Chapman M Shane, Schachner Lawrence A, Breneman Debra, Boguniewicz Mark, Gold Michael H, Shull Toni, Linowski Gregory J, Jaracz Eileen
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA.
J Am Acad Dermatol. 2005 Aug;53(2 Suppl 2):S177-85. doi: 10.1016/j.jaad.2005.04.061.
BACKGROUND/OBJECTIVE: Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD.
Two identically designed, independent, randomized, double-blind, 6-week studies--one pediatric and one adult--in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as "clear" or "almost clear" on the Investigator's Global AD Assessment) at end of study.
As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle ( P = .003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P = .03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging.
Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action.
背景/目的：他克莫司软膏已被批准用于治疗中重度特应性皮炎（AD）。我们旨在评估0.03%他克莫司软膏与赋形剂相比治疗轻至中度AD患者的疗效和安全性。
针对轻至中度AD患者开展了两项设计相同、独立、随机、双盲、为期6周的研究，一项针对儿童，一项针对成人。分析采用了617例患者的合并数据。主要疗效终点为研究结束时治疗成功（根据研究者整体AD评估定义为“清除”或“几乎清除”）的患者百分比。
早在第4天，使用他克莫司治疗的患者中有17.7%治疗成功，而使用赋形剂治疗的患者为9.8%（P = 0.003），到研究结束时，他克莫司组升至49.7%，赋形剂组为29.0%（P < 0.0001）。与赋形剂相比，他克莫司引起的用药部位瘙痒明显更少（29.0%对37.5%；P = 0.03）。他克莫司与赋形剂在用药部位皮肤烧灼感和刺痛发生率方面无差异。
0.03%他克莫司软膏对成人和儿童轻至中度AD的治疗有效且安全，起效迅速。
