RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis.
Int Forum Allergy Rhinol
; 4(11): 861-70, 2014 Nov.
Article
em En
| MEDLINE
| ID: mdl-25266981
ABSTRACT
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Pregnadienodiois
/
Pólipos Nasais
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Anti-Inflamatórios
Tipo de estudo:
Clinical_trials
Limite:
Female
/
Humans
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Male
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Middle aged
Idioma:
En
Ano de publicação:
2014
Tipo de documento:
Article