氢气吸入疗法治疗特发性突发性感音神经性听力损失的双盲随机对照临床试验。
A double-blinded, randomized controlled clinical trial of hydrogen inhalation therapy for idiopathic sudden sensorineural hearing loss.
作者信息
Okada Masahiro, Ogawa Hideo, Takagi Taro, Nishihara Eriko, Yoshida Tadashi, Hyodo Jun, Shinomori Yusuke, Honda Nobumitsu, Fujiwara Takashi, Teraoka Masato, Yamada Hiroyuki, Hirano Shin-Ichi, Hato Naohito
机构信息
Department of Otolaryngology, Head and Neck Surgery, Ehime University Graduate School of Medicine, Toon, Japan.
Department of Otolaryngology, Head and Neck Surgery, Ehime Prefectural Central Hospital, Matsuyama, Japan.
出版信息
Front Neurosci. 2022 Nov 24;16:1024634. doi: 10.3389/fnins.2022.1024634. eCollection 2022.
BACKGROUND
Hydrogen (H) has been reported to be effective in reducing hearing loss due to several causes in animal studies. However, no study has examined the effectiveness of H in treating hearing loss in humans. Thus, we investigated whether H is effective for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL).
MATERIALS AND METHODS
We conducted a double-blind randomized controlled trial at six hospitals between June 2019 and March 2022. The study protocol and trial registration have been published in the Japan Registry of Clinical Trials (jRCT, No. jRCTs06119004). We randomly assigned patients with ISSNHL to receive either H (H group) or air as a placebo (control group) through inhalation combined with the administration of systemic glucocorticoids and prostaglandin E1. The primary outcome was the hearing threshold and changes in hearing threshold 3 months after therapy. In contrast, the secondary outcomes included the proportion of patients with a good prognosis (complete recovery or marked improvement).
RESULTS
Sixty-five patients with ISSNHL (31 and 34 in the H and control groups, respectively) were included in this study. The hearing threshold 3 months after treatment was not significantly different between the groups; 39.0 decibels (dB) (95% confidence interval [CI]: 28.7-49.3) and 49.5 dB (95% CI: 40.3-58.7) in the H and control groups, respectively. In contrast, the changes in hearing threshold 3 months after treatment was 32.7 dB (95% CI: 24.2-41.3) and 24.2 dB (95% CI: 18.1-30.3) in the H and control groups, respectively. Consequently, the changes in hearing threshold were significantly better in the H group than in the control group ( = 0.048). However, no adverse effects due to the inhalation of H gas have been reported.
CONCLUSION
This is the first study to investigate the efficacy of H for the treatment of ISSNHL in humans. The results suggest that H therapy may be effective for ISSNHL treatment.
CLINICAL TRIAL REGISTRATION
[https://jrct.niph.go.jp/re/reports/detail/10442], identifier [jRCTs06119004].
背景
在动物研究中，氢气（H）已被报道可有效减轻多种原因导致的听力损失。然而，尚无研究探讨氢气在治疗人类听力损失方面的有效性。因此，我们调查了氢气对特发性突发性感音神经性听力损失（ISSNHL）的治疗是否有效。
材料与方法
2019年6月至2022年3月期间，我们在六家医院进行了一项双盲随机对照试验。该研究方案和试验注册信息已发表在日本临床试验注册中心（jRCT，编号jRCTs06119004）。我们将ISSNHL患者随机分为两组，一组通过吸入氢气（氢气组），另一组吸入空气作为安慰剂（对照组），同时联合全身使用糖皮质激素和前列腺素E1。主要结局指标是治疗3个月后的听力阈值及听力阈值变化。相比之下，次要结局指标包括预后良好（完全恢复或显著改善）的患者比例。
结果
本研究纳入了65例ISSNHL患者（氢气组31例，对照组34例）。治疗3个月后，两组的听力阈值无显著差异；氢气组为39.0分贝（dB）（95%置信区间[CI]：28.7 - 49.3），对照组为49.5 dB（95% CI：40.3 - 58.7）。相比之下，治疗3个月后，氢气组和对照组的听力阈值变化分别为32.7 dB（95% CI：24.2 - 41.3）和24.2 dB（95% CI：18.1 - 30.3）。因此，氢气组的听力阈值变化显著优于对照组（P = 0.048）。然而，未报告因吸入氢气导致的不良反应。
结论
这是第一项研究氢气治疗人类ISSNHL疗效的研究。结果表明氢气疗法可能对ISSNHL治疗有效。
临床试验注册
[https://jrct.niph.go.jp/re/reports/detail/10442]，标识符[jRCTs06119004]
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