鼓室内注射硫代硫酸钠凝胶预防顺铂诱导耳毒性的疗效
Efficacy of Intratympanic Sodium Thiosulfate Gel Injection to Prevent Cisplatin-Induced Ototoxicity.
文献信息
| PMID | 42971568 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Kunyakorn Vittayakoonsakulchai |
| 作者单位 | Department of Otolaryngology - Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Thailand. |
| 期刊 | The Laryngoscope |
| SCI 分区 | Q2 |
| IF | 2.3 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 耳科 |
中文摘要
目的： 本研究旨在评估鼓室内注射硫代硫酸钠（STS）凝胶预防顺铂诱导听力损失的疗效和安全性。
方法： 我们开展了一项单盲随机对照试验，纳入接受顺铂化疗的头颈部癌症成人患者。在每个顺铂周期前3小时内向一只耳鼓室内注射STS凝胶，对侧耳作为对照。在每次注射前以及化疗结束后1-3个月进行临床和听力学评估。测量各频率听阈相对于基线的变化。根据美国言语-语言-听力协会（ASHA）标准定义耳毒性。同时监测与鼓室内STS凝胶注射相关的不良事件。
结果： 本研究共纳入28例患者。根据ASHA标准，在0.25-8 kHz频率范围内，治疗耳与对照耳的耳毒性发生率无统计学显著差异（p = 0.683）。与对照耳相比，治疗耳在4、6、8、9和11 kHz的阈值偏移较基线显著降低，平均差异约为7-10 dB。对74次注射的安全性分析显示轻微不良事件，包括耳痛（10.8%）、一过性眩晕（10.8%）、头晕（14.8%）和鼓膜穿孔（4.0%）。
结论： 我们的研究结果显示，注射STS耳与对照耳的顺铂耳毒性发生率无显著差异。尽管如此，鼓室内注射STS凝胶在高频和扩展高频保留听力方面显示出潜在益处。该操作总体耐受良好，不良事件可控。
证据等级： 不适用。
英文摘要
OBJECTIVE: This study aimed to evaluate the efficacy and safety of intratympanic sodium thiosulfate (STS) gel injection in preventing cisplatin-induced hearing loss.
METHODS: We conducted a single-blinded randomized controlled trial, enrolling adults with head and neck cancer undergoing cisplatin chemotherapy. Intratympanic STS gel was injected into one ear within 3 h before each cisplatin cycle, while the contralateral ear served as a control. Clinical and audiometric assessments were performed before each injection and 1-3 months after the completion of chemotherapy. Changes in hearing thresholds from baseline at each frequency were measured. Ototoxicity was defined according to the American Speech-Language-Hearing Association (ASHA) criteria. Adverse events associated with intratympanic STS gel injections were also monitored.
RESULTS: Twenty-eight patients were included in the study. Based on ASHA criteria within the frequency range of 0.25-8 kHz, there was no statistically significant difference in the incidence of ototoxicity between the treated and control ears (p = 0.683). Compared with control ears, treated ears exhibited significantly reduced threshold shifts from baseline in the 4, 6, 8, 9, and 11 kHz, with mean differences of approximately 7-10 dB. A safety analysis of 74 injections revealed minor adverse effects, including otalgia (10.8%), transient vertigo (10.8%), dizziness (14.8%), and tympanic membrane perforation (4.0%).
CONCLUSION: Our findings showed no significant difference in the incidence of cisplatin ototoxicity between STS injected and control ears. Nonetheless, intratympanic STS gel injections demonstrated potential benefits in preserving hearing at high and extended-high frequencies. The procedure was generally well-tolerated, with manageable adverse effects.
LEVEL OF EVIDENCE: N/A.