Pub Date : 2025-02-01Epub Date: 2022-05-11DOI: 10.1177/01455613221088702
Cindy Orinx, Quentin Mat, Sophie Tainmont, Pierre Cabaraux, Jean-Pierre Duterme
{"title":"Moving from H.I.N.T.S. to H.I.N.T.S. PLUS in the Management of Acute Vestibular Syndrome.","authors":"Cindy Orinx, Quentin Mat, Sophie Tainmont, Pierre Cabaraux, Jean-Pierre Duterme","doi":"10.1177/01455613221088702","DOIUrl":"10.1177/01455613221088702","url":null,"abstract":"","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP109-NP110"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45774393","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}
Pub Date : 2025-02-01Epub Date: 2022-05-09DOI: 10.1177/01455613221101087
Andrea Colizza, Piero Giuseppe Meliante, Samantha Donsante, Mara Riminucci, Antonio Greco, Marco De Vincentiis, Alessandro Corsi
Only 0.3-1% of laryngeal cancer are non-squamous cell neoplasms. Of these, a rare entity is inflammatory myofibroblastic tumour (IMT), in which anaplastic lymphoma kinase-1 (ALK-1) is frequently expressed. Just 50 cases of IMT have been reported. Therefore, many otolaryngologists may be unfamiliar with this type of tumour and be prone to its over- or undertreatment.We report a case of ALK-1-negative IMT treated with transoral endoscopic excision and disease-free 6 months after surgery.
{"title":"Inflammatory myofibroblastic tumour of the larynx: report of a case.","authors":"Andrea Colizza, Piero Giuseppe Meliante, Samantha Donsante, Mara Riminucci, Antonio Greco, Marco De Vincentiis, Alessandro Corsi","doi":"10.1177/01455613221101087","DOIUrl":"10.1177/01455613221101087","url":null,"abstract":"<p><p>Only 0.3-1% of laryngeal cancer are non-squamous cell neoplasms. Of these, a rare entity is inflammatory myofibroblastic tumour (IMT), in which anaplastic lymphoma kinase-1 (ALK-1) is frequently expressed. Just 50 cases of IMT have been reported. Therefore, many otolaryngologists may be unfamiliar with this type of tumour and be prone to its over- or undertreatment.We report a case of ALK-1-negative IMT treated with transoral endoscopic excision and disease-free 6 months after surgery.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP68-NP71"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46240826","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}
Pub Date : 2025-02-01Epub Date: 2022-04-14DOI: 10.1177/01455613221088728
Li-Li Shi, Peng Xiong, Hong-Tao Zhen
Objective: Current management of fibrous dysplasia (FD) involving the paranasal sinuses and the adjacent skull base is currently controversial. This study aims to present our experience in the management strategy of FD that involves the paranasal sinuses and the adjacent skull base.
Methods: Twenty three patients from 2006 to 2019 with monostotic fibrous dysplasia (MFD), polyostotic fibrous dysplasia (PFD), or McCune-Albright syndrome (MAS) involving the paranasal sinuses and the adjacent skull base were retrospectively reviewed. This study series was divided into 3 groups based on management strategies: the observation group, the surgery group, and the optic nerve decompression group.
Results: The observation group included 9 patients with asymptomatic MFD with stable condition during the follow-up period of 15 to 164 months. The surgery group included 10 symptomatic patients with MFD who had personalized endoscopic endonasal surgery. The symptoms of the patients were relieved after surgery. The optic nerve decompression group included 4 patients with visual loss, who underwent endonasal endoscopic optic nerve decompression (EOND) with the aid of image-guided navigation. Their vision improved after surgery.
Conclusions: Clinical observation and periodic computed tomography (CT) scan are adopted for asymptomatic patients. Surgery is indicated in symptomatic patients. Optic nerve decompression is recommended as soon as possible if the patient has visual loss, whereas prophylactic decompression is not recommended if the optic nerve is encroached by FD without visual loss. Navigation plays an important role in endoscopic surgery involving the paranasal sinuses and the adjacent skull base, especially in FD resection and optic nerve decompression.
{"title":"Management Strategies of Fibrous Dysplasia Involving the Paranasal Sinus and the Adjacent Skull Base.","authors":"Li-Li Shi, Peng Xiong, Hong-Tao Zhen","doi":"10.1177/01455613221088728","DOIUrl":"10.1177/01455613221088728","url":null,"abstract":"<p><strong>Objective: </strong>Current management of fibrous dysplasia (FD) involving the paranasal sinuses and the adjacent skull base is currently controversial. This study aims to present our experience in the management strategy of FD that involves the paranasal sinuses and the adjacent skull base.</p><p><strong>Methods: </strong>Twenty three patients from 2006 to 2019 with monostotic fibrous dysplasia (MFD), polyostotic fibrous dysplasia (PFD), or McCune-Albright syndrome (MAS) involving the paranasal sinuses and the adjacent skull base were retrospectively reviewed. This study series was divided into 3 groups based on management strategies: the observation group, the surgery group, and the optic nerve decompression group.</p><p><strong>Results: </strong>The observation group included 9 patients with asymptomatic MFD with stable condition during the follow-up period of 15 to 164 months. The surgery group included 10 symptomatic patients with MFD who had personalized endoscopic endonasal surgery. The symptoms of the patients were relieved after surgery. The optic nerve decompression group included 4 patients with visual loss, who underwent endonasal endoscopic optic nerve decompression (EOND) with the aid of image-guided navigation. Their vision improved after surgery.</p><p><strong>Conclusions: </strong>Clinical observation and periodic computed tomography (CT) scan are adopted for asymptomatic patients. Surgery is indicated in symptomatic patients. Optic nerve decompression is recommended as soon as possible if the patient has visual loss, whereas prophylactic decompression is not recommended if the optic nerve is encroached by FD without visual loss. Navigation plays an important role in endoscopic surgery involving the paranasal sinuses and the adjacent skull base, especially in FD resection and optic nerve decompression.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"85-92"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46631759","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}
Pub Date : 2025-02-01Epub Date: 2022-04-19DOI: 10.1177/01455613221091098
Yan-Ting Ho, Ta-Jen Lee, Chia-Hsiang Fu
Objective: While septoplasty with turbinoplasty is commonly performed for patients with nasal obstruction, no study has addressed its efficacy and related determinants in patients with allergic rhinitis (AR) and various symptoms. This study aimed to identify potential factors associated with surgical outcomes in patients with persistent AR (PAR) who underwent septoplasty with turbinoplasty. Methods: We prospectively recruited patients with PAR and positive allergy test results for surgical treatment. We also collected relevant preoperative laboratory data. The Sinonasal Outcome Test-22 (SNOT-22) survey was administered to all patients one day before and one year after surgery. Results: A total of 128 patients who completed a one-year postoperative follow-up were enrolled. The total SNOT-22 score and five subdomain scores significantly improved postoperatively. We found that women and those with higher preoperative SNOT-22 scores experienced more postoperative improvement and had a greater potential to reach minimal clinically important differences (MCID). A preoperative SNOT-22 score greater than the determined cut-off value of 42.5 had an approximately 6-fold likelihood of MCID achievement. Patients in the nasal obstruction group and non-smokers demonstrated greater postoperative improvement in the sleep subdomain. Conclusions: Women with PAR and those with a preoperative SNOT-22 score above 42.5 were preferable candidates for surgery and expressed greater satisfaction. Notably, rhinologic presentations and non-rhinologic symptoms of PAR patients could benefit from within one year after surgery. Here, we discuss the factors associated with subjective surgical outcomes to help physicians and patients with AR in preoperative consultations.
{"title":"Association between Clinical Factors and Surgical Outcomes for Patients with Persistent Allergic Rhinitis.","authors":"Yan-Ting Ho, Ta-Jen Lee, Chia-Hsiang Fu","doi":"10.1177/01455613221091098","DOIUrl":"10.1177/01455613221091098","url":null,"abstract":"<p><p><b>Objective:</b> While septoplasty with turbinoplasty is commonly performed for patients with nasal obstruction, no study has addressed its efficacy and related determinants in patients with allergic rhinitis (AR) and various symptoms. This study aimed to identify potential factors associated with surgical outcomes in patients with persistent AR (PAR) who underwent septoplasty with turbinoplasty. <b>Methods:</b> We prospectively recruited patients with PAR and positive allergy test results for surgical treatment. We also collected relevant preoperative laboratory data. The Sinonasal Outcome Test-22 (SNOT-22) survey was administered to all patients one day before and one year after surgery. <b>Results:</b> A total of 128 patients who completed a one-year postoperative follow-up were enrolled. The total SNOT-22 score and five subdomain scores significantly improved postoperatively. We found that women and those with higher preoperative SNOT-22 scores experienced more postoperative improvement and had a greater potential to reach minimal clinically important differences (MCID). A preoperative SNOT-22 score greater than the determined cut-off value of 42.5 had an approximately 6-fold likelihood of MCID achievement. Patients in the nasal obstruction group and non-smokers demonstrated greater postoperative improvement in the sleep subdomain. <b>Conclusions:</b> Women with PAR and those with a preoperative SNOT-22 score above 42.5 were preferable candidates for surgery and expressed greater satisfaction. Notably, rhinologic presentations and non-rhinologic symptoms of PAR patients could benefit from within one year after surgery. Here, we discuss the factors associated with subjective surgical outcomes to help physicians and patients with AR in preoperative consultations.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"102-108"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48877374","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}
Pub Date : 2025-02-01Epub Date: 2022-04-29DOI: 10.1177/01455613221098780
Cengiz Beyan, Esin Beyan
{"title":"Mean platelet volume may not be associated with the prognosis of oral cancer.","authors":"Cengiz Beyan, Esin Beyan","doi":"10.1177/01455613221098780","DOIUrl":"10.1177/01455613221098780","url":null,"abstract":"","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP107-NP108"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43074908","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}
Pub Date : 2025-02-01Epub Date: 2022-04-27DOI: 10.1177/01455613211054628
Andrew Elton, Jenna Van Beck, Bin Li, Frank G Ondrey
Large cell neuroendocrine carcinoma (LCNEC) of the larynx is an exceedingly rare cancer of the head and neck that is difficult to diagnose. Few case reports of laryngeal LCNEC exist within the literature, and it was not until recently that LCNEC was recognized as a discrete subtype of neuroendocrine carcinoma. Given its recent recognition as a distinct subtype, histologic characteristics distinguishing LCNEC from other poorly differentiated carcinomas remain under investigation. Various reports have shown genetic alterations such as p53 and/or p16 overexpression, which are typically associated with infection by human papilloma virus (HPV). However, some reports have shown p53 and/or p16 overexpression in HPV negative samples. In this case, we discuss a 67-year-old patient with a history of extensive alcohol and tobacco use with a newly diagnosed T4N0M0, high grade, LCNEC of the subglottic larynx. Tumor pathology demonstrated positive staining for typical neuroendocrine (NE) markers like synaptophysin and chromogranin A; however, there was diffuse CK34βE12 and p16 expression. LCNEC is a newly classified subtype of poorly differentiated neuroendocrine (NE) tumors, and the diagnosis requires consideration of the clinical presentation, microscopic features, and immunostaining markers.
{"title":"Large cell neuroendocrine carcinoma originating in the subglottic larynx.","authors":"Andrew Elton, Jenna Van Beck, Bin Li, Frank G Ondrey","doi":"10.1177/01455613211054628","DOIUrl":"10.1177/01455613211054628","url":null,"abstract":"<p><p>Large cell neuroendocrine carcinoma (LCNEC) of the larynx is an exceedingly rare cancer of the head and neck that is difficult to diagnose. Few case reports of laryngeal LCNEC exist within the literature, and it was not until recently that LCNEC was recognized as a discrete subtype of neuroendocrine carcinoma. Given its recent recognition as a distinct subtype, histologic characteristics distinguishing LCNEC from other poorly differentiated carcinomas remain under investigation. Various reports have shown genetic alterations such as p53 and/or p16 overexpression, which are typically associated with infection by human papilloma virus (HPV). However, some reports have shown p53 and/or p16 overexpression in HPV negative samples. In this case, we discuss a 67-year-old patient with a history of extensive alcohol and tobacco use with a newly diagnosed T4N0M0, high grade, LCNEC of the subglottic larynx. Tumor pathology demonstrated positive staining for typical neuroendocrine (NE) markers like synaptophysin and chromogranin A; however, there was diffuse CK34βE12 and p16 expression. LCNEC is a newly classified subtype of poorly differentiated neuroendocrine (NE) tumors, and the diagnosis requires consideration of the clinical presentation, microscopic features, and immunostaining markers.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP46-NP49"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43428066","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}
Pub Date : 2025-02-01Epub Date: 2022-04-29DOI: 10.1177/01455613221098787
Tae-Hun Lee, Sang-Wook Park, Somi Ryu, Ki Ju Cho, Seong Jun Won, Jung Je Park
Laryngopharyngeal or cervical pain following ingestion of foreign bodies is one of the most frequently encountered emergencies in otolaryngologic practice. Although most of these foreign bodies can be easily removed under laryngoscopic examination without any complications, surgical removal may be required when foreign bodies migrate extraluminally. This report describes two rare cases of ingested fishbones that had migrated, one each to the thyroid gland and submandibular gland. Extraluminal migration fishbones should always be considered in otolaryngologic clinics.
{"title":"Two cases of extraluminal migration of fishbones into the thyroid gland and submandibular gland.","authors":"Tae-Hun Lee, Sang-Wook Park, Somi Ryu, Ki Ju Cho, Seong Jun Won, Jung Je Park","doi":"10.1177/01455613221098787","DOIUrl":"10.1177/01455613221098787","url":null,"abstract":"<p><p>Laryngopharyngeal or cervical pain following ingestion of foreign bodies is one of the most frequently encountered emergencies in otolaryngologic practice. Although most of these foreign bodies can be easily removed under laryngoscopic examination without any complications, surgical removal may be required when foreign bodies migrate extraluminally. This report describes two rare cases of ingested fishbones that had migrated, one each to the thyroid gland and submandibular gland. Extraluminal migration fishbones should always be considered in otolaryngologic clinics.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP63-NP67"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43926351","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}
Pub Date : 2025-02-01Epub Date: 2022-05-14DOI: 10.1177/01455613221103084
Captain Ja de Ru
{"title":"Brutalized by Bias.","authors":"Captain Ja de Ru","doi":"10.1177/01455613221103084","DOIUrl":"10.1177/01455613221103084","url":null,"abstract":"","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"73-74"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47848322","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}
Pub Date : 2025-02-01Epub Date: 2022-04-13DOI: 10.1177/01455613221089994
Yubin Wu, Shihai Wu, Xianming Li
Purpose: We aim to investigate the clinical factors that affect the prognosis of overall survival (OS) for patients with high-grade parotid gland mucoepidermoid carcinoma (high-grade pMEC) and construct a nomogram for prognosis prediction. Subjects and method: Totally, 519 patients diagnosed as high-grade pMEC from the surveillance, epidemiology, and end results (SEER) database between 2004 and 2015 were reviewed. Independent prognostic factors for OS were identified by univariate and multivariate Cox regression analyses. Nomogram was generated to predict the individual's 3- and 5- year OS rates by using R software. Prediction ability was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC) and model calibration was evaluated through calibration plots. Decision curve analysis (DCA) was used to assess the clinical usefulness and net benefit. Results: The results of univariate analysis demonstrated that age, AJCC stage, T stage, N stage, M stage, extraparenchymal lesions, regional lymph nodes status, lymph node dissection status, radiotherapy, chemotherapy, and surgery were significantly correlated with the OS (P < 0.05). Multivariate Cox regression analyses showed that older age at diagnosis, advanced AJCC stage, and positive regional lymph nodes were independent risk factors for OS. In addition, the present study revealed that radiotherapy and surgery were independent protective factors for OS (P < 0.05). The nomograms showed accurate prognostic ability that individually predict 3-years and 5-years overall survival (OS) rates based on age, AJCC stage, regional lymph nodes status, radiotherapy, and surgery. The area under the receiver operating characteristic (ROC) curve (AUC) of the nomogram used to predict the 3-year and 5-year overall survival rate were 0.779 and 0.793, indicating that the model had a good predictive power for the overall survival in high-grade pMEC patient. Conclusions: Using the SEER database, we performed univariate and multivariate analyses to determine independent prognostic factors in high-grade pMEC patients. Subsequently, we constructed and validated a prognostic nomogram to predict 3-and 5-year OS rates based on the SEER database and can assist clinicians to intuitively evaluate prognosis of high-grade pMEC patients.
{"title":"Establishment of prognostic nomogram for high-grade parotid gland mucoepidermoid carcinoma based on the SEER database.","authors":"Yubin Wu, Shihai Wu, Xianming Li","doi":"10.1177/01455613221089994","DOIUrl":"10.1177/01455613221089994","url":null,"abstract":"<p><p><b>Purpose</b>: We aim to investigate the clinical factors that affect the prognosis of overall survival (OS) for patients with high-grade parotid gland mucoepidermoid carcinoma (high-grade pMEC) and construct a nomogram for prognosis prediction. <b>Subjects and method</b>: Totally, 519 patients diagnosed as high-grade pMEC from the surveillance, epidemiology, and end results (SEER) database between 2004 and 2015 were reviewed. Independent prognostic factors for OS were identified by univariate and multivariate Cox regression analyses. Nomogram was generated to predict the individual's 3- and 5- year OS rates by using R software. Prediction ability was evaluated using the area under the receiver operating characteristic (ROC) curve (AUC) and model calibration was evaluated through calibration plots. Decision curve analysis (DCA) was used to assess the clinical usefulness and net benefit. <b>Results</b>: The results of univariate analysis demonstrated that age, AJCC stage, T stage, N stage, M stage, extraparenchymal lesions, regional lymph nodes status, lymph node dissection status, radiotherapy, chemotherapy, and surgery were significantly correlated with the OS (P < 0.05). Multivariate Cox regression analyses showed that older age at diagnosis, advanced AJCC stage, and positive regional lymph nodes were independent risk factors for OS. In addition, the present study revealed that radiotherapy and surgery were independent protective factors for OS (P < 0.05). The nomograms showed accurate prognostic ability that individually predict 3-years and 5-years overall survival (OS) rates based on age, AJCC stage, regional lymph nodes status, radiotherapy, and surgery. The area under the receiver operating characteristic (ROC) curve (AUC) of the nomogram used to predict the 3-year and 5-year overall survival rate were 0.779 and 0.793, indicating that the model had a good predictive power for the overall survival in high-grade pMEC patient. <b>Conclusions</b>: Using the SEER database, we performed univariate and multivariate analyses to determine independent prognostic factors in high-grade pMEC patients. Subsequently, we constructed and validated a prognostic nomogram to predict 3-and 5-year OS rates based on the SEER database and can assist clinicians to intuitively evaluate prognosis of high-grade pMEC patients.</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"NP75-NP84"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43510183","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}
Pub Date : 2025-02-01Epub Date: 2022-04-18DOI: 10.1177/01455613221088698
Randall A Ow, John P McGinnis, Harry J Sacks, Mark E Mehle
Background: Exhalation delivery system with fluticasone (EDS-FLU) delivers medication high and deep in the nasal passages and has been shown to reduce nasal polyp (NP) grade, an objective measure of efficacy, and to yield clinically meaningful improvements on subjective measures of symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
Objectives: To better characterize EDS-FLU treatment, we analyzed responder rates for four outcome measures used in the EDS-FLU pivotal trials, in the overall study population as well as in subgroups of patients with or without prior sinus surgery or prior use of a standard intranasal corticosteroid spray (INS).
Methods: Data were pooled from two randomized, 24-week (16-week, double-blind + 8-week, open-label), placebo-controlled studies (NAVIGATE I and II). Results for patients receiving EDS-FLU (186 µg [n = 161] or 372 µg [n = 160]) or EDS-placebo (n = 161) twice daily during the double-blind phase are described. Responder criteria included NP grade reduction (≥1-point), 22-item Sino-Nasal Outcome Test (SNOT-22) reduction (>12-points), Patient Global Impression of Change (PGIC) (much/very much improved), and congestion score improvement (>0.5-points).
Results: More patients in the EDS-FLU group responded to each of the four responder criteria compared with EDS-placebo. More patients receiving EDS-FLU responded to ≥ 1 criterion compared with EDS-placebo at week 4 (82.7% and 60.4%, respectively) and week 16 (95.7% and 80.3%, respectively). Patients responded similarly irrespective of prior sinus surgery or prior INS use. Patient-reported outcome measures showed earlier responses than NP scores.
Conclusions: Meaningful improvements were seen across multiple response criteria with EDS-FLU, suggesting that the broad treatment effect of EDS-FLU includes objective reduction in polyp grade and improvements in several patient-reported outcomes.
Trial registration: ClinicalTrials.gov (NAVIGATE I: NCT01622569 and NAVIGATE II: NCT01624662).
{"title":"The Effect of EDS-FLU on Objective and Patient-Reported Subjective Outcomes for Patients with Chronic Rhinosinusitis with Nasal Polyps.","authors":"Randall A Ow, John P McGinnis, Harry J Sacks, Mark E Mehle","doi":"10.1177/01455613221088698","DOIUrl":"10.1177/01455613221088698","url":null,"abstract":"<p><strong>Background: </strong>Exhalation delivery system with fluticasone (EDS-FLU) delivers medication high and deep in the nasal passages and has been shown to reduce nasal polyp (NP) grade, an objective measure of efficacy, and to yield clinically meaningful improvements on subjective measures of symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).</p><p><strong>Objectives: </strong>To better characterize EDS-FLU treatment, we analyzed responder rates for four outcome measures used in the EDS-FLU pivotal trials, in the overall study population as well as in subgroups of patients with or without prior sinus surgery or prior use of a standard intranasal corticosteroid spray (INS).</p><p><strong>Methods: </strong>Data were pooled from two randomized, 24-week (16-week, double-blind + 8-week, open-label), placebo-controlled studies (NAVIGATE I and II). Results for patients receiving EDS-FLU (186 µg [n = 161] or 372 µg [n = 160]) or EDS-placebo (n = 161) twice daily during the double-blind phase are described. Responder criteria included NP grade reduction (≥1-point), 22-item Sino-Nasal Outcome Test (SNOT-22) reduction (>12-points), Patient Global Impression of Change (PGIC) (much/very much improved), and congestion score improvement (>0.5-points).</p><p><strong>Results: </strong>More patients in the EDS-FLU group responded to each of the four responder criteria compared with EDS-placebo. More patients receiving EDS-FLU responded to ≥ 1 criterion compared with EDS-placebo at week 4 (82.7% and 60.4%, respectively) and week 16 (95.7% and 80.3%, respectively). Patients responded similarly irrespective of prior sinus surgery or prior INS use. Patient-reported outcome measures showed earlier responses than NP scores.</p><p><strong>Conclusions: </strong>Meaningful improvements were seen across multiple response criteria with EDS-FLU, suggesting that the broad treatment effect of EDS-FLU includes objective reduction in polyp grade and improvements in several patient-reported outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NAVIGATE I: NCT01622569 and NAVIGATE II: NCT01624662).</p>","PeriodicalId":51041,"journal":{"name":"Ent-Ear Nose & Throat Journal","volume":"1 1","pages":"93-101"},"PeriodicalIF":1.0,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41515619","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}