一种含青刺果油等提取物的润肤剂改善儿童特应性皮炎缓解期临床症状的多中心、随机、平行对照临床研究

Objective To evaluate the effect of an emollient containing Prinsepia utilis Royle oil extracts and other extracts on clinical symptoms and disease recurrence in children aged 2 - 12 years with atopic dermatitis (AD) in the remission period. Methods A multicenter, randomized, parallel-group, controlled clinical trial was conducted from December 2017 to September 2018. A total of 297 children aged 2 - 12 years with moderate AD were enrolled from 5 hospitals in China, and randomly divided into the test group (148 cases) and control group (149 cases) . In the acute stage, the two groups were both topically treated with mometasone furoate cream once a day on the skin lesions, and with an emollient containing Prinsepia utilis Royle oil extracts and other extracts twice a day throughout the whole body for 2 - 4 weeks. The children would be enrolled into the remission stage if their Investigator′s Global Assessment (IGA) score was ≤ 1 at following visits. In the remission stage, the test group was only topically treated with the emollient twice a day throughout the whole body, while mometasone furoate cream and the emollient were both withdrawn in the control group. At weeks 4, 8 and 12 in the remission stage, the recurrence of AD, eczema area and severity index (EASI) , children′s dermatology life quality index (CDQOL) and adverse events were evaluated. Statistical analysis was carried out with SAS 9.4 software by using t test for comparison of normally distributed continuous data between two groups, chi-square test for comparison of unordered categorical data, Kaplan-Meier method for analysis of survival rates, Cox regression analysis for evaluating the effect of different therapies on AD recurrence in children in the remission stage, and Logistic regression analysis for analysis of odds ratio (OR) of EASI or CDQOL at week 4 in the remission stage between the test group and control group. Results Of the 297 children with AD, 31 breached the clinical trial protocol, and 266 were included in the per protocol set (PPS) , including 132 in the test group and 134 in the control group. In the PPS, 114 and 106 patients completed the follow-up in the test group and control group respectively, and the recurrence rate was significantly lower in the test group (47, 41.23%) than in the control group (84, 79.25%; χ2 = 32.96, P 0.05) . Conclusion Maintenance treatment with the emollient containing Prinsepia utilis Royle oil extracts and other extracts can markedly reduce the recurrence risk in AD children, improve clinical symptoms, and enhance the quality of life. Key words: Dermatitis, atopic; Child; Randomized controlled trial; Remission period; Maintenance treatment; Emollients; Prinsepia utilis Royle oil