Abstract：
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.
METHODS: Prospective, unblinded, cohort study.
METHODS: Tertiary care neurotology clinic.
METHODS: Adults 18 to 85 years with a diagnosis of unilateral definite Menière\'s disease per Barany society criteria.
METHODS: A single injection of a long-acting gel formulation under direct visualization into the round window niche.
METHODS: 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.
METHODS: Prospective, unblinded, cohort study.
METHODS: Tertiary care neurotology clinic.
METHODS: Adults 18 to 85 years with a diagnosis of unilateral definite Menière\'s disease per Barany society criteria.
METHODS: A single injection of a long-acting gel formulation under direct visualization into the round window niche.
METHODS: 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.
摘要：
目的：研究将含有6%地塞米松的长效凝胶制剂（SPT-2101）精确递送至圆窗膜治疗梅尼埃病的安全性和可行性。
方法：前瞻性，未失明,队列研究。
方法：三级护理神经学诊所。
方法：根据Barany协会标准，诊断为单侧确定的Menière病的18至85岁成年人。
方法：在直接可视化的情况下将长效凝胶制剂单次注射到圆窗小生境中。
方法：手术成功率，不良事件,和眩晕控制。眩晕控制以确定的眩晕天数(DVD)进行测量，定义为眩晕发作持续20分钟或更长时间的任何一天。
结果：纳入10例单侧梅尼埃病患者。在所有使用办公室显微内窥镜检查的受试者中，都可以将SPT-2101精确放置在圆窗上。不良事件包括一个鼓膜穿孔，在研究后自发愈合，还有两个中耳炎,用抗生素解决。在基准月份，DVD的平均数量为7.6张，1个月减少到3.3，2个月减少到3.7，3个月减少到1.9。70%的受试者在治疗后的第三个月内没有DVD。
结论：SPT-2101传送到圆窗是安全可行的，和对照试验有必要正式评估疗效.
方法：前瞻性，未失明,队列研究。
方法：三级护理神经学诊所。
方法：根据Barany协会标准，诊断为单侧确定的Menière病的18至85岁成年人。
方法：在直接可视化的情况下将长效凝胶制剂单次注射到圆窗小生境中。
方法：手术成功率，不良事件,和眩晕控制。眩晕控制以确定的眩晕天数(DVD)进行测量，定义为眩晕发作持续20分钟或更长时间的任何一天。
结果：纳入10例单侧梅尼埃病患者。在所有使用办公室显微内窥镜检查的受试者中，都可以将SPT-2101精确放置在圆窗上。不良事件包括一个鼓膜穿孔，在研究后自发愈合，还有两个中耳炎,用抗生素解决。在基准月份，DVD的平均数量为7.6张，1个月减少到3.3，2个月减少到3.7，3个月减少到1.9。70%的受试者在治疗后的第三个月内没有DVD。
结论：SPT-2101传送到圆窗是安全可行的，和对照试验有必要正式评估疗效.
