监测散发性前庭神经鞘瘤患者的听力功能：一项为未来随机对照试验提供信息的可行性研究
Monitoring Hearing Function in Patients With Sporadic Vestibular Schwannoma: A Feasibility Study to Inform a Future Randomized Controlled Trial.
文献信息
| PMID | 42727938 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Daniel Lewis |
| 作者单位 | Division of Cancer Sciences, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK. |
| 期刊 | Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology |
| SCI 分区 | Q2 |
| IF | 1.9 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 需要一项确定性随机对照试验（RCT），比较前期立体定向放射外科（SRS）与观察等待（WW）在前庭神经鞘瘤（VS）长期听力保留方面的效果。本可行性研究的具体目标为：（1）评估患者资格及招募/保留率，（2）确定完成率/完成时间，（3）估计关键拟议结局指标的方差，以为RCT的样本量估算提供信息。
研究设计： 非随机、单中心、前瞻性研究。
地点： 三级转诊中心。
患者： 31例接受WW（n = 22）或SRS（n = 9）的散发性VS患者。
干预： 四频率平均纯音听阈（4FAPTA）、言语识别评分（WRS）、单耳/反相数字噪声言语接受阈（DiN SRT50），以及自我报告的结局指标，包括言语、空间和听觉质量量表（SSQ）与耳鸣功能指数（TFI）。
主要结局指标： 可行性指标（招募率、完成率、测试时间）。结局指标的方差（听力相关：4FAPTA、单耳/反相DiN-SRT50、WRS。患者报告结局：SSQ、TFI）。
结果： 7个月内招募了44例患者。31例（70.5%）符合纳入标准，25例（80%）完成了所有测试。完成评估的平均时间为1小时42分钟。VS患耳的平均4FAPTA（±SD）为42 ± 14 dB HL（WW）和55 ± 9.4 dB HL（SRS）。反相DiN-SRT50阈值分别为WW：-14.2 dB SNR ± 4.1；SRS：-11.6 dB SNR ± 1.9，并且在VS患耳中4FAPTA与反相DiN-SRT50相关（P < 0.001）。
结论： 本研究表明，拟议RCT具有足够的资格率及招募/保留率，并且测试完成率高、测试时长可接受。还提供了关键结局指标（DiN-SRT50、4FAPTA）的变异性估计，以确定RCT的样本量。
英文摘要
OBJECTIVE: There is a need for a definitive RCT comparing upfront stereotactic radiosurgery (SRS) versus watch-and-wait (WW) for long-term hearing preservation in vestibular schwannoma (VS). Specific objectives of this feasibility study were to: (1) assess patient eligibility and recruitment/ retention rates, (2) determine completion rates/ times, and (3) estimate the variance in key proposed outcome measures to inform sample-size estimation for an RCT.
STUDY DESIGN: Nonrandomized, single-centre, prospective study.
SETTING: Tertiary-referral centre.
PATIENTS: Thirty-one patients with sporadic VS undergoing WW (n = 22) or SRS (n = 9).
INTERVENTIONS: Four-frequency average pure-tone audiometry (4FAPTA) thresholds, Word Recognition Scores (WRS), monaural/antiphasic Digits-in-Noise speech reception thresholds (DiN SRT50), and self-reported outcomes including the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Tinnitus Functional Index (TFI).
MAIN OUTCOME MEASURES: Feasibility metrics (recruitment, completion rates, testing times). Variance of outcome measures (hearing-related: 4FAPTA, monoaural/ antiphasic DiN-SRT50, WRS. Patient-reported outcomes: SSQ, TFI.
RESULTS: Forty-four patients were recruited over 7 months. Thirty-one (70.5%) met inclusion criteria, and 25 (80%) completed all tests. Average time to complete the assessments was 1 hour 42 minutes. Mean 4FAPTA (±SD) in VS-affected ears was 42 ± 14 dB HL (WW) and 55 ± 9.4 dB HL (SRS). Antiphasic DiN-SRT50 thresholds were WW: -14.2 dB SNR ± 4.1; SRS: -11.6 dB SNR ± 1.9, and 4FAPTA and antiphasic DiN-SRT50 were correlated (P < 0.001) in VS-affected ears.
CONCLUSIONS: This study has demonstrated sufficient eligibility and recruitment/retention rates for the proposed RCT and high-test completion rates with acceptable duration. Variability estimates of key outcome measures (DiN-SRT50, 4FAPTA) have also been provided to determine the sample size for the RCT.