Hanifin Jon M, Paller Amy S, Eichenfield Lawrence, Clark Richard A, Korman Neil, Weinstein Gerald, Caro Ivor, Jaracz Eileen, Rico M Joyce
Oregon Health Sciences University, Portland, Oregon 97239, USA.
J Am Acad Dermatol. 2005 Aug;53(2 Suppl 2):S186-94. doi: 10.1016/j.jaad.2005.04.062.
This study was designed to evaluate the long-term safety and efficacy of 0.1% tacrolimus ointment in adult and pediatric patients with atopic dermatitis (AD).
A total of 408 adult and 391 pediatric patients with AD who had participated in a previous clinical trial of tacrolimus ointment were enrolled in this long-term, open-label, noncomparative trial. Tacrolimus ointment 0.1% was applied twice daily either intermittently or continuously to the affected areas. Efficacy and safety assessments included percent body surface area affected, Eczema Area and Severity Index score, individual signs of AD, and the incidence of adverse events.
A total of 799 patients were evaluated, of whom 300 (37.5%) were followed for more than 3 years (maximum 49 months). Improvements in efficacy parameters were observed within 1 week of treatment and continued for the duration of the study. Common adverse events included skin burning, pruritus, skin infection, skin erythema, flu-like symptoms, and headache. The incidence of adverse events, including cutaneous infections, did not increase with time on study.
Tacrolimus ointment therapy is a rapidly effective and safe treatment for the management of AD in pediatric and adult patients for up to 4 years.
本研究旨在评估0.1%他克莫司软膏治疗成人和儿童特应性皮炎（AD）的长期安全性和有效性。
共有408例成年和391例儿童AD患者参与了本次长期、开放标签、非对照试验，这些患者曾参加过他克莫司软膏的一项临床试验。0.1%他克莫司软膏每天两次间歇或持续涂抹于患处。疗效和安全性评估包括体表面积受累百分比、湿疹面积和严重程度指数评分、AD的个体体征以及不良事件的发生率。
共评估了799例患者，其中300例（37.5%）随访超过3年（最长49个月）。治疗1周内观察到疗效参数有所改善，且在研究期间持续改善。常见不良事件包括皮肤烧灼感、瘙痒、皮肤感染、皮肤红斑、流感样症状和头痛。不良事件的发生率，包括皮肤感染，并未随研究时间的延长而增加。
他克莫司软膏治疗是一种快速有效且安全的治疗方法，可用于治疗儿童和成人AD长达4年。
