某润肤霜联合周末外用糖皮质激素对延缓儿童特应性皮炎维持期疾病复发的随机、空白对照、多中心临床研究  

Efficacy of daily use of a test emollient combined with topical glucocorticoids applied at the weekend for delaying the recurrence of atopic dermatitis in children during the maintenance period:a randomized,blank-controlled,multicenter clinical study

作　　者：申春平[1] 李萍[2] 罗晓燕[3] 梁源[1] 刘盈[1] 赵牧童 王珊[1] 田晶[1] 焦磊[1] 汪洋[1] 罗珍[2] 余时娟 方晓[3] 王华[3] 马琳[1] Shen Chunping;Li Ping;Luo Xiaoyan;Liang Yuan;Liu Ying;Zhao Mutong;Wang Shan;Tian Jing;Jiao Lei;Wang Yang;Luo Zhen;Yu Shijuan;Fang Xiao;Wang Hua;Ma Lin(Department of Dermatology,Beijing Children′s Hospital,Capital Medical University,National Center for Children′s Health,China,Beijing 100045,China;Department of Dermatology,Shenzhen Children′s Hospital,Shenzhen 518000,China;Department of Dermatology,Children′s Hospital of Chongqing Medical University,Chongqing 400014,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]深圳市儿童医院皮肤科,深圳518000 [3]重庆医科大学附属儿童医院皮肤科,重庆400014

出　　处：《中华皮肤科杂志》2023年第8期756-762,共7页Chinese Journal of Dermatology

摘　　要：目的评价某润肤霜联合周末外用糖皮质激素对延缓儿童特应性皮炎(AD)维持期疾病复发的作用。方法以2021年3月至2022年2月首都医科大学附属北京儿童医院、重庆医科大学附属儿童医院和深圳市儿童医院就诊的AD患儿为研究对象,进行随机、空白对照、多中心的临床研究。127例0~12岁中度AD患儿经外用糖皮质激素联合润肤霜治疗,112例达到研究者整体评分(IGA)≤1分,按1∶1的比例随机分为试验组56例和对照组56例。试验组:润肤霜2次/d+周末外用糖皮质激素;对照组:周末外用糖皮质激素。两组患儿分别在基线、第2周(±3 d)、4周(±5 d)、12周(±7 d)或AD复发时随访评估,观察润肤霜对儿童AD维持期缓解率和对外用糖皮质激素使用量、瘙痒、睡眠及皮肤pH值等的影响,同时观察记录治疗相关不良事件的发生。研究终点定义为维持期AD复发,随访12周结束或发生严重不良事件。采用χ2检验、Kaplan-Meier生存分析、Satterthwaite t′检验、Mann-Whitney U检验等比较组间疗效指标。结果全分析集数据结果显示,试验组(56例)AD维持期维持缓解45例(80.36%),对照组(56例)维持缓解30例(53.57%),两组缓解率率差(95%CI)为26.79%(10.09%,43.49%),χ^(2)=9.11,P=0.003;观察至维持期第12周,试验组AD患儿首次复发时间为(75.05±25.07)d,明显长于对照组(49.55±33.92)d,t′=4.52,P<0.001。研究终点时,试验组AD疾病严重程度评分湿疹面积及严重程度指数(EASI)[0.00(0.00,1.20)分]、瘙痒视觉模拟尺(VAS)评分[0.00(0.00,2.00)分]、睡眠VAS评分[0.00(0.00,0.00)分]均显著低于对照组[0.60(0.00,4.00)分、2.00(0.00,10.00)分、1.00(0.00,4.00)分],差异均有统计学意义(Z=-2.77、2.43、3.48,P=0.006、=0.015、<0.001),而试验组与对照组皮损区pH值差异无统计学意义(t=0.97,P=0.335)。对于0~2岁组,试验组AD患儿维持期周末日均糖皮质激素使用量显著低于对照组(Z=-1.97,P=0.049);对于>2~12岁组,试�Objective To evaluate the efficacy of daily use of a test emollient combined with topical glucocorticoids applied at the weekend for delaying the recurrence of atopic dermatitis(AD)in children during the maintenance period.Methods A randomized,blank-controlled,multicenter clinical study was conducted in children with moderate AD from Beijing Children′s Hospital,Capital Medical University,Children′s Hospital of Chongqing Medical University and Shenzhen Children′s Hospital from March 2021 to February 2022.A total of 127 children aged 0-12 years with moderate AD were treated with topical glucocorticoids combined with emollients during the run-in period,112 out of them achieved the investigator′s global assessment(IGA)score≤1 point,and then the 112 patients were randomly divided into a test group(56 cases)and a control group(56 cases)at a ratio of 1∶1.Patients in the test group received treatment with a test emollient twice a day in combination with topical glucocorticoids applied at the weekend,and those in the control group were only treated with topical glucocorticoids at the weekend.Patients in the two groups were followed up at baseline,week 2(±3 d),week 4(±5 d),and week 12(±7 d),as well as at the time of AD relapse,and the effect of the test emollient on the remission rate of AD in children during the maintenance period was evaluated,so were its effects on the dosage of topical glucocorticoids,pruritus,sleep,and skin pH.The occurrence of treatment-related adverse events was evaluated and recorded at the same time.Study endpoints were defined as AD relapse during the maintenance period,end of 12-week follow-up,or occurrence of serious adverse events.Comparisons of efficacy indicators between groups were conducted by using chi-square test,Kaplan-Meier survival analysis,Satterthwaite t′test and Mann-Whitney U test.Results In the full-analysis set,45(80.36%)patients with AD maintained remission in the test group(56 cases)and 30(53.57%)in the control group(56 cases),and the remission rate difference

关 键 词：皮炎 特应性 儿童 复发 润肤霜 维持期 

分 类 号：R758.2[医药卫生—皮肤病学与性病学]