类人胶原蛋白修复敷料辅助治疗儿童特应性皮炎的临床研究  

Human-like collagen dressing in the adjunctive treatment of atopic dermatitis in children

作　　者：申春平[1] 刘晓雁 王榴慧 王华[4] 马琳[1] SHEN Chun-ping;LIU Xiao-yan;WANG Liu-hui(Department of Dermatology,Beijing Children’s Hospital,Capital Medical University,National Center for Children’s Health,Beijing 100045,China)

机构地区：[1]国家儿童医学中心·首都医科大学附属北京儿童医院皮肤科,北京100045 [2]北京儿科研究所附属儿童医院皮肤科 [3]复旦大学附属儿科医院皮肤科 [4]重庆医科大学附属儿童医院皮肤科

出　　处：《实用皮肤病学杂志》2023年第4期193-196,205,共5页Journal of Practical Dermatology

摘　　要：目的评价类人胶原蛋白修复敷料用于治疗轻、中度儿童特应性皮炎(AD)的有效性和安全性。方法采用多中心、随机、双盲、对照研究的方法,共入组AD患儿80例,分为两组。试验组40例,外用丁酸氢化可的松乳膏(1周)+类人胶原蛋白修复敷料(4周);对照组40例,外用丁酸氢化可的松乳膏(1周)+不含类人胶原蛋白的敷料基质(4周),评估基线、第7天、第14天及第28天时两组患儿皮肤干燥程度、皮肤屏障功能改善情况、皮损严重程度评分、生活质量改善情况及不良事件和不良反应的发生情况。结果全分析集数据分析结果显示,(1)患儿经治疗后皮肤干燥程度明显改善,试验组优于对照组。试验组基线(38例)及治疗第4周(37例)时皮肤干燥程度值分别为1.29±0.46和0.27±0.45,对照组基线(39例)及治疗第4周(37例)时皮肤干燥程度值分别为1.28±0.46和0.81±0.46;两组间前后变化率比较,差异有显著统计学意义(P<0.001)。(2)两组患儿经治疗后皮肤屏障功能明显改善,试验组优于对照组。试验组患儿在基线(28例)及治疗第4周(27例)时,经表皮水分丢失(TEWL)分别为19.13±3.26和11.26±1.44;表皮含水量分别为22.16±6.34和42.52±1.99;对照组患儿在基线(29例)及治疗第4周(27例)时,TEWL分别为25.65±10.72和16.40±4.96,表皮含水量为25.31±9.28和39.20±12.36;TEWL两组前后变化率比较,差异有统计学意义(P<0.05);表皮含水量两组前后变化率比较,差异有统计学意义(P<0.05)。(3)两组患儿经治疗后皮损严重程度减轻,两组间差异无统计学意义(P>0.05);(4)两组患儿经治疗后4周,1~6岁患儿生活质量明显改善,试验组优于对照组(P≤0.01);7~12岁患儿生活质量无明显差异(P>0.05);(5)本研究期间无不良事件及严重不良事件的发生。结论类人胶原蛋白修复敷料对缓解轻中度儿童AD的皮肤干燥及恢复皮肤屏障功能疗效确切,耐受性好,可作为AD患儿辅助治疗选择方�Objective To evaluate the efficacy and safety of human-like collagen dressing in the adjunctive treatment of mild-to-moderate atopic dermatitis(AD)in children.Methods A multicenter,randomized,double-blind,controlled clinical trial was conducted.A total of 80 children with AD were enrolled and randomly divided into 2 groups to be topically treated with 0.1%hydrocortisone ointments+human-like collagen(test group,n=40)and 0.1%hydrocortisone ointments+human-like collagen matrix(control group,n=40).The improvement of skin dryness,skin barrier function,severity of AD and quality of life were evaluated at baseline,1 week,2 weeks and 4 weeks,so was the incidence of adverse reactions.Results Analysis of full analysis set(FAS)data results were shown as follows:①he skin dryness of all patients were obviously improved after treatment,the test group was superior to the control group(P<0.001);②The skin barrier function of the two groups were significantly improved than baselines,especially the TEWL and hydration(P<0.05);③The severity of skin lesions of all patients were reduced after treatment,while there were no significant difference between the two groups(P>0.05);④The quality of life of children aged 1 to 6 years was significantly improved after 4 weeks of treatment,the test group was better than that in the control group(P≥0.01);⑤The incidence of adverse events in the two groups was 13.2%and 7.7%,there was no significant difference between them(P>0.05),and no serious adverse reactions occurred.Conclusion Human-like collagen dressing was effective in relieving the skin dryness and restoring the function of skin barrier in mild children with AD.It maybe one of adjuvant therapy options for children with mild AD.

关 键 词：皮炎 特应性 儿童 类人胶原蛋白修复敷料 皮肤干燥 

分 类 号：R758.23[医药卫生—皮肤病学与性病学]