他克莫司软膏治疗成人中、重度特应性皮炎的临床研究

目的:比较0.1%,0.03%他克莫司软膏与赋形剂治疗中、重度特应性皮炎(AD)的疗效和安全性.方法:采用随机、双盲、赋形剂平行对照临床研究方法,入选病例按1:1:1比例分为三组,分别随机接受0.1%,0.03%他克莫司软膏或赋形剂治疗,每天2次外搽患处,共3周.结果:有效率:他克莫司软膏0.1%组和0.03%组分别为88.9%和87.5%,赋形剂组为25%;治愈率:他克莫司软膏0.1%组和0.03%组分别为55.6%和50%,赋形剂组为25%,差异有统计学意义(P＜0.05).结论:他克莫司软膏(0.1%和0.03%)治疗成人中、重度特应性皮炎疗效好,安全和耐受性均良好.

Clinical Study of Tacrolimus Cream in Topical Treatment of Moderate to Severe Atopic Dermatitis in Adults

Objective:To observe the clinical efficacy and safety of 0.1% and 0.03% tacrolimus cream in topical treatment of moderate to severe atopic dermatitis in adults. Methods:A randomized, double-blinded, parallel placebo-controlled clinical study was conducted. The patients were divided into 3 groups randomly and treated topically with trail drugs, 2 times a day for 3 weeks. Results:Results showed that the effective rates of 0.1% and 0.03% tacrolimus cream were 88.9% and 87.5% respectively. The effective rate of placebo-controlled group was 25%. The cure rates of 0.1% and 0.03% tacrolimus cream were 55.6% and 50% respectively. The cure rate of placebo-controlled group was 25%. The difference was statistically significant (P<0.05). Conclusion:0.1% and 0.03% tacrolimus cream can be used in topical treatment of moderate to severe atopic dermatitis in adults, the study was showed that the medication is effective, safe and tolerable.