关键词: 皮炎, 特应性, 儿童, 复发, 润肤霜, 维持期

Abstract: 【Abstract】 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 between the two groups was 26.79% （95% confidence interval ［CI］: 10.09%, 43.49%; χ2 = 9.11, P = 0.003）; the 12-week follow-up during the maintenance period showed that the time to first relapse was 75.05 ± 25.07 days in the test group, which was significantly longer than that in the control group （49.55 ± 33.92 days, t′ = 4.52, P < 0.001）. At the study endpoint, the test group showed significantly decreased AD disease severity score （eczema area and severity index ［EASI］ score: 0.00 ［0.00, 1.20］ points vs. 0.60 ［0.00，4.00］ points）, pruritus visual analog scale （VAS） score （0.00 ［0.00, 2.00］ points vs. 2. 00 ［0.00, 10.00］ points）, and sleep VAS score （0.00 ［0.00, 0.00］ points vs. 1.00 ［0.00, 4.00］ points） compared with the control group （Z = -2.77, 2.43, 3.48, P = 0.006, = 0.015, < 0.001, respectively）, while there was no significant difference in the pH value at the lesional sites between the test group and control group （t = 0.97, P = 0.335）. For the group aged 0 - 2 years, the average daily glucocorticoid dosage at the weekend in AD children during the maintenance period was significantly lower in the test group than in the control group （Z = -1.97, P = 0.049）; for the group aged＞2 - 12 years, there was no significant difference in the average daily glucocorticoid dosage at the weekend between the two groups （Z = -0.25, P = 0.802）. During the study period, no significant difference was observed in the incidence of treatment-related adverse events between the test group （2/56, 3.57%） and control group （3/56, 5.36%; P = 1.000）, and no serious adverse events occurred. Conclusion Compared with the weekend treatment with topical glucocorticoids alone, the daily use of the test emollient combined with topical glucocorticoids at the weekend could markedly improve the remission rate of AD, prolong the time to relapse, and reduce the disease severity at relapse in children with AD during the maintenance period, which provides a new option for maintenance treatment of children with AD.

Key words: Dermatitis, atopic, Child, Recurrence, Emollient, Maintenance period