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A single-center, randomized, double-blinded, placebo-controlled clinical study on the efficacy and safety of voriconazole ear drops in the treatment of otomycosis 一项单中心、随机、双盲、安慰剂对照的伏立康唑滴耳液治疗耳真菌病的疗效和安全性临床研究
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 Epub Date: 2026-01-13 DOI: 10.1016/j.amjoto.2026.104792
Shen'er Qian , Guolin Tan , Hongyi Tan , Lihua Chen , Yonghong Yu , Ru Gao , Wei Li

Objective

This study aimed to investigate the efficacy and safety of voriconazole ear drops.

Methods

A single-center, randomized, double-blind, placebo-controlled clinical design was adopted. A total of 108 patients with otomycosis were enrolled and randomly assigned in a 2:1 ratio to the experimental group (n = 72) and the control group (n = 36). The experimental group received voriconazole ear drops for 7 days followed by placebo for 7 days; the control group received the treatments in reverse order. The primary efficacy endpoint was the clinical response rate. Secondary endpoints included improvement in ear symptoms and signs, and the recurrence rate after discontinuation of treatment.

Results

The experimental group showed significant superiority over the control group in the clinical response rate (62.50% vs 38.89%, P < 0.05). Among the secondary endpoints, the improvement rates for ear fullness and ear swelling were significantly higher in the experimental group (P < 0.05), while no significant statistical differences were observed for the other symptoms. The recurrence rate after treatment discontinuation was 7.89%. Regarding safety, no drug-related clinical abnormalities, adverse events, or serious adverse events were observed in any patient.

Conclusion

Voriconazole ear drops demonstrated good efficacy and safety in the treatment of otomycosis, showing significant therapeutic effects particularly against filamentous fungal infections. Topical application showed no significant toxicity, indicating promising clinical application prospects.
目的探讨伏立康唑滴耳液的有效性和安全性。方法采用单中心、随机、双盲、安慰剂对照的临床设计。共纳入108例耳真菌病患者,按2:1的比例随机分为实验组(72例)和对照组(36例)。试验组患者先服用伏立康唑滴耳液7 d,再服用安慰剂7 d;对照组按相反的顺序进行治疗。主要疗效终点为临床有效率。次要终点包括耳部症状和体征的改善以及停止治疗后的复发率。结果实验组在临床有效率上明显优于对照组(62.50% vs 38.89%, P < 0.05)。在次要终点中,实验组在耳丰满、耳肿胀方面的改善率显著高于对照组(P < 0.05),其他症状的改善率差异无统计学意义。停药后复发率为7.89%。在安全性方面,未观察到任何患者出现与药物相关的临床异常、不良事件或严重不良事件。结论伏立康唑滴耳液治疗耳真菌病疗效好,安全性高,对丝状真菌感染疗效显著。局部应用无明显毒性,具有良好的临床应用前景。
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引用次数: 0
Effectiveness of drug-induced sleep endoscopy in improving patients selection and outcomes of mandibular advancement device therapy for obstructive sleep apnea: A multicenter case-control study 药物诱导睡眠内窥镜在改善下颌推进装置治疗阻塞性睡眠呼吸暂停患者选择和疗效方面的有效性:一项多中心病例对照研究
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 Epub Date: 2025-11-11 DOI: 10.1016/j.amjoto.2025.104740
Giannicola Iannella , Sergio Terranova , Marco Brunori , Claudio Vicini , Alberto Caranti , Ruggero Campisi , Vincenzo De Ceglie , Manuele Casale , Antonio Moffa , Fabrizio Salamanca , Federico Leone , Andrea De Vito , Giovanni Cammaroto , Salvatore Cocuzza , Antonino Maniaci , Armando De Virgilio , Jerome R. Lechien , Carlos-Miguel Chiesa-Estomba , Luigi A. Vaira , Paolo Boscolo-Rizzo , Annalisa Pace

Purpose

To evaluate, in Obstructive sleep apnea (OSA) patients, the use of pre-treatment drug-induced sleep endoscopy (DISE) as a patient selection tool, that could improve the outcomes of mandibular advancement device (MAD) therapy. A multicenter retrospective case-control study has been performed.

Methods

A multicenter case-control study with two parallel arms was conducted to compare functional outcomes in patients undergoing MAD therapy. Group A (n = 118) received MAD therapy based solely on static clinical assessments, including dentoskeletal features, oropharyngeal anatomy, and upper airway endoscopy. Group B (n = 87) underwent pre-treatment DISE to dynamically evaluate the site, type, and pattern of upper airway collapse, thereby guiding patient selection for MAD therapy.

Results

In Group A, the mean pre-treatment apnea-hypopnea index (AHI) was 28.1, decreasing significantly to 12.4 post-treatment (p = 0.0001). In Group B, the mean AHI decreased from 31.3 to 9.5 (p = 0.0001). The Delta apnea-hypopnea index (ΔAHI) was significantly greater in Group B (−21.7) than in Group A (−16.6; p = 0.04). Similarly, the Delta Oxigen desaturation index (ΔODI) was −18.6 in Group B versus −14.1 in Group A (p = 0.04). The therapeutic success rate was significantly higher in Group B (82.7 %) compared to Group A (60.1 %) (p = 0.001).

Conclusion

In OSA patients, a pre-treatment DISE evaluation, improves the selection of appropriate candidates for MAD therapy by enabling dynamic assessment of upper airway collapsibility during a pharmacologically induced sleep. This targeted selection results in significantly better therapeutic outcomes for MAD therapy for the OSA treatment.
目的探讨在阻塞性睡眠呼吸暂停(OSA)患者中,治疗前药物诱导睡眠内镜(DISE)作为患者选择工具,对下颌推进装置(MAD)治疗效果的影响。进行了一项多中心回顾性病例对照研究。方法采用双平行臂多中心病例对照研究,比较MAD治疗患者的功能结局。A组(n = 118)仅根据静态临床评估(包括牙骨骼特征、口咽解剖和上呼吸道内窥镜检查)接受MAD治疗。B组(n = 87)在治疗前进行DISE,动态评估上呼吸道塌陷的部位、类型和模式,指导患者选择MAD治疗方案。结果A组患者治疗前平均呼吸暂停低通气指数(AHI)为28.1,治疗后为12.4,差异有统计学意义(p = 0.0001)。B组平均AHI从31.3降至9.5 (p = 0.0001)。B组δ呼吸暂停低通气指数(ΔAHI)(- 21.7)显著高于A组(- 16.6,p = 0.04)。同样,B组的δ氧去饱和指数(ΔODI)为−18.6,而A组为−14.1 (p = 0.04)。B组治疗成功率(82.7%)明显高于A组(60.1%)(p = 0.001)。结论在OSA患者中,治疗前的DISE评估可以通过动态评估药理学诱导睡眠期间的上呼吸道塌陷性来改善对合适的MAD治疗候选者的选择。这种有针对性的选择使MAD治疗OSA的治疗效果明显更好。
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引用次数: 0
Sarcopenia and postoperative morbidity in head & neck cancer: A systematic review and meta-analysis 头颈癌骨骼肌减少症与术后发病率:一项系统综述和荟萃分析。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 Epub Date: 2025-12-06 DOI: 10.1016/j.amjoto.2025.104758
Michael Xie , Han Zhang , Phillip Staibano , Zahra Abdallah , Michael K. Gupta , Nhu Tram Nguyen

Objective

To identify the prognostic value of sarcopenia in surgically treated HNC patients on postoperative morbidity.

Design

Systematic review and meta-analysis.

Information sources, study selection, and methods

EMBASE, MEDLINE, SCOPUS, and CINAHL databases were searched from January 1, 1946 to November 4, 2024. Published trials and observational studies reporting the association of sarcopenia and postoperative complications in surgically treated HNC patients were included. Two reviewers independently screened, extracted, and appraised studies using Covidence. Disagreements were resolved through consensus, and/or by consulting a third reviewer. Data were pooled using a random-effects model in RevMan 5.4.1.

Results

Of 6345 screened studies, 17 out of the 23 included studies had outcomes which were incorporated in the meta-analysis (2884 patients from studies between 1996 and 2024). The meta-analysis revealed a statistically significant association between sarcopenia and all postoperative complications (odds ratio (OR) 2.26, 95 % CI [1.54, 3.33], p < 0.0001), postoperative complications grade 3 (OR 2.34, 95 % CI [1.80, 3.03], p < 0.00001), fistula (OR 2.64, 95 % CI [1.68, 4.16], p < 0.0001), and flap complications (OR 2.77, 95 % CI [1.58, 4.85], p = 0.0004). Subgroup analysis revealed the high risk of bias studies did not significantly bias the results (p = 0.76), but the different measurements of sarcopenia contributed significant heterogeneity (p < 0.00001). The level of evidence is moderate, primarily due to publication bias, for all outcomes, as per GRADE.

Conclusions

In patients undergoing curative surgery for HNC, preoperative sarcopenia is associated with higher odds of postoperative complications.
目的:探讨手术治疗的HNC患者肌肉减少症对术后发病率的预后价值。设计:系统回顾和荟萃分析。信息来源、研究选择和方法:检索1946年1月1日至2024年11月4日的EMBASE、MEDLINE、SCOPUS和CINAHL数据库。已发表的试验和观察性研究报告了手术治疗的HNC患者肌肉减少症与术后并发症的关系。两名审稿人独立筛选、提取和评价了使用covid - ence的研究。分歧通过协商一致和/或咨询第三方审稿人来解决。数据采用RevMan 5.4.1中的随机效应模型进行汇总。结果:在6345项筛选的研究中,23项纳入的研究中有17项的结果纳入了荟萃分析(来自1996年至2024年研究的2884名患者)。荟萃分析显示,肌肉减少症与所有术后并发症之间存在统计学意义上的相关性(优势比(OR) 2.26, 95% CI [1.54, 3.33], p)。结论:在接受根治性手术的HNC患者中,术前肌肉减少症与术后并发症的发生率较高相关。
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引用次数: 0
Rethinking congenital cytomegalovirus: A narrative review of the clinical, public health, and ethical challenges of a preventable cause of childhood hearing loss 重新思考先天性巨细胞病毒:一种可预防的儿童听力损失病因的临床、公共卫生和伦理挑战的叙述性回顾
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-05-20 DOI: 10.1016/j.amjoto.2025.104682
M. Peyton Simons , Gauri Mankekar
Congenital cytomegalovirus (cCMV) is the most common non-genetic cause of pediatric sensorineural hearing loss, affecting approximately tens of thousands of infants annually in the United States. While cCMV may present symptomatically at birth, many infants are asymptomatic initially and later develop progressive or fluctuating hearing loss, which is often undiagnosed without early screening. Despite advances in diagnostic methods such as polymerase chain reaction (PCR) testing, the absence of a national screening policy in the U.S. results in significant variability in early detection and follow-up care. This narrative review provides an overview of the clinical manifestations, diagnostic strategies, and treatment options for cCMV, while highlighting critical gaps in public health infrastructure, policy coordination, and ethical oversight. Cost considerations remain a major factor in determining the feasibility of universal versus targeted screening approaches, with emerging data suggesting that both strategies offer cost-effective benefits depending on implementation context. Additionally, disparities in access to follow-up care and interventions raise important questions about health equity. Current efforts by some states to include cCMV in newborn screening protocols are promising, but without consistent national guidance, large portions of affected infants will continue to be missed. Addressing cCMV effectively will require a multidisciplinary, systems-based approach that combines early detection with sustainable follow-up, robust policy frameworks, and ethical consideration for families navigating diagnosis and care.
先天性巨细胞病毒(cCMV)是儿童感音神经性听力损失最常见的非遗传原因,在美国每年约有数万名婴儿受到影响。虽然cCMV可能在出生时出现症状,但许多婴儿最初无症状,后来发展为进行性或波动性听力损失,通常没有早期筛查就无法诊断。尽管在聚合酶链反应(PCR)检测等诊断方法方面取得了进步,但美国缺乏全国性的筛查政策,导致早期发现和后续护理方面存在显著差异。这篇叙述性综述概述了cCMV的临床表现、诊断策略和治疗方案,同时强调了公共卫生基础设施、政策协调和伦理监督方面的关键差距。成本方面的考虑仍然是决定普遍筛查方法与靶向筛查方法可行性的主要因素,新出现的数据表明,根据实施情况,这两种策略都具有成本效益。此外,在获得后续护理和干预措施方面存在的差距,引发了有关卫生公平的重要问题。目前一些州将cCMV纳入新生儿筛查方案的努力很有希望,但如果没有一致的国家指导,很大一部分受影响的婴儿将继续被遗漏。有效应对cCMV需要多学科、基于系统的方法,将早期发现与可持续的后续行动、强有力的政策框架以及对家庭进行诊断和护理的伦理考虑相结合。
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引用次数: 0
Examination of opioid prescribing guidelines on sinus surgery opioid prescription trends 检查阿片类药物处方指南对鼻窦手术阿片类药物处方趋势的影响
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-21 DOI: 10.1016/j.amjoto.2025.104747
Robert E. Africa, Amber M. Dunmire, Shahrukh R. Ali, Brian J. McKinnon, Charles A. Hughes, Tyler A. Janz, Farrah Siddiqui, Scott A. Hardison

Background

To evaluate the trends in opioid and non-opioid prescribing for functional endoscopic sinus surgery (FESS) in relation to the publication of guidelines by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in April 2021.

Methods

This is a retrospective study utilizing de-identified patient data obtained from the TriNetX database including patients who were prescribed either opioid or non-opioid analgesics within 1–5 days following FESS from January 1, 2023 to December 31, 2023. To evaluate the trends of prescription before and after the new opioid prescription guidelines, interrupted time series analysis in Statistical Analysis System (SAS) 9.4 was performed with significance at p < 0.05.

Results

Opioid prescription had an immediate increase by 0.87 % after guideline publication, but it was not statistically significant (p = 0.92). Throughout the rest of the study period, the trend decreased by 0.20 %, but it was not statistically significant (p = 0.35). For non-opioid prescriptions, there was a significant sustained increase in non-opioid prescriptions after the guideline change by 0.07 % (p = 0.03).

Conclusions

No associated decrease in opioid prescription for FESS after the guideline publication was observed. Non-opioid prescription did not have an immediate increase, but the trend increased in the post-publication period.
根据美国耳鼻喉头颈外科学会(AAO-HNS)于2021年4月发布的指南,评估功能性内窥镜鼻窦手术(FESS)中阿片类药物和非阿片类药物处方的趋势。方法:本研究是一项回顾性研究,利用从TriNetX数据库中获得的去识别患者数据,包括2023年1月1日至2023年12月31日FESS后1 - 5天内处方阿片类或非阿片类镇痛药的患者。为评价新阿片类药物处方指南前后的处方变化趋势,采用SAS 9.4进行中断时间序列分析,p <; 0.05为显著性水平。结果阿片类药物处方在指南发布后立即增加0.87%,但差异无统计学意义(p = 0.92)。在其余研究期间,该趋势下降了0.20%,但无统计学意义(p = 0.35)。对于非阿片类药物处方,指南改变后非阿片类药物处方持续显著增加0.07% (p = 0.03)。结论指南发布后,FESS患者阿片类药物处方未见相关减少。非阿片类药物处方没有立即增加,但在出版后的时期有增加的趋势。
{"title":"Examination of opioid prescribing guidelines on sinus surgery opioid prescription trends","authors":"Robert E. Africa,&nbsp;Amber M. Dunmire,&nbsp;Shahrukh R. Ali,&nbsp;Brian J. McKinnon,&nbsp;Charles A. Hughes,&nbsp;Tyler A. Janz,&nbsp;Farrah Siddiqui,&nbsp;Scott A. Hardison","doi":"10.1016/j.amjoto.2025.104747","DOIUrl":"10.1016/j.amjoto.2025.104747","url":null,"abstract":"<div><h3>Background</h3><div>To evaluate the trends in opioid and non-opioid prescribing for functional endoscopic sinus surgery (FESS) in relation to the publication of guidelines by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in April 2021.</div></div><div><h3>Methods</h3><div>This is a retrospective study utilizing de-identified patient data obtained from the TriNetX database including patients who were prescribed either opioid or non-opioid analgesics within 1–5 days following FESS from January 1, 2023 to December 31, 2023. To evaluate the trends of prescription before and after the new opioid prescription guidelines, interrupted time series analysis in Statistical Analysis System (SAS) 9.4 was performed with significance at <em>p</em> &lt; 0.05.</div></div><div><h3>Results</h3><div>Opioid prescription had an immediate increase by 0.87 % after guideline publication, but it was not statistically significant (<em>p</em> = 0.92). Throughout the rest of the study period, the trend decreased by 0.20 %, but it was not statistically significant (<em>p</em> = 0.35). For non-opioid prescriptions, there was a significant sustained increase in non-opioid prescriptions after the guideline change by 0.07 % (<em>p</em> = 0.03).</div></div><div><h3>Conclusions</h3><div>No associated decrease in opioid prescription for FESS after the guideline publication was observed. Non-opioid prescription did not have an immediate increase, but the trend increased in the post-publication period.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 6","pages":"Article 104747"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145358401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Machine learning model for predicting hearing preservation after vestibular schwannoma surgery: A meta-analysis 预测前庭神经鞘瘤手术后听力保存的机器学习模型:荟萃分析。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-03 DOI: 10.1016/j.amjoto.2025.104727
Paweł Łajczak , Emma Ann Finnegan , Enzo von Quednow , Fabio Victor Vieira Rocha , Yasmin Picanço Silva , Oguz Kagan Sahin , Walter Fagundes

Introduction

Vestibular schwannomas (VS) are benign tumors that can cause hearing loss, tinnitus and balance disorders. Radiosurgery and open surgery remain the primary treatments, but predicting hearing preservation post-surgery remains challenging due to a variety of factors. Machine learning (ML) has emerged as a promising tool for predicting hearing outcomes in VS patients. This meta-analysis aims to systematically evaluate the diagnostic accuracy of ML models in predicting hearing preservation in VS patients undergoing surgery.

Methods

We conducted a systematic review and meta-analysis following PRISMA-DTA guidelines, including studies that applied ML to predict hearing preservation in VS patients undergoing surgery. Studies were selected based on predefined inclusion criteria, and diagnostic accuracy metrics, such as sensitivity, specificity and accuracy were extracted.

Results

A total of 15 models from 3 studies were included. The overall pooled sensitivity was 0.856 (95% CI 0.758–0.919), specificity was 0.853 (95% CI 0.713–0.931), and accuracy was 0.839 (95% CI 0.748–0.902). The area under the summary ROC curve was 0.883 (95% CI 0.770–0.910), indicating high diagnostic effectiveness. Significant heterogeneity was observed.

Conclusions

ML models achieve high accuracy in predicting hearing preservation in VS patients undergoing surgery. However, significant heterogeneity exists across studies, indicating the need for further research to optimize model performance and enhance their generalizability across diverse patient populations. ML has the potential to assist clinicians in providing personalized treatment strategies and improving patient outcomes in the management of vestibular schwannomas.
前庭神经鞘瘤(VS)是一种良性肿瘤,可引起听力损失、耳鸣和平衡障碍。放疗和开放手术仍然是主要的治疗方法,但由于各种因素,预测术后听力保留仍然具有挑战性。机器学习(ML)已成为预测VS患者听力结果的一种有前途的工具。本荟萃分析旨在系统评估ML模型在预测接受手术的VS患者听力保留方面的诊断准确性。方法:我们根据PRISMA-DTA指南进行了系统回顾和荟萃分析,包括应用ML预测接受手术的VS患者听力保留的研究。根据预定义的纳入标准选择研究,提取诊断准确性指标,如敏感性、特异性和准确性。结果:共纳入3项研究的15个模型。总体合并敏感性为0.856 (95% CI 0.758-0.919),特异性为0.853 (95% CI 0.713-0.931),准确性为0.839 (95% CI 0.748-0.902)。综合ROC曲线下面积为0.883 (95% CI 0.77 ~ 0.910),诊断效能高。观察到显著的异质性。结论:ML模型在预测VS手术患者的听力保留方面具有较高的准确性。然而,各研究之间存在显著的异质性,表明需要进一步研究以优化模型性能并增强其在不同患者群体中的普遍性。ML有可能帮助临床医生提供个性化的治疗策略,并改善前庭神经鞘瘤的治疗结果。
{"title":"Machine learning model for predicting hearing preservation after vestibular schwannoma surgery: A meta-analysis","authors":"Paweł Łajczak ,&nbsp;Emma Ann Finnegan ,&nbsp;Enzo von Quednow ,&nbsp;Fabio Victor Vieira Rocha ,&nbsp;Yasmin Picanço Silva ,&nbsp;Oguz Kagan Sahin ,&nbsp;Walter Fagundes","doi":"10.1016/j.amjoto.2025.104727","DOIUrl":"10.1016/j.amjoto.2025.104727","url":null,"abstract":"<div><h3>Introduction</h3><div>Vestibular schwannomas (VS) are benign tumors that can cause hearing loss, tinnitus and balance disorders. Radiosurgery and open surgery remain the primary treatments, but predicting hearing preservation post-surgery remains challenging due to a variety of factors. Machine learning (ML) has emerged as a promising tool for predicting hearing outcomes in VS patients. This meta-analysis aims to systematically evaluate the diagnostic accuracy of ML models in predicting hearing preservation in VS patients undergoing surgery.</div></div><div><h3>Methods</h3><div>We conducted a systematic review and meta-analysis following PRISMA-DTA guidelines, including studies that applied ML to predict hearing preservation in VS patients undergoing surgery. Studies were selected based on predefined inclusion criteria, and diagnostic accuracy metrics, such as sensitivity, specificity and accuracy were extracted.</div></div><div><h3>Results</h3><div>A total of 15 models from 3 studies were included. The overall pooled sensitivity was 0.856 (95% CI 0.758–0.919), specificity was 0.853 (95% CI 0.713–0.931), and accuracy was 0.839 (95% CI 0.748–0.902). The area under the summary ROC curve was 0.883 (95% CI 0.770–0.910), indicating high diagnostic effectiveness. Significant heterogeneity was observed.</div></div><div><h3>Conclusions</h3><div>ML models achieve high accuracy in predicting hearing preservation in VS patients undergoing surgery. However, significant heterogeneity exists across studies, indicating the need for further research to optimize model performance and enhance their generalizability across diverse patient populations. ML has the potential to assist clinicians in providing personalized treatment strategies and improving patient outcomes in the management of vestibular schwannomas.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 6","pages":"Article 104727"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145494190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comparative efficacy and safety of monoclonal antibodies biologic therapies for chronic rhinosinusitis with nasal polyps: A systematic review and network meta-analysis 单克隆抗体生物治疗慢性鼻窦炎伴鼻息肉的比较疗效和安全性:系统综述和网络荟萃分析
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-21 DOI: 10.1016/j.amjoto.2025.104734
Abdulhakeem Almutairi , Lina Yousef Aloraini , Bader Muzhier Alshahrani , Maan Omar Alzuhairi , Rabab Hussain Alzanadi , Khalid Fahad Alanazi , Yahya Ali Khubrani , Ahmed Y. Azzam

Introduction

Chronic rhinosinusitis with nasal polyps (CRSwNP) represents a significant therapeutic challenge with high recurrence rates despite the current standard treatments. Several biologic therapies targeting type-2 inflammation have emerged, but detailed comparisons between these agents are lacking.

Methods

We conducted a systematic review and network meta-analysis of randomized controlled trials evaluating biologics for CRSwNP. Literature databases were searched up to the date of 28th of April 2025. Primary outcomes included changes in nasal polyp score (NPS), nasal congestion, SNOT-22, and surgery/systemic corticosteroid reduction.

Results

Sixteen studies (with total of 3040 patients included) investigating six biologics (dupilumab, omalizumab, mepolizumab, benralizumab, tezepelumab, reslizumab) were included. For NPS reduction, dupilumab showed greatest improvement (−2.44; 95 %CI: −2.85,-2.03), followed by tezepelumab (−2.07; 95 %CI:-2.39,-1.74). Mepolizumab demonstrated superior nasal congestion improvement (−2.64; 95 %CI:-3.24,-2.04). For quality of life, preliminary findings from a single study showed tezepelumab with the greatest SNOT-22 improvement (−27.26; 95 %CI:-32.32,-22.21), however validation in additional trials is needed. Surgery/systemic corticosteroid need was most reduced with tezepelumab in this single study (HR:0.02; 95 %CI:0.00–0.09). Omalizumab had the lowest adverse event rate (49.6 %). Network meta-analysis identified omalizumab and tezepelumab as highest-ranked overall (efficacy/safety combination).

Conclusion

Our study demonstrated significant efficacy and safety profiles among biologics for CRSwNP. Treatment selection should consider specific symptom focus and comorbidity patterns, with network meta-analysis suggesting favorable overall profiles for omalizumab, with tezepelumab showing promise but requiring additional validation.
慢性鼻窦炎伴鼻息肉(CRSwNP)是一个显著的治疗挑战,尽管目前的标准治疗具有高复发率。几种针对2型炎症的生物疗法已经出现,但缺乏这些药物之间的详细比较。方法对评价生物制剂治疗CRSwNP的随机对照试验进行系统综述和网络荟萃分析。检索文献数据库至2025年4月28日。主要结局包括鼻息肉评分(NPS)、鼻塞、SNOT-22和手术/全身皮质类固醇减少的变化。结果纳入16项研究(共3040例患者),研究了6种生物制剂(dupilumab、omalizumab、mepolizumab、benralizumab、tezepelumab、reslizumab)。对于NPS的降低,dupilumab表现出最大的改善(- 2.44;95% CI:- 2.85,-2.03),其次是tezepelumab (- 2.07; 95% CI:-2.39,-1.74)。Mepolizumab表现出较好的鼻塞改善(- 2.64;95% CI:-3.24,-2.04)。对于生活质量,一项研究的初步结果显示tezepelumab具有最大的SNOT-22改善(- 27.26;95% CI:-32.32,-22.21),但需要在其他试验中验证。在这项单一研究中,tezepelumab最能减少手术/全身皮质类固醇的需求(HR:0.02; 95% CI: 0.00-0.09)。Omalizumab的不良事件发生率最低(49.6%)。网络荟萃分析确定omalizumab和tezepelumab是总体排名最高的(疗效/安全性组合)。结论我们的研究显示了CRSwNP在生物制剂中的显著有效性和安全性。治疗选择应考虑特定的症状焦点和合并症模式,网络荟萃分析显示omalizumab总体概况良好,tezepelumab显示出希望,但需要额外的验证。
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引用次数: 0
Modified uvulopalatopharyngoplasty: “8” suture abduction-suspension of the palatopharyngeal muscle 改良悬垂腭咽成形术:“8”号线外展-悬吊腭咽肌。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-03 DOI: 10.1016/j.amjoto.2025.104729
Yingxiang Xu , Shan Zhu , Jinlian Li , Siyu He , Riqing Yu , Haiyu Hong , Peng He

Objective

To evaluate the efficacy of a modified uvulopalatopharyngoplastyof “8” suture abduction-suspension of the palatopharyngeal muscle (8-ASP) in the treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS).

Material and methods

Twenty-eight consecutive patients with OSAHS with AHI > 15 with tonsillar hypertrophy, Friedman stage ≤3 and palatal collapse or obstruction were included, and all patients underwent modified uvulopalatopharyngoplasty that consisted of bilateral tonsillectomy, dissection and removal of submucosal adipose tissue of the soft palate and supratonsillar area; partial incision (0.4–0.6 cm) of the dorsal mucosa and muscle; and 8-ASP to the pterygomandibular ligament. Variables of polysomnography included the apnoea-hypo pnoea index (AHI), minimum oxygen saturation (MSAT), Stage N3 sleep, and Epworth sleepiness scale (ESS) score was also used to evaluate surgical results. Surgical success was defined as a greater than 50 % reduction in pre-operative AHI and a post-operative AHI of less than 20 per hour.

Results

Six months after operation, 24 patients (85.71 %) responded successfully. The mean apnoea-hypo pnoea index decreased from 51.72 ± 26.45 to 12.97 ± 8.49 (P < 0.001), and the mean MSAT, Stage N3 sleep and ESS score improved significantly (P < 0.001). The postoperative sequelae were mild with 3.57 % of occasional nasal regurgitation.

Conclusions

8-ASP is a novel, simplified and effective surgical treatment for OSAHS patients with a high success rate (85.71 %) and minimal adverse effect in selected patients, and this technique suggests a role of abduction-suspension of the palatopharyngeal muscle in the palatal surgery for OSAHS.
目的:评价改良腭咽成形术(8- asp)治疗阻塞性睡眠呼吸暂停低通气综合征(OSAHS)的疗效。材料和方法:纳入连续28例伴有扁桃体肥大、Friedman期≤3期、腭塌陷或梗阻的AHI bbb15型OSAHS患者,所有患者均行改良腭咽成形术,包括双侧扁桃体切除术、软腭和腭上区粘膜下脂肪组织的剥离和去除;背部黏膜和肌肉部分切口(0.4-0.6 cm);8-ASP连接到翼状下颌韧带。多导睡眠图的变量包括呼吸暂停-呼吸不足指数(AHI)、最低血氧饱和度(MSAT)、N3期睡眠,Epworth嗜睡量表(ESS)评分也用于评估手术效果。手术成功的定义是术前AHI降低50%以上,术后AHI每小时低于20。结果:术后6个月,24例(85.71%)有效率。结论:8-ASP是一种新颖、简便、有效的OSAHS手术治疗方法,成功率高(85.71%),在部分患者中不良反应最小,提示腭咽肌外旋-悬吊术在OSAHS腭部手术中的作用。
{"title":"Modified uvulopalatopharyngoplasty: “8” suture abduction-suspension of the palatopharyngeal muscle","authors":"Yingxiang Xu ,&nbsp;Shan Zhu ,&nbsp;Jinlian Li ,&nbsp;Siyu He ,&nbsp;Riqing Yu ,&nbsp;Haiyu Hong ,&nbsp;Peng He","doi":"10.1016/j.amjoto.2025.104729","DOIUrl":"10.1016/j.amjoto.2025.104729","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the efficacy of a modified uvulopalatopharyngoplastyof “8” suture abduction-suspension of the palatopharyngeal muscle (8-ASP) in the treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS).</div></div><div><h3>Material and methods</h3><div>Twenty-eight consecutive patients with OSAHS with AHI &gt; 15 with tonsillar hypertrophy, Friedman stage ≤3 and palatal collapse or obstruction were included, and all patients underwent modified uvulopalatopharyngoplasty that consisted of bilateral tonsillectomy, dissection and removal of submucosal adipose tissue of the soft palate and supratonsillar area; partial incision (0.4–0.6 cm) of the dorsal mucosa and muscle; and 8-ASP to the pterygomandibular ligament. Variables of polysomnography included the apnoea-hypo pnoea index (AHI), minimum oxygen saturation (MSAT), Stage N3 sleep, and Epworth sleepiness scale (ESS) score was also used to evaluate surgical results. Surgical success was defined as a greater than 50 % reduction in pre-operative AHI and a post-operative AHI of less than 20 per hour.</div></div><div><h3>Results</h3><div>Six months after operation, 24 patients (85.71 %) responded successfully. The mean apnoea-hypo pnoea index decreased from 51.72 ± 26.45 to 12.97 ± 8.49 (<em>P</em> &lt; 0.001), and the mean MSAT, Stage N3 sleep and ESS score improved significantly (P &lt; 0.001). The postoperative sequelae were mild with 3.57 % of occasional nasal regurgitation.</div></div><div><h3>Conclusions</h3><div>8-ASP is a novel, simplified and effective surgical treatment for OSAHS patients with a high success rate (85.71 %) and minimal adverse effect in selected patients, and this technique suggests a role of abduction-suspension of the palatopharyngeal muscle in the palatal surgery for OSAHS.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 6","pages":"Article 104729"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
National trends in the utilization of office-based transnasal esophagoscopy 全国办公室经鼻食管镜检查应用趋势
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-10-24 DOI: 10.1016/j.amjoto.2025.104746
Lauren Kwa , Ashley Bodnar , Maxwell Scher , Jacob Pieter Noordzij , Lauren Tracy

Objective

To analyze national trends in the prevalence of office-based transnasal esophagoscopy (TNE) procedures and compare with traditional operating room-based procedures utilizing transoral flexible and rigid esophagoscopy.

Methods

From 2013 to 2022, the US Medicare Part B claims database was searched for Current Procedural Terminology (CPT) codes 43,197/43198: diagnostic transnasal flexible esophagoscopy/with biopsy, 43200/43202: diagnostic transoral flexible esophagoscopy/with biopsy, 43191/43193: diagnostic rigid esophagoscopy/with biopsy. For each CPT code, the total number of charges billed to the Medicare database in each calendar year were recorded and analyzed using trendlines and linear regression.

Results

From 2013 to 2022, there was a significant decrease in the prevalence of transoral flexible esophagoscopy, both diagnostic (trendline slope = −1078, R2 = 0.83) and with biopsy (trendline slope = −192, R2 = 0.80). The prevalence of rigid esophagoscopy, both diagnostic and with biopsy, remained stable (trendline slope = −51, R2 = 0.14; trendline slope = −9.6, R2 = 0.26, respectively). Diagnostic TNE represented a small percentage of total diagnostic esophagoscopies performed (range: 9.37–14.94 %), and this percentage remained relatively constant over time (trendline slope = 0.0017, R2 = 0.08). TNE with biopsy was a small percentage of total esophageal biopsy procedures (range: 6.54–10.66 %), with a slight increase over time as a percentage of all esophageal biopsies performed (trendline slope = 0.0037, R2 = 0.48).

Conclusion

Benefits of office-based TNE procedures include the avoidance of general anesthesia, shorter procedure times, and cost savings. However, TNE remains a small percentage of all esophagoscopies performed, without significant trends toward increased utilization. Further investigation is needed to evaluate the lack of utilization of these office-based procedures.
目的分析全国办公室经鼻食管镜(TNE)手术的流行趋势,并与传统的手术室经口柔性和刚性食管镜手术进行比较。方法从2013年至2022年,检索美国医疗保险B部分索赔数据库,检索当前程序术语(CPT)代码43197 /43198:诊断性经鼻柔性食管镜/活检,43200/43202:诊断性经口柔性食管镜/活检,43191/43193:诊断性刚性食管镜/活检。对于每个CPT代码,每个日历年向医疗保险数据库收取的费用总数被记录下来,并使用趋势线和线性回归进行分析。结果从2013年到2022年,经口柔性食管镜诊断(趋势线斜率= - 1078,R2 = 0.83)和活检(趋势线斜率= - 192,R2 = 0.80)的患病率均显著下降。诊断性和活检性硬食管镜检查的患病率保持稳定(趋势线斜率= - 51,R2 = 0.14;趋势线斜率= - 9.6,R2 = 0.26)。诊断性TNE占全部诊断性食管镜检查的一小部分(范围:9.37 - 14.94%),这一比例随着时间的推移保持相对恒定(趋势线斜率= 0.0017,R2 = 0.08)。活检的TNE占食管活检总手术的百分比很小(范围:6.54 - 10.66%),随着时间的推移,TNE在所有食管活检中所占的百分比略有增加(趋势线斜率= 0.0037,R2 = 0.48)。结论办公室TNE手术的优点是避免了全身麻醉,缩短了手术时间,节省了费用。然而,TNE仍然占所有食管镜检查的一小部分,没有明显的增加使用的趋势。需要进一步调查以评价缺乏利用这些办公室程序的情况。
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引用次数: 0
Assessment of clinical efficacy and safety of sublingual immunotherapy for house dust mite-induced allergic pharyngitis with rhinitis 舌下免疫治疗屋尘螨致变应性咽炎合并鼻炎的临床疗效及安全性评价
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-11-01 Epub Date: 2025-05-27 DOI: 10.1016/j.amjoto.2025.104683
Quan Qiu , Qingqiao Fu , Dan Luo , Xia Lin, Jing Zheng, Jiabin Zhan, Rui Li, Wei Wei, Jinli Wu, Xin Wei

Background

Sublingual immunotherapy (SLIT) has been widely established as a disease-modifying treatment for allergic airway diseases. However, its efficacy and safety in allergic pharyngitis (AP) remain insufficiently investigated and require further clinical validation.

Methods

In this retrospective study, 100 patients diagnosed with house dust mite (HDM)-induced AP concomitant with allergic rhinitis (AR) were enrolled. All participants received standardized SLIT for three consecutive years. Clinical outcomes, including total pharyngolaryngeal symptom score (TPLSS), total nasal symptom score (TNSS), total medication score (TMS), visual analog scale (VAS) scores, and quality of life measures, were systematically assessed at baseline and subsequently at 3 months, 6 months, 1 year, 2 years, and 3 years post-treatment initiation. Safety was evaluated through adverse events (AEs).

Results

Compared to the baseline, patients with AP accompanied by AR exhibited significant improvements in both pharyngeal and nasal symptoms during the follow-up, with a reduction in symptomatic medication use and an improvement in quality of life. Subgroup comparisons revealed no significant difference in efficacy between mono- and poly-sensitized patients. Furthermore, a positive correlation was observed between nasal and pharyngeal symptoms (R2 = 0.44, P < 0.001). Major AEs occurred primarily within the first three months, and no serious AEs were reported.

Conclusion

Three years of HDM-SLIT may alleviate both pharyngeal and nasal symptoms in patients with AP and AR, thereby expanding the application of SLIT in the treatment of airway allergic diseases.
舌下免疫治疗(SLIT)已被广泛认为是过敏性气道疾病的一种疾病改善治疗方法。然而,其在过敏性咽炎(AP)中的有效性和安全性仍未得到充分的研究,需要进一步的临床验证。方法回顾性研究100例屋尘螨(HDM)诱发AP合并变应性鼻炎(AR)患者。所有参与者连续三年接受标准化的SLIT治疗。临床结果,包括总咽部症状评分(TPLSS)、总鼻症状评分(TNSS)、总用药评分(TMS)、视觉模拟量表(VAS)评分和生活质量测量,在基线和治疗开始后3个月、6个月、1年、2年和3年进行系统评估。通过不良事件(ae)评估安全性。结果与基线相比,AP合并AR患者在随访期间咽部和鼻部症状均有显著改善,有症状的药物使用减少,生活质量提高。亚组比较显示单致敏和多致敏患者的疗效无显著差异。此外,鼻部和咽部症状呈正相关(R2 = 0.44, P < 0.001)。主要不良反应主要发生在前三个月内,未见严重不良反应报告。结论HDM-SLIT治疗3年可同时缓解AP和AR患者的咽鼻症状,从而扩大了SLIT在气道变应性疾病治疗中的应用。
{"title":"Assessment of clinical efficacy and safety of sublingual immunotherapy for house dust mite-induced allergic pharyngitis with rhinitis","authors":"Quan Qiu ,&nbsp;Qingqiao Fu ,&nbsp;Dan Luo ,&nbsp;Xia Lin,&nbsp;Jing Zheng,&nbsp;Jiabin Zhan,&nbsp;Rui Li,&nbsp;Wei Wei,&nbsp;Jinli Wu,&nbsp;Xin Wei","doi":"10.1016/j.amjoto.2025.104683","DOIUrl":"10.1016/j.amjoto.2025.104683","url":null,"abstract":"<div><h3>Background</h3><div>Sublingual immunotherapy (SLIT) has been widely established as a disease-modifying treatment for allergic airway diseases. However, its efficacy and safety in allergic pharyngitis (AP) remain insufficiently investigated and require further clinical validation.</div></div><div><h3>Methods</h3><div>In this retrospective study, 100 patients diagnosed with house dust mite (HDM)-induced AP concomitant with allergic rhinitis (AR) were enrolled. All participants received standardized SLIT for three consecutive years. Clinical outcomes, including total pharyngolaryngeal symptom score (TPLSS), total nasal symptom score (TNSS), total medication score (TMS), visual analog scale (VAS) scores, and quality of life measures, were systematically assessed at baseline and subsequently at 3 months, 6 months, 1 year, 2 years, and 3 years post-treatment initiation. Safety was evaluated through adverse events (AEs).</div></div><div><h3>Results</h3><div>Compared to the baseline, patients with AP accompanied by AR exhibited significant improvements in both pharyngeal and nasal symptoms during the follow-up, with a reduction in symptomatic medication use and an improvement in quality of life. Subgroup comparisons revealed no significant difference in efficacy between mono- and poly-sensitized patients. Furthermore, a positive correlation was observed between nasal and pharyngeal symptoms (R<sup>2</sup> = 0.44, <em>P</em> &lt; 0.001). Major AEs occurred primarily within the first three months, and no serious AEs were reported.</div></div><div><h3>Conclusion</h3><div>Three years of HDM-SLIT may alleviate both pharyngeal and nasal symptoms in patients with AP and AR, thereby expanding the application of SLIT in the treatment of airway allergic diseases.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 6","pages":"Article 104683"},"PeriodicalIF":1.7,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144988275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
American Journal of Otolaryngology
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