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在靶向治疗时代,0.1%他克莫司治疗白癜风的价值。

Value of tacrolimus 0.1% in the treatment of vitiligo in the era of targeted therapy.

作者信息

Duplaine A, Tannous J, Seneschal J, Ezzedine K, Passeron T, Dupin N, Quereux G, Beylot-Barry M, Chosidow O, Guillot B

机构信息

Department of Dermatology and Paediatric Dermatology, National Reference Centre for Rare Skin Disorders, Hôpital Saint-André, CNRS, UMR-5164, ImmunoConcEpT, F-33000 Bordeaux, France.

Centre of Evidence of the French Society of Dermatology, Paris, France.

出版信息

Ann Dermatol Venereol. 2025 Jun;152(2):103352. doi: 10.1016/j.annder.2025.103352. Epub 2025 Mar 11.

Abstract

BACKGROUND

Vitiligo, a prevalent depigmenting condition, affects both adults and children, significantly impacting their quality of life. The standard treatment approach involves the application of topical corticosteroids in conjunction with narrow-band ultraviolet B (UVB) phototherapy. A novel topical treatment, ruxolitinib (a Janus kinase inhibitor), has recently received approval. Notwithstanding the absence of marketing authorization for this particular indication in France, numerous practitioners have adopted the use of tacrolimus ointment 0.1% for the treatment of vitiligo, frequently in conjunction with phototherapy. The objective of this study is to present the benefit/risk ratio of tacrolimus in the treatment of vitiligo.

METHODS

A comprehensive literature search was conducted by the Centre of Evidence (CDP) of the French Society of Dermatology (SFD) to ascertain the efficacy and safety of topical calcineurin inhibitors (TCIs) in vitiligo. The search strategy encompassed meta-analyses (MAs) and prospective multicentric cohort studies.

RESULTS

Literature data - in particular three meta-analyses and one randomised controlled trial - confirm the superiority of tacrolimus versus placebo and its non-inferiority versus super-potent topical corticosteroids. In a subgroup analysis, tacrolimus suggests superior efficacy in children and in facial vitiligo. The combined use of tacrolimus and phototherapy exhibited synergistic efficacy.

CONCLUSION

Notwithstanding the market access of topical ruxolitinib, tacrolimus remains a viable treatment option for vitiligo, as substantiated by extant efficacy and safety in the literature. A recent decision of the French National Agency for the Safety of Medicines and Health Products (ANSM) authorized the compassionate prescription of tacrolimus and its reimbursement for patients.

摘要

背景

白癜风是一种常见的色素脱失性疾病,影响成人和儿童,严重影响他们的生活质量。标准治疗方法包括外用皮质类固醇联合窄谱中波紫外线(UVB)光疗。一种新型外用治疗药物鲁索替尼(一种Janus激酶抑制剂)最近已获批准。尽管在法国该特定适应症未获得上市许可,但许多从业者已采用0.1%他克莫司软膏治疗白癜风,通常与光疗联合使用。本研究的目的是呈现他克莫司治疗白癜风的获益/风险比。

方法

法国皮肤病学会(SFD)循证中心(CDP)进行了全面的文献检索,以确定外用钙调神经磷酸酶抑制剂(TCIs)治疗白癜风的疗效和安全性。检索策略包括荟萃分析(MAs)和前瞻性多中心队列研究。

结果

文献数据——特别是三项荟萃分析和一项随机对照试验——证实他克莫司优于安慰剂,且不劣于超强效外用皮质类固醇。在亚组分析中,他克莫司在儿童和面部白癜风中显示出更高的疗效。他克莫司与光疗联合使用表现出协同疗效。

结论

尽管外用鲁索替尼已上市,但他克莫司仍然是白癜风的一种可行治疗选择,文献中的现有疗效和安全性证明了这一点。法国国家药品和健康产品安全局(ANSM)最近的一项决定批准了他克莫司用于同情用药处方并为患者报销费用。

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