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Short-term postoperative efficacy of steroid-eluting stents for eosinophilic chronic rhinosinusitis with nasal polyps: A randomized clinical trial

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机构: [1]Department of Otolaryngology, Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, China [3]Department of Otolaryngology, Head and Neck Surgery, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China [4]Otorhinolaryngology Hospital, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China [5]Department of Otolaryngology, Head and Neck Surgery, China-Japan Union Hospital of Jilin University, Changchun, Jilin, China [6]Department of Allergy, Beijing Tongren Hospital, Capital Medical University, Beijing, China
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关键词: corticosteroid endoscopic sinus surgery eosinophilic chronic rhinosinusitis nasal polyps stent

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Background Eosinophilic chronic rhinosinusitis with nasal polyps (ECRSwNP) is a refractory clinical phenotype with a high symptom burden and relapse rate. Steroid-eluting stents are safe and effective for reducing polyp size, symptom burden, and the need for revision sinus surgery. In this study we aimed to evaluate the efficacy and safety of steroid-eluting stent implantation on the surgical outcomes of patients with ECRSwNP. Methods This prospective, multicenter, randomized, intrapatient-controlled trial recruited patients 18 to 65 years of age with ECRSwNP who required surgery. Ninety-eight patients were enrolled and randomly implanted with absorbable steroid-eluting stents containing mometasone furoate in one sinus at the end of surgery. All patients received standard postoperative care and follow-up. The primary outcome was the Lund-Kennedy endoscopic score within 12 weeks postsurgery. Secondary outcomes included nasal symptoms scores, nasal resistance, acoustic rhinometry, nasal nitric oxide levels, 3-dimensional volumetric computed tomography scores, and eosinophil counts in the ethmoid mucosa. Results Ninety-five patients completed the trial. At postoperative weeks 4, 8, and 12, the Lund-Kennedy scores were significantly lower on the treatment side than on the control side (all p < 0.01). Compared with the treatment side, the control side exhibited higher tissue eosinophilia at week 4 and higher volumetric, nasal obstruction, and total nasal symptom scores at postoperative week 8 (p = 0.011, p = 0.011, p < 0.01, and p = 0.001, respectively). No adrenal cortical suppression or serious side effects were observed. Conclusion Steroid-eluting stents reduce postoperative sinus mucosal edema, and eosinophilic inflammation, with persistent effects after stent disintegration, and are a good supplementary postsurgical treatment in patients with ECRSwNP.

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基金编号: IRT13082 82025010 82071022 81870698 2019-I2M-5-022 XMLX201816 SML20150203 DFL20190202 Z181100001618002 Z211100002921057

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出版当年[2022]版:
大类 | 1 区 医学
小类 | 1 区 耳鼻喉科学
最新[2023]版:
大类 | 2 区 医学
小类 | 1 区 耳鼻喉科学
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出版当年[2021]版:
Q1 OTORHINOLARYNGOLOGY
最新[2023]版:
Q1 OTORHINOLARYNGOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

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第一作者机构: [1]Department of Otolaryngology, Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, China
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通讯机构: [1]Department of Otolaryngology, Head and Neck Surgery, Beijing Tongren Hospital, Capital Medical University, Beijing, China [2]Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, China [6]Department of Allergy, Beijing Tongren Hospital, Capital Medical University, Beijing, China [*1]Beijing Tongren Hospital, Capital Medical University, No. 1, Dong Jiao Min Xiang, Dongcheng District, Beijing 100051, China. [*2]Beijing Tongren Hospital, Capital Medical University, No. 17, HouGou Hu Tong,Dongcheng District, Beijing 100005, China.
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