人工耳蜗植入患者听力保留干预措施的有效性：系统综述与荟萃分析

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中文摘要

背景： 人工耳蜗植入（CI）是感音神经性听力损失患者听力重建的公认方法。研究表明，CI后残余听力，尤其是低频范围的听力，可以得到保留。本系统综述与荟萃分析旨在基于系统检索，提供关于CI受者听力保留与听阈的可靠证据。
方法： 我们系统检索了PubMed、Scopus和Web of Science三个电子数据库以收集相关记录。我们纳入了研究单纯CI或联合听力保留方法对听阈或听力保留发生率影响的临床试验和观察性研究。使用OpenMeta[Analyst]软件进行双臂和单臂荟萃分析模型，以检验类固醇和术中听觉监测作为听力保留方法的效果。此外，单臂分析模型汇总了采用软手术技术的研究。
结果： 本研究共纳入35项观察性研究、9项非随机临床试验和8项随机对照试验。在五项研究的荟萃分析模型中，在开机时，所有可用频率的植入后听阈及相对基线的变化，其合并SMD均支持类固醇组优于对照组（植入后：SMD=-0.706，P<0.001；相对基线变化：SMD=-0.337，P=0.009）。此外，在植入后6个月，植入后听阈及相对基线变化的合并SMD支持类固醇组优于对照组（植入后：SMD=-0.901，P=0.001；相对基线变化：SMD=-0.422，P=0.033）。此外，在植入后12个月，植入后听阈的合并SMD支持类固醇组优于对照组（SMD=-0.666，P<0.00）。然而，12个月时相对基线变化的合并SMD既不支持类固醇组也不支持对照组（SMD=-0.216，P=0.078）。与无实时反馈的组相比，具有实时反馈的术中监测显示出更好的植入后听阈和更有利的相对基线变化（植入后：SMD=-0.888，P=0.001；相对基线变化：SMD=-0.565，P=0.01）。在单臂荟萃分析中，截至12个月相对基线的合并阈值变化在所有可用频率、低频、中频和高频分别为15.239、14.944、9.691和2.489。
结论： 本荟萃分析表明，使用类固醇可显著增强人工耳蜗植入术后短期听力保留。虽然术中听觉监测显示出前景，但其一致获益仍需进一步明确。采用软手术技术也提供了有利结果；然而，仍需更多随机对照试验。

英文摘要

BACKGROUND: Cochlear implantation (CI) is a well-recognized method for hearing restoration in patients with sensorineural hearing loss. Studies demonstrated that residual hearing, especially the low frequency range, can be preserved after CI. The current systematic review and meta-analysis aim to provide solid evidence based on systematic search regarding hearing preservation and hearing thresholds in CI recipients.
METHODS: We systematically searched three electronic databases, PubMed, Scopus and Web of Science, to collect relevant records. We included clinical trials and observational studies that investigated the effect of CI alone or accompanied with a hearing preservation method on hearing thresholds or incidence of hearing preservation. Double-arm and single-arm meta-analysis models were conducted using OpenMeta[Analyst] software to examine the effect of steroids and intra-operative auditory monitoring as a hearing preservation method. Also, Single-arm analysis models pooled studies that adopted soft surgical techniques.
RESULTS: The current study included a total of 35 observational studies, 9 non-randomized clinical trials, and 8 RCTs. In a meta-analysis model of five studies, the pooled SMD of both hearing threshold post-implantation and change from baseline - at all available frequencies - favored steroid group over control group (post-implantation: SMD=-0.706, P < 0.001; change from baseline: SMD=-0.337, P = 0.009) at the time of activation. Also, the pooled SMD of post-implantation hearing threshold and change from baseline favored steroid group over control group (post-implantation: SMD=-0.901, P = 0.001; change from baseline: SMD=-0.422, P = 0.033) at 6 months post-implantation. Moreover, the pooled SMD of post-implantation hearing threshold favored steroid group over control group (SMD=-0.666, P < 0.00) at 12 months post-implantation. However, the pooled SMD of change from baseline at 12 months did not favor either steroid or control groups (SMD=-0.216, P = 0.078). Intra-operative monitoring with real-time feedback showed better post-implantation hearing thresholds and more favorable change from baseline compared to groups with no real-time feedback (post-implantation: SMD=-0.888, P = 0.001; change from baseline: SMD=-0.565, P = 0.01). In a single-arm meta-analysis, the pooled threshold change from baseline up to 12 months was 15.239, 14.944, 9.691 and 2.489 at all available, low, middle and high frequencies, respectively.
CONCLUSION: This meta-analysis demonstrates that steroid use significantly enhances short-term hearing preservation following cochlear implant surgery. While intra-operative auditory monitoring shows promise, further clarity is needed regarding its consistent benefits. The adoption of soft surgical techniques also offers favourable outcomes; however, more randomized controlled trials are needed.