Article record

耳蜗内皮质类固醇递送作为全聋型突发性感音神经性听力损失挽救治疗的疗效与安全性

Efficacy and safety of intracochlear corticosteroid delivery as salvage therapy for complete sudden sensorineural hearing loss.

临床研究耳科IF 3.2Q1

文献信息

PMID	42822221
原文	在 PubMed 查看原文 ↗
发表日期	2026
作者	Wei Li 查看其他 14 位作者 Andi Zhang；Yanqing Fang；Yi Wang；Dongmei Tang；Ying Ma；Xintai Fan；Yibo Huang；Jianghong Xu；Hui Zhao；Jing Wang；Chunfu Dai；Wuqing Wang；Yilai Shu；Huawei Li
作者单位	ENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China; Shanghai Key Laboratory of Gene Editing and Cell Therapy for Rare Diseases, Fudan University, Shanghai, China; NHC Key Laboratory of Hearing Medicine, Shanghai, China; Institutes of Biomedical Sciences, Fudan University, Shanghai, China; State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, Shanghai, China. 查看其他 3 条单位信息 ENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China; Shanghai Key Laboratory of Gene Editing and Cell Therapy for Rare Diseases, Fudan University, Shanghai, China; NHC Key Laboratory of Hearing Medicine, Shanghai, China; Institutes of Biomedical Sciences, Fudan University, Shanghai, China; State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, Shanghai, China. Electronic address: wwuqing@eent.shmu.edu.cn.；ENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China; Shanghai Key Laboratory of Gene Editing and Cell Therapy for Rare Diseases, Fudan University, Shanghai, China; NHC Key Laboratory of Hearing Medicine, Shanghai, China; Institutes of Biomedical Sciences, Fudan University, Shanghai, China; State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, Shanghai, China. Electronic address: yilai_shu@fudan.edu.cn.；ENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China; Shanghai Key Laboratory of Gene Editing and Cell Therapy for Rare Diseases, Fudan University, Shanghai, China; NHC Key Laboratory of Hearing Medicine, Shanghai, China; Institutes of Biomedical Sciences, Fudan University, Shanghai, China; State Key Laboratory of Medical Neurobiology and MOE Frontiers Center for Brain Science, Fudan University, Shanghai, China. Electronic address: hwli@shmu.edu.cn.
期刊	Hearing research
SCI 分区	Q1
IF	3.2
研究类型	临床研究 · 临床
所属专科	耳科

中文摘要

重要性： 完全性特发性突发性感音神经性听力损失（ISSNHL，根据2021年WHO听力损失分类定义为纯音平均听阈≥95 dB HL）是一种难治性耳神经科急症，预后极差。传统鼓室内治疗依赖药物被动扩散通过圆窗膜，导致耳蜗内药物蓄积不足，听力恢复有限。
目的： 评估耳蜗内皮质类固醇递送作为经2周常规治疗无效的完全性ISSNHL挽救治疗的疗效与安全性。
设计、场所和参与者： 前瞻性对照临床研究。共纳入83例经常规治疗无效的完全性ISSNHL患者，并分配至3个耳蜗内组和1个鼓室内对照组。其中80例患者完成了1个月随访并纳入分析。
干预： 耳蜗内曲安奈德（IC-TA）、耳蜗内地塞米松磷酸钠（IC-Dex）、耳蜗内Dex加Dex浸泡明胶海绵（IC-Dex-TMgel），或鼓室内Dex（IT-Dex）。耳蜗内递送通过微注射系统以30 µL等分试样进行。
主要结局和指标： 主要结局为1个月时PTA变化（ΔPTA）和不良事件（AEs）。次要结局包括言语识别率、眩晕、耳鸣和预后因素。
结果： 耳蜗内组报告了8例轻度、短暂的不良事件（AEs）（眩晕加重，n=5；舌麻木，n=2；耳鸣加重，n=1），均在2周内缓解。1个月时ΔPTA中位数：IC-TA为13.75 dB HL（四分位距，9.69-24.69），IC-Dex为23.13 dB HL（11.25-32.50），IC-Dex-TMgel为21.25 dB HL（15.00-28.13），IT-Dex为6.88 dB HL（0.00-16.88）（总体P=0.005）。所有耳蜗内组均显示出显著优于对照组的听力改善。轻度恢复（SR，ΔPTA≥15 dB HL）发生率分别为80%（IC-Dex-TMgel）、70%（IC-Dex）、50%（IC-TA）和30%（IT-Dex）。病程（P<0.001）和术前眩晕障碍量表（DHI）评分（P=0.020）与听力结局独立相关。症状发作后17.5天内进行干预与更优恢复相关。
结论与意义： 据我们所知，这是首个前瞻性对照临床试验，提供初步证据表明耳蜗内皮质类固醇注射与完全性ISSNHL挽救治疗的听力改善和良好安全性特征相关。病程和术前眩晕（DHI评分）与听力结局独立相关。发作后17.5天内早期干预与更优恢复相关。该策略可能代表一种有前景的挽救方法，用于管理这一难治性耳神经科急症。

英文摘要

IMPORTANCE: Complete idiopathic sudden sensorineural hearing loss (ISSNHL, defined as pure-tone average ≥ 95 dB HL according to the 2021 WHO hearing loss classification) is a refractory otoneurological emergency with extremely poor prognosis. Conventional intratympanic therapy depends on passive diffusion across the round window membrane, leading to inadequate intracochlear drug accumulation and limited hearing recovery.
OBJECTIVE: To evaluate the efficacy and safety of intracochlear corticosteroid delivery as salvage treatment for complete ISSNHL that is refractory to 2 weeks of conventional therapy.
DESIGN, SETTING, AND PARTICIPANTS: Prospective and controlled clinical study. A total of 83 patients with complete ISSNHL refractory to conventional treatment were enrolled and assigned to 3 intracochlear groups and 1 intratympanic control group. Of these, 80 patients completed the 1-month follow-up and were analyzed.
INTERVENTIONS: Intracochlear triamcinolone acetonide (IC-TA), intracochlear dexamethasone sodium phosphate (IC-Dex), intracochlear Dex plus Dex-soaked gelfoam (IC‑Dex‑TMgel), or intratympanic Dex (IT-Dex). Intracochlear delivery was performed via a microinjection system using 30 µL aliquots.
MAIN OUTCOMES AND MEASURES: Primary outcomes were 1-month change in PTA (ΔPTA) and adverse events (AEs). Secondary outcomes included speech recognition rate, vertigo, tinnitus, and prognostic factors.
RESULTS: Eight mild, transient adverse events (AEs) were reported in the intracochlear groups (exacerbated vertigo, n=5; tongue numbness, n=2; exacerbated tinnitus, n=1), all resolving within 2 weeks. The median 1-month ΔPTA was 13.75 dB HL (interquartile range, 9.69-24.69) for IC-TA, 23.13 dB HL (11.25-32.50) for IC-Dex, 21.25 dB HL (15.00-28.13) for IC-Dex-TMgel, and 6.88 dB HL (0.00-16.88) for IT-Dex (overall P = 0.005). All intracochlear groups demonstrated significantly greater hearing improvement than the control group. Slight recovery (SR, ΔPTA ≥ 15 dB HL) occurred in 80% (IC-Dex-TMgel), 70% (IC-Dex), 50% (IC-TA), and 30% (IT-Dex). Disease duration (P < 0.001) and preoperative Dizziness Handicap Inventory (DHI) score (P = 0.020) were independently associated with hearing outcomes. Intervention within 17.5 days of symptom onset was associated with superior recovery.
CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first prospective controlled clinical trial providing preliminary evidence that intracochlear corticosteroid injection was associated with hearing improvement and a favorable safety profile for salvage treatment of complete ISSNHL. Disease duration and preoperative vertigo (DHI score) were independently associated with hearing outcomes. Early intervention within 17.5 days of onset was associated with superior recovery. This strategy may represent a promising salvage approach for managing this refractory otoneurological emergency.