未经证实:据报道,由于动物研究中的几种原因,氢气(H2)可有效减少听力损失。然而,尚无研究检查H2治疗人类听力损失的有效性。因此,我们调查了H2对特发性突发性感音神经性耳聋(ISSNHL)的治疗是否有效.
UNASSIGNED:我们在2019年6月至2022年3月期间在六家医院进行了一项双盲随机对照试验。研究方案和试验注册已发表在日本临床试验注册中心(jRCT,不。jRCTs06119004)。我们随机分配ISSNHL患者接受H2(H2组)或空气作为安慰剂(对照组),通过吸入联合全身糖皮质激素和前列腺素E1给药。主要结果是治疗后3个月的听力阈值和听力阈值的变化。相比之下,次要结局包括预后良好(完全恢复或明显改善)的患者比例.
未经证实:65例ISSNHL患者(H2组和对照组分别为31例和34例,分别)纳入本研究。治疗后3个月的听阈在两组之间没有显着差异;H2组和对照组的39.0分贝(dB)(95%置信区间[CI]:28.7-49.3)和49.5dB(95%CI:40.3-58.7),分别。相比之下,H2组和对照组治疗后3个月的听力阈值变化分别为32.7dB(95%CI:24.2-41.3)和24.2dB(95%CI:18.1-30.3),分别。因此,H2组的听力阈值变化明显优于对照组(P=0.048)。然而,没有报告由于吸入H2气体引起的不良反应。
UNASSIGNED:这是第一项研究H2在人类中治疗ISSNHL的功效。结果表明,H2治疗可能对ISSNHL治疗有效。
UNASSIGNED:[https://jrct.尼夫.走吧。jp/re/reports/detail/10442],标识符[jRCTs06119004]。
UNASSIGNED: Hydrogen (H2) 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 H2 in treating hearing loss in humans. Thus, we investigated whether H2 is effective for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL).
UNASSIGNED: 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 H2 (H2 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).
UNASSIGNED: Sixty-five patients with ISSNHL (31 and 34 in the H2 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 H2 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 H2 and control groups, respectively. Consequently, the changes in hearing threshold were significantly better in the H2 group than in the control group (P = 0.048). However, no adverse effects due to the inhalation of H2 gas have been reported.
UNASSIGNED: This is the first
study to investigate the efficacy of H2 for the treatment of ISSNHL in humans. The results suggest that H2 therapy may be effective for ISSNHL treatment.
UNASSIGNED: [https://jrct.niph.go.jp/re/reports/detail/10442], identifier [jRCTs06119004].