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Controversies in thyroid and parathyroid surgery 甲状腺和甲状旁腺手术的争议
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-21 DOI: 10.1016/j.amjoto.2025.104703
Courtney Brooke Shires , Aaron Parsons , Karuna Dewan , Merry Sebelik

Background/purpose

Clinicians involved in thyroid and parathyroid surgical care can harbor strongly held beliefs meant to achieve the best outcomes, sometimes based on erroneous or outdated evidence. This article will clarify some common practices that can be refuted by critical analysis of the literature.

Methods

Observations in clinical practice of the most strongly communicated practice patterns were compared to review of published literature. Those practice patterns most discordant with evidence were included in the list of myths.

Results

Eligible clinical practices were organized by source: Surgeon, Anesthesiologist, Endocrinologist, and Institution. Examples of practices that can be disputed by evidence included the avoidance of muscle relaxants during recurrent nerve monitoring, awake fiberoptic airway management during induction for large or retrosternal goiter surgery, avoidance of contrast for CT imaging, and utilization of neural monitor technicians during surgery. Overall, 10 practice patterns that are discordant with published evidence were identified as appropriate for myth-busting.

Discussion

All clinicians caring for thyroid and parathyroid surgery patients share a desire for highest quality outcomes, especially since the patient may have many years to live with the consequences of complications. It is understandable that practice patterns can be strongly adhered to even if evidence suggests alternatives. This project identified some of the more controversial or heterogeneously applied practice patterns.

Conclusions

Identification of 10 practice patterns that can be altered based on high quality evidence may provide an opportunity for clinicians to reflectively modify what they do, possibly resulting in better, less complex, or more precise clinical care.
背景/目的参与甲状腺和甲状旁腺手术护理的临床医生可能怀有旨在获得最佳结果的强烈信念,有时基于错误或过时的证据。本文将澄清一些常见的做法,这些做法可以通过文献的批判性分析来反驳。方法将临床观察结果与已发表的文献进行比较。那些与证据最不一致的练习模式被列入神话清单。结果符合条件的临床实践按来源分列:外科医生、麻醉师、内分泌师和机构。有证据表明,在反复神经监测中避免使用肌肉松弛剂,在诱导大甲状腺肿或胸骨后甲状腺肿手术中避免使用清醒的纤维气道管理,避免使用CT造影剂,以及在手术中使用神经监测技术人员。总的来说,与已发表的证据不一致的10种练习模式被确定为适合打破神话。所有治疗甲状腺和甲状旁腺手术患者的临床医生都希望获得最高质量的结果,特别是因为患者可能要忍受并发症的后果多年。可以理解的是,即使有证据表明有其他选择,也可以强烈地坚持练习模式。这个项目确定了一些更有争议的或异质应用的实践模式。结论:根据高质量的证据,确定10种可以改变的实践模式,可能为临床医生提供一个反思修改他们所做的事情的机会,可能导致更好、更简单或更精确的临床护理。
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引用次数: 0
Association between vitamin D deficiency and residual dizziness in idiopathic BPPV: Focus on otolith dysfunction and regression insights 特发性BPPV中维生素D缺乏与残留头晕之间的关系:耳石功能障碍和回归见解的重点
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104704
Xuanchen Zhou , Tao Lin , Qiang Zhang , Changle Li , Ling Ding

Background

Residual dizziness (RD) following successful canalith repositioning maneuvers (CRMs) in idiopathic benign paroxysmal positional vertigo (BPPV) is multifactorial, with vitamin D (VD) deficiency hypothesized to influence otolith-mediated vestibular pathways.

Objective

To determine the impact of VD deficiency severity on RD incidence and vestibular dysfunction, and to evaluate the effects of VD supplementation on vestibular dysfunction.

Methods

A cross-sectional study enrolled 138 idiopathic BPPV patients with different VD level. Participants were stratified by deficiency severity: normal (>20 ng/mL), insufficiency (10–20 ng/mL), and deficiency (<10 ng/mL). RD risk factors (gender, age, times of CRMs, involved semicircular canals) were recorded. Otolith function was assessed via cervical/ocular vestibular-evoked myogenic potentials (cVEMP/oVEMP), and vestibular function via bithermal caloric testing. RD severity was measured using the Dizziness Handicap Inventory (DHI) at 1 week post-CRM. A subgroup (n = 30) with deficiency/insufficiency received 12-week VD3 supplementation (0.25 μg of oral calcitriol twice daily). Binary regression analysis was used to analyze predictors of RD.
Results: A moderate positive correlation emerged between serum VD and DHI scores (r = 0.365, P < 0.001). cVEMP abnormalities were the only otolith parameter associated with RD (χ2 = 9.75, P = 0.002). The degree of VD deficiency, cVEMP, and age emerged as significant predictors of RD. There was a significant increase in VD levels before and after treatment (13.29 ± 2.99 vs. 23.24 ± 4.78, P = 0.00) in the treatment group. Both groups showed significant shortening of cVEMP N23 wave latency after three months (P = 0.01 and P = 0.02), but only the treatment group showed significant reduction in oVEMP N10 wave latency (P = 0.01), with DHI scores reduced by 48.2 % (P = 0.008).

Conclusions

We confirmed that VD enhances otolith function and neural integrity. CVEMP, age, and VD levels predict RD likelihood. This research is the first to show VD supplementation improves saccule function and transmission pathways.
背景:特发性良性阵发性体位性眩晕(BPPV)患者成功进行管道复位手术(CRMs)后的持续性头晕(RD)是多因素的,维生素D (VD)缺乏可能影响耳石介导的前庭通路。目的探讨VD缺乏严重程度对RD发病率和前庭功能障碍的影响,评价补充VD对前庭功能障碍的影响。方法采用横断面研究方法,纳入138例不同VD水平的特发性BPPV患者。参与者按缺陷严重程度分层:正常(20 ng/mL)、不全(10 - 20 ng/mL)和缺陷(10 ng/mL)。记录RD危险因素(性别、年龄、CRMs次数、累及半规管)。耳石功能通过颈/眼前庭诱发肌生成电位(cemp /oVEMP)评估,前庭功能通过双热热测试评估。在crm后1周使用头晕障碍量表(DHI)测量RD严重程度。一个缺乏/不足的亚组(n = 30)接受为期12周的VD3补充(0.25 μg口服骨化三醇,每日两次)。结果:血清VD与DHI评分呈中度正相关(r = 0.365, P <;0.001)。cemp异常是唯一与RD相关的耳石参数(χ2 = 9.75, P = 0.002)。VD缺乏程度、cVEMP和年龄是RD的重要预测因素。治疗组VD水平在治疗前后显著升高(13.29±2.99∶23.24±4.78,P = 0.00)。3个月后,两组的cemp N23波潜伏期均显著缩短(P = 0.01和P = 0.02),但只有治疗组的oVEMP N10波潜伏期显著缩短(P = 0.01), DHI评分降低48.2% (P = 0.008)。结论VD可增强耳石功能和神经完整性。cemp、年龄和VD水平预测RD的可能性。这项研究首次表明补充VD可以改善囊功能和传递途径。
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引用次数: 0
Treatment effects of combined transcranial direct current stimulation and counseling for the treatment of chronic tinnitus 经颅直流电刺激联合心理咨询治疗慢性耳鸣的疗效观察
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104699
Zoo Young Lee , Seung-Ho Shin , Sung Wan Byun , Soo Hee Oh , Ho Yun Lee

Aims

We aimed to evaluate the comparative efficacy of three treatment modalities for chronic tinnitus: TRT-based directive counseling, transcranial direct current stimulation (tDCS), and their combination. Primary endpoints were changes in tinnitus severity and psychological distress; secondary endpoints included treatment response rates and anxiety reduction.

Methods

Forty-one patients with chronic tinnitus lasting 3 months or more of duration were enrolled who were treated at a tertiary hospital between November 2021 and December 2023. Patients were allocated to counseling (n = 11), tDCS (n = 19), or combined therapy (n = 11) based on informed preference. Treatment outcomes were assessed using the Tinnitus Handicap Inventory (THI), Visual Analog Scale (VAS), Beck's Depression Inventory (BDI), and Hospital Anxiety-Depression Scale (HADS). Statistical analysis included Wilcoxon Signed-Rank tests for within-group comparisons and Kruskal-Wallis tests for between-group analyses.

Results

Clinically significant improvement (THI reduction ≥7 points) was achieved in 70.7 % of patients overall: 63.6 % in counseling, 73.7 % in tDCS, and 72.7 % in combined therapy groups. Mean THI scores decreased significantly from 54.3 ± 22.8 to 37.7 ± 19.7 (p < 0.01). The combined therapy group showed superior anxiety reduction (HAD-A, p = 0.034) compared to single modalities. Both tDCS and combined therapy demonstrated greater improvements in multiple psychological measures compared to counseling alone.

Conclusion

Combined tDCS and counseling therapy shows enhanced efficacy in managing chronic tinnitus, particularly for patients with concurrent anxiety symptoms. This multimodal approach may provide a more comprehensive treatment strategy than single modalities alone. Future randomized controlled trials are needed to confirm these findings and establish optimal treatment protocols.
目的:我们旨在评估三种治疗慢性耳鸣的方式:基于trt的指导性咨询、经颅直流电刺激(tDCS)及其联合治疗的比较疗效。主要终点是耳鸣严重程度和心理困扰的变化;次要终点包括治疗反应率和焦虑减少。方法选取2021年11月至2023年12月在某三级医院接受治疗的41例持续3个月及以上的慢性耳鸣患者。根据知情偏好,患者被分配到咨询(n = 11)、tDCS (n = 19)或联合治疗(n = 11)。采用耳鸣障碍量表(THI)、视觉模拟量表(VAS)、贝克抑郁量表(BDI)和医院焦虑抑郁量表(HADS)评估治疗结果。统计分析包括组内比较的Wilcoxon Signed-Rank检验和组间分析的Kruskal-Wallis检验。结果70.7%的患者临床显著改善(THI降低≥7点):咨询组63.6%,tDCS组73.7%,联合治疗组72.7%。THI平均评分由54.3±22.8降至37.7±19.7 (p <;0.01)。与单一治疗方式相比,联合治疗组表现出更好的焦虑减轻(HAD-A, p = 0.034)。与单独咨询相比,tDCS和联合治疗在多种心理测量方面都显示出更大的改善。结论tDCS联合咨询治疗对慢性耳鸣有较好的治疗效果,尤其是对伴有焦虑症状的患者。这种多模式的方法可能提供比单一模式更全面的治疗策略。需要未来的随机对照试验来证实这些发现并建立最佳治疗方案。
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引用次数: 0
Primary external auditory canal cholesteatoma: Clinical characteristics and role of endoscopic ear surgery 原发性外耳道胆脂瘤:临床特点及内窥镜耳手术的作用
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104701
Yuvatiya Plodpai, Pittayapon Pitathawatchai, Pattarawadee Prayuenyong

Purpose

Primary external auditory canal cholesteatomas (PEACCs) are uncommon, and the role of endoscopy in managing the lesion has not yet been clarified. We aimed to investigate the clinical characteristics of PEACC and explore the feasibility of endoscopy for its treatment.

Material and methods

A retrospective study in patients who diagnosed with PEACC from January 2012 to January 2024 was conducted. The presenting features, disease extension according to Naim's classification, and treatment option used were assessed. The clinical characteristics were compared between the conservative successful group and the surgical group.

Results

A total of 72 patients who completed the treatment protocols were enrolled. Per the classification by Naim et al., PEACC was categorized as stage II, III, and IV in 7, 42, and 23 cases, respectively. Successful nonoperative treatment using the transcanal endoscopic approach was achieved in 46 patients without tympanic perforation (p = 0.035), scutum erosion (p < 0.001), ossicular involvement (p = 0.02), erosion of the vertical segment of the facial canal (p = 0.018), or mastoid involvement (p = 0.046), with maintenance of dry ear for 2 months (p < 0.001). Endoscopy-assisted and exclusive endoscopic surgery were performed in nine and ten patients, respectively. Canal wall-down mastoidectomy with obliteration was performed in seven patients with advanced stage IV disease. Complications were not reported in either group.

Conclusion

Endoscopy is useful for PEACC management even in advanced stages. However, the approach varies according to the lesion extent. Successful nonoperative management feasible in patients without tympanic membrane perforation, scutum erosion, facial canal erosion, ossicular or mastoid involvement and in those with ear drainage for <2 months.
目的原发性外耳道胆脂瘤(PEACCs)并不常见,内窥镜检查在其治疗中的作用尚不明确。我们旨在探讨pacc的临床特点,探讨内镜治疗的可行性。材料与方法对2012年1月至2024年1月诊断为PEACC的患者进行回顾性研究。根据Naim分类法评估患者的表现特征、疾病扩展及治疗方案。比较保守成功组与手术组的临床特点。结果共纳入72例完成治疗方案的患者。根据Naim等人的分类,PEACC分别在7例、42例和23例中被划分为II期、III期和IV期。经鼻内镜入路非手术治疗46例患者,无鼓膜穿孔(p = 0.035)、皮囊糜烂(p <;0.001),听骨受累(p = 0.02),面耳管垂直段糜烂(p = 0.018)或乳突受累(p = 0.046),保持干耳2个月(p <;0.001)。内镜辅助手术和单独内镜手术分别为9例和10例。对7例晚期IV期疾病患者行乳突根治术。两组均未出现并发症。结论内窥镜检查对晚期pacc的治疗有重要意义。然而,根据病变程度的不同,入路也不同。对于无鼓膜穿孔、胸膜糜烂、面管糜烂、听骨或乳突受累者及耳部引流2个月的患者,非手术治疗成功可行。
{"title":"Primary external auditory canal cholesteatoma: Clinical characteristics and role of endoscopic ear surgery","authors":"Yuvatiya Plodpai,&nbsp;Pittayapon Pitathawatchai,&nbsp;Pattarawadee Prayuenyong","doi":"10.1016/j.amjoto.2025.104701","DOIUrl":"10.1016/j.amjoto.2025.104701","url":null,"abstract":"<div><h3>Purpose</h3><div>Primary external auditory canal cholesteatomas (PEACCs) are uncommon, and the role of endoscopy in managing the lesion has not yet been clarified. We aimed to investigate the clinical characteristics of PEACC and explore the feasibility of endoscopy for its treatment.</div></div><div><h3>Material and methods</h3><div>A retrospective study in patients who diagnosed with PEACC from January 2012 to January 2024 was conducted. The presenting features, disease extension according to Naim's classification, and treatment option used were assessed. The clinical characteristics were compared between the conservative successful group and the surgical group.</div></div><div><h3>Results</h3><div>A total of 72 patients who completed the treatment protocols were enrolled. Per the classification by Naim et al., PEACC was categorized as stage II, III, and IV in 7, 42, and 23 cases, respectively. Successful nonoperative treatment using the transcanal endoscopic approach was achieved in 46 patients without tympanic perforation (<em>p</em> <em>=</em> <em>0.035</em>), scutum erosion (<em>p</em> <em>&lt;</em> <em>0.001</em>), ossicular involvement (<em>p</em> <em>=</em> <em>0.02</em>), erosion of the vertical segment of the facial canal (<em>p</em> <em>=</em> <em>0.018</em>), or mastoid involvement (<em>p</em> <em>=</em> <em>0.046</em>), with maintenance of dry ear for 2 months (<em>p</em> <em>&lt;</em> <em>0.001</em>). Endoscopy-assisted and exclusive endoscopic surgery were performed in nine and ten patients, respectively. Canal wall-down mastoidectomy with obliteration was performed in seven patients with advanced stage IV disease. Complications were not reported in either group.</div></div><div><h3>Conclusion</h3><div>Endoscopy is useful for PEACC management even in advanced stages. However, the approach varies according to the lesion extent. Successful nonoperative management feasible in patients without tympanic membrane perforation, scutum erosion, facial canal erosion, ossicular or mastoid involvement and in those with ear drainage for &lt;2 months.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 5","pages":"Article 104701"},"PeriodicalIF":1.8,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144702645","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 auricular vagus nerve stimulation for globus pharyngeus: A prospective pilot study 耳迷走神经刺激对咽球的疗效:一项前瞻性先导研究
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104714
Chao Hang , Xiangming Meng

Purpose

Globus pharyngeus (persistent “lump in the throat” sensation) is a common, often benign condition with unclear etiology and limited treatment options. This study aimed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing globus symptoms in affected patients.

Methods

We conducted a prospective single-arm trial at a tertiary care center. Adult patients with GP received taVNS therapy once daily for 30 min over a two-week period. Stimulation was delivered via an electrode placed on the auricular branch of the vagus nerve. Symptom severity was assessed using the Laryngopharyngeal Measure of Perceived Sensation (LUMP) questionnaire. Anxiety and depression were assessed using the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Pre- and post-treatment scores were compared using paired nonparametric or t-tests, as appropriate. Subgroup analyses were conducted in patients with baseline anxiety or depression, defined as a SAS or SDS score ≥ 50.

Results

A total of 35 patients completed the trial (mean age 51.4 ± 10.9 years), of whom 28 (80 %) were female. All patients tolerated the taVNS protocol well, and no serious adverse effects were reported. There was a significant reduction in globus symptom severity following treatment: the median LUMP score decreased from 10 (IQR 7.5–15) at baseline to 5 (IQR 3–9) post-treatment (p < 0.001). Mean anxiety and depression scores also decreased (SAS: 46.0 ± 8.4 to 43.0 ± 7.7, p = 0.002; SDS: 49.5 ± 11.7 to 44.7 ± 9.4, p = 0.005). Subgroup analyses indicated that mood-related improvements were confined to participants with baseline anxiety (−5.6 points; p = 0.008) or depression (−9.3 points; p = 0.001), while no significant changes were observed in those without baseline emotional symptoms.

Conclusion

taVNS significantly reduced globus pharyngeus symptoms and improved anxiety and depression scores, especially in patients with baseline emotional distress. These findings support the potential of taVNS as a well-tolerated neuromodulation approach for managing globus and warrant further validation in controlled trials.
目的咽球症(持续的“喉咙肿块”感)是一种常见的良性疾病,病因不明,治疗方法有限。本研究旨在评估经皮耳迷走神经刺激(taVNS)减轻受累患者的球症状的疗效。方法:我们在一家三级保健中心进行了一项前瞻性单臂试验。成年GP患者接受taVNS治疗,每天一次,持续30分钟,为期两周。刺激是通过放置在迷走神经耳支上的电极传递的。使用喉咽知觉测量(肿块)问卷评估症状严重程度。采用焦虑自评量表(SAS)和抑郁自评量表(SDS)对焦虑和抑郁进行评估。治疗前后的评分采用配对非参数检验或t检验进行比较。对基线焦虑或抑郁患者进行亚组分析,定义为SAS或SDS评分≥50。结果共35例患者完成试验,平均年龄51.4±10.9岁,其中女性28例(80%)。所有患者对taVNS方案耐受良好,无严重不良反应报告。治疗后,全球症状严重程度显著降低:治疗后的中位肿块评分从基线时的10分(IQR 7.5-15)降至5分(IQR 3-9) (p <;0.001)。平均焦虑和抑郁评分也下降(SAS: 46.0±8.4至43.0±7.7,p = 0.002;SDS: 49.5±11.7 ~ 44.7±9.4,p = 0.005)。亚组分析表明,情绪相关的改善仅限于基线焦虑的参与者(- 5.6分;P = 0.008)或抑郁(- 9.3分;P = 0.001),而在没有基线情绪症状的患者中没有观察到显著变化。结论avns可显著减轻咽球症状,改善焦虑和抑郁评分,尤其是基线情绪困扰患者。这些发现支持taVNS作为一种耐受性良好的神经调节方法来管理球体的潜力,并需要在对照试验中进一步验证。
{"title":"Efficacy of auricular vagus nerve stimulation for globus pharyngeus: A prospective pilot study","authors":"Chao Hang ,&nbsp;Xiangming Meng","doi":"10.1016/j.amjoto.2025.104714","DOIUrl":"10.1016/j.amjoto.2025.104714","url":null,"abstract":"<div><h3>Purpose</h3><div>Globus pharyngeus (persistent “lump in the throat” sensation) is a common, often benign condition with unclear etiology and limited treatment options. This study aimed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) in reducing globus symptoms in affected patients.</div></div><div><h3>Methods</h3><div>We conducted a prospective single-arm trial at a tertiary care center. Adult patients with GP received taVNS therapy once daily for 30 min over a two-week period. Stimulation was delivered via an electrode placed on the auricular branch of the vagus nerve. Symptom severity was assessed using the Laryngopharyngeal Measure of Perceived Sensation (LUMP) questionnaire. Anxiety and depression were assessed using the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS). Pre- and post-treatment scores were compared using paired nonparametric or <em>t</em>-tests, as appropriate. Subgroup analyses were conducted in patients with baseline anxiety or depression, defined as a SAS or SDS score ≥ 50.</div></div><div><h3>Results</h3><div>A total of 35 patients completed the trial (mean age 51.4 ± 10.9 years), of whom 28 (80 %) were female. All patients tolerated the taVNS protocol well, and no serious adverse effects were reported. There was a significant reduction in globus symptom severity following treatment: the median LUMP score decreased from 10 (IQR 7.5–15) at baseline to 5 (IQR 3–9) post-treatment (<em>p</em> &lt; 0.001). Mean anxiety and depression scores also decreased (SAS: 46.0 ± 8.4 to 43.0 ± 7.7, <em>p</em> = 0.002; SDS: 49.5 ± 11.7 to 44.7 ± 9.4, <em>p</em> = 0.005). Subgroup analyses indicated that mood-related improvements were confined to participants with baseline anxiety (−5.6 points; <em>p</em> = 0.008) or depression (−9.3 points; <em>p</em> = 0.001), while no significant changes were observed in those without baseline emotional symptoms.</div></div><div><h3>Conclusion</h3><div>taVNS significantly reduced globus pharyngeus symptoms and improved anxiety and depression scores, especially in patients with baseline emotional distress. These findings support the potential of taVNS as a well-tolerated neuromodulation approach for managing globus and warrant further validation in controlled trials.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 5","pages":"Article 104714"},"PeriodicalIF":1.7,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738297","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
Analysis of adverse reaction characteristics of four biologics for the treatment of chronic sinusitis with nasal polyps: A descriptive analysis from WHO-VigiAccess 四种生物制剂治疗慢性鼻窦炎伴鼻息肉的不良反应特征分析:来自WHO-VigiAccess的描述性分析
IF 1.7 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104705
Xiaobi Fang , Tingfeng Zhou , Fan Ye

Background

Chronic rhinosinusitis with nasal polyps (CRSwNP) imposes a significant global disease burden. However, systematic comparisons of adverse drug reaction (ADR) profiles among these agents remain scarce, necessitating large-scale pharmacovigilance evaluation.

Methods

Utilizing the WHO VigiAccess database, we analyzed 402,778 ADR reports for four biologics—omalizumab, dupilumab, mepolizumab, and tezepelumab. Descriptive statistics and disproportionality analyses (reporting odds ratio [ROR], proportional reporting ratio [PRR]) were performed to identify safety signals across 27 system organ classes (SOCs). Severity stratification included fatal, hospitalization-requiring, and major adverse events.

Results

Females accounted for 56.08 %–65.80 % of reports, with geographic disparities (Americas: 70.91 %–91.98 %). Temporal trends revealed surging reports for newer agents (dupilumab: 26.62 % in 2024) versus declining rates for older therapies (omalizumab: 44.71 % pre-2019). Distinct SOC patterns emerged: dupilumab dominated cutaneous (24.40 %) and ocular ADRs (ROR = 6.51), while omalizumab showed elevated pregnancy-related risks (ROR = 12.15). Mepolizumab exhibited a 4.6-fold higher severe event incidence (1.81 %) versus dupilumab (0.39 %). Tezepelumab demonstrated unique musculoskeletal ADRs (10.02 %) and cardiac risks (ROR = 3.21).

Conclusions

This study delineates agent-specific ADR profiles tied to mechanistic targets, advocating for tailored monitoring strategies. Findings underscore the imperative for risk-stratified biologic selection in CRSwNP management, supported by ongoing pharmacovigilance and mechanistic investigations.
慢性鼻窦炎伴鼻息肉(CRSwNP)造成了重大的全球疾病负担。然而,对这些药物不良反应(ADR)的系统比较仍然很少,因此需要进行大规模的药物警戒评估。方法利用WHO VigiAccess数据库,分析了4种生物制剂(omalizumab、dupilumab、mepolizumab和tezepelumab)的402778份不良反应报告。采用描述性统计和不成比例分析(报告优势比[ROR],比例报告比[PRR])来识别27个系统器官类别(soc)的安全信号。严重程度分层包括致命、需要住院治疗和主要不良事件。结果报告中女性占56.08% ~ 65.80%,存在地域差异(美洲:70.91% ~ 91.98%)。时间趋势显示,新药物的报告激增(dupilumab: 2024年为26.62%),而旧疗法的报告率下降(omalizumab: 2019年前为44.71%)。不同的SOC模式出现:杜匹单抗主导皮肤(24.40%)和眼部不良反应(ROR = 6.51),而奥玛单抗显示妊娠相关风险升高(ROR = 12.15)。Mepolizumab的严重事件发生率(1.81%)比dupilumab(0.39%)高4.6倍。Tezepelumab表现出独特的肌肉骨骼不良反应(10.02%)和心脏风险(ROR = 3.21)。本研究描述了与机制靶点相关的药物特异性ADR概况,倡导量身定制的监测策略。研究结果强调了在CRSwNP管理中进行风险分层生物学选择的必要性,并得到了正在进行的药物警戒和机制研究的支持。
{"title":"Analysis of adverse reaction characteristics of four biologics for the treatment of chronic sinusitis with nasal polyps: A descriptive analysis from WHO-VigiAccess","authors":"Xiaobi Fang ,&nbsp;Tingfeng Zhou ,&nbsp;Fan Ye","doi":"10.1016/j.amjoto.2025.104705","DOIUrl":"10.1016/j.amjoto.2025.104705","url":null,"abstract":"<div><h3>Background</h3><div>Chronic rhinosinusitis with nasal polyps (CRSwNP) imposes a significant global disease burden. However, systematic comparisons of adverse drug reaction (ADR) profiles among these agents remain scarce, necessitating large-scale pharmacovigilance evaluation.</div></div><div><h3>Methods</h3><div>Utilizing the WHO VigiAccess database, we analyzed 402,778 ADR reports for four biologics—omalizumab, dupilumab, mepolizumab, and tezepelumab. Descriptive statistics and disproportionality analyses (reporting odds ratio [ROR], proportional reporting ratio [PRR]) were performed to identify safety signals across 27 system organ classes (SOCs). Severity stratification included fatal, hospitalization-requiring, and major adverse events.</div></div><div><h3>Results</h3><div>Females accounted for 56.08 %–65.80 % of reports, with geographic disparities (Americas: 70.91 %–91.98 %). Temporal trends revealed surging reports for newer agents (dupilumab: 26.62 % in 2024) versus declining rates for older therapies (omalizumab: 44.71 % pre-2019). Distinct SOC patterns emerged: dupilumab dominated cutaneous (24.40 %) and ocular ADRs (ROR = 6.51), while omalizumab showed elevated pregnancy-related risks (ROR = 12.15). Mepolizumab exhibited a 4.6-fold higher severe event incidence (1.81 %) versus dupilumab (0.39 %). Tezepelumab demonstrated unique musculoskeletal ADRs (10.02 %) and cardiac risks (ROR = 3.21).</div></div><div><h3>Conclusions</h3><div>This study delineates agent-specific ADR profiles tied to mechanistic targets, advocating for tailored monitoring strategies. Findings underscore the imperative for risk-stratified biologic selection in CRSwNP management, supported by ongoing pharmacovigilance and mechanistic investigations.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 5","pages":"Article 104705"},"PeriodicalIF":1.7,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144750762","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
Outcomes after radiofrequency neurolysis of the posterior nasal nerve for treating Chinese adults with moderate to severe allergic rhinitis 鼻后神经射频松解术治疗中国成人中重度变应性鼻炎的疗效
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-20 DOI: 10.1016/j.amjoto.2025.104708
Jibin Huang, Ming Xu, Jiayan Wang, Di Wu

Background

Temperature-controlled radiofrequency ablation (TCRA) represents a minimally invasive alternative to surgical posterior nasal neurectomy for the management of allergic rhinitis (AR). However, to date, the impact of this minimally invasive operation on Chinese adult individuals suffering from AR remains unclear.

Objectives

To assess the safety and efficacy of TCRA for the treatment of perennial moderate and severe AR in Chinese adults.

Methods

This retrospective case-control study included 48 consecutive patients assigned to two groups: one received TCRA and the other received posterior nasal neurectomy (PNN). Follow-up assessments were conducted at 11–13 months post-surgery. The reflective total nasal symptom score (rTNSS), total non-nasal symptom score (rTNNSS), total rhinitis medication score (TRMS), and total nasal resistance were measured both preoperatively and postoperatively.

Results

At the tertiary endpoint, the TCRA group demonstrated an 73.1 % improvement in rTNSS compared to baseline, while the PNN group showed a 74.0 % improvement. However, the mean change in rTNNSS at the tertiary endpoint was 72.7 % for the TCRA group and 73.1 % for the PNN group. The mean change in TRMS from baseline to the tertiary endpoint was 68.8 % for the TCRA group and 70.9 % for the PNN group. TCRA yielded a striking 62.5 % reduction in total nasal resistance. Notably, a positive linear correlation was observed between the subjective and objective assessments of nasal resistance at baseline, the secondary and the tertiary endpoints.

Conclusion

The findings suggest that the minimally invasive TCRA technique, as a safe and effective surgical procedure, can provide a novel and superior alternative to PNN for Chinese adults with AR.
背景:温控射频消融(TCRA)是治疗变应性鼻炎(AR)的一种微创替代手术后鼻神经切除术。然而,迄今为止,这种微创手术对中国成人AR患者的影响尚不清楚。目的评价TCRA治疗中国成人常年性中重度AR的安全性和有效性。方法回顾性病例对照研究将48例患者分为两组:一组接受TCRA,另一组接受鼻后神经切除术(PNN)。术后11-13个月进行随访评估。术前、术后分别测量鼻症状总评分(rTNSS)、非鼻症状总评分(rTNNSS)、鼻炎用药总评分(TRMS)和鼻总阻力。结果在第三终点,与基线相比,TCRA组rTNSS改善了73.1%,而PNN组改善了74.0%。然而,第三终点rTNNSS的平均变化在TCRA组为72.7%,在PNN组为73.1%。TCRA组从基线到第三终点的TRMS平均变化为68.8%,PNN组为70.9%。TCRA显著降低了鼻腔总阻力62.5%。值得注意的是,在基线,次要和第三个终点,主观和客观的鼻阻力评估之间观察到正线性相关。结论微创TCRA技术作为一种安全、有效的手术方法,为我国成人AR患者提供了一种新颖、优越的替代方案。
{"title":"Outcomes after radiofrequency neurolysis of the posterior nasal nerve for treating Chinese adults with moderate to severe allergic rhinitis","authors":"Jibin Huang,&nbsp;Ming Xu,&nbsp;Jiayan Wang,&nbsp;Di Wu","doi":"10.1016/j.amjoto.2025.104708","DOIUrl":"10.1016/j.amjoto.2025.104708","url":null,"abstract":"<div><h3>Background</h3><div>Temperature-controlled radiofrequency ablation (TCRA) represents a minimally invasive alternative to surgical posterior nasal neurectomy for the management of allergic rhinitis (AR). However, to date, the impact of this minimally invasive operation on Chinese adult individuals suffering from AR remains unclear.</div></div><div><h3>Objectives</h3><div>To assess the safety and efficacy of TCRA for the treatment of perennial moderate and severe AR in Chinese adults.</div></div><div><h3>Methods</h3><div>This retrospective case-control study included 48 consecutive patients assigned to two groups: one received TCRA and the other received posterior nasal neurectomy (PNN). Follow-up assessments were conducted at 11–13 months post-surgery. The reflective total nasal symptom score (rTNSS), total non-nasal symptom score (rTNNSS), total rhinitis medication score (TRMS), and total nasal resistance were measured both preoperatively and postoperatively.</div></div><div><h3>Results</h3><div>At the tertiary endpoint, the TCRA group demonstrated an 73.1 % improvement in rTNSS compared to baseline, while the PNN group showed a 74.0 % improvement. However, the mean change in rTNNSS at the tertiary endpoint was 72.7 % for the TCRA group and 73.1 % for the PNN group. The mean change in TRMS from baseline to the tertiary endpoint was 68.8 % for the TCRA group and 70.9 % for the PNN group. TCRA yielded a striking 62.5 % reduction in total nasal resistance. Notably, a positive linear correlation was observed between the subjective and objective assessments of nasal resistance at baseline, the secondary and the tertiary endpoints.</div></div><div><h3>Conclusion</h3><div>The findings suggest that the minimally invasive TCRA technique, as a safe and effective surgical procedure, can provide a novel and superior alternative to PNN for Chinese adults with AR.</div></div>","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 5","pages":"Article 104708"},"PeriodicalIF":1.8,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144702647","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
Correspondence: Use of ChatGPT for patient education involving HPV-associated oropharyngeal cancer 通信:使用ChatGPT对hpv相关口咽癌患者进行教育
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-11 DOI: 10.1016/j.amjoto.2025.104697
Hinpetch Daungsupawong , Viroj Wiwanitkit
{"title":"Correspondence: Use of ChatGPT for patient education involving HPV-associated oropharyngeal cancer","authors":"Hinpetch Daungsupawong ,&nbsp;Viroj Wiwanitkit","doi":"10.1016/j.amjoto.2025.104697","DOIUrl":"10.1016/j.amjoto.2025.104697","url":null,"abstract":"","PeriodicalId":7591,"journal":{"name":"American Journal of Otolaryngology","volume":"46 5","pages":"Article 104697"},"PeriodicalIF":1.8,"publicationDate":"2025-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656552","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
Annotating risk stratification of thyroid nodules: Assessing the suitability of ChatGPT for text-based analysis in thyroidology 注释甲状腺结节的风险分层:评估ChatGPT在甲状腺学文本分析中的适用性
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-07-11 DOI: 10.1016/j.amjoto.2025.104696
Ilker Sengul , Demet Sengul
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引用次数: 0
Mastoid obliteration with bone dust mixed with concentrated growth factor 乳突封堵用骨粉混合浓缩生长因子
IF 1.8 4区 医学 Q2 OTORHINOLARYNGOLOGY Pub Date : 2025-06-23 DOI: 10.1016/j.amjoto.2025.104695
Sabri Baki Eren , Alper Yenigun , Erol Senturk , Abdullah Ozdem , Remzi Dogan , Orhan Ozturan

Background

Mastoid obliteration is a useful surgical step in the treatment of chronic ear operation. The technique of mastoid obliteration involves filling the cavity with self-tissue and/or osseocartilaginous graft material, following removing the mastoid air cell.

Objective

The aim of this study is to show the advantages of mastoid obliteration using a mixture of CGF and bone dust.

Material and method

Bone dust was collected with an apparatus from the healthy mastoid cortex. Collected bone dust was mixed with CGF to form a gel. Then, mastoid cavity and epitympanum obliteration were performed.

Results

Fifteen patients who underwent canal wall down mastoidectomy for cholesteatoma were included in the study. In all patients, the targeted external ear canal and hearing results were obtained after obliteration.

Conclusion

It is an effective surgical technique for creating a natural external ear path after mastoidectomy applied for mastoid obliteration, chronic ear infections and cholesteatoma treatment with CGF. Mastoid obliteration using bone dust mixed with CFG is an effective surgical technique to create a natural and healthy external ear canal.
背景乳突封堵术是治疗慢性耳部手术的有效手术步骤。乳突填塞技术包括用自体组织和/或骨软骨材料填充腔体,然后移除乳突空气细胞。目的本研究的目的是显示乳突封堵使用的CGF和骨粉的混合物的优势。材料与方法用仪器采集健康乳突皮质骨粉。将收集的骨粉与CGF混合形成凝胶。然后行乳突腔和上腔封堵术。结果15例因胆脂瘤行乳突管壁下切除术的患者纳入研究。所有患者耳塞后均获得目标外耳道及听力结果。结论乳突切除术后建立自然外耳通道是一种有效的手术技术,适用于乳突闭塞、慢性耳部感染和胆脂瘤的CGF治疗。骨粉与CFG混合的乳突封堵术是一种创造自然健康外耳道的有效手术技术。
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引用次数: 0
期刊
American Journal of Otolaryngology
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