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局部载有丙戊酸钠的纳米弹性体治疗斑秃与传统局部皮质类固醇治疗的随机对照研究。

Topical sodium valproate-loaded nanospanlastics versus conventional topical steroid therapy in alopecia areata: a randomized controlled study.

机构信息

Dermatology Department, Kasr Alainy Faculty of Medicine, Cairo University, Cairo, Egypt.

Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.

出版信息

Arch Dermatol Res. 2024 Jan 3;316(2):64. doi: 10.1007/s00403-023-02785-1.

DOI:10.1007/s00403-023-02785-1
PMID:38170256
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10764371/
Abstract

BACKGROUND

A myriad of therapeutic modalities for alopecia areata are available; however, none is of high level of evidence, creating an immense need for the evaluation of other treatment modalities, of which topical sodium valproate is of potential role via proposed decrease in beta-catenin breakdown, despite its well-known side effect of hair fall as an oral therapy.

OBJECTIVE

Evaluating the efficacy and the safety of sodium valproate (SV)-loaded nanospanlastics, in comparison to topical corticosteroids, this is the currently available gold standard topical treatment for patchy AA.

METHODOLOGY

A total of 66 patients with patchy AA were randomly assigned to receive either topical mometasone furoate lotion or topical SV applied twice daily to all patches except a control patch, which was left untreated. Clinical, trichoscopic and biochemical assessments of beta-catenin tissue levels and Axin-2 gene expression were carried out at baseline and after 3 months.

RESULTS

Both therapeutic modalities were comparable. Potential efficacy was highlighted by significant improvement in the representative patch, the largest treated patch, to the control patch, the smallest untreated patch in both steroid and valproate groups (p = 0.027, 0.003 respectively). Both beta-catenin levels and Axin-2 gene expression were reduced after treatment, pointing to the inhibitory effect of dominating uncontrolled inflammatory milieu. Baseline beta-catenin was found to significantly negatively correlate with improvement in the representative patch in patients with baseline level above 0.42 ng/ml (p = - 0.042).

CONCLUSION

Both topical SV and steroids are of comparable modest efficacy. Thus, further evaluation of SV is due in combination with intralesional steroids and other anti-inflammatory treatment modalities, together with developing individualized approaches based on baseline beta-catenin level.

GOV IDENTIFIER

NCT05017454, https://clinicaltrials.gov/ct2/show/NCT05017454 .

摘要

背景

斑秃有多种治疗方法;然而,没有一种方法具有高水平的证据,因此迫切需要评估其他治疗方法,其中局部用丙戊酸钠通过减少β-连环蛋白的分解具有潜在作用,尽管其作为口服治疗的已知副作用是脱发。

目的

评估丙戊酸钠(SV)纳米粒载剂的疗效和安全性,并与局部皮质类固醇进行比较,这是目前治疗斑片状 AA 的标准局部治疗方法。

方法

共有 66 名斑片状 AA 患者被随机分为接受局部糠酸莫米松乳膏或局部 SV 治疗,每天两次涂于所有斑块,除了一个对照斑块外,对照斑块未接受治疗。在基线和 3 个月后进行临床、毛发镜和组织β-连环蛋白水平和 Axin-2 基因表达的生物化学评估。

结果

两种治疗方法具有可比性。在类固醇和丙戊酸钠组中,代表斑块(最大治疗斑块)与对照斑块(未治疗最小斑块)相比,都显示出显著改善(p=0.027,0.003),这表明潜在疗效。治疗后β-连环蛋白水平和 Axin-2 基因表达均降低,表明主导不受控制的炎症环境的抑制作用。在基线β-连环蛋白水平高于 0.42ng/ml 的患者中,基线β-连环蛋白与代表斑块的改善呈显著负相关(p=-0.042)。

结论

局部 SV 和皮质类固醇的疗效相当温和。因此,需要进一步评估 SV 与皮质内类固醇和其他抗炎治疗方法的联合应用,以及基于基线β-连环蛋白水平制定个体化方法。

GOV IDENTIFIER

NCT05017454,https://clinicaltrials.gov/ct2/show/NCT05017454。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecf6/10764371/d2744caf51c8/403_2023_2785_Fig5_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecf6/10764371/fa70e3c25f70/403_2023_2785_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecf6/10764371/937fdce23386/403_2023_2785_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecf6/10764371/6837702d599f/403_2023_2785_Fig3_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ecf6/10764371/d2744caf51c8/403_2023_2785_Fig5_HTML.jpg

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本文引用的文献

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An Updated Review on Current Treatment of Alopecia Areata and Newer Therapeutic Options.斑秃当前治疗方法及新型治疗选择的最新综述
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Alopecia areata: a review on diagnosis, immunological etiopathogenesis and treatment options.斑秃:诊断、免疫学发病机制及治疗选择的综述。
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Formulation of Sodium Valproate Nanospanlastics as a Promising Approach for Drug Repurposing in the Treatment of Androgenic Alopecia.
丙戊酸钠纳米弹性体的配方作为雄激素性脱发治疗中药物重新利用的一种有前景的方法。
Pharmaceutics. 2020 Sep 11;12(9):866. doi: 10.3390/pharmaceutics12090866.
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Targeting Wnt/β-Catenin Pathway for Developing Therapies for Hair Loss.靶向 Wnt/β-连环蛋白通路治疗脱发。
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Novel bergamot oil nanospanlastics combined with PUVB therapy as a clinically translatable approach for vitiligo treatment.新型佛手柑油纳米弹性体联合 PUVB 治疗作为一种临床转化的白癜风治疗方法。
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Dickkopf-1 Expression in Androgenetic Alopecia and Alopecia Areata in Male Patients.男性患者雄激素性脱发和斑秃中Dickkopf-1的表达
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Development of Pityriasis Amiantacea after Valproic Acid Therapy.丙戊酸治疗后石棉样糠疹的发生
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Hair Follicle Immune Privilege Revisited: The Key to Alopecia Areata Management.重新审视毛囊免疫赦免:斑秃治疗的关键
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Objective outcome measures: Collecting meaningful data on alopecia areata.客观结果测量:收集斑秃有意义的数据。
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Stress Signals, Mediated by Membranous Glucocorticoid Receptor, Activate PLC/PKC/GSK-3β/β-catenin Pathway to Inhibit Wound Closure.由膜性糖皮质激素受体介导的应激信号激活PLC/PKC/GSK-3β/β-连环蛋白通路以抑制伤口愈合。
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