Kang S, Lucky A W, Pariser D, Lawrence I, Hanifin J M
University of Michigan Medical Center, Ann Arbor 48109-0314, USA.
J Am Acad Dermatol. 2001 Jan;44(1 Suppl):S58-64. doi: 10.1067/mjd.2001.109812.
Tacrolimus ointment is a nonsteroidal topical immunomodulator that was formulated specifically for the treatment of atopic dermatitis. A total of 255 children, 2 to 15 years of age, with moderate to severe atopic dermatitis applied 0.1% tacrolimus ointment twice daily for up to 12 months to assess long-term safety and efficacy. Patients on average were treated with tacrolimus ointment for 279 days or 87% of study days. Substantial improvements in the signs and symptoms of atopic dermatitis, percent body surface area affected, and the patient's or parent's assessment of pruritus were observed during the first week of treatment and were maintained throughout the study. Transient skin burning and itching were the most common drug application site adverse events. Occurrence of these symptoms decreased after the first few days of treatment. There was no increased incidence of infections or other significant adverse events. Effectiveness of tacrolimus was maintained with prolonged daily use. Tacrolimus ointment (0.1%) is safe and effective for long-term treatment of atopic dermatitis in children.
他克莫司软膏是一种非甾体类外用免疫调节剂，专为治疗特应性皮炎而研制。共有255名2至15岁的中重度特应性皮炎患儿，每天两次涂抹0.1%他克莫司软膏，持续12个月，以评估其长期安全性和疗效。患者平均使用他克莫司软膏治疗279天，占研究天数的87%。在治疗的第一周观察到特应性皮炎的体征和症状、受影响的体表面积百分比以及患者或家长对瘙痒的评估有显著改善，且在整个研究过程中保持不变。短暂的皮肤烧灼感和瘙痒是最常见的用药部位不良事件。这些症状在治疗开始后的头几天之后发生率下降。感染或其他重大不良事件的发生率没有增加。长期每日使用可维持他克莫司的有效性。0.1%他克莫司软膏对儿童特应性皮炎的长期治疗是安全有效的。
