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生物制剂:耳鼻喉科的现状、问题与未来

Biologics: The Good, the Bad and the Future of Ear, Nose and Throat.

作者信息

Vincent Victoria

机构信息

Faculty of Health, University of Plymouth, John Bull Building, 16 Research Way, Plymouth Science Park, Plymouth, PL6 8BU UK.

出版信息

Indian J Otolaryngol Head Neck Surg. 2024 Apr;76(2):2176-2181. doi: 10.1007/s12070-023-04309-9. Epub 2023 Nov 10.

Abstract

Sensorineural hearing loss and chronic rhinosinusitis with nasal polyps affect a large proportion of the UK population. However, treatment with high efficacy to manage these pathologies remains to be found. With the development of biologic drug treatments, there is hope that this will improve quality of life for patients affected by these conditions. A literature review was carried out using PubMed. Studies that investigated the use of biologic drug treatment in chronic rhinosinusitis with nasal polyps, head and neck squamous cell carcinoma and sensorineural hearing loss were included in this paper. Studies have demonstrated that cost is quite possibly the greatest limiting factor for the licencing of these novel drugs by the National Institute for Health and Care Excellence. Biologics are currently approved in the management of squamous cell carcinoma of the head and neck for curative and palliative management. Although sensorineural hearing loss and chronic rhinosinusitis with nasal polyps are not life-threatening conditions, they do have a great effect upon a patients' quality of life. Current literature has identified several drug targets for biologics to be developed. Biologics, used off-licence, have been demonstrated to be effective in the management of the ear, nose and throat pathologies described. Although the off-licence use of biologics have been found to be beneficial, larger randomised control trials will be required to demonstrate the true efficacy of these drugs and allow for approval by the National Institute for Health and Care Excellence. Cost will become less of a limiting factor as time progresses as biosimilars will be able to be produced once drug patents expire, thus making the market more competitive, driving prices down.

摘要

感音神经性听力损失和伴有鼻息肉的慢性鼻-鼻窦炎影响着英国很大一部分人口。然而,尚未找到高效治疗这些病症的方法。随着生物药物治疗的发展,有望改善受这些病症影响患者的生活质量。使用PubMed进行了文献综述。本文纳入了调查生物药物治疗在伴有鼻息肉的慢性鼻-鼻窦炎、头颈部鳞状细胞癌和感音神经性听力损失中的应用的研究。研究表明,成本很可能是英国国家卫生与临床优化研究所批准这些新药的最大限制因素。生物制剂目前已被批准用于头颈部鳞状细胞癌的根治性和姑息性治疗。虽然感音神经性听力损失和伴有鼻息肉的慢性鼻-鼻窦炎并非危及生命的病症,但它们确实对患者的生活质量有很大影响。当前文献已经确定了几种有待开发的生物制剂药物靶点。已证明未经许可使用的生物制剂在治疗上述耳、鼻、喉疾病方面有效。虽然已发现未经许可使用生物制剂有益,但仍需要更大规模的随机对照试验来证明这些药物的真正疗效,并获得英国国家卫生与临床优化研究所的批准。随着时间的推移,成本将不再是一个限制因素,因为一旦药物专利到期,就能够生产生物类似药,从而使市场更具竞争力,压低价格。

相似文献

1
Biologics: The Good, the Bad and the Future of Ear, Nose and Throat.生物制剂:耳鼻喉科的现状、问题与未来
Indian J Otolaryngol Head Neck Surg. 2024 Apr;76(2):2176-2181. doi: 10.1007/s12070-023-04309-9. Epub 2023 Nov 10.
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Biologics for chronic rhinosinusitis.用于慢性鼻-鼻窦炎的生物制剂。
Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD013513. doi: 10.1002/14651858.CD013513.pub2.
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Biologics for chronic rhinosinusitis.生物制剂治疗慢性鼻-鼻窦炎。
Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD013513. doi: 10.1002/14651858.CD013513.pub3.
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Surgical versus medical interventions for chronic rhinosinusitis with nasal polyps.慢性鼻-鼻窦炎伴鼻息肉的手术与药物治疗干预对比
Cochrane Database Syst Rev. 2014;2014(12):CD006991. doi: 10.1002/14651858.CD006991.pub2. Epub 2014 Dec 1.

本文引用的文献

1
Use of biologics for treatment of autoimmune inner ear disease.生物制剂治疗自身免疫性内耳疾病。
Am J Otolaryngol. 2022 Sep-Oct;43(5):103576. doi: 10.1016/j.amjoto.2022.103576. Epub 2022 Aug 5.
2
Intratympanic corticosteroids for sudden sensorineural hearing loss.鼓室内皮质类固醇治疗突发性聋。
Cochrane Database Syst Rev. 2022 Jul 22;7(7):CD008080. doi: 10.1002/14651858.CD008080.pub2.
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Immune-Mediated Sensorineural Hearing Loss in the Pediatric Population.儿童人群中的免疫介导的感音神经性听力损失。
Otolaryngol Head Neck Surg. 2022 Apr;166(4):768-771. doi: 10.1177/01945998211028796. Epub 2021 Jul 13.
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Biologics for Immune-Mediated Sensorineural Hearing Loss.用于免疫介导的感音神经性听力损失的生物制剂。
Otolaryngol Clin North Am. 2021 Aug;54(4):803-813. doi: 10.1016/j.otc.2021.05.005. Epub 2021 Jun 10.
6
Biologics in Otolaryngology: Past, Present, and Future.耳鼻喉科中的生物制剂:过去、现在和未来。
Otolaryngol Clin North Am. 2021 Aug;54(4):675-687. doi: 10.1016/j.otc.2021.04.001. Epub 2021 Jun 9.
7
Biologic Therapies for Allergic Rhinitis and Nasal Polyposis.变应性鼻炎和鼻息肉的生物学治疗。
Curr Allergy Asthma Rep. 2021 Jun 10;21(6):36. doi: 10.1007/s11882-021-01013-y.

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