凯普斯泰冷敷凝胶联合地奈德乳膏治疗儿童特应性皮炎的随机双盲对照研究

【摘要】 目的 评估凯普斯泰冷敷凝胶联合地奈德乳膏治疗儿童特应性皮炎（AD）的短期有效性和安全性。方法 采用随机、双盲、对照研究,2019年11月至2020年9月收集就诊于四川大学华西医院皮肤科的儿童AD患者60例,最终56例完成随访,试验组和对照组各28例。试验组前3 d早晚外涂地奈德乳膏,中午外涂凯普斯泰冷敷凝胶,后11 d早中晚外涂凯普斯泰冷敷凝胶,对照组前3 d早晚外涂地奈德乳膏,中午外涂安慰剂,后11 d早中晚外涂安慰剂,治疗2周。分别于治疗前、治疗（7 ± 3） d及治疗（14 ± 3） d随访,记录湿疹面积及严重程度指数（EASI评分）、瘙痒视觉模拟评分法（VAS）评分、研究者总体评分（IGA评分）、皮肤生活质量评分（DLQI评分）等临床指标及不良反应。结果 治疗1周时,试验组1例（3.57%）,对照组1例（3.57%）有效;治疗2周时,试验组12例（42.86%）有效,对照组2例（7.14%）有效;经秩和检验,治疗1周和2周时两组疗效差异有统计学意义（Z = -4.318、-5.474,均P < 0.05）。治疗前,试验组和对照组EASI、VAS、IGA、DLQI评分差异均无统计学意义（P > 0.05）;经非参数Friedman检验,两组EASI评分随治疗时间的变化差异具有统计学意义（χ2 = 45.720,P < 0.05）。经两因素重复测量方差分析,治疗1周后,两组间VAS评分差异有统计学意义（F = 10.738,P = 0.002）,IGA、DLQI评分差异无统计学意义（F = 0.066、0.804,P = 0.135、0.374）;治疗2周后,两组间VAS、IGA、DLQI评分差异均有统计学意义（F = 67.313、38.949、51.503,均P < 0.001）。研究期间,试验组和对照组各发生1例不良反应事件,均表现为外用药物部位刺痛感或刺激感,两组不良事件发生率差异无统计学意义（P > 0.05）。结论 短期应用凯普斯泰冷敷凝胶联合地奈德乳膏可有效治疗儿童AD,且与安慰剂比较未增加不良反应的发生。

Efficacy of a cooling gel containing calcium-based antimicrobial peptide compounds combined with desonide cream in the treatment of atopic dermatitis in children: a randomized,double-blind controlled clinical study

【Abstract】 Objective To evaluate short-term clinical efficacy and safety of a cooling gel containing calcium-based antimicrobial peptide compounds （CAPCS cooling gel） combined with desonide cream in the treatment of atopic dermatitis （AD） in children. Methods From November 2019 to September 2020, a randomized, double-blind controlled clinical trial was conducted in 60 children with AD enrolled from Department of Dermatology and Venereology, West China Hospital, Sichuan University. The 60 patients were randomly and equally divided into 2 groups: test group treated with topical desonide cream in the morning and evening as well as topical CAPCS cooling gel at noon during the first 3 days of treatment, followed by topical CAPCS cooling gel in the morning, at midday and in the evening for 11 days; control group treated with topical desonide cream in the morning and evening as well as topical CAPCS-free placebo gel at noon during the first 3 days of treatment, followed by topical CAPCS-free placebo gel in the morning, at midday and in the evening for 11 days. The treatment lasted 2 weeks. Finally, 56 AD patients completed the follow-up, and 28 in each group were included into the following analysis. Clinical indices, such as eczema area and severity index （EASI）, visual analogue scale （VAS）, investigator′s global assessment （IGA） and dermatology life quality index （DLQI）, were recorded before, 7 ± 3 days and 14 ± 3 days after the treatment, so were adverse reactions. Results After 1-week treatment, 1 patient in the test group and 1 in the control group showed response to the treatment, with the response rate being 3.57% in both groups; after 2-week treatment, 12 patients in the test group and 2 in the control group showed response to the treatment, with response rates being 42.86% and 7.14% respectively; there were significant differences in the treatment outcomes between the two groups after 1- and 2-week treatment （Z = -4.318,-5.474, respectively, both P < 0.05）. There was no significant difference in the EASI, VAS, IGA or DLQI score between the two groups before treatment （all P > 0.05）; nonparametric Friedman test showed a significant difference in the changing trend of the EASI score over time between the two groups （χ2 = 45.720, P < 0.05）. Two-way repeated measurement analysis of variance showed a significant difference in the VAS score （F = 10.738, P = 0.002）, but no significant difference in IGA or DLQI score between the test group and control group after 1-week treatment （F = 0.066, 0.804, P = 0.135, 0.374, respectively）; after 2-week treatment, there were significant differences in the VAS, IGA and DLQI score between the 2 groups （F = 67.313, 38.949, 51.503, respectively, all P < 0.001）. During the clinical study period, 1 adverse event occurred in the test group and control group each, which manifested as tingling or irritating sensation at the topically treated sites, and there was no significant difference in the incidence rate of adverse events between the two groups （P > 0.05）. Conclusion Short-term topical application of CAPCS cooling gel combined with desonide cream is effective for the treatment of AD in children, and does not increase the incidence of adverse reactions compared with the placebo.