Supplementary Material for: A Randomized Comparative Study of Oral Corticosteroid Minipulse and Low-Dose Oral Methotrexate in the Treatment of Unstable Vitiligo

<b><i>Background:</i></b> Despite continued progress towards elucidation of the biochemical, genetic and immunopathological pathways in vitiligo, a definitive cure remains elusive. The initial therapy must be directed to arrest disease progression. Oral minipulse therapy (OMP) with betamethasone/dexamethasone has been tried and shown to be an effective modality to arrest the disease progression in vitiligo. <b><i>Objectives:</i></b> Methotrexate (MTX) is a time-tested effective treatment extensively used in various autoimmune disorders with good efficacy, safety and tolerability on a long-term basis. We intended to compare the efficacy of MTX with that of OMP in patients with unstable vitiligo vulgaris. <b><i>Patients and Methods:</i></b> In a prospective randomized open label study, 52 patients with vitiligo were divided into two groups. Patients in group 1 received 10 mg methotrexate weekly. Group 2 patients received corticosteroid OMP which comprised tablets of dexamethasone 2.5 mg (5 tablets), taken on 2 consecutive days in a week (total weekly dose of 5 mg dexamethasone). <b><i>Results:</i></b> In the MTX group, among 25 patients analyzed, during the course of treatment for 24 weeks, overall 6 patients developed new vitiliginous lesions. In the OMP group, 7/25 patients developed new lesions. Statistical correlation between the two groups showed no significance in the number of patients who developed new lesions (increasing disease activity) in either of the groups. At the end of the study, it was demonstrated that patients in both groups had a similar reduction in the vitiligo disease activity score. <b><i>Conclusion:</i></b> Our study demonstrated that both drugs are equally effective in controlling the disease activity of vitiligo. MTX can be used in patients with active vitiligo, wherever corticosteroids are contraindicated.

**背景**：尽管目前在阐明白癜风（vitiligo）的生化、遗传及免疫病理通路方面已取得持续进展，但仍难以实现根治。白癜风的初始治疗需以阻断疾病进展为核心目标。已有研究尝试采用倍他米松/地塞米松（betamethasone/dexamethasone）口服脉冲疗法（OMP），并证实该疗法可有效阻断白癜风的疾病进展。**研究目的**：甲氨蝶呤（MTX）是一款经过长期临床验证的有效治疗药物，广泛应用于多种自身免疫性疾病，长期使用兼具良好疗效、安全性与耐受性。本研究旨在对比甲氨蝶呤（MTX）与口服脉冲疗法（OMP）治疗不稳定型寻常型白癜风患者的疗效。**患者与研究方法**：本研究为一项前瞻性随机开放标签试验，共纳入52例白癜风患者并将其随机分为两组。第1组患者每周口服10mg甲氨蝶呤；第2组患者接受糖皮质激素口服脉冲疗法（OMP），具体方案为每周连续2天服用地塞米松片2.5mg（共5片），每周总地塞米松剂量为5mg。**研究结果**：在甲氨蝶呤组的25例可评估患者中，经过24周的治疗后，共有6例患者出现新发白癜风皮损。在口服脉冲疗法组中，25例患者中有7例出现新发皮损。两组间出现新发皮损（即疾病活动度升高）的患者数量无统计学显著性差异。研究结束时，两组患者的白癜风疾病活动度评分均出现相似程度的下降。**结论**：本研究证实，两种药物在控制白癜风疾病活动度方面疗效相当。当糖皮质激素存在使用禁忌时，甲氨蝶呤可用于活动期白癜风患者的治疗。