他克莫司软膏治疗成人和儿童特应性皮炎51例

Efficacy and safety of tacrolimus ointment in treatment of atopic dermatitis of child and adult in 51 patients

目的:评价他克莫司软膏治疗特应性皮炎的疗效和安全性。方法:运用随机双盲平行对照方法,将成人特应性皮炎分为3组(每组均15例),分别外用0.1%,0.03%他克莫司软膏和赋形剂;将儿童特应性皮炎分为2组,分别外用0.03%他克莫司软膏(21例)和赋形剂(21例)。每日2次,疗程为3wk。结果:成人他克莫司软膏0.1%组、0.03%组和赋形剂对照组的有效率分别为100%,80%和27%;儿童他克莫司软膏0.03%组和赋形剂对照组的有效率分别为85%和33%。成人和儿童他克莫司软膏治疗组的有效率均显著高于赋形剂组(P<0.01),症状和体征显著缓解。成人他克莫司软膏0.1%组,0.03%组和赋形剂对照组不良反应发生率分别为47%,40%和27%(P>0.05)。不良反应主要为用药部位的灼热、瘙痒、红斑等,大部分可自行消退。结论:0.1%和0.03%他克莫司软膏治疗成人特应性皮炎及0.03%他克莫司软膏治疗儿童特应性皮炎是有效和安全的。

AIM： To evaluate the efficacy and safety of tacrolimus ointment in the treatment of atopic dermatitis of child and adult patients. METHODS： Forty-five adults with atopic dermatitis were divided into three groups with 15 in each, were applied with tacrolimus ointment （0. 1% or 0.03 %） or vehicle twice daily for 3 wk in a randomized, double-blind, parallel-controlled study. Another 42 children withatopic dermatitis were divided into two groups with 21 patients under 0.03 % tacrolimus ointment and 21 patients for vehicle treatment in the same way for a course of 3 wk. RESULTS： The clinical efficacy rates of 0.1%, 0.03 % tacrolimus groups and the vehicle group in the adult patients were 100 %, 80 %, 27 %. The efficacy rates of 0.03 % tacrolimus group and the vehicle group in child patients were 85 % and 33 %. 0.1% and 0.03 % tacrolimus were significantly more effective than vehicle in adult, while 0.03 % tacrolimus was more effective than vehicle in children with atopic dermatitis （ P 〈 0. 01 ）. Adverse reaction rates of 0.1 % , 0.03 % tacrolimus groups and the vehicle group in the adult patients were 47 %, 40%, 27 % （P〉0.05）, respectively. The most common adverse reactions were the sensation of skin burning, pruritus and skin erythema. CONCLUSION： The tacrolimus ointment in the treatment of atopic dermatitis in adult and child patients is effective and safe.