他克莫司软膏治疗儿童中重度特应性皮炎随机双盲对照临床研究

目的 观察0．03％他克莫司软膏治疗儿童中重度特应性皮炎的疗效和安全性。方法 用随机双盲安慰剂平行对照临床试验，共人组30例儿童中重度特应性皮炎患者，用药3周，其中29例患者完成本试验。结果 治疗结束时，0．03％他克莫司软膏组痊愈率、显效率和有效率分别为35．7％（5／14），50．0％（7／14）和85．7％（12／14），与安慰组痊愈率6．7％（1／15）、显效率13．3％（2／15）和有效率为20．0％（3／15）相比，差异均有统计学意义。试验组主要药物不良反应多为轻到中度，且均为一过性；实验室检查治疗前后也未见明显异常。结论0．03％他克莫司软膏治疗儿童中重度特应性皮炎安全有效。

Randomized controlled double blind clinical trial of tarcrolimus ointment in children with moderate to severe atopic dermatitis

Objective To investigate the efficacy and safety of 0.03% tarcrolimus ointment in children with moderate to severe atopic dermatitis. Methods Using random, double-blind, placebo(excipient) control, pa- rallel comparative study, 30 patients aged 2 to 17 years old with moderate to severe atopic dermatitis for 3 weeks were enrolled. Twenty-nine patients completed the study. Results The cure rate of 0.03% tacrolimus ointment (trial group) was 35.7%(5/14), markedly improvement rate was 50.0%(7/14), and effective rate was 85.7%(12/14). The cure rate of placebo (control group) was 6.7%(1/15), markedly improvement rate was 13.3%(2/15), and effective rate was 20.0% (3/15). The cure rate, markedly improvement rate and effective rate between the two groups have significant difference(P<0.05). In 0.03% tarcrolimus ointment group, local irritation adverse events were common but all these adverse events were transient. Laboratory values showed no marked changes over time. Conclusion The 0.03% tarcrolimus ointment is safe and effective in the treatment of children with moderate to severe atopic dermatitis.