demonstrated that the steroid-eluting implant represents a safe and effective alternative to current management for this patient population.