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阿利特罗汀:严重慢性手部湿疹的综述。

Alitretinoin: A Review in Severe Chronic Hand Eczema.

机构信息

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2016 Sep;76(13):1271-1279. doi: 10.1007/s40265-016-0621-0.

DOI:10.1007/s40265-016-0621-0
PMID:27438290
Abstract

Chronic hand eczema is a common but frequently disabling skin condition which poses a significant social and economic burden. Although skin protection measures and topical therapies are fundamental in its management, some patients are refractory to first-line therapy with topical corticosteroids and require systemic treatment. Alitretinoin (9-cis-retinoic acid; Toctino(®)) is an endogenous vitamin A derivative with high binding affinity for both retinoic acid receptors and retinoid X receptors. Alitretinoin is the first systemic treatment to be approved in the EU for use in patients with severe chronic hand eczema unresponsive to potent topical corticosteroids. This article updates an earlier review of alitretinoin in this indication, focusing on recently published data. In clinical trials, treatment with alitretinoin 10 or 30 mg once daily for up to 24 weeks improved the severity and extent of severe chronic hand eczema in adults, with significantly more alitretinoin than placebo recipients achieving ratings of 'clear' or 'almost clear' hands on the Physician Global Impression of Change scale. For the most part, data obtained in real-world studies were consistent with those observed in clinical trials. Alitretinoin was generally well tolerated, with most adverse events being reversible, dose-dependent and of mild or moderate severity. Thus, oral alitretinoin is a useful treatment option for patients with severe chronic hand eczema unresponsive to potent topical corticosteroids.

摘要

慢性手部湿疹是一种常见但常导致残疾的皮肤疾病,给社会和经济带来重大负担。虽然皮肤保护措施和局部治疗是其管理的基础,但有些患者对外用皮质类固醇的一线治疗无反应,需要进行系统治疗。阿利特罗汀(9-顺式视黄酸;Toctino(®))是一种内源性维生素 A 衍生物,对视黄酸受体和视黄醛 X 受体均具有高亲和力。阿利特罗汀是欧盟批准的首个用于治疗对强效外用皮质类固醇无反应的严重慢性手部湿疹的全身性治疗药物。本文更新了早期关于该适应证的阿利特罗汀综述,重点关注最近发表的数据。在临床试验中,阿利特罗汀 10 或 30mg 每日 1 次治疗长达 24 周,改善了成人严重慢性手部湿疹的严重程度和范围,与安慰剂组相比,更多的阿利特罗汀组患者在医师整体印象变化量表上达到“清除”或“几乎清除”手部的评分。在大多数情况下,真实世界研究中获得的数据与临床试验观察到的数据一致。阿利特罗汀总体耐受性良好,大多数不良反应是可逆的、剂量依赖性的,且为轻度或中度。因此,口服阿利特罗汀是一种治疗对强效外用皮质类固醇无反应的严重慢性手部湿疹的有效治疗选择。

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本文引用的文献

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Safety of alitretinoin for severe refractory chronic hand eczema: Clinical studies and postmarketing surveillance.阿利维A酸治疗重度难治性慢性手部湿疹的安全性:临床研究与上市后监测
J Dermatolog Treat. 2016;27(1):54-8. doi: 10.3109/09546634.2015.1034080. Epub 2015 Apr 17.
2
Guidelines for diagnosis, prevention and treatment of hand eczema.手部湿疹的诊断、预防和治疗指南。
J Dtsch Dermatol Ges. 2015 Jan;13(1):e1-22. doi: 10.1111/ddg.12510_1.
3
A phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of alitretinoin (BAL4079) in the treatment of severe chronic hand eczema refractory to potent topical corticosteroid therapy.
Int J Mol Sci. 2023 Dec 27;25(1):362. doi: 10.3390/ijms25010362.
4
Drugs for the Treatment of Chronic Hand Eczema: Successes and Key Challenges.治疗慢性手部湿疹的药物:成就与关键挑战
Ther Clin Risk Manag. 2020 Dec 31;16:1319-1332. doi: 10.2147/TCRM.S292504. eCollection 2020.
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[Recommendations when switching therapy from immunosuppressive drugs to dupilumab in patients with atopic dermatitis].[特应性皮炎患者从免疫抑制药物转换为度普利尤单抗治疗时的建议]
Hautarzt. 2021 Apr;72(4):321-327. doi: 10.1007/s00105-020-04720-1.
6
Development of a Conceptual Model of Chronic Hand Eczema (CHE) Based on Qualitative Interviews with Patients and Expert Dermatologists.基于患者和皮肤科专家定性访谈的慢性手部湿疹(CHE)概念模型的构建。
Adv Ther. 2020 Feb;37(2):692-706. doi: 10.1007/s12325-019-01164-5. Epub 2020 Jan 19.
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Interventions for hand eczema.手部湿疹的干预措施。
Cochrane Database Syst Rev. 2019 Apr 26;4(4):CD004055. doi: 10.1002/14651858.CD004055.pub2.
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Systemic retinoids for treatment of recalcitrant IgA pemphigus.系统类视黄醇治疗难治性 IgA 天疱疮。
Orphanet J Rare Dis. 2018 Sep 18;13(1):163. doi: 10.1186/s13023-018-0899-y.
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Alitretinoin reduces erythema in inherited ichthyosis.阿利维 A 酸可减少遗传性鱼鳞病的红斑。
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Br J Dermatol. 2014 Feb;170(2):408-14. doi: 10.1111/bjd.12546.
6
Extended treatment with oral alitretinoin for patients with chronic hand eczema not fully responding to initial treatment.口服阿利维 A 酯治疗初始治疗未能充分缓解的慢性手部湿疹患者的延长治疗。
Clin Exp Dermatol. 2012 Oct;37(7):712-7. doi: 10.1111/j.1365-2230.2012.04396.x. Epub 2012 Jun 25.
7
Efficacy and tolerability of alitretinoin for chronic hand eczema under daily practice conditions: results of the TOCCATA open study comprising 680 patients.alitretinoin 治疗慢性手部湿疹的疗效和耐受性:TOCCATA 开放性研究结果,纳入 680 例患者。
Acta Derm Venereol. 2012 May;92(3):251-5. doi: 10.2340/00015555-1256.
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Low levels of alitretinoin in seminal fluids after repeated oral doses in healthy men.健康男性重复口服阿利维 A 酸后精液中的阿利维 A 酸浓度较低。
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Influence of alitretinoin on the pharmacokinetics of the oral contraceptive ethinyl estradiol/norgestimate.阿利维 A 酸对口服避孕药炔雌醇/去氧孕烯药代动力学的影响。
Clin Exp Dermatol. 2011 Apr;36 Suppl 2:4-11. doi: 10.1111/j.1365-2230.2011.04031.x.