Ramzi Ahmed, Maya Subhia, Balousha Nadeen, Amin Mufreh, Rouby Rovan Ahmed, Aljarrah Ghalia, Elnady Dalia Gamal, Samir Ahmed, Ghanm Thoria Ibrahim Essa, Bhaya Zahraa Natheer, Altarras Abdallah, Abdelsalam Fares, Yasser Mohamed, Samir Mahmoud, Shiha Mostafa Ramzi
Faculty of Medicine, Mansoura University, Mansoura, Egypt.
Faculty of Medicine, Damascus University, Damascus, Syria.
Eur J Clin Pharmacol. 2025 May 7. doi: 10.1007/s00228-025-03844-4.
Labyrinth or the inner ear consists of the cochlea (for hearing) and vestibular system (for balance), with disorders affecting hearing, balance, or both, and symptomatology including hearing loss, tinnitus, and vertigo. Regulatory-approved medications for inner ear diseases are rare worldwide relative to the frequency of those diseases. There are no FDA-approved medications for any inner ear disease. This is due to multiple reasons, including the lack of conclusive evidence for various drugs that have been investigated. We aim to contribute to the review endeavor by addressing pentoxifylline (PTX), a medication that has been studied for cochlear and vestibular disorders, yet its efficacy and safety have not been systematically reviewed in a publication.
More than a dozen databases from around the globe were systematically searched, including PubMed, EMBASE, Scopus, Web of Science, Cochrane/CENTRAL, ScienceDirect, Google Scholar, Europe PMC, ICTRP, ClinicalTrials.gov, EU-CTR, PsycInfo, LILACS, WPRIM, IBECS, SciELO, CNKI, VIP, and Wanfang, to methodically compile experimental and analytical studies. Search results are up to January 2025. This work focused on workable reports in which PTX had distinct or attributable results and organized them into overarching categories of vertigo, hearing loss, and tinnitus.
Forty studies, including 15 randomized controlled trials (RCTs), were included. Each condition was addressed in seven RCTs, with some overlap. Studies on inner ear vertigo reported significant outcomes for PTX. A large proportion of the literature involved idiopathic sudden sensorineural hearing loss (ISSNHL), but its results were mixed. Studies on tinnitus suggest that PTX has similar efficacy to Ginkgo biloba extract and corticosteroids, two of the most prescribed medications. Adverse events were generally mild and rarely necessitated discontinuation.
Pentoxifylline could improve inner ear vertigo and tinnitus. In ISSNHL, results are inconsistent in the context of spontaneous recovery rates, albeit leaning toward ineffectiveness. Over a variety of regimens, it sustained good safety. The rigor and designs of the reports could not produce robust recommendations.
内耳,即迷路,由耳蜗(用于听力)和前庭系统(用于平衡)组成,疾病会影响听力、平衡或两者,症状包括听力损失、耳鸣和眩晕。相对于这些疾病的发病率,全球范围内经监管部门批准用于内耳疾病的药物很少。美国食品药品监督管理局(FDA)未批准任何用于内耳疾病的药物。这是由多种原因造成的,包括对各种已研究药物缺乏确凿证据。我们旨在通过研究己酮可可碱(PTX)来为综述工作做出贡献,PTX是一种已针对耳蜗和前庭疾病进行研究的药物,但其疗效和安全性尚未在出版物中得到系统综述。
系统检索了全球十几个数据库,包括PubMed、EMBASE、Scopus、科学网、Cochrane/CENTRAL、ScienceDirect、谷歌学术、欧洲PMC、国际临床试验注册平台(ICTRP)、ClinicalTrials.gov、欧盟临床试验注册库(EU-CTR)、PsycInfo、拉丁美洲和加勒比地区卫生科学数据库(LILACS)、世界卫生组织西太平洋地区医学索引(WPRIM)、伊比利亚美洲 Cochrane 中心临床试验注册库(IBECS)、SciELO、中国知网(CNKI)、维普资讯(VIP)和万方数据,以系统整理实验性和分析性研究。检索结果截至2025年1月。这项工作聚焦于PTX有明确或可归因结果的可行报告,并将其归类为眩晕、听力损失和耳鸣等总体类别。
共纳入40项研究,其中包括15项随机对照试验(RCT)。每种情况在7项RCT中进行了研究,存在一些重叠。关于内耳眩晕的研究报告了PTX的显著疗效。大部分文献涉及特发性突发性感音神经性听力损失(ISSNHL),但其结果不一。关于耳鸣的研究表明,PTX与最常用的两种药物银杏叶提取物和皮质类固醇具有相似的疗效。不良事件一般较轻,很少需要停药。
己酮可可碱可改善内耳眩晕和耳鸣。在ISSNHL中,尽管倾向于无效,但在自发恢复率的背景下结果并不一致。在各种治疗方案中,它的安全性良好。报告的严谨性和设计无法得出有力的推荐意见。