他克莫司软膏治疗成人和儿童特应性皮炎51例

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。

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

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 with atopic 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.