Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.

Investigational Medicinal Products for the Inner Ear: Review of Clinical Trial Characteristics in ClinicalTrials.gov.
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内耳的研究性药物:临床试验特征的综述。

DOI:
10.1055/s-0041-1735522
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发表时间:
2021-11
影响因子:
1.2
通讯作者:
Le Prell, Colleen G.
Le Prell, Colleen G.
中科院分区:
医学4区
文献类型:
--
作者:
Le Prell, Colleen G.

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背景 在过去的30年里,已经提供了关于噪声暴露、耳毒性药物损伤和衰老过程中内耳细胞死亡机制的信息,并且已经出现了针对所有这些获得性听力损失的临床试验。对突发性听力损失的了解较少,但在突发性听力损失后恢复听力也是一个长期存在的药物靶点,通常使用类固醇作为干预,但也使用其他感兴趣的药物。目的 本综述的目的是描述内耳研究用药物在治疗或预防获得性听力损失方面的临床试验的科学状况。数据收集和分析 对国家医学图书馆()数据库中列出的临床试验进行全面搜索和总结,确定了61项临床试验。结果总结了 研究的阶段、现状、干预措施以及主要、继发性和其他结果,这些研究评估了噪声性听力损失的预防、药物性听力损失的预防、稳定型感音神经性耳聋的治疗和突发性感音神经性耳聋的治疗。结论 这篇综述全面总结了在人类临床试验中评估的内耳研究药物的科学状况,以及该领域目前面临的挑战。
Background  The previous 30 years have provided information on the mechanisms of cell death in the inner ear after noise exposure, ototoxic drug injury, and during aging, and clinical trials have emerged for all of these acquired forms of hearing loss. Sudden hearing loss is less well understood, but restoration of hearing after sudden hearing loss is also a long-standing drug target, typically using steroids as an intervention but with other agents of interest as well. Purpose  The purpose of this review was to describe the state of the science regarding clinical testing of investigational medicinal products for the inner ear with respect to treatment or prevention of acquired hearing loss. Data Collection and Analysis  Comprehensive search and summary of clinical trials listed in the National Library of Medicine ( ) database identified 61 clinical trials. Results  Study phase, status, intervention, and primary, secondary, and other outcomes are summarized for studies assessing prevention of noise-induced hearing loss, prevention of drug-induced hearing loss, treatment of stable sensorineural hearing loss, and treatment of sudden sensorineural hearing loss. Conclusion  This review provides a comprehensive summary of the state of the science with respect to investigational medicinal products for the inner ear evaluated in human clinical trials, and the current challenges for the field.
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