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一个多中心随机对照试验的协议类固醇给药途径对于异常症突发感神经损失听力损失:STARFISH试验

Matthew E Smith^1,2, Rachel Knappett², Deborah Vickers¹

¹University of Cambridge, Cambridge, United Kingdom.

|February 29, 2024

概括

这项研究比较了口服,内耳耳膜和联合类固醇治疗异形突发感神经听力损失 (ISSNHL) 的治疗方法. 它的目的是为患有突然听力损失的患者找到最有效和最具成本效益的听力恢复方法.

科学领域:

耳鼻喉科耳鼻喉科耳鼻喉科
临床试验临床试验
药理学药理学是指药理学的学科.

背景情况:

异形突发感神经听力损失 (ISSNHL) 是一种原因不明的快速听力损失.
早期的类固醇治疗改善了ISSNHL的听力恢复.
对于ISSNHL的最佳类固醇注射路线需要进一步调查.

研究的目的:

确定在ISSNHL的第一线治疗中使用类固醇的最临床和最具成本效益的途径.
为了比较成年人的口服,内耳内和联合类固醇治疗与ISSNHL.

主要方法:

一个务实的,多中心的,评估者盲目的,三臂优势随机对照试验 (STARFISH).
525名患有ISSNHL的成年参与者从英国耳鼻科单位招募.
随机分配给口服普雷迪尼索隆,静脉内甲或联合疗法.

主要成果:

主要结局:12周后纯音声听力图平均值的绝对改善.
二次结果:语音感知,听力质量,耳,前庭功能和不良事件.
卫生经济评估包括成本效益分析.

结论:

STARFISH试验将为ISSNHL提供关于最佳类固醇治疗策略的关键数据.
研究结果将为临床指导方针提供信息,并改善患者突然听力损失的治疗结果.
该研究将确定在ISSNHL中最有效和最具成本效益的类固醇治疗方法.

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