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Fibrin glue enhances early hearing recovery in tympanoplasty: A randomised controlled trial 纤维蛋白胶增强鼓室成形术患者早期听力恢复:一项随机对照试验。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-25 DOI: 10.1016/j.amjoto.2026.104791
Benyamin Rahmaty , Sanam Asgari , Mohammad Sayyadi , Ali Kouhi , Saeed Golparavaran , Ali Aalizade , Mohammad Taghi Khorsandi Ashtiani , Kayvan Aghazadeh

Objective

To compare the efficacy of fibrin glue versus Gelfoam in cartilage tympanoplasty, focusing on graft uptake rates and short-term hearing outcomes.

Methods

In this double-blind, randomised clinical trial, forty-six patients with dry tympanic membrane perforations were randomly allocated to two groups: fibrin glue with cartilage graft (Group A) and Gelfoam with cartilage graft (Group B). A single surgeon carried out all surgeries. Graft integrity and air–bone gap (ABG) closure (≤15 dB) were evaluated three months post-surgery.

Results

Graft uptake rates were 91.3% in the fibrin group and 82.6% in the Gelfoam group (p > 0.05). However, ABG closure ≤15 dB was achieved in 87% of the fibrin group compared to 60.9% of the Gelfoam group (p = 0.044), indicating a significant improvement in early hearing outcomes.

Conclusion

Fibrin glue tympanoplasty achieved comparable graft uptake rates to conventional Gelfoam tympanoplasty, while providing superior short-term hearing improvement. Both techniques demonstrated comparable graft integration, while fibrin glue was associated with superior early hearing recovery.
目的:比较纤维蛋白胶与明胶泡沫在软骨鼓室成形术中的疗效,重点观察移植物的吸收率和短期听力结果。方法:将46例干性鼓膜穿孔患者随机分为纤维蛋白胶软骨移植组(A组)和明胶泡沫软骨移植组(B组)。一个外科医生完成了所有的手术。术后3个月评估移植物完整性和气骨间隙(ABG)闭合(≤15 dB)。结果:纤维蛋白组移植物摄取率为91.3%,明胶泡沫组为82.6% (p < 0.05)。然而,87%的纤维蛋白组达到ABG闭合≤15 dB,而凝胶泡沫组为60.9% (p = 0.044),表明早期听力结果显着改善。结论:纤维蛋白胶鼓膜成形术与常规明胶鼓膜成形术相比,获得了相当的移植物吸收率,同时提供了较好的短期听力改善。两种技术均表现出相当的移植物融合,而纤维蛋白胶与较好的早期听力恢复相关。
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引用次数: 0
Comprehensive big database analysis of outcomes and complications of combination endoscopic sinus surgery and septorhinoplasty 内窥镜鼻窦手术联合鼻中隔成形术疗效及并发症的综合大数据库分析。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-22 DOI: 10.1016/j.amjoto.2026.104795
Robert E. Africa , Scott A. Hardison , Felix Maldonado-Chapa , Brian J. McKinnon

Objective

To evaluate postoperative outcomes and complications of combination functional endoscopic sinus surgery (FESS) and septorhinoplasty (SRP).

Methods

This is a multicenter retrospective database study utilizing data from 106 healthcare organizations in the United States from January 1, 2010 to July 31, 2025. The TriNetX database was used to obtain summary statistics on adult patients aged 18 years or older who underwent combination FESS/SRP, FESS alone, or SRP alone. Postoperative outcomes and complications evaluated in comparing combined FESS/SRP with either procedure alone included epistaxis, mucocele formation, postoperative pain, orbital injury, abscess or infection, revision rhinoplasty, and septal perforation needing repair among others.

Results

Compared with FESS alone, combination FESS/SRP showed higher rates of acute postoperative pain and nasal mucocele (RR: 1.25 [1.02–1.52]; 1.33 [1.15–1.53]) but no increased risk of recurrent acute sinusitis or chronic sinusitis (RR: 0.97 [0.89–1.06]; 0.99 [0.97–1.03]). Combination FESS/SRP did not have a higher rate of cerebrospinal fluid (CSF) leak (RR: 0.24 [0.13–0.44), meningitis (0.44 [0.21–0.91]), and orbital injury (0.84 [0.74–0.95]) compared to FESS alone. Compared with SRP alone, combination surgery was associated with more persistent septal deviation (RR: 1.18 [1.10–1.26]) and higher rates of epistaxis and control of epistaxis procedures (RR: 1.85 [1.49–2.29]; 2.00 [1.28–3.12]). Septal perforation repair was not significantly increased with combination surgery (RR: 1.11 [0.60–2.05]), though nasal infection or abscess was more frequent (RR: 1.17 [1.13–1.21]).

Conclusion

Combination surgery did not show significant major complications, though rates of epistaxis, nasal congestion, and infection were higher. Differences in complications and outcomes may reflect patient selection, potentially explaining the lower risk of major complications in the combined surgery group. The data from this study does not support combined surgery for complicated sinus disease, as anatomic complexity could not be distinguished.
目的:评价功能性内窥镜鼻窦手术(FESS)联合鼻中隔成形术(SRP)的术后疗效和并发症。方法:这是一项多中心回顾性数据库研究,利用了2010年1月1日至2025年7月31日美国106家医疗机构的数据。TriNetX数据库用于获得18岁或以上接受FESS/SRP联合、FESS单独或SRP单独治疗的成年患者的汇总统计数据。比较FESS/SRP联合手术与单独手术的术后结果和并发症包括鼻出血、粘液囊肿形成、术后疼痛、眼眶损伤、脓肿或感染、鼻整形和鼻中隔穿孔需要修复等。结果:与单用FESS相比,FESS/SRP联合治疗术后急性疼痛和鼻黏液囊肿的发生率更高(RR: 1.25[1.02-1.52]; 1.33[1.15-1.53]),但急性鼻窦炎和慢性鼻窦炎复发的风险未增加(RR: 0.97[0.89-1.06]; 0.99[0.97-1.03])。联合FESS/SRP与单独FESS相比,脑脊液漏(RR: 0.24[0.13-0.44])、脑膜炎(RR: 0.44[0.21-0.91])和眼眶损伤(RR: 0.84[0.74-0.95])发生率不高。与单纯SRP相比,联合手术与更持久的鼻中隔偏曲(RR: 1.18[1.10-1.26])、更高的鼻衄发生率和鼻衄手术控制(RR: 1.85[1.49-2.29]; 2.00[1.28-3.12])相关。联合手术的鼻中隔穿孔修补率未显著增加(RR: 1.11[0.60-2.05]),但鼻部感染或脓肿发生率更高(RR: 1.17[1.13-1.21])。结论:联合手术虽有较高的出血、鼻塞和感染发生率,但未出现明显的主要并发症。并发症和结果的差异可能反映了患者的选择,这可能解释了联合手术组主要并发症风险较低的原因。本研究的数据不支持联合手术治疗复杂的鼻窦疾病,因为解剖复杂性无法区分。
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引用次数: 0
Can microbial profiles influence type II inflammation in chronic rhinosinusitis with nasal polyps? 微生物谱能影响慢性鼻窦炎伴鼻息肉的II型炎症吗?
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-19 DOI: 10.1016/j.amjoto.2026.104786
Gaia Vertillo Aluisio, Maria Santagati, Giovanna Stilo, Mario Lentini, Leigh J Sowerby, Miguel Mayo-Yáñez, Ahmad R Sedaghat, Jerome R Lechien, Stefania Stefani, Igo La Mantia, Antonino Maniaci

Objective: This study aimed to assess how different treatments - dupilumab vs surgery - influence the nasal microbiota, type 2 inflammation, and clinical outcomes in CRSwNP patients.

Methods: This was a prospective observational study of 44 CRSwNP patients assigned to 6 months of biweekly dupilumab injections or functional endoscopic sinus surgery (FESS). Nasal microbiotas were analyzed at baseline and 6 months using culture techniques. Inflammatory biomarkers (IgE, eosinophils) and clinical endpoints (polyp score, SNOT-22, smell test) were measured. Patients were also stratified into groups based on which bacteria were cultured from their sinuses.

Results: At baseline, the most prevalent bacteria were Staphylococcus aureus (43%), Stapylococcus epidermidis (36%), and Pseudomonas aeruginosa (16%). After 6 months, S. aureus and S. epidermidis significantly increased while P. aeruginosa decreased. Eosinophil counts were stable. IgE levels notably decreased in the S. aureus and S. epidermidis groups but increased with P. aeruginosa. All bacterial groups showed reduced polyp score and SNOT-22, and improved smell, but P. aeruginosa had smaller gains. Higher baseline S. aureus and S. epidermidis correlated with more significant IgE decrease.

Conclusions: Dupilumab and surgery-induced favourable microbiota changes by reducing pathogenic bacteria. Nasal microbiota composition may be associated inflammatory and clinical treatment responses in CRSwNP. S. aureus and S. epidermidis correlated with a greater improvement of IgE levels, whereas P. aeruginosa correlated with worse IgE outcomes. Analyzing each patient's nasal microbiome could enable more personalized, microbiome-directed treatment approaches for optimal CRSwNP management.

目的:本研究旨在评估不同治疗方法(dupilumab与手术)如何影响CRSwNP患者的鼻腔微生物群、2型炎症和临床结局。方法:这是一项前瞻性观察研究,44名CRSwNP患者被分配到6个月的双周杜匹单抗注射或功能性内窥镜鼻窦手术(FESS)。在基线和6个月时使用培养技术分析鼻腔微生物群。测量炎症生物标志物(IgE、嗜酸性粒细胞)和临床终点(息肉评分、SNOT-22、嗅觉测试)。根据从患者鼻窦中培养的细菌,将患者分层。结果:基线时,最常见的细菌是金黄色葡萄球菌(43%)、表皮葡萄球菌(36%)和铜绿假单胞菌(16%)。6个月后,金黄色葡萄球菌和表皮葡萄球菌数量显著增加,铜绿假单胞菌数量减少。嗜酸性粒细胞计数稳定。金黄色葡萄球菌组和表皮葡萄球菌组的IgE水平显著降低,铜绿假单胞菌组的IgE水平显著升高。所有细菌组的息肉评分和SNOT-22都有所降低,嗅觉也有所改善,但铜绿假单胞菌的改善幅度较小。金黄色葡萄球菌和表皮葡萄球菌的基线值越高,IgE下降越明显。结论:Dupilumab和手术通过减少致病菌诱导有利的微生物群变化。鼻微生物群组成可能与CRSwNP的炎症和临床治疗反应有关。金黄色葡萄球菌和表皮葡萄球菌与IgE水平的显著改善相关,而铜绿假单胞菌与更差的IgE结果相关。分析每位患者的鼻腔微生物组可以实现更个性化的、以微生物组为导向的治疗方法,以实现最佳的CRSwNP管理。
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引用次数: 0
Role of migraine in recurrent benign paroxysmal positional vertigo 偏头痛在复发性良性阵发性位置性眩晕中的作用。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-19 DOI: 10.1016/j.amjoto.2026.104794
Pelin Koçdor , Emel Işık , Oğuzhan Çetin , Rüya Somer , Suat Avcı , Merve Kaşıkcı , Levent Naci Özlüoğlu

Objective

Benign paroxysmal positional vertigo (BPPV) frequently recurs, affecting quality of life. Although migraine and environmental factors such as atmospheric pressure and temperature have been proposed as predictors, their precise influence remains unclear. We aimed to evaluate whether migraine, thyroid disease, and environmental factors (atmospheric pressure and temperature) predict recurrence of BPPV.

Methods

We retrospectively analyzed data from 374 patients diagnosed with BPPV between 2018 and 2024 at a university otolaryngology clinic. Clinical history, migraine and thyroid status, and meteorological data were evaluated. Multivariate logistic regression assessed independent predictors of recurrence.

Results

Recurrence occurred in 20.1% of patients. Migraine was significantly associated with increased recurrence risk (OR 2.07; 95% CI: 1.01–4.22; p = 0.046), independent of age and sex, independent of thyroid disease, and environmental conditions. No significant associations were found between recurrence and atmospheric pressure (p = 0.586), temperature (p = 0.224), or thyroid disease (p = 0.089).

Conclusion

Migraine significantly predicts BPPV recurrence, independent of environmental factors. These findings strongly support routine migraine screening in clinical practice for patients with BPPV, to facilitate early identification and tailored management strategies aimed at reducing recurrence.
目的:探讨良性阵发性体位性眩晕(BPPV)多发,影响生活质量的原因。虽然偏头痛和环境因素如大气压力和温度被认为是预测因素,但它们的确切影响尚不清楚。我们的目的是评估偏头痛、甲状腺疾病和环境因素(气压和温度)是否能预测BPPV的复发。方法:回顾性分析某大学耳鼻喉科门诊2018年至2024年间诊断为BPPV的374例患者的数据。评估临床病史、偏头痛和甲状腺状况以及气象资料。多因素logistic回归评估复发的独立预测因素。结果:复发率为20.1%。偏头痛与复发风险增加显著相关(OR 2.07; 95% CI: 1.01-4.22; p = 0.046),与年龄、性别、甲状腺疾病和环境条件无关。复发率与气压(p = 0.586)、温度(p = 0.224)或甲状腺疾病(p = 0.089)无显著相关性。结论:偏头痛可显著预测BPPV复发,不受环境因素影响。这些发现有力地支持在临床实践中对BPPV患者进行常规偏头痛筛查,以促进早期识别和定制旨在减少复发的管理策略。
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引用次数: 0
The impact of vitamin D supplementation on sudden sensorineural hearing loss in vitamin D deficient patients: A double-blind, placebo-controlled trial: A pilot study 补充维生素D对维生素D缺乏患者突发性感音神经性听力损失的影响:一项双盲、安慰剂对照试验:一项初步研究。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-13 DOI: 10.1016/j.amjoto.2026.104793
Bahareh Tavakoli, Sohrab Rabiei

Background

Given the high prevalence of vitamin D deficiency among sudden sensorineural hearing loss (SSNHL) patients, this study endeavours to evaluate the impact of incorporating vitamin D supplementation into the standard treatment for individuals confirmed to be vitamin D deficient.

Method

In this randomized, placebo-controlled study, patients with SSNHL occurring within 45 days prior to the study and serum vitamin D levels less than 50 nmol/L or 20 ng/mL were divided into two groups. The control group received routine corticosteroid treatment plus placebo, whereas the intervention group received routine corticosteroid treatment plus Pearl, 50000 IU vitamin D3. Patients were assessed for pure-tone average (PTA) frequencies of 500, 1000, 2000, 4000, and 6000 Hz, speech reception threshold (SRT), and speech discrimination score (SDS) at baseline, 10th, and 30-day follow-up.

Results

Baseline demographic, biochemical, and audiological characteristics showed no significant differences between groups. PTA, SRT, and SDS were assessed at baseline, 10 days, and 30 days post-treatment. Both groups exhibited significant hearing improvement at one month; however, vitamin D supplementation led to significantly greater improvements at 2000 Hz and 4000 Hz frequencies (P = 0.004 and P = 0.001, respectively), which are critical for speech perception. No significant benefits were observed at lower frequencies (500 Hz and 1000 Hz) or at 6000 Hz, where the control group showed greater improvement. Vitamin D levels significantly increased in the intervention group without affecting serum phosphorus or calcium concentrations.

Conclusion

Vitamin D supplementation may enhance auditory recovery at key speech-related frequencies in SSNHL patients with vitamin D deficiency.
背景:鉴于突发性感音神经性听力损失(SSNHL)患者中维生素D缺乏症的高发率,本研究试图评估将维生素D补充纳入确诊维生素D缺乏症个体的标准治疗的影响。方法:在这项随机、安慰剂对照的研究中,研究前45天内发生的SSNHL患者,血清维生素D水平低于50 nmol/L或20 ng/mL,分为两组。对照组给予常规皮质类固醇治疗加安慰剂,干预组给予常规皮质类固醇治疗加Pearl, 50000 IU维生素D3。在基线、第10天和30天随访时,对患者进行500、1000、2000、4000和6000 Hz的纯音平均频率(PTA)、语音接收阈值(SRT)和语音辨别评分(SDS)的评估。结果:基线人口学、生化和听力学特征在两组间无显著差异。在治疗后基线、10天和30天分别评估PTA、SRT和SDS。两组在1个月时均表现出显著的听力改善;然而,在2000 Hz和4000 Hz频率(P = 0.004和P = 0.001)下,补充维生素D显著提高了语音感知能力(P = 0.004和P = 0.001)。在较低的频率(500hz和1000hz)或6000hz时没有观察到明显的益处,对照组在其中表现出更大的改善。干预组维生素D水平显著升高,但不影响血清磷或钙浓度。结论:补充维生素D可促进SSNHL缺乏维生素D患者关键语音相关频率的听觉恢复。
{"title":"The impact of vitamin D supplementation on sudden sensorineural hearing loss in vitamin D deficient patients: A double-blind, placebo-controlled trial: A pilot study","authors":"Bahareh Tavakoli,&nbsp;Sohrab Rabiei","doi":"10.1016/j.amjoto.2026.104793","DOIUrl":"10.1016/j.amjoto.2026.104793","url":null,"abstract":"<div><h3>Background</h3><div>Given the high prevalence of vitamin D deficiency among sudden sensorineural hearing loss (SSNHL) patients, this study endeavours to evaluate the impact of incorporating vitamin D supplementation into the standard treatment for individuals confirmed to be vitamin D deficient.</div></div><div><h3>Method</h3><div>In this randomized, placebo-controlled study, patients with SSNHL occurring within 45 days prior to the study and serum vitamin D levels less than 50 nmol/L or 20 ng/mL were divided into two groups. The control group received routine corticosteroid treatment plus placebo, whereas the intervention group received routine corticosteroid treatment plus Pearl, 50000 IU vitamin D3. Patients were assessed for pure-tone average (PTA) frequencies of 500, 1000, 2000, 4000, and 6000 Hz, speech reception threshold (SRT), and speech discrimination score (SDS) at baseline, 10th, and 30-day follow-up.</div></div><div><h3>Results</h3><div>Baseline demographic, biochemical, and audiological characteristics showed no significant differences between groups. PTA, SRT, and SDS were assessed at baseline, 10 days, and 30 days post-treatment. Both groups exhibited significant hearing improvement at one month; however, vitamin D supplementation led to significantly greater improvements at 2000 Hz and 4000 Hz frequencies (<em>P</em> = 0.004 and <em>P</em> = 0.001, respectively), which are critical for speech perception. No significant benefits were observed at lower frequencies (500 Hz and 1000 Hz) or at 6000 Hz, where the control group showed greater improvement. Vitamin D levels significantly increased in the intervention group without affecting serum phosphorus or calcium concentrations.</div></div><div><h3>Conclusion</h3><div>Vitamin D supplementation may enhance auditory recovery at key speech-related frequencies in SSNHL patients with vitamin D deficiency.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 2","pages":"Article 104793"},"PeriodicalIF":1.7,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028069","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
A clinical shift toward personalized cochlear implantation: Using preoperative planning to optimize insertion depth 临床向个性化人工耳蜗植入的转变:利用术前计划优化植入深度。
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.amjoto.2025.104777
Benjamin Bircher , Philipp Aebischer , Wilhelm Wimmer , Georgios Mantokoudis , Stephan Schraivogel , Marco Caversaccio , Stefan Weder

Objective:

To evaluate the clinical implementation of preoperative, anatomy-tailored planning for electrode selection in cochlear implantation, quantify planning accuracy under routine conditions, and identify factors associated with deviations from the planned angular insertion depth (AID).

Methods:

We retrospectively analyzed 71 consecutive implantations; 17 cases were excluded due to unsuccessful segmentation/fusion, yielding 54 implanted ears. Before 2023 (Group A, n=32), electrode choice followed surgeon preference independent of cochlear duct length (CDL). From 2023 (Group B, n=22), automated OTOPLAN-based planning targeted an AID of 600° (cap 650°). Pre- and postoperative computed tomography scans provided cochlear metrics and postoperative AID. Planning accuracy was defined as the difference between planned and achieved AID. Linear models assessed demographic/clinical, anatomical, and surgical predictors. Speech outcomes at 6 months used Freiburger monosyllables at 65 dB HL.

Results:

Group B showed deeper and more consistent insertions (median AID 568° [IQR 62°]) than Group A (527° [IQR 99°]; p<0.01). Median planning deviation was 9 (IQR 78°) with no relationship to planned depth ( R2=0.008, p=0.514). Greater inaccuracies were found in patients with shorter CDL (p=0.001) and in cases with observed intraoperative resistance (p<0.001).

Conclusion:

cochlear anatomy exhibited substantial inter-individual variability. Implementing preoperative, anatomy-tailored planning was associated with the selection of longer arrays, deeper and more consistent AID, and overall high planning accuracy. Deviations from the planned position were primarily linked to shorter CDL and intraoperative resistance, whereas deeper targets themselves did not reduce accuracy. Audiological performance at 6 months did not differ significantly between groups, although a modest trend favored the planned cohort. These findings support the feasibility of routine, examiner-independent planning and suggest that patient-specific anatomical markers should inform the selection of an appropriate electrode array.
目的:评价人工耳蜗植入术中术前解剖定制电极选择计划的临床实施情况,量化常规条件下电极选择计划的准确性,并确定与计划角植入深度(AID)偏差相关的因素。方法:回顾性分析71例连续种植体;17例因分割/融合不成功而被排除,植入耳54例。2023年以前(A组,n=32),电极选择遵循外科医生的喜好,与耳蜗管长度无关。从2023年开始(B组,n=22),基于otoplan的自动化规划目标为600°(上限650°)。术前和术后计算机断层扫描提供了耳蜗指标和术后AID。规划精度定义为计划与实现AID之间的差值。线性模型评估了人口统计学/临床、解剖学和外科预测因素。6个月的语音结果使用65 dB HL的Freiburger单音节。结果:B组的插入角比A组(527°[IQR 99°])更深、更一致(中位倾角568°[IQR 62°]);p°(IQR 78°)与计划深度无关(R2=0.008, p=0.514)。在CDL较短的患者(p=0.001)和术中观察到阻力的患者中发现了更大的不准确性(结论:耳蜗解剖表现出很大的个体差异。实施术前解剖定制规划,可选择更长的排列,更深更一致的AID,总体规划精度高。偏离计划位置主要与较短的CDL和术中阻力有关,而更深的靶标本身并不会降低准确性。6个月的听力学表现在两组之间没有显著差异,尽管有适度的趋势有利于计划队列。这些发现支持常规的、独立于检查人员的计划的可行性,并建议患者特异性解剖标记应告知选择合适的电极阵列。
{"title":"A clinical shift toward personalized cochlear implantation: Using preoperative planning to optimize insertion depth","authors":"Benjamin Bircher ,&nbsp;Philipp Aebischer ,&nbsp;Wilhelm Wimmer ,&nbsp;Georgios Mantokoudis ,&nbsp;Stephan Schraivogel ,&nbsp;Marco Caversaccio ,&nbsp;Stefan Weder","doi":"10.1016/j.amjoto.2025.104777","DOIUrl":"10.1016/j.amjoto.2025.104777","url":null,"abstract":"<div><h3>Objective:</h3><div>To evaluate the clinical implementation of preoperative, anatomy-tailored planning for electrode selection in cochlear implantation, quantify planning accuracy under routine conditions, and identify factors associated with deviations from the planned angular insertion depth (AID).</div></div><div><h3>Methods:</h3><div>We retrospectively analyzed 71 consecutive implantations; 17 cases were excluded due to unsuccessful segmentation/fusion, yielding 54 implanted ears. Before 2023 (Group A, <span><math><mrow><mi>n</mi><mo>=</mo><mn>32</mn></mrow></math></span>), electrode choice followed surgeon preference independent of cochlear duct length (CDL). From 2023 (Group B, <span><math><mrow><mi>n</mi><mo>=</mo><mn>22</mn></mrow></math></span>), automated OTOPLAN-based planning targeted an AID of 600° (cap 650°). Pre- and postoperative computed tomography scans provided cochlear metrics and postoperative AID. Planning accuracy was defined as the difference between planned and achieved AID. Linear models assessed demographic/clinical, anatomical, and surgical predictors. Speech outcomes at 6 months used Freiburger monosyllables at 65 dB HL.</div></div><div><h3>Results:</h3><div>Group B showed deeper and more consistent insertions (median AID 568° [IQR 62°]) than Group A (527° [IQR 99°]; <span><math><mrow><mi>p</mi><mo>&lt;</mo><mn>0</mn><mo>.</mo><mn>01</mn></mrow></math></span>). Median planning deviation was <span><math><mrow><mo>−</mo><msup><mrow><mn>9</mn></mrow><mrow><mo>∘</mo></mrow></msup></mrow></math></span> (IQR 78°) with no relationship to planned depth ( <span><math><mrow><msup><mrow><mi>R</mi></mrow><mrow><mn>2</mn></mrow></msup><mo>=</mo><mn>0</mn><mo>.</mo><mn>008</mn></mrow></math></span>, <span><math><mrow><mi>p</mi><mo>=</mo><mn>0</mn><mo>.</mo><mn>514</mn></mrow></math></span>). Greater inaccuracies were found in patients with shorter CDL (<span><math><mrow><mi>p</mi><mo>=</mo><mn>0</mn><mo>.</mo><mn>001</mn></mrow></math></span>) and in cases with observed intraoperative resistance (<span><math><mrow><mi>p</mi><mo>&lt;</mo><mn>0</mn><mo>.</mo><mn>001</mn></mrow></math></span>).</div></div><div><h3>Conclusion:</h3><div>cochlear anatomy exhibited substantial inter-individual variability. Implementing preoperative, anatomy-tailored planning was associated with the selection of longer arrays, deeper and more consistent AID, and overall high planning accuracy. Deviations from the planned position were primarily linked to shorter CDL and intraoperative resistance, whereas deeper targets themselves did not reduce accuracy. Audiological performance at 6 months did not differ significantly between groups, although a modest trend favored the planned cohort. These findings support the feasibility of routine, examiner-independent planning and suggest that patient-specific anatomical markers should inform the selection of an appropriate electrode array.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 1","pages":"Article 104777"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145910005","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
Treatment preferences and values in chronic tinnitus patients: A cross-sectional survey study 慢性耳鸣患者的治疗偏好和价值:一项横断面调查研究
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.amjoto.2026.104790
Jeon Mi Lee , Hyun Jung Kim , Yong-Hwi An , Ah. Rang Cho , Jae Ho Chung , Jae Sang Han , Woojae Han , Da Jung Jung , Jung-Yup Lee , Euyhyun Park , Kyu-Yup Lee , Ho Yun Lee

Purpose

Tinnitus is a common condition that can severely impact patients' quality of life. However, little is known about how individuals with chronic tinnitus evaluate and prioritize available treatment options. This study aimed to explore the preferences, values and expectations of patients with chronic tinnitus to inform more patient-centered strategies in clinical care.

Material and methods

A cross-sectional survey was conducted from May 8 to June 19, 2025, involving 45 patients with chronic tinnitus. A structured 36-item questionnaire assessed demographic information, tinnitus severity using the Tinnitus Handicap Inventory (THI) and the Visual Analog Scale (VAS), treatment preferences across 16 key questions, perceived information needs, and impact on daily functioning.

Results

Participants (mean age 50.7 ± 14.8 years, 62.2% male, median tinnitus duration 12 months) showed strong preferences for non-invasive treatments: sound therapy (73.4%), tinnitus retraining therapy (TRT; 55.6%), and cognitive behavioral therapy (CBT; 44.4%). Pharmaceutical interventions had lower acceptance, with hearing aids showing highest rejection (33.3%). Key concerns included drug dependency (48.9%) and psychiatric medication stigma (28.9%). 51.1% of respondents expected complete symptom resolution despite limited evidence. Information needs were high across all modalities (40–50%). Sleep disorders (THI difference: 12.9 points) and anxiety (6.5 points) significantly associated with increased tinnitus severity.

Conclusions

Tinnitus patients strongly prefer non-invasive treatments while harboring unrealistic expectations for cure. These findings underscore the importance of structured education and shared decision-making to align clinical care with patient values and promote more effective tinnitus management.
目的耳鸣是一种严重影响患者生活质量的常见疾病。然而,人们对慢性耳鸣患者如何评估和优先考虑可用的治疗方案知之甚少。本研究旨在探讨慢性耳鸣患者的偏好、价值观和期望,为临床护理提供更多以患者为中心的策略。材料与方法于2025年5月8日至6月19日对45例慢性耳鸣患者进行横断面调查。一份结构化的36项问卷评估了人口统计信息、使用耳鸣障碍量表(THI)和视觉模拟量表(VAS)的耳鸣严重程度、16个关键问题的治疗偏好、感知信息需求以及对日常功能的影响。结果参与者(平均年龄50.7±14.8岁,男性62.2%,中位耳鸣持续时间12个月)对非侵入性治疗有强烈的偏好:声音治疗(73.4%)、耳鸣再训练治疗(TRT; 55.6%)和认知行为治疗(CBT; 44.4%)。药物干预的接受度较低,助听器的拒绝率最高(33.3%)。主要问题包括药物依赖(48.9%)和精神药物耻辱(28.9%)。尽管证据有限,51.1%的受访者期望症状完全缓解。所有模式的信息需求都很高(40-50%)。睡眠障碍(THI差:12.9分)和焦虑(6.5分)与耳鸣严重程度的增加显著相关。结论耳鸣患者对非侵入性治疗有强烈的偏好,对治愈抱有不切实际的期望。这些发现强调了结构化教育和共同决策的重要性,以使临床护理与患者的价值观保持一致,并促进更有效的耳鸣管理。
{"title":"Treatment preferences and values in chronic tinnitus patients: A cross-sectional survey study","authors":"Jeon Mi Lee ,&nbsp;Hyun Jung Kim ,&nbsp;Yong-Hwi An ,&nbsp;Ah. Rang Cho ,&nbsp;Jae Ho Chung ,&nbsp;Jae Sang Han ,&nbsp;Woojae Han ,&nbsp;Da Jung Jung ,&nbsp;Jung-Yup Lee ,&nbsp;Euyhyun Park ,&nbsp;Kyu-Yup Lee ,&nbsp;Ho Yun Lee","doi":"10.1016/j.amjoto.2026.104790","DOIUrl":"10.1016/j.amjoto.2026.104790","url":null,"abstract":"<div><h3>Purpose</h3><div>Tinnitus is a common condition that can severely impact patients' quality of life. However, little is known about how individuals with chronic tinnitus evaluate and prioritize available treatment options. This study aimed to explore the preferences, values and expectations of patients with chronic tinnitus to inform more patient-centered strategies in clinical care.</div></div><div><h3>Material and methods</h3><div>A cross-sectional survey was conducted from May 8 to June 19, 2025, involving 45 patients with chronic tinnitus. A structured 36-item questionnaire assessed demographic information, tinnitus severity using the Tinnitus Handicap Inventory (THI) and the Visual Analog Scale (VAS), treatment preferences across 16 key questions, perceived information needs, and impact on daily functioning.</div></div><div><h3>Results</h3><div>Participants (mean age 50.7 ± 14.8 years, 62.2% male, median tinnitus duration 12 months) showed strong preferences for non-invasive treatments: sound therapy (73.4%), tinnitus retraining therapy (TRT; 55.6%), and cognitive behavioral therapy (CBT; 44.4%). Pharmaceutical interventions had lower acceptance, with hearing aids showing highest rejection (33.3%). Key concerns included drug dependency (48.9%) and psychiatric medication stigma (28.9%). 51.1% of respondents expected complete symptom resolution despite limited evidence. Information needs were high across all modalities (40–50%). Sleep disorders (THI difference: 12.9 points) and anxiety (6.5 points) significantly associated with increased tinnitus severity.</div></div><div><h3>Conclusions</h3><div>Tinnitus patients strongly prefer non-invasive treatments while harboring unrealistic expectations for cure. These findings underscore the importance of structured education and shared decision-making to align clinical care with patient values and promote more effective tinnitus management.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 1","pages":"Article 104790"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145973015","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
Efficacy of acupuncture combined with various traditional Chinese medicine therapies for peripheral facial paralysis: A systematic review and network meta-analysis 针刺联合各种中医疗法治疗周围性面瘫的疗效:系统评价和网络荟萃分析
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.amjoto.2026.104787
Mengzhong Li , Wenjie Liang , Wei Liang , Jianguo Zhang , Xiaoping Lei

Background and purpose

This meta-analysis aimed to evaluate whether acupuncture combined with other traditional Chinese medicine (TCM) therapies is more effective in the treatment of peripheral facial palsy (PFP) than acupuncture alone.

Methods

Eight databases were searched until May 2025. Two independent reviewers extracted relevant data on study characteristics and used the Cochrane Risk of Bias Assessment Tool 2 (RoB2) to assess the risk of bias of the included studies.

Results

266 articles were included. Results showed that compared with acupuncture alone, acupuncture combined with tuina and cupping (surface under the cumulative ranking curve (SUCRA) = 99.33%) was the most effective intervention for improving the overall effective rate; acupuncture combined with topical application of TCM (SUCRA = 90.61%) was the optimal approach for enhancing facial nerve function (House-Brackmann (HB) scale); acupuncture combined with herbal fumigation and steaming therapy (SUCRA = 80.40%) was the best intervention for improving social function (Facial Disability Index - Social Function (FDIS)) in patients with facial paralysis; acupuncture combined with pricking blood (SUCRA = 87.62%) was the most effective method for improving physical function (Facial Disability Index - Physical Function (FDIP)) in patients with facial paralysis; and acupuncture combined with cupping and pricking blood (SUCRA = 86.90%) was associated with the lowest incidence of adverse reactions.

Conclusion

This study showed that interventions such as acupuncture+tuina+cupping, acupuncture+topical application of TCM, acupuncture+herbal fumigation and steaming therapy, and acupuncture+pricking blood are all associated with facial nerve recovery and demonstrate superior efficacy compared with acupuncture alone.
背景与目的本荟萃分析旨在评价针灸联合其他中医疗法治疗周围性面瘫(PFP)是否比单独针灸更有效。方法检索至2025年5月。两名独立审稿人提取了研究特征的相关数据,并使用Cochrane偏倚风险评估工具2 (RoB2)评估纳入研究的偏倚风险。结果共纳入266篇文献。结果表明,与单独针灸治疗相比,针灸联合推拿、拔罐(累计排序曲线下曲面(SUCRA) = 99.33%)对提高总有效率最为有效;针刺结合中药外敷是增强面神经功能的最佳方法(supra = 90.61%) (House-Brackmann (HB)量表);针刺配合中药熏蒸治疗(SUCRA = 80.40%)是改善面瘫患者社会功能(面部残疾指数-社会功能(FDIS))的最佳干预措施;针刺联合刺血治疗对改善面瘫患者身体功能(面部残疾指数-身体功能(FDIP))最有效(SUCRA = 87.62%);针刺联合拔罐刺血(SUCRA = 86.90%)不良反应发生率最低。结论本研究表明,针刺+推拿+拔罐、针刺+中药外敷、针刺+中药熏蒸疗法、针刺+刺血等干预措施均与面神经恢复相关,且效果优于单纯针刺。
{"title":"Efficacy of acupuncture combined with various traditional Chinese medicine therapies for peripheral facial paralysis: A systematic review and network meta-analysis","authors":"Mengzhong Li ,&nbsp;Wenjie Liang ,&nbsp;Wei Liang ,&nbsp;Jianguo Zhang ,&nbsp;Xiaoping Lei","doi":"10.1016/j.amjoto.2026.104787","DOIUrl":"10.1016/j.amjoto.2026.104787","url":null,"abstract":"<div><h3>Background and purpose</h3><div>This meta-analysis aimed to evaluate whether acupuncture combined with other traditional Chinese medicine (TCM) therapies is more effective in the treatment of peripheral facial palsy (PFP) than acupuncture alone.</div></div><div><h3>Methods</h3><div>Eight databases were searched until May 2025. Two independent reviewers extracted relevant data on study characteristics and used the Cochrane Risk of Bias Assessment Tool 2 (RoB2) to assess the risk of bias of the included studies.</div></div><div><h3>Results</h3><div>266 articles were included. Results showed that compared with acupuncture alone, acupuncture combined with tuina and cupping (surface under the cumulative ranking curve (SUCRA) = 99.33%) was the most effective intervention for improving the overall effective rate; acupuncture combined with topical application of TCM (SUCRA = 90.61%) was the optimal approach for enhancing facial nerve function (House-Brackmann (H<img>B) scale); acupuncture combined with herbal fumigation and steaming therapy (SUCRA = 80.40%) was the best intervention for improving social function (Facial Disability Index - Social Function (FDIS)) in patients with facial paralysis; acupuncture combined with pricking blood (SUCRA = 87.62%) was the most effective method for improving physical function (Facial Disability Index - Physical Function (FDIP)) in patients with facial paralysis; and acupuncture combined with cupping and pricking blood (SUCRA = 86.90%) was associated with the lowest incidence of adverse reactions.</div></div><div><h3>Conclusion</h3><div>This study showed that interventions such as acupuncture+tuina+cupping, acupuncture+topical application of TCM, acupuncture+herbal fumigation and steaming therapy, and acupuncture+pricking blood are all associated with facial nerve recovery and demonstrate superior efficacy compared with acupuncture alone.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 1","pages":"Article 104787"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145973150","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
Dual-scale fusion vision transformer model for vocal cord leukoplakia risk stratification: A multicenter study 声带白斑风险分层的双尺度融合视觉变形模型:一项多中心研究
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.amjoto.2026.104789
Jie-Lin Huang , Li-Juan Li , Ji-Qing Zhu , Li-Zhou Dou , Yu-Meng Liu , Yan Ke , Yu-Da Zhao , Mei-Ling Wang , Jian-Hui Wang , Quan-Mao Zhang , Xiao-Guang Ni

Objective

This study aimed to develop an artificial intelligence (AI) system for accurate three-tier risk stratification of vocal cord leukoplakia (VCL), with particular focus on distinguishing high-risk lesions (severe dysplasia and carcinoma in situ) from low-risk and malignant lesions, while enhancing diagnostic performance among clinicians with limited experience.

Methods

This retrospective multicenter study analyzed 8510 laryngoscopic images from 743 patients across three tertiary hospitals in China. A dual-scale Vision Transformer (ViT) architecture was constructed, integrating multi-scale feature analysis with cross-attention fusion mechanisms. The model was rigorously evaluated through internal-external validation and a prospective reader study involving 12 endoscopists of varying expertise.

Results

The AI system demonstrated superior performance in three-tier classification, achieving F1-scores of 0.883 (95% CI: 0.869–0.896) and 0.861 (95% CI: 0.844–0.878) for high-risk lesion identification in internal and external validation, respectively. AI assistance significantly improved junior endoscopists' sensitivity from 67.1% to 81.4% (P < 0.001), effectively narrowing diagnostic performance disparities with senior experts. The system maintained robust generalizability across institutions, with 90.5% accuracy under heterogeneous imaging protocols.

Conclusion

The proposed AI framework provides a clinically effective solution for reliable VCL risk stratification and reduces diagnostic variability between clinicians. Validated across multiple centers, this dual-scale ViT approach establishes a novel paradigm for laryngoscopic diagnosis and holds significant potential to standardize diagnostic workflows in resource-limited settings.
本研究旨在开发一种人工智能(AI)系统,对声带白斑(VCL)进行准确的三层风险分层,重点区分高风险病变(严重发育不良和原位癌)与低风险和恶性病变,同时提高经验有限的临床医生的诊断能力。方法本回顾性多中心研究分析了中国三所三级医院743例患者的8510张喉镜图像。构建了一种融合多尺度特征分析和交叉注意融合机制的双尺度视觉变压器(ViT)体系结构。该模型通过内部外部验证和涉及12名不同专业知识的前瞻性读者研究进行了严格评估。结果人工智能系统在三层分类中表现优异,在内部和外部验证中分别获得f1分0.883 (95% CI: 0.869-0.896)和0.861 (95% CI: 0.844-0.878)的高危病变识别。人工智能辅助显著提高了初级内窥镜医生的敏感度,从67.1%提高到81.4% (P < 0.001),有效地缩小了与高级专家的诊断表现差距。该系统在不同的机构中保持了强大的通用性,在不同的成像方案下准确率达到90.5%。结论所提出的人工智能框架为可靠的VCL风险分层提供了临床有效的解决方案,并减少了临床医生之间的诊断差异。通过多个中心的验证,这种双尺度ViT方法为喉镜诊断建立了一种新的范例,并在资源有限的环境中具有标准化诊断工作流程的巨大潜力。
{"title":"Dual-scale fusion vision transformer model for vocal cord leukoplakia risk stratification: A multicenter study","authors":"Jie-Lin Huang ,&nbsp;Li-Juan Li ,&nbsp;Ji-Qing Zhu ,&nbsp;Li-Zhou Dou ,&nbsp;Yu-Meng Liu ,&nbsp;Yan Ke ,&nbsp;Yu-Da Zhao ,&nbsp;Mei-Ling Wang ,&nbsp;Jian-Hui Wang ,&nbsp;Quan-Mao Zhang ,&nbsp;Xiao-Guang Ni","doi":"10.1016/j.amjoto.2026.104789","DOIUrl":"10.1016/j.amjoto.2026.104789","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to develop an artificial intelligence (AI) system for accurate three-tier risk stratification of vocal cord leukoplakia (VCL), with particular focus on distinguishing high-risk lesions (severe dysplasia and carcinoma in situ) from low-risk and malignant lesions, while enhancing diagnostic performance among clinicians with limited experience.</div></div><div><h3>Methods</h3><div>This retrospective multicenter study analyzed 8510 laryngoscopic images from 743 patients across three tertiary hospitals in China. A dual-scale Vision Transformer (ViT) architecture was constructed, integrating multi-scale feature analysis with cross-attention fusion mechanisms. The model was rigorously evaluated through internal-external validation and a prospective reader study involving 12 endoscopists of varying expertise.</div></div><div><h3>Results</h3><div>The AI system demonstrated superior performance in three-tier classification, achieving F1-scores of 0.883 (95% CI: 0.869–0.896) and 0.861 (95% CI: 0.844–0.878) for high-risk lesion identification in internal and external validation, respectively. AI assistance significantly improved junior endoscopists' sensitivity from 67.1% to 81.4% (<em>P</em> &lt; 0.001), effectively narrowing diagnostic performance disparities with senior experts. The system maintained robust generalizability across institutions, with 90.5% accuracy under heterogeneous imaging protocols.</div></div><div><h3>Conclusion</h3><div>The proposed AI framework provides a clinically effective solution for reliable VCL risk stratification and reduces diagnostic variability between clinicians. Validated across multiple centers, this dual-scale ViT approach establishes a novel paradigm for laryngoscopic diagnosis and holds significant potential to standardize diagnostic workflows in resource-limited settings.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 1","pages":"Article 104789"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145973187","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
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 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。
{"title":"A single-center, randomized, double-blinded, placebo-controlled clinical study on the efficacy and safety of voriconazole ear drops in the treatment of otomycosis","authors":"Shen'er Qian ,&nbsp;Guolin Tan ,&nbsp;Hongyi Tan ,&nbsp;Lihua Chen ,&nbsp;Yonghong Yu ,&nbsp;Ru Gao ,&nbsp;Wei Li","doi":"10.1016/j.amjoto.2026.104792","DOIUrl":"10.1016/j.amjoto.2026.104792","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to investigate the efficacy and safety of voriconazole ear drops.</div></div><div><h3>Methods</h3><div>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 (<em>n</em> = 72) and the control group (<em>n</em> = 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.</div></div><div><h3>Results</h3><div>The experimental group showed significant superiority over the control group in the clinical response rate (62.50% vs 38.89%, <em>P</em> &lt; 0.05). Among the secondary endpoints, the improvement rates for ear fullness and ear swelling were significantly higher in the experimental group (P &lt; 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.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"47 1","pages":"Article 104792"},"PeriodicalIF":1.7,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145973190","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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