Nitta Yoshihiro, Sano Hajime, Kurioka Takaomi, Yamashita Taku
Department of Otorhinolaryngology and Head and Neck Surgery, Kitasato University School of Medicine, Kanagawa, Japan.
Department of Rehabilitation, School of Allied Health Sciences, Kitasato University, Kanagawa, Japan.
J Int Adv Otol. 2025 May 22;21(3):1-7. doi: 10.5152/iao.2025.251875.
In Japan, edaravone, a free radical scavenger, is used clinically to reduce neuronal damage after acute cerebral infarction. In this study, a clinical trial has been designed utilizing intratympanic edaravone injection (ITE), which was hypothesized to exhibit high transitivity into the inner ear, with the aim of identifying an improved treatment modality for patients with idiopathic sudden sensorineural hearing loss (ISSHL) presenting with profound hearing loss. METHODS: Between April 2012 and December 2015, 17 patients with ISSHL, with mean hearing levels equal to or greater than 90 dB HL at the time of the initial visit, were treated with ITE. Fourteen patients with ISSHL under the same conditions were extracted, who received intratym- panic steroid injection (ITS) in the department between January 2015 and December 2019 as a historical control. The hearing thresholds were compared between the ITE and ITS groups. RESULTS: The improvement between the initial and final hearing levels was significantly greater in the ITE group than in the ITS group at 250- 1000 Hz. The average hearing improvement was 49.1 (± 21.0) dB in ITE group and 35.2 (± 11.8) dB in ITS group, and the degree of improvement was significantly greater in ITE group. No detectable adverse events associated with ITE were observed in patients' subjective symptoms. CONCLUSION: The final hearing thresholds of patients treated with ITE were significantly better than those of patients treated with ITS. It has been concluded that ITE treatment may be useful in future clinical studies.
在日本,自由基清除剂依达拉奉临床上用于减轻急性脑梗死之后的神经元损伤。在本研究中,设计了一项利用鼓室内注射依达拉奉(ITE)的临床试验,该方法被推测对内耳具有高通透性,目的是为患有严重听力损失的特发性突发性感音神经性听力损失(ISSHL)患者确定一种改进的治疗方式。
在2012年4月至2015年12月期间,对17例ISSHL患者进行了ITE治疗,这些患者初诊时平均听力水平等于或大于90 dB HL。提取了14例在相同条件下的ISSHL患者作为历史对照,他们于2015年1月至2019年12月在该科室接受了鼓室内类固醇注射(ITS)。比较了ITE组和ITS组之间的听力阈值。
在250 - 1000 Hz时,ITE组初始和最终听力水平之间的改善明显大于ITS组。ITE组平均听力改善为49.1(±21.0)dB,ITS组为35.2(±11.8)dB,ITE组的改善程度明显更大。在患者主观症状方面未观察到与ITE相关的可检测到的不良事件。
接受ITE治疗的患者的最终听力阈值明显优于接受ITS治疗的患者。得出结论,ITE治疗在未来的临床研究中可能有用。