他克莫司软膏治疗特应性皮炎疗效观察及患者生活质量评价

目的:评价0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度特应性皮炎(AD)患者后其生活质量的改善情况。方法:采用多中心、双盲、随机、赋形剂平行对照的方法对327例中、重度AD患者给予0.03%和0.1%他克莫司软膏治疗3周,在治疗前、后采用皮肤病学生活质量指数量表对患者进行生活质量评价。结果:3周后成人组总体生活质量评分及症状、日常活动和休闲3个方面评分的改善有统计学差异(P<0.05)。儿童组总体生活质量评分及症状、休闲、学校、假期、日常活动、睡眠和治疗的影响各方面改善均有统计学差异(P<0.05)。幼儿组各方面的改善无统计学差异(P>0.05)。结论:0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度AD患者3周后,成人及儿童(>4岁)患者的生活质量均有显著改善。

The impact of tacrolimus ointment on health-related quality of life of Chinese adult and pediatric patients with atopic dermatitis

Objective:To analysis the quality of life(QOL)impact of tacrolimus in Chinese adult and pediatric patients with atopic dermatitis.Methods:A multicenter,randomized,double-blind,placebo-controlled clinical studies.Results:Among adults,both tacrolimus ointment groups experienced significant improvement of QOL score compared to vehicle control group in symptoms and feelings,daily activities,leisure and total QOL score(P < 0.05).Among children,tacrolimus ointment group demonstrated significant improvement compared to vehicle control group for all QOL scales and the personal relationship scale(P < 0.05).Among toddlers,there was no significant improvement in tacrolimus group in all QOL scale compared to vehicle group(P > 0.05).Conclusion:Topical tacrolimus ointment is associated with significant QOL improvements in both Chinese adult and pediatric patients with atopic dermatitis.