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Double-Blinded Randomised Controlled Trial Evaluating the Efficacy of Chitogel Versus PureRegen Gel on Postoperative Outcomes from Endoscopic Sinus Surgery. 双盲随机对照试验评价壳聚糖与普瑞根凝胶对内镜鼻窦手术术后预后的疗效。
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-03-19 DOI: 10.1177/19458924251321142
Marina N Cavada, Michael Fook-Ho Lee, Arjuna Ananda, Raymond Sacks, Yuresh S Naidoo

ObjectivesThis study aims to compare Chitogel® with topical corticosteroid versus PureRegen® gel on wound healing and postoperative outcomes in the treatment of chronic rhinosinusitis.MethodsA double-blinded randomized controlled trial was performed with patients undergoing functional endoscopic sinus surgery who were prospectively recruited and randomized to receive Chitogel with triamcinolone to one side of the sinuses and PureRegen to the contralateral sinuses. The patients underwent endoscopic follow-up at 2, 6, and 12 weeks postoperatively. Patient factors including age, gender, smoking status, comorbidities (reflux, allergy, and asthma), and disease specific factor (chronic rhinosinusitis phenotype) were collected. Sinus ostial measurements, adhesions, mucopurulent discharge, edema, crusting, and granulation were assessed. A visual analogue scale questionnaire on quality of life was assessed in each follow-up appointment.ResultsA total of 40 patients were randomized. At 12 weeks, Chitogel had a 10.7 mm2 reduction in frontal sinus ostium area compared to 15 mm2 in the PureRegen group; Chitogel had a 2.2 mm2 increase in maxillary ostium area compared to 0.1 mm2 in the PureRegen group; Chitogel had a 27.6 mm2 reduction in area of the sinus ostium compared to 28.7 mm2 in the PureRegen group. However, these differences were not statistically significant. The difference between the two groups when analysing adhesion, mucopurulent discharge, mucosal oedema, crusting, granulation, and phenotype was not statistically significant. Patient self-directed grading on quality of life was not statistically significant.ConclusionBoth Chitogel with triamcinolone and PureRegen have demonstrated to be great options to prevent adhesion, stenosis, and optimize healing. There were no clinical and statistical differences between both products in wound healing and postoperative outcomes in the treatment of chronic rhinosinusitis.

目的:本研究旨在比较Chitogel®与外用皮质类固醇与PureRegen®凝胶治疗慢性鼻窦炎的伤口愈合和术后结果。方法采用双盲随机对照试验,前瞻性招募接受功能性鼻窦内窥镜手术的患者,随机分配一侧鼻窦使用Chitogel和曲安奈德酮,对侧鼻窦使用PureRegen。患者在术后2周、6周和12周接受内镜随访。收集患者因素,包括年龄、性别、吸烟状况、合并症(反流、过敏和哮喘)和疾病特异性因素(慢性鼻窦炎表型)。评估窦口测量、粘连、粘液脓性排出、水肿、结痂和肉芽。在每次随访中对生活质量进行视觉模拟问卷调查。结果共纳入40例患者。12周时,Chitogel使额窦口面积减少10.7 mm2,而PureRegen组减少15 mm2;与PureRegen组的0.1 mm2相比,Chitogel组上颌口面积增加了2.2 mm2;与PureRegen组的28.7 mm2相比,Chitogel组的窦口面积减少了27.6 mm2。然而,这些差异没有统计学意义。两组在粘连、粘液脓性分泌物、粘膜水肿、结痂、肉芽和表型分析上差异无统计学意义。患者自我指导的生活质量评分无统计学意义。结论壳聚糖与曲安奈德酮和普瑞根都是预防粘连、狭窄和优化愈合的好选择。两种产品在治疗慢性鼻窦炎的伤口愈合和术后结果方面没有临床和统计学差异。
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引用次数: 0
Complication Rates Following Endoscopic Sinus Surgery for Chronic Sinusitis. 慢性鼻窦炎内窥镜鼻窦手术后的并发症发生率。
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-01-29 DOI: 10.1177/19458924251315434
Ravi Dhamija, Nikita Das, Peng Ding

BackgroundEndoscopic sinus surgery (ESS) is a minimally invasive procedure indicated for medically refractory chronic sinusitis (CRS). As with any surgical procedure, there are potential risks and complications.ObjectiveThe purpose of this study is to report skull base, orbital, and hemorrhagic-associated complication rates following ESS.MethodsA retrospective query on the TriNetX platform identified patients diagnosed with CRS who subsequently underwent ESS in the last 20 years. Outcomes analyses were performed to determine the incidence of skull base (cerebrospinal fluid rhinorrhea, bacterial meningitis, dural tear), orbital (diplopia, optic nerve injury, blindness, epiphora, orbital hemorrhage, canthotomy/canthoplasty), and hemorrhagic (epistaxis, carotid artery injury, blood transfusion) complications within 30 days postoperatively. Kaplan-Meier Analysis estimated survival probability from each complication type. Outcome rates were also compared between female and male patients.ResultsA total of 116 669 patients from 55 healthcare organizations fit the study criteria. The average age at surgery was 47.9 ± 17.9 years. The gender distribution of the cohort was 50% female and 48% male. The risk of skull base, orbital, and hemorrhagic complications within 30 days of the surgery was found to be 0.212%, 0.741%, and 3.00%, respectively. Kaplan-Meier Analysis revealed that survival probability from each complication type was 99.783%, 99.260%, and 96.903%, respectively. Comparison of outcome risks stratified by gender revealed no major differences for skull base and orbital complications; however, males exhibited a significantly higher risk of hemorrhagic complications (3.2% vs 2.8%, P < .0001).ConclusionsThe study supports ESS as a safe procedure for the management of CRS. Though rare, hemorrhagic complications are more common than orbital and skull base complications. Hemorrhagic complications are also more common in men than women. These findings provide insights for counseling patients about ESS risks and benefits.

背景:内窥镜鼻窦手术(ESS)是一种微创手术,适用于难治性慢性鼻窦炎(CRS)。与任何外科手术一样,有潜在的风险和并发症。目的:本研究的目的是报告ESS术后颅底、眼眶和出血相关并发症的发生率。方法:在TriNetX平台上进行回顾性查询,确定了在过去20年中诊断为CRS并随后接受ESS的患者。结果分析确定术后30天内颅底(脑脊液鼻漏、细菌性脑膜炎、硬脑膜撕裂)、眼眶(复视、视神经损伤、失明、眼珠突出、眼眶出血、眦切开/眦成形术)和出血(鼻出血、颈动脉损伤、输血)并发症的发生率。Kaplan-Meier分析估计了每种并发症类型的生存概率。还比较了女性和男性患者的转归率。结果:来自55家医疗机构的116 669名患者符合研究标准。平均手术年龄47.9±17.9岁。该队列的性别分布为50%的女性和48%的男性。术后30天内颅底、眼眶和出血性并发症的发生率分别为0.212%、0.741%和3.00%。Kaplan-Meier分析显示,各并发症类型的生存率分别为99.783%、99.260%和96.903%。按性别分层的结局风险比较显示,颅底和眶部并发症无显著差异;然而,男性出现出血性并发症的风险明显更高(3.2% vs 2.8%)。结论:该研究支持ESS是一种安全的CRS治疗方法。虽然罕见,但出血并发症比眼眶和颅底并发症更常见。出血性并发症在男性中也比女性更常见。这些发现为咨询ESS患者的风险和益处提供了见解。
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引用次数: 0
Therapeutic Potential of Chitosan Nasal Gel in Addressing Olfactory Dysfunction: A Clinical Trial and Mechanistic Study. 壳聚糖鼻凝胶治疗嗅觉功能障碍的潜力:临床试验和机理研究。
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-02-25 DOI: 10.1177/19458924251322058
Majed A Algarni, Mohamed H Abdelazim, Fahad T Alsulami, Abdulaziz Ibrahim Alzarea, Adnan Alharbi, Abdullah H Altemani, Abdullah S Alshammari, Faisal Alsenani, Ahmed H Abdelazim

BackgroundOlfactory dysfunction significantly impacts daily life, affecting safety, appetite, and sensory enjoyment. Olfactory receptor neurons (ORNs) are essential for odor detection, but environmental exposure can lead to dysfunction. Regeneration of these neurons is crucial for maintaining olfactory function, and elevated calcium levels in nasal mucus are linked to this dysfunction.ObjectiveThe study evaluated chitosan nasal gel for persistent olfactory dysfunction lasting over 6 months, focusing on ORNs regeneration and reduced calcium levels in nasal mucus.MethodsA randomized, double-blind trial included 215 participants with persistent olfactory dysfunction lasting over 6 months. Participants were divided into two groups: 116 received nasal chitosan gel, and 99 received a control sodium chloride gel. Over 3 months, 11 participants in the chitosan group and 9 in the control group were lost to follow-up. Olfactory function was assessed with the Sniffin' Sticks test, and calcium levels were measured before and after treatment.ResultsPatients treated with chitosan nasal gel showed an increased composite threshold, discrimination, identification (TDI) score, indicating improved olfactory function. Discrimination and identification scores improved, while threshold scores showed no significant change. Notably, while the total TDI score improved by 4.55 points, it did not reach the threshold for clinical significance (5.5 points). Furthermore, chitosan nasal gel significantly reduced calcium levels in nasal secretions compared to the control group. No improvement was observed in the placebo group, likely due to the strict inclusion criteria targeting individuals with treatment-resistant olfactory dysfunction persisting over 6 months.ConclusionThis small-scale pilot study highlights the potential of chitosan nasal gel to improve specific domains of olfactory dysfunction and reduce nasal calcium levels. However, further studies with larger sample sizes, diverse populations, and longer follow-up periods are required to confirm these preliminary findings.

背景:嗅觉功能障碍显著影响日常生活,影响安全、食欲和感官享受。嗅觉受体神经元(orn)对气味检测至关重要,但环境暴露会导致功能障碍。这些神经元的再生对于维持嗅觉功能至关重要,鼻粘液中钙含量的升高与这种功能障碍有关。目的:研究壳聚糖鼻凝胶对持续6个月以上的持续性嗅觉功能障碍的治疗效果,重点关注鼻黏膜中orn的再生和钙水平的降低。方法:一项随机双盲试验包括215名持续6个月以上的持续性嗅觉功能障碍患者。参与者被分为两组:116人服用鼻用壳聚糖凝胶,99人服用对照氯化钠凝胶。3个月后,壳聚糖组11例,对照组9例失访。用嗅探棒试验评估嗅觉功能,并测量治疗前后的钙水平。结果:经壳聚糖鼻凝胶治疗后,患者的综合阈值、鉴别、识别(TDI)评分明显提高,嗅觉功能得到改善。辨别和识别得分提高,而阈值得分无显著变化。值得注意的是,TDI总分虽然提高了4.55分,但没有达到具有临床意义的阈值(5.5分)。此外,与对照组相比,壳聚糖鼻凝胶显著降低了鼻分泌物中的钙水平。安慰剂组未观察到任何改善,可能是由于针对持续6个月以上的难治性嗅觉功能障碍患者的严格纳入标准。结论:这项小规模的初步研究强调了壳聚糖鼻凝胶在改善特定嗅觉功能障碍和降低鼻钙水平方面的潜力。然而,进一步的研究需要更大的样本量、不同的人群和更长的随访期来证实这些初步发现。
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引用次数: 0
Efficacy and Safety of a Medical Robot for Non-Face-to-Face Nasopharyngeal Swab Specimen Collection: Nonclinical and Clinical Trial Findings for COVID-19 Testing. 非面对面鼻咽拭子标本采集医疗机器人的有效性和安全性:COVID-19检测的非临床和临床试验结果
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-03-02 DOI: 10.1177/19458924251323363
Jae-Min Shin, Munsoo Han, Dabin Lee, Joonho Seo, Jeoung-Min Lee, Yeongjun Chang, Tae Hoon Kim

ObjectivesTo meet the high demand for polymerase chain reaction (PCR) tests to diagnose COVID-19 and rapidly control the outbreak, an efficient and safe molecular diagnostic protocol is necessary. In this study, we evaluated the efficacy and safety of the medical robot developed for non-face-to-face nasopharyngeal swab specimen collection.MethodsIn a nonclinical study, an otorhinolaryngologist collected swab specimens manually and using a medical robot. In a single-institution, randomized, open-label, prospective, exploratory clinical trial, nasopharyngeal swab specimens were collected from the enrolled participants both manually and by using the medical robot.ResultsEvaluation of the efficacy and safety of nasopharyngeal swab collection using a medical robot was assessed. After the operation of the robot, subjective discomfort experienced by the participants and any side effects or abnormalities in the nose were also monitored. Preliminary nonclinical data revealed comparable results between robotic and manual methods in terms of RNA metrics and cytokeratin-8 expression. Minor initial damage to A549 cells by the robot improved with subsequent use. In the clinical setting, the robot-assisted technique yielded a 92.31% detection rate for human RNase P, while the manual method achieved 100%. Post-swabbing discomfort reported by participants was similar for both methods and resolved within 48 h.ConclusionsThe medical robot system could efficiently, safely, and accurately collect nasopharyngeal swab samples in a non-face-to-face manner. Its installation in respiratory clinics, airports, or ports could minimize the infection risk between individuals and healthcare workers, thereby contributing to an efficient distribution of medical resources.

目的:为满足对聚合酶链反应(PCR)检测诊断新冠肺炎的高需求,快速控制疫情,需要一种高效、安全的分子诊断方案。在本研究中,我们评估了用于非面对面鼻咽拭子标本采集的医疗机器人的有效性和安全性。方法:在一项非临床研究中,耳鼻喉科医生使用医疗机器人人工采集拭子标本。在一项单机构、随机、开放标签、前瞻性、探索性临床试验中,通过人工和使用医疗机器人收集入组参与者的鼻咽拭子标本。结果:评估了医疗机器人采集鼻咽拭子的有效性和安全性。在机器人操作后,参与者的主观不适感以及鼻子的任何副作用或异常也被监测。初步的非临床数据显示,在RNA指标和细胞角蛋白-8表达方面,机器人和人工方法的结果相当。机器人最初对A549细胞的轻微损伤在随后的使用中得到了改善。在临床环境中,机器人辅助技术对人类RNase P的检出率为92.31%,而人工方法的检出率为100%。两种方法的参与者报告的拭子后不适相似,并在48小时内解决。结论:该医疗机器人系统能够高效、安全、准确地进行鼻咽拭子标本的非面对面采集。在呼吸道诊所、机场或港口安装这种设备,可以最大限度地降低个人与医护人员之间的感染风险,从而有助于有效分配医疗资源。
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引用次数: 0
Trends in Dupilumab-Related Payments to Physicians Across Five Specialties. dupilumab在五个专业向医生支付相关费用的趋势。
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-01-30 DOI: 10.1177/19458924251316686
Zoe Hsiao, Sina J Torabi, Edward C Kuan

BackgroundDupilumab was first approved by the United States Food and Drug Administration in 2017 for atopic dermatitis and has since been approved for many other indications. The use of dupilumab has grown, but industry payments to physicians have yet to be explored.ObjectiveThe study objective is to characterize the change in payments by pharmaceutical companies to physicians for dupilumab-related promotional activities.MethodsData from 2017 to 2023 was extracted from the Open Payments website and filtered to determine the number of dupilumab-related payments to physicians, the amounts of these payments, the number of unique physicians that were paid, and the amount of money going towards different payment purposes.ResultsIn 2017, pharmaceutical companies paid a total of $6.1 million to allergists/immunologists, dermatologists, gastroenterologists, otolaryngologists, and pulmonologists for dupilumab-related activities. This amount grew to a total of $22.6 million in 2023. These specialties all experienced an increase in the number of unique physicians paid; the number of allergists/immunologists paid increased by 1.8-fold, dermatologists by 1.4-fold, gastroenterologists by 640-fold, otolaryngologists by 95-fold, and pulmonologists by 118-fold. Across all five specialties, pharmaceutical companies paid the most money for the purpose of non-consulting, non-continuing education speaker fees.ConclusionFrom 2017 to 2023, pharmaceutical companies have paid increasing numbers of payments to increasing numbers of unique allergists/immunologists, dermatologists, gastroenterologists, otolaryngologists, and pulmonologists for dupilumab-related promotional events.

背景:Dupilumab于2017年首次被美国食品和药物管理局批准用于治疗特应性皮炎,此后已被批准用于许多其他适应症。dupilumab的使用已经增加,但行业支付给医生的费用尚未探索。目的:研究目的是表征制药公司支付给医生的dupilumab相关的促销活动的变化。方法:从Open Payments网站提取2017年至2023年的数据,并进行筛选,确定向医生支付dupilumab相关费用的次数、支付金额、支付的独特医生数量以及用于不同支付目的的金额。结果:2017年,制药公司为dupilumab相关活动向过敏科/免疫学家、皮肤科医生、胃肠科医生、耳鼻喉科医生和肺科医生支付了610万美元。到2023年,这一数额增加到2260万美元。这些专业都经历了付费的独特医生数量的增加;获发薪酬的变态反应科/免疫科医生增加1.8倍,皮肤科医生增加1.4倍,胃肠科医生增加640倍,耳鼻喉科医生增加95倍,肺科医生增加118倍。在所有五个专业中,制药公司为非咨询、非继续教育演讲者支付的费用最多。结论:从2017年到2023年,制药公司为杜匹单抗相关促销活动向越来越多的过敏/免疫专科医生、皮肤科医生、胃肠科医生、耳鼻喉科医生和肺科医生支付的费用越来越多。
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引用次数: 0
A Predictive Model for Diagnosis of Acute Invasive Fungal Rhinosinusitis Among High-Risk Patients. 诊断高危患者急性侵袭性真菌性鼻炎的预测模型
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-02-25 DOI: 10.1177/19458924251322949
Danunuch Pasupat, Songklot Aeumjaturapat, Kornkiat Snidvongs, Supinda Chusakul, Kachorn Seresirikachorn, Jesada Kanjanaumporn

BackgroundAcute invasive fungal rhinosinusitis (AIFR) is a life-threatening disease mainly affecting immunocompromised patients. Early detection is therefore key to improving patient survival. To date, there are still no standard clinical criteria for AIFR diagnosis.ObjectiveThis study develops a predictive model that utilizes clinical presentation and computed tomography (CT) findings to diagnose AIFR.MethodsA retrospective cohort study was conducted on patients with high risk for AIFR at King Chulalongkorn Memorial Hospital over the past 15 years (2008-2022). We constructed several multivariate logistic regression models for AIFR diagnosis based on different subsets of variables from 3 categories: signs/symptoms, endoscopy, and CT imaging.ResultsThere were 67 AIFR-positive patients and 68 AIFR-negative patients. Combining variables from 3 categories, a 6-variable model (fever, visual loss, mucosal discoloration, crusting, mucosal loss of contrast, retroantral fat stranding) achieved the highest area under the receiver operating characteristic curve of 0.8900 (74.63% sensitivity, 89.71% specificity).ConclusionsWe proposed predictive models for AIFR diagnosis in high-risk patients using clinical variables. The models can be used to guide the decision for further management such as biopsy or surgical intervention.

背景:急性侵袭性真菌性鼻炎(AIFR)是一种威胁生命的疾病,主要影响免疫力低下的患者。因此,早期发现是提高患者生存率的关键。迄今为止,仍没有诊断 AIFR 的标准临床标准:本研究建立了一个预测模型,利用临床表现和计算机断层扫描(CT)结果来诊断 AIFR:方法:我们对朱拉隆功国王纪念医院过去 15 年(2008-2022 年)的 AIFR 高危患者进行了回顾性队列研究。我们根据体征/症状、内窥镜检查和 CT 成像 3 个类别的不同变量子集构建了多个 AIFR 诊断的多变量逻辑回归模型:AIFR阳性患者67例,AIFR阴性患者68例。结合 3 个类别的变量,一个 6 变量模型(发热、视力下降、粘膜变色、结痂、粘膜造影剂流失、肛门后脂肪滞留)的接收者操作特征曲线下面积最高,达到 0.8900(灵敏度 74.63%,特异度 89.71%):我们提出了利用临床变量诊断高危患者 AIFR 的预测模型。结论:我们提出了利用临床变量对高危患者进行 AIFR 诊断的预测模型,这些模型可用于指导进一步的治疗决策,如活检或手术干预。
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引用次数: 0
Deep Learning-Derived Quantitative Scores for Chronic Rhinosinusitis Assessment: Correlation With Quality of Life Outcomes. 深度学习衍生的慢性鼻窦炎定量评分评估:与生活质量结果的相关性。
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-01-17 DOI: 10.1177/19458924251313845
Zhefan Shen, Ying Wei, Kexin Liu, Zhiqi Ma, Zhiliang Zhang, Xuechun Wang, Yong Li, Feng Shi, Zhongxiang Ding

BackgroundComputed tomography (CT) plays a crucial role in assessing chronic rhinosinusitis, but lacks objective quantifiable indicators.ObjectiveThis study aimed to use deep learning for automated sinus segmentation to generate distinct quantitative scores and explore their correlations with disease-specific quality of life.MethodsFrom July 2021 to August 2022, 445 CT data were collected from 2 medical centers. A deep learning model based on nnU-Net was trained for automatic sinus segmentation and internally validated using 300 cases. The remaining 145 cases were split into an external testing set (74 cases) and an independent testing set (71 cases). Two quantitative scores, the quantitative Lund-MacKay score and the quantitative opacification score (QOS), were derived from the segmentation results. The quantitative scores' efficacy was assessed by comparing them with the Lund-MacKay score (LMS), the 22-item Sinonasal Outcome Test score (SNOT-22), and other clinical variables through correlation analyses. Furthermore, the relationship between quantitative scores and postoperative quality of life improvement was explored using single-factor logistic regression.ResultThe segmentation model achieved average Dice similarity coefficients of 0.993, 0.978, 0.958, and 0.871 for the training, validation, external testing, and independent testing sets, respectively. Both quantitative scores significantly correlated with the LMS (rho = 0.87 and rho = 0.70, P < .001). Neither score correlated with the total SNOT-22 score, although the modified QOS showed significant correlations with the nasal and sleep subdomains (rho = 0.26 and rho = 0.27, P <.05). No significant association was found between quantitative score and postoperative improvement in quality of life.ConclusionDeep learning enables the automated segmentation of sinuses on CT scans, producing quantitative scores of sinus opacification. These automatic quantitative scores may serve as tools for chronic rhinosinusitis assessment.

背景:计算机断层扫描(CT)在评估慢性鼻窦炎中起着至关重要的作用,但缺乏客观的量化指标。目的:本研究旨在利用深度学习进行自动鼻窦分割,以产生不同的定量评分,并探讨其与疾病特异性生活质量的相关性。方法:于2021年7月至2022年8月收集2个医疗中心的445份CT数据。基于nnU-Net的深度学习模型进行了自动鼻窦分割训练,并使用300例进行了内部验证。其余145例分为外部检测组(74例)和独立检测组(71例)。从分割结果中得到两个定量评分,即定量Lund-MacKay评分和定量不透明评分(QOS)。通过相关分析,将定量评分与lmd - mackay评分(LMS)、22项鼻窦结局测试评分(SNOT-22)及其他临床变量进行比较,评价定量评分的疗效。此外,采用单因素logistic回归探讨定量评分与术后生活质量改善的关系。结果:分割模型在训练集、验证集、外部测试集和独立测试集上的平均Dice相似系数分别为0.993、0.978、0.958和0.871。两项定量评分均与LMS显著相关(rho = 0.87、rho = 0.70, P = 0.26、rho = 0.27, P < 0.05)。定量评分与术后生活质量改善无显著相关性。结论:深度学习可以在CT扫描上自动分割鼻窦,产生鼻窦混浊的定量评分。这些自动定量评分可以作为慢性鼻窦炎评估的工具。
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引用次数: 0
AI, Chitosan, and Biologics, Oh My! 人工智能、壳聚糖和生物制剂,天哪!
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-04-16 DOI: 10.1177/19458924251330026
Brian D'Anza
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引用次数: 0
Long-Term Effectiveness of Dupilumab in Severe Uncontrolled Chronic Rhinosinusitis with Nasal Polyps: A Multicenter Retrospective Study. Dupilumab治疗严重未控制的慢性鼻窦炎伴鼻息肉的长期疗效:一项多中心回顾性研究
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-05-01 Epub Date: 2025-01-15 DOI: 10.1177/19458924251313493
Paolo Russo, Edoardo Bassano, Marcella Menichetti, Daniela Lucidi, Rosa Maria Minniti, Elisa Cigarini, Silvia Menabue, Daniele Marchioni, Daniele Perano, Angelo Ghidini

BackgroundChronic rhinosinusitis with nasal polyps (CRSwNP) is a complex immunological disease associated with significant morbidity and reduced health-related quality of life. Dupilumab is an anti-T2-inflammatory biological drug registered for chronic rhinosinusitis with nasal polyps, indicated by integrated care pathways when optimal medico-surgical treatment yields insufficient control of sinonasal symptoms.ObjectiveThe purpose of this study was to confirm the long-term efficacy of dupilumab in the treatment of severe uncontrolled CRSwNP.MethodsMulticentric data collection of patients with severe uncontrolled CRSwNP treated with Dupilumab was retrospectively performed. Mixed Model Anova test was used to evaluate the effect of the biological therapy in the improvement of nasal polyp score and quality of life measured with Sinonasal Outcome Test-22 (SNOT-22) and visual analog scale (VAS) scores.ResultsThe study showed a statistically significant and progressive improvement in the Nasal Polyp Score with a decrease from a median baseline value of 6 (IQR 5-6) to 0 (IQR 0-2) at 24 months. Furtherly, optimal results were found for SNOT-22 scores from baseline (62 ± 19) to 6 months (15± 11), with further variations on each successive timepoint remaining below the minimal clinically important difference. VAS scores of nasal obstruction, rhinorrhea, sleep disorders, and craniofacial pain, demonstrated consistent and significant improvements over time until one year of treatment, confirming substantial relief for the most pertinent symptoms of the conditionConclusionsThe results of this study show high therapeutic efficacy and safety of dupilumab for severe CRswNP particularly in the first 6-12 months, with sustained benefits up to 24 months.

背景:慢性鼻窦炎伴鼻息肉(CRSwNP)是一种复杂的免疫性疾病,发病率高,健康相关生活质量降低。Dupilumab是一种抗t2炎症生物药物,注册用于慢性鼻窦炎伴鼻息肉,当最佳内科-外科治疗不能充分控制鼻窦症状时,应采用综合护理途径。目的:本研究的目的是确认dupilumab治疗严重不受控制的CRSwNP的长期疗效。方法:回顾性收集Dupilumab治疗的严重不受控制的CRSwNP患者的多中心数据。采用混合模型方差分析(Mixed Model Anova)检验评价生物治疗对鼻息肉评分和生活质量的改善效果,生活质量由鼻鼻窦预后测试-22 (SNOT-22)和视觉模拟量表(VAS)评分衡量。结果:研究显示鼻息肉评分在24个月时从中位基线值6 (IQR 5-6)下降到0 (IQR 0-2),具有统计学意义和进进性改善。此外,从基线(62±19)到6个月(15±11),SNOT-22评分的最佳结果被发现,每个连续时间点的进一步变化保持在最小的临床重要差异以下。鼻塞、鼻漏、睡眠障碍和颅面疼痛的VAS评分显示,随着时间的推移,直到治疗一年,症状得到了持续和显著的改善,证实了该疾病最相关的症状得到了实质性缓解。结论:本研究结果显示dupilumab治疗严重CRswNP具有较高的疗效和安全性,特别是在前6-12个月,持续获益可达24个月。
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引用次数: 0
The Effect of the Nasal Structure on the Olfactory Cleft Airflow: A Systematic Review. 鼻腔结构对嗅裂气流的影响:系统回顾
IF 2.5 3区 医学 Q1 OTORHINOLARYNGOLOGY Pub Date : 2025-03-01 Epub Date: 2024-11-11 DOI: 10.1177/19458924241296457
Lina Chen, Yuxing Liu, Dawei Wu

Objective: Conductive olfactory losses mainly involve obstruction of the olfactory cleft (OC) and diminished OC airflow. This study investigated the association between abnormal nasal structure and OC airflow.

Methods: A systematic search was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis to identify studies on the effect of the nasal structure on the OC airflow and olfaction.

Results: A total of 11 studies were included. Nasal vestibule morphological variabilities directly impact the transport of molecules in odorant-laden air to the OC. A greater airflow vortex and a narrower vestibule region intensified the airflow vortex toward the olfactory region. Middle turbinectomy significantly increased the average flux to the OC. The location of the major airflow and airflow velocity maxima shifted towards the OC in patients with septal deviation. The airflow has been redirected into the upper part of the nasal airway in patients with inferior turbinate hypertrophy. For patients with unilateral cleft lip, unilateral nasal airflow on the cleft side has a lower rate and flow. The mean velocity in the posterior OC correlated well with olfaction compared to that in the anterior OC. The nasal polyps (NP) within the middle meatus increased the olfactory airflow but did not enhance the olfaction. NP in the olfactory region or anterior to the olfactory region significantly decreased the olfactory airflow and olfaction. Furthermore, obstruction of the OC did not change the nasal patency. When the OC shape presented with a stenotic slit or lumen structure among patients with conductive olfactory dysfunction without NP, the inspiratory velocity and flow rate within OC were significantly lower than in the healthy control group.

Conclusion: Various nasal structural factors affect patterns of OC airflow and olfaction. Identifying the related airflow-limiting structures may promote the comprehensive evaluation of conductive olfactory losses in patients with olfactory dysfunction.

目的:传导性嗅觉缺失主要涉及嗅裂(OC)阻塞和OC气流减弱。本研究调查了鼻腔结构异常与 OC 气流之间的关系:方法:根据《系统综述和元分析首选报告项目》进行了系统检索,以确定有关鼻腔结构对 OC 气流和嗅觉影响的研究:结果:共纳入 11 项研究。鼻前庭形态的变化直接影响到含有气味的空气中分子向主控器的输送。较大的气流漩涡和较窄的前庭区域加强了向嗅觉区域的气流漩涡。中涡轮切除术大大增加了流向主控室的平均流量。室间隔偏曲患者的主要气流和气流速度最大值的位置向 OC 转移。下鼻甲肥大患者的气流已转向鼻腔气道的上部。对于单侧唇裂患者,裂侧的单侧鼻腔气流速度和流量较低。与前鼻孔相比,后鼻孔的平均速度与嗅觉有很好的相关性。中鼻孔内的鼻息肉(NP)会增加嗅觉气流,但不会增强嗅觉。嗅区或嗅区前部的鼻息肉会显著降低嗅气流和嗅觉。此外,阻塞 OC 并不会改变鼻腔的通畅性。当无 NP 的传导性嗅觉功能障碍患者的 OC 形状呈现狭窄缝隙或管腔结构时,OC 内的吸气速度和流速明显低于健康对照组:结论:各种鼻腔结构因素会影响 OC 气流和嗅觉模式。结论:各种鼻腔结构因素会影响 OC 气流和嗅觉模式,识别相关的气流限制结构可促进对嗅觉功能障碍患者传导性嗅觉损失的全面评估。
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American Journal of Rhinology & Allergy
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