Intratympanic Injection of Edaravone for Idiopathic Sudden Sensorineural Hearing Loss with Profound Hearing Loss.

Yoshihiro Nitta, Hajime Sano, Takaomi Kurioka, Taku Yamashita
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Abstract

Background: 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 intratympanic 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.

鼓室内注射依达拉奉治疗特发性突发性感音神经性听力损失伴深度听力损失。
背景:在日本,依达拉奉是一种自由基清除剂,临床上用于减轻急性脑梗死后的神经元损伤。本研究设计了一项临床试验,利用鼓膜内依达拉奉注射液(ITE),假设其具有进入内耳的高传递性,目的是为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。方法:在2012年4月至2015年12月期间,17例初次就诊时平均听力水平等于或大于90 dB HL的ISSHL患者接受ITE治疗。选取相同条件下的14例ISSHL患者,作为历史对照,于2015年1月至2019年12月在该科接受胸腔内恐慌类固醇注射(ITS)。比较ITE组和ITS组的听力阈值。结果:在250- 1000 Hz时,ITE组的初始听力水平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49.1(±21.0)dB, ITS组平均听力改善35.2(±11.8)dB,且ITE组改善程度显著高于ITS组。在患者的主观症状中未观察到与ITE相关的可检测到的不良事件。结论:ITE治疗患者的最终听力阈值明显优于ITS治疗患者。结论是ITE治疗在未来的临床研究中可能是有用的。
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