迷走神经刺激联合声音疗法治疗耳鸣的效果：一项系统综述与荟萃分析
Effect of the vagus nerve stimulation combined with sound therapy for tinnitus treatment: a systematic review and meta-analysis.
文献信息
| PMID | 42867641 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Mitra Rezapour |
| 作者单位 | Otorhinolaryngology Research Center, Department of Otolaryngology and Head and Neck Surgery, School of Medicine, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran. |
| 期刊 | European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery |
| SCI 分区 | Q1 |
| IF | 2.3 |
| 研究类型 | 综述 Meta · 临床 |
| 所属专科 | 耳科 |
中文摘要
背景： 耳鸣是一种常见的听力问题，与焦虑和抑郁相关。目前尚无治愈方法。本系统综述与荟萃分析旨在探讨迷走神经刺激（VNS）联合听觉刺激在缓解耳鸣方面的潜在关联，同时认识到证据的探索性性质。
方法： 检索了六个数据库，时间范围为1990年至2023年（2025年更新），纳入随机临床试验、观察性研究和病例研究，其中至少一组接受有创或无创VNS联合声音治疗以管理耳鸣。符合条件的研究使用经过验证的问卷来量化患者的耳鸣困扰或严重程度，并与对照组或治疗前状态进行比较。两名评审员提取了参与者、干预、盲法、评估和结局数据。使用ROBINS-I评估非随机研究的偏倚风险，使用ROB2评估随机对照试验的偏倚风险。遵循PRISMA指南。
结果： 系统综述纳入八项研究，荟萃分析纳入六项研究。耳鸣残疾量表（THI）和视觉模拟量表（VAS）适合进行荟萃分析。分析主要基于组内前后变化，而非组间比较。对于THI，标准化均数差（SMD）为0.53（95% CI：0.12-0.94，p = 0.01），而加权均数差（WMD）为12.52（95% CI：4.56-20.48，p < 0.001），超过了7的最小临床重要差异（MCID）阈值。对于VAS，SMD为0.55（95% CI：0.14-0.96，p = 0.01），但WMD为11.21（95% CI：4.79-17.63，p < 0.001），改善未达到15的MCID。
结论： 在探索性组内荟萃分析的局限性内，VNS联合声音疗法观察到THI在统计学和临床上均显著降低。然而，VAS的改善在临床上不显著。这些探索性发现提示可能存在协同效应，但不应被视为比较疗效的确凿证据。需要进一步的对照研究。
英文摘要
BACKGROUND: Tinnitus is a prevalent hearing problem linked to anxiety and depression. It currently has no cure. This systematic review and meta-analysis aimed to explore the potential association of combining vagus nerve stimulation (VNS) with auditory stimulation in alleviating tinnitus, recognizing the exploratory nature of evidence.
METHODS: Six databases were searched from 1990 to 2023 (2025 updated) for randomized clinical trials, observational studies, and case studies with at least one group receiving invasive or non-invasive VNS with sound for tinnitus management. Eligible studies used validated questionnaires to quantify tinnitus distress or severity in patients compared with controls or pre-treatment status. Two reviewers extracted participant, intervention, blinding, assessment, and outcome data. The risk of bias was assessed with ROBINS-I for non-randomized studies and ROB2 for randomized controlled trials. PRISMA guidelines were followed.
RESULTS: Eight studies were included in the systematic review and six in the meta-analysis. The Tinnitus Handicap Inventory (THI) and the Visual Analogue Scale (VAS) were suitable for meta-analysis. The analysis was primarily based on within-group pre‑post changes, not between‑group comparisons. For THI, the standardized mean difference (SMD) was 0.53 (95% CI: 0.12-0.94, p = 0.01), while the weighted mean difference (WMD) was 12.52 (95% CI: 4.56-20.48, p < 0.001), surpassing 7 minimal clinically important difference (MCID) threshold. For VAS, SMD was 0.55 (95% CI: 0.14-0.96, p = 0.01), but WMD was 11.21 (95% CI: 4.79-17.63, p < 0.001) and the improvement fell short of the 15 MCID.
CONCLUSIONS: Within the limitations of an exploratory within‑group meta‑analysis, statistically and clinically significant reductions in THI were observed when VNS plus sound therapy. However, improvement in VAS was not clinically significant. These exploratory findings suggest a possible synergistic effect, but should not be considered conclusive evidence of comparative efficacy. Further controlled studies are needed.