Department of Dermatology, Shin-Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
J Dermatol. 2010 Feb;37(2):125-9. doi: 10.1111/j.1346-8138.2009.00774.x.
Vitiligo is a common acquired idiopathic hypomelanotic disorder characterized by circumscribed depigmented maculae. The conventional treatments are limited by their inconsistent and incomplete responses, relapse rate, inconvenience to apply, side-effects and especially long-term effects. The aim of the present study was to determine the efficacy and safety of topical tacrolimus as monotherapy for the treatment of face/neck vitiligo in Taiwan. This was a multicenter, open-label, non-comparative study. Patients were at least 16 years old and had vitiligo lesions with Vitiligo Index of Disease Activity score +1 or more on face or neck. Patients received a monotherapy with 0.1% of tacrolimus ointment twice daily for 12 weeks. The efficacy was measured by the percentage of repigmentation of target lesion, which was graded as minimal (1-25%), mild (26-50%), moderate (51-75%) or excellent (76-100%). Patients who had at least mild repigmentation were defined as responders. A total of 61 patients were enrolled in this investigation. Most of the patients showed repigmentation at week 4. At the end of treatment, all patients showed repigmentation and 45.9% of patients were responders. During the study, 15 adverse events related to the ointment were reported. All the reported adverse events were mild and similar to the well-known adverse effect of tacrolimus in the treatment of atopic dermatitis. Tacrolimus ointment is effective and well tolerated for the treatment of patients with vitiligo in Taiwan. It will be another drug of choice for persons with vitiligo who are unable to receive regular phototherapy and fear the side-effects of topical steroid in long-term use.
白癜风是一种常见的后天性、特发性、色素减退性疾病，表现为局限性色素脱失斑。传统的治疗方法存在疗效不确切、不持久、复发率高、使用不便、不良反应多等缺点，特别是长期应用有较大的副作用。本研究旨在评估他克莫司软膏外用治疗台湾地区面部/颈部白癜风的疗效和安全性。这是一项多中心、开放性、非对照研究。纳入标准为年龄至少 16 岁、面部或颈部至少有一处 Vitiligo Index of Disease Activity 评分≥+1 的白癜风患者。患者接受他克莫司软膏 0.1%，每日 2 次，外用治疗 12 周。疗效评估采用目标皮损复色率，分为轻度（1%-25%）、中度（26%-50%）、显著（51%-75%）和完全（76%-100%）复色。复色率≥26%定义为有效。共纳入 61 例患者，大多数患者在治疗 4 周时即开始出现复色，治疗结束时所有患者均出现复色，其中 45.9%的患者疗效显著。研究期间共有 15 例患者发生与用药相关的不良反应，均为轻度，与他克莫司软膏治疗特应性皮炎已知的不良反应相似。他克莫司软膏治疗台湾地区白癜风患者安全有效，可作为无法接受常规光疗或长期应用外用糖皮质激素治疗患者的另一种选择。
