دورية أكاديمية
Early Experience with a Novel Treatment for Menière's Disease: A Long Acting Dexamethasone Formulation for Precise Delivery to the Round Window Membrane.
| العنوان: | Early Experience with a Novel Treatment for Menière's Disease: A Long Acting Dexamethasone Formulation for Precise Delivery to the Round Window Membrane. |
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| المؤلفون: | Kuthubutheen J; Division of Surgery, Medical School, University of Western Australia, Perth, Australia., Sharon JD, Jung BT; Spiral Therapeutics Inc., South San Franciso, California., Sepahdari AR; Spiral Therapeutics Inc., South San Franciso, California., Ng JH; Department of Otorhinolaryngology-Head & Neck Surgery, Singapore General Hospital, Singapore., Erickson S; Myra Vision, Campbell, California., Peris H; Spiral Therapeutics Inc., South San Franciso, California., De Juan E; Spiral Therapeutics Inc., South San Franciso, California., Limb CJ |
| المصدر: | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology [Otol Neurotol] 2024 Jun 01; Vol. 45 (5), pp. 564-571. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 100961504 Publication Model: Print Cited Medium: Internet ISSN: 1537-4505 (Electronic) Linking ISSN: 15317129 NLM ISO Abbreviation: Otol Neurotol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Hagerstown, MD : Lippincott Williams & Wilkins, c2001- |
| مواضيع طبية MeSH: | Meniere Disease*/drug therapy , Dexamethasone*/administration & dosage , Dexamethasone*/therapeutic use , Round Window, Ear*, Humans ; Middle Aged ; Male ; Female ; Aged ; Adult ; Treatment Outcome ; Prospective Studies ; Aged, 80 and over ; Delayed-Action Preparations ; Cohort Studies ; Vertigo/drug therapy ; Anti-Inflammatory Agents/administration & dosage ; Anti-Inflammatory Agents/therapeutic use ; Gels ; Young Adult |
| مستخلص: | Objective: To investigate the safety and feasibility of precise delivery of a long-acting gel formulation containing 6% dexamethasone (SPT-2101) to the round window membrane for the treatment of Menière's disease. Study Design: Prospective, unblinded, cohort study. Setting: Tertiary care neurotology clinic. Patients: Adults 18 to 85 years with a diagnosis of unilateral definite Menière's disease per Barany society criteria. Interventions: A single injection of a long-acting gel formulation under direct visualization into the round window niche. Main Outcome Measures: Procedure success rate, adverse events, and vertigo control. Vertigo control was measured with definitive vertigo days (DVDs), defined as any day with a vertigo attack lasting 20 minutes or longer. Results: Ten subjects with unilateral Menière's disease were enrolled. Precise placement of SPT-2101 at the round window was achieved in all subjects with in-office microendoscopy. Adverse events included one tympanic membrane perforation, which healed spontaneously after the study, and two instances of otitis media, which resolved with antibiotics. The average number of DVDs was 7.6 during the baseline month, decreasing to 3.3 by month 1, 3.7 by month 2, and 1.9 by month 3. Seventy percent of subjects had zero DVDs during the third month after treatment. Conclusions: SPT-2101 delivery to the round window is safe and feasible, and controlled trials are warranted to formally assess efficacy. (Copyright © 2024, Otology & Neurotology, Inc.) |
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| المشرفين على المادة: | 7S5I7G3JQL (Dexamethasone) 0 (Delayed-Action Preparations) 0 (Anti-Inflammatory Agents) 0 (Gels) |
| تواريخ الأحداث: | Date Created: 20240510 Date Completed: 20240510 Latest Revision: 20240511 |
| رمز التحديث: | 20240512 |
| DOI: | 10.1097/MAO.0000000000004174 |
| PMID: | 38728560 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1537-4505 |
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| DOI: | 10.1097/MAO.0000000000004174 |