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口服硫唑嘌呤与口服小剂量脉冲类固醇治疗白癜风的比较:一项开放标签随机对照试验

Comparison of Oral Azathioprine and Oral Mini Pulse Steroid in the Treatment of Vitiligo: An Open-Label Randomized Controlled Trial.

作者信息

Jawade Sugat, Saoji Vikrant, Madke Bhushan, Singh Adarshlata

机构信息

From the Department of Dermatology, Jawaharlal Nehru Medical College, DMIHER, Sawangi (Meghe), Wardha, Maharashtra, India.

出版信息

Indian J Dermatol. 2023 Nov-Dec;68(6):591-597. doi: 10.4103/ijd.ijd_865_22. Epub 2024 Jan 9.

Abstract

BACKGROUND

Vitiligo is a common acquired depigmentory skin disorder supposed to be of autoimmune aetiology. Different immunosuppressants have been tried with varying success. Azathioprine has been less studied in vitiligo.

AIMS AND OBJECTIVES

To study the efficacy of oral azathioprine and compare with systemic steroid in the treatment of vitiligo.

MATERIALS AND METHODS

It was an interventional study with multi-armed (three), parallel group, an open-label, randomized controlled trial with allocation ratio of 1:1:1. Patients of vitiligo aged between 18 and 60 years having more than 5% body surface involvement were included in the study. Patients were divided into three groups. Group A-patients received oral azathioprine 50 mg OD daily, group B-patients received combination of oral azathioprine 50 mg OD and PUVASOL and group C-patients received combination of betamethasone oral mini pulse (OMP) and PUVASOL. All the groups were treated for 1 year. Repigmentation was evaluated by vitiligo area severity index (VASI), and stabilization was evaluated by vitiligo disease activity (VIDA).

RESULTS

Group A, group B and group C showed 24.24%, 53.24% and 47.28% improvement in VASI score, respectively, at the end of 1 year. Group B and group C showed statistically significant superior repigmentation as compared to azathioprine monotherapy. Though azathioprine and betamethasone showed equivalent efficacy, azathioprine has a better safety profile. Side effects were minimal in azathioprine groups, whereas 50% patients developed various side effects in group C.

CONCLUSION

Azathioprine is safe and effective option in the treatment of vitiligo.

摘要

背景

白癜风是一种常见的后天性色素脱失性皮肤病,被认为是自身免疫性病因。人们尝试了不同的免疫抑制剂,效果各异。硫唑嘌呤在白癜风方面的研究较少。

目的

研究口服硫唑嘌呤的疗效,并与系统性类固醇治疗白癜风的效果进行比较。

材料与方法

这是一项多臂(三组)、平行组、开放标签、随机对照试验的干预性研究,分配比例为1:1:1。年龄在18至60岁之间、体表受累超过5%的白癜风患者被纳入研究。患者分为三组。A组患者每天口服硫唑嘌呤50毫克,B组患者接受口服硫唑嘌呤50毫克和补骨脂素紫外线A光化学疗法(PUVASOL)的联合治疗,C组患者接受倍他米松口服小剂量脉冲疗法(OMP)和PUVASOL的联合治疗。所有组均治疗1年。通过白癜风面积严重程度指数(VASI)评估色素再生情况,通过白癜风疾病活动度(VIDA)评估病情稳定情况。

结果

1年后,A组、B组和C组的VASI评分分别改善了24.24%、53.24%和47.28%。与硫唑嘌呤单一疗法相比,B组和C组的色素再生在统计学上有显著优势。虽然硫唑嘌呤和倍他米松显示出同等疗效,但硫唑嘌呤的安全性更好。硫唑嘌呤组的副作用最小,而C组有50%的患者出现了各种副作用。

结论

硫唑嘌呤是治疗白癜风的安全有效选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9914/10869012/abdc81a10e8b/IJD-68-591-g001.jpg

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