Introduction: This study aimed to evaluate the incidence of balance disorders and the efficacy of dexamethasone in protecting patients undergoing cisplatin-based cancer treatment against vestibulototoxicity. Methods: This study was a randomized controlled phase IIIB clinical trial. The subjects participating in the clinical trial were patients with a neoplastic disease whose treatment protocol included cisplatin. The average dose of cisplatin was 444.87 mg (SD 235.2 mg). Treatment consisted of intratympanically administering dexamethasone via a passive diffusion device called Microwick (8 mg/24 h dose) from the start of treatment with cisplatin to 3 weeks after the last cycle. Patients were administered the medication to one ear, and the contralateral ear was used as the control. The treated ears were randomly chosen using a computer system (randomization). Vestibular system was evaluated by video head impulse test before each cisplatin cycle. Results: Thirty-four patients were recruited over a 2-year period at a reference tertiary hospital, of whom 11 were excluded. Forty-six ears were analyzed (23 treated and 23 control ears). Vestibular analysis presented no changes in the mean increase in the vestibulo-ocular response in all patients evaluated, both in treated and control ears. Both 8.69% infection complications during treatment and 34.8% permanent perforation at 6 months were detected after device removal. Conclusion: Ototoxicity related to cisplatin-based treatment does not affect the vestibular system. Long-term high-dose intratympanic dexamethasone treatment is safe for the vestibular system.
Audiol Neurotol

中文翻译：

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接受基于顺铂的癌症治疗的患者的前庭毒性：一项 IIIB 期随机对照临床试验

简介：本研究旨在评估平衡障碍的发生率和地塞米松保护接受基于顺铂的癌症治疗的患者免受前庭毒性的疗效。方法：本研究为随机对照IIIB期临床试验。参与临床试验的受试者是患有肿瘤疾病的患者，其治疗方案包括顺铂。顺铂的平均剂量为 444.87 mg (SD 235.2 mg)。治疗包括从开始用顺铂治疗到最后一个周期后 3 周，通过称为 Microwick 的被动扩散装置（8 毫克/24 小时剂量）在鼓室内施用地塞米松。将药物施用于患者的一只耳朵，并将对侧耳朵用作对照。使用计算机系统随机选择经过治疗的耳朵（随机化）。在每个顺铂周期之前，通过视频头脉冲测试评估前庭系统。结果：在 2 年期间，在参考三级医院招募了 34 名患者，其中 11 名被排除在外。分析了 46 个耳朵（23 个治疗耳朵和 23 个对照耳朵）。前庭分析显示，在所有接受评估的患者中，治疗耳和对照耳的前庭眼反应平均增加没有变化。装置移除后检测到治疗期间 8.69% 的感染并发症和 6 个月时 34.8% 的永久性穿孔。结论：与基于顺铂的治疗相关的耳毒性不影响前庭系统。长期大剂量鼓室内地塞米松治疗对前庭系统是安全的。
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