他克莫司软膏治疗儿童与成人特应性皮炎的随机双盲对照临床研究  

Double blind randomized controlled clinical trial of tacrolimus ointmentin the treatment of atopic dermatitis in children and adults

作　　者：魏明辉[1] 余碧娥[1] 陈连军[1] 朱敏[1] 杨勤萍[1] 傅雯雯[1] 郑志忠[1] 

机构地区：[1]复旦大学华山医院皮肤科,上海200040

出　　处：《中国临床药理学杂志》2006年第1期11-14,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价他克莫司软膏治疗特应性皮炎的疗效和安全性。方法用随机双盲平行对照方法,将成人特应性皮炎分为3组,分别外用0.1%,0.03%他克莫司软膏和赋形剂(对照组);将儿童特应性皮炎分为2组,分别外用0.03%他克莫司软膏和赋形剂(对照组);每日2次,疗程为3周;作症状和体征总评分、受累体表面积百分比(BSA%)和特应性皮炎面积与严重程度指数(EASI)评估;患者作视觉尺度VAS瘙痒症状测试及皮炎改善程度的自我评估。结果成人他克莫司软膏0.1%组、0.03%组和对照组的有效率分别为100%,80.0%和26.7%;儿童他克莫司软膏0.03%组和对照组的有效率分别为85.0%和33.3%。治疗组的有效率均显著高于对照组(P<0.001)。治疗后,治疗组的症状和体征总评分、BSA%和EASI显著下降,与患者自我评价符合。药物不良反应轻微。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有效、安全。Objective To evaluate the efficacy and safety of tacrolimus ointment in the treatment of atopic dermatitis in child and adult patients.Methods A total of 45 adults with atopic dermatitis applied tacrolimus ointment（0.1% or 0.03% ） or placebo twice daily for 3 weeks in the randomized, double- blind, parallel- controlled trial. A total of 42 children with atopic dermatitis applied 0.03% tacrolimus ointment or placebo twice daily for 3 weeks in the same way. Efficacy was evaluated by investigator observation and patient self - assessment. Results The clinical efficacy rates of 0.1%, 0.03% tacrolimus and the placebo group in adult patients were 100%, 80.0%, 26.7%. The efficacy rates of 0.03% tacrolimus group and the placebo group in children patients were 85.0% and 33.3%. 0. 1% ,0.03% Tacrolimus were significantly more effective than placebo in adults with atopic dermatitis. 0.03% Tacrolimus was significantly more effective than placebo in children with atopic dermatitis.The results are in consistent with patients self - assessment and investigators observation. The most common adverse events were the sensation of skin burning, pruritus, skin erythema. Conclusion The resuhs show that tacrolimus ointment in the treatment of atopic dermatitis in adult and child patients is effective and safe.

关 键 词：特应性皮炎 他克莫司软膏 安慰剂 

分 类 号：R758.31[医药卫生—皮肤病学与性病学] R986[医药卫生—临床医学]