Bioabsorbable steroid‐releasing implants in the frontal sinus ostia: a pooled analysis
| Autor: | Karen J. Fong, Randall A. Ow, Joseph K. Han, Amber U Luong, Roland Gerencer, J. Pablo Stolovitzky, Ameet Singh, James W. Stambaugh, Aarthi Raman |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty corticosteroid medicine.drug_class Mometasone furoate 03 medical and health sciences 0302 clinical medicine Nasal Polyps Restenosis Occlusion Absorbable Implants medicine Immunology and Allergy revision ESS Humans Sinusitis 030223 otorhinolaryngology Asthma Aged Rhinitis Drug Implants Frontal sinus business.industry Original Articles asthma Middle Aged medicine.disease Confidence interval Surgery mometasone furoate medicine.anatomical_structure Treatment Outcome Otorhinolaryngology 030220 oncology & carcinogenesis Chronic Disease Corticosteroid Frontal Sinus Original Article Female Implant business endoscopic sinus surgery medicine.drug |
| Zdroj: | International Forum of Allergy & Rhinology |
| ISSN: | 2042-6984 2042-6976 |
| Popis: | BACKGROUND Bioabsorbable steroid-releasing implants (mometasone furoate, 370 μg) are effective for improving postsurgical outcomes in the frontal sinus ostia (FSO). In this study we evaluated the effect of these implants on frontal outcomes in various patient subgroups with chronic rhinosinusitis (CRS) using pooled data from 2 randomized, controlled trials (RCTs). METHODS A total of 160 subjects were enrolled in 2 RCTs. After surgery, subjects were randomized to receive an implant in 1 FSO with the contralateral side as control. Data through day 90 from the 2 studies were pooled and subgroup analyses were performed. RESULTS At day 30, relative to controls, steroid-releasing implants significantly reduced the need for postoperative interventions by 46.8% (95% confidence interval [CI], -60.7 to -27.9), for surgical interventions by 51.2% (95% CI, -68.2 to -25.2), and for oral steroid interventions by 37.2% (95% CI, -54.6 to -13.1) in the pooled data set. At day 90, statistically significant reductions (p < 0.05) in the need for postoperative interventions (relative reduction [RR], 30.2%), restenosis/occlusion rate (RR, 31.7%), and inflammation score (absolute difference, -6.0), and increase in estimated FSO diameter (absolute difference, 1 mm), favoring the treated side, were observed. Subgroup analyses of the pooled data showed statistically significant improvements (p < 0.05) at day 90 in restenosis/occlusion rate, and estimated FSO diameter, favoring the treated side across subgroups, with no statistically significant subgroup-by-treatment interactions. CONCLUSION Bioabsorbable steroid-releasing sinus implants improve outcomes of frontal sinus surgery through 90 days, irrespective of asthma status, previous endoscopic sinus surgery, extent of surgery, extent of polyps, or Lund-Mackay computed tomography stage in the FSO. |
| Databáze: | OpenAIRE |
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