地奈德乳膏与丁酸氢化可的松乳膏治疗婴幼儿特应性皮炎的多中心、随机、平行对照临床研究

Abstract

Objective To evaluate the efficacy and safety of desonide 0.05% cream in the treatment of mild to moderate infantile atopic dermatitis (AD) . Methods A multicenter, randomized, open-labeled, active-controlled clinical trial was conducted. A total of 120 infants with AD were enrolled from Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, Children′s Hospital of Chongqing Medical University and Children′s Hospital of Fudan University between December 2016 and November 2017. These patients were randomly divided into 2 groups to be topically treated with desonide 0.05% cream (test group, n= 61) and hydrocortisone butyrate 0.1% cream (control group, n= 59) , respectively. After the treatment for 1, 2 and 3 weeks, the response rate, improvement of eczema area and severity index (EASI) and infants′ dermatitis quality of life (IDQOL) were evaluated, and adverse events and reactions were recorded. Statistical analysis was carried out with SAS 9.4 software using confidence interval method and non-inferiority test for the comparison of response rates between the test group and control group, two-sample t test for the comparison of quantitative data between two groups, paired t test for comparing pre- and post-treatment EASI scores and IDQOL scores. If the data were not normally distributed or there was heterogeneity of variance, Wilcoxon rank sum test was used for the comparisons of pre- and post-treatment EASI scores and IDQOL scores before and after the treatment, and chi-square test was used for the comparison of unordered categorical data between the test group and control group. Results At weeks 1, 2 and 3 after the initial treatment, analysis of the full analysis set (FAS) showed that 46 (86.79%) , 49 (92.45%) and 51 (96.23%) patients in the test group received improvement respectively, and 36 (83.72%) , 35 (81.40%) and 41 (95.35%) in the control group received improvement respectively. The non-inferiority test showed that the response rate in the test group was non-inferior to that in the control group (non-inferiority boundary value was -0.15) . At the baseline, 1, 2 and 3 weeks, the EASI scores in the test group were 4.57 ± 3.19, 0.72 ± 0.89, 0.45 ± 0.87 and 0.18 ± 0.40 respectively, and the EASI scores in control group were 4.50 ± 3.29, 1.03 ± 1.81, 0.62 ± 0.85 and 0.28 ± 0.82 respectively. Paired Wilcoxon rank sum test showed that the EASI scores in the test group and control group significantly decreased after the treatment for 1, 2 and 3 weeks compared with those at the baseline (the test group: T=-715.5, -9.4,-715.5, respectively, all P 0.05) . Paired Wilcoxon rank sum test showed that IDQOL scores in the test group significantly decreased at the above time points after the treatment compared with those at the baseline (all P 0.05) . Adverse reactions were observed in 12 (19.7%) patients in the test group, and 10 (16.9%) in the control group, and there was no significant difference in the adverse reactions between the two groups (χ2= 0.029, P > 0.05) . Conclusion The efficacy of desonide 0.05% cream in the treatment of mild to moderate infantile AD is equivalent to that of hydrocortisone butyrate 0.1% cream, so desonide 0.05% cream can be a treatment option for mild to moderate infantile AD. Key words: Dermatitis, atopic; Desonide; Hydrocortisone; Multicenter study; Randomized controlled trial; Infant