Ahmed Ramzi, Subhia Maya, Nadeen Balousha, Mufreh Amin, Rovan Ahmed Rouby, Ghalia Aljarrah, Dalia Gamal Elnady, Ahmed Samir, Thoria Ibrahim Essa Ghanm, Zahraa Natheer Bhaya, Abdallah Altarras, Fares Abdelsalam, Mohamed Yasser, Mahmoud Samir, Mostafa Ramzi Shiha
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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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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. 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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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Pentoxifylline could improve inner ear vertigo and tinnitus. In ISSNHL, results are inconsistent in the context of spontaneous recovery rates, albeit leaning toward ineffectiveness. 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引用次数: 0
摘要
背景:迷路或内耳由耳蜗(用于听力)和前庭系统(用于平衡)组成,其障碍影响听力、平衡或两者兼而有之,症状包括听力损失、耳鸣和眩晕。相对于内耳疾病的发病率,监管部门批准的内耳疾病药物在世界范围内是罕见的。目前还没有fda批准的内耳疾病药物。这是由多种原因造成的,包括缺乏对各种药物进行调查的确凿证据。己酮茶碱(PTX)是一种用于耳蜗和前庭疾病的药物,但其疗效和安全性尚未在出版物中得到系统的评价。方法:系统检索PubMed、EMBASE、Scopus、Web of Science、Cochrane/CENTRAL、ScienceDirect、谷歌Scholar、european PMC、ICTRP、ClinicalTrials.gov、EU-CTR、PsycInfo、LILACS、WPRIM、IBECS、SciELO、CNKI、VIP、万方等全球十几个数据库,系统地编制实验和分析研究。搜索结果截止到2025年1月。这项工作的重点是可行的报告,其中PTX有不同的或可归因的结果,并将它们分为眩晕、听力损失和耳鸣的总体类别。结果:共纳入40项研究,包括15项随机对照试验(RCTs)。每种情况在7项随机对照试验中得到了解决,有一些重叠。对内耳眩晕的研究报告了PTX的显著结果。大部分文献涉及特发性突发性感音神经性听力损失(ISSNHL),但其结果好坏参半。对耳鸣的研究表明,PTX与银杏叶提取物和皮质类固醇这两种最常用的药物具有相似的功效。不良事件一般轻微,很少需要停药。结论:己酮茶碱能改善内耳眩晕和耳鸣。在ISSNHL中,自发恢复率的结果不一致,尽管倾向于无效。在各种治疗方案中,它保持了良好的安全性。报告的严谨和设计无法提出有力的建议。
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
期刊介绍:
The European Journal of Clinical Pharmacology publishes original papers on all aspects of clinical pharmacology and drug therapy in humans. Manuscripts are welcomed on the following topics: therapeutic trials, pharmacokinetics/pharmacodynamics, pharmacogenetics, drug metabolism, adverse drug reactions, drug interactions, all aspects of drug development, development relating to teaching in clinical pharmacology, pharmacoepidemiology, and matters relating to the rational prescribing and safe use of drugs. Methodological contributions relevant to these topics are also welcomed.
Data from animal experiments are accepted only in the context of original data in man reported in the same paper. EJCP will only consider manuscripts describing the frequency of allelic variants in different populations if this information is linked to functional data or new interesting variants. Highly relevant differences in frequency with a major impact in drug therapy for the respective population may be submitted as a letter to the editor.
Straightforward phase I pharmacokinetic or pharmacodynamic studies as parts of new drug development will only be considered for publication if the paper involves
-a compound that is interesting and new in some basic or fundamental way, or
-methods that are original in some basic sense, or
-a highly unexpected outcome, or
-conclusions that are scientifically novel in some basic or fundamental sense.