Paller A, Eichenfield L F, Leung D Y, Stewart D, Appell M
Division of Dermatology, Children's Memorial Hospital, Chicago, IL 60614, USA.
J Am Acad Dermatol. 2001 Jan;44(1 Suppl):S47-57. doi: 10.1067/mjd.2001.109813.
The safety and efficacy of 0.03% and 0.1% tacrolimus ointment for the treatment of atopic dermatitis were evaluated in a 12-week, randomized, double-blind, vehicle-controlled study of 351 children 2 to 15 years of age with moderate to severe atopic dermatitis. The mean age of patients was 6.1 years. A total of 61.5% of patients had severe atopic dermatitis at baseline. The mean percentage of body surface area affected was 47.7%, and 83.5% of patients were affected on the head and/or neck. Significantly more patients (P<.001) achieved clinical improvement of 90% or better with 0.03% or 0.1% tacrolimus ointment compared with vehicle. Significant improvements in the signs and symptoms of atopic dermatitis, percent body surface area affected, and the patient's assessment of pruritus were also observed early in treatment and were maintained throughout the study. Adverse events with a statistically significantly greater incidence in the 0.03% tacrolimus ointment treatment group compared with vehicle were limited to the sensation of skin burning, pruritus, varicella, and vesiculobullous rash ("blisters"). Varicella and vesiculobullous rash occurred at a low incidence (<5%). No adverse event occurred at a statistically higher incidence in the 0.1% tacrolimus ointment-treated group compared with vehicle. Tacrolimus ointment was equally safe for younger (2-6 years) and older (7-15 years) children. Both tacrolimus ointment concentrations (0.03% and 0.1%) were safe and significantly more effective than vehicle for the treatment of atopic dermatitis in children.
在一项针对351名2至15岁中重度特应性皮炎儿童的为期12周的随机、双盲、赋形剂对照研究中，评估了0.03%和0.1%他克莫司软膏治疗特应性皮炎的安全性和有效性。患者的平均年龄为6.1岁。共有61.5%的患者在基线时患有重度特应性皮炎。受影响的体表面积平均百分比为47.7%，83.5%的患者头部和/或颈部受到影响。与赋形剂相比，使用0.03%或0.1%他克莫司软膏实现90%或更好临床改善的患者明显更多（P<0.001）。在治疗早期也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对瘙痒的评估有显著改善，并在整个研究过程中保持。与赋形剂相比，0.03%他克莫司软膏治疗组中不良事件发生率在统计学上显著更高的情况仅限于皮肤烧灼感、瘙痒、水痘和水疱性皮疹（“水泡”）。水痘和水疱性皮疹的发生率较低（<5%）。与赋形剂相比，0.1%他克莫司软膏治疗组中不良事件的发生率在统计学上没有更高。他克莫司软膏对年幼儿童（2至6岁）和年长儿童（7至15岁）同样安全。两种他克莫司软膏浓度（0.03%和0.1%）在治疗儿童特应性皮炎方面均安全且比赋形剂显著更有效。
