含马齿苋等提取物的润肤剂改善(2~12)岁儿童缓解期特应性皮炎严重性的多中心、随机、平行对照临床研究

A multicenter,randomized,parallel controlled clinical study on the relationship between an emollient containing purslane extract and continuous improvement of itching in atopic dermatitis in children aged 2~12 years in remission period

目的观察含马齿苋等提取物的润肤剂是否对进入缓解期的(2~12)岁特应性皮炎(AD)患儿的临床严重性有持续改善性。方法采用多中心、随机、平行对照实验方法,在全国5家儿童医院中,入选(2~12)岁中度AD患儿297例,随机数字表法分试验组(148例)和对照组(149例)。AD急性期两组均在患处使用糠酸莫米松乳膏1次/d,全身外用润肤剂2次/d,疗程不超过4周,直至IGA≤1分,进入缓解期。缓解期时,试验组停用糠酸莫米松乳膏,继续全身使用润肤剂2次/d,而对照组停用药物和润肤剂。分别在基线、急性期4周(缓解期第0周)、缓解期第4周和第8周以及复发时,通过湿疹面积及严重度指数(EASI)评分对疾病的严重性进行评分,通过视觉模拟评分量表进行瘙痒严重性的评估,应用德国CK公司的皮肤屏障测量仪测量经表皮脱水(TWEL)值、皮肤含水量。结果主要结局是缓解期第4周、第8周时EASI及两组比较,差异有统计学意义。次要结局是缓解期第4周、第8周时两组瘙痒严重性VAS评分、皮肤含水量比较,两组差异有统计学意义;TWEL值在维持期第4周时无统计学差异,在维持期第8周时两组存在统计学差异。结论儿童AD患者维持期持续使用润肤剂可以改善皮损严重性,可以持续改善瘙痒、降低经表皮失水、增加皮肤含水量。

Objective To observe the correlation of a moisturizer containing purslane extract(hereinafter referred to as emollient)on the continuous improvement of pruritus in 2-12-year-old children with atopic dermatitis(AD).Methods A multicenter,randomized,parallel controlled trial was conducted.297 children with moderate AD aged 2 to 12 years old were enrolled in 5 hospitals in China.They were randomly divided into experimental group(n=148)and control group(n=149).In the acute stage,both groups were treated with momethasonefuroate cream once a day and emollients twice a day for 2 to 4 weeks,until the overall score of(IGA)≤1,and entered the remission stage.During the remission period,the experimental group stopped using momethasonefuroate cream and continued to use emollients twice a day,while the control group stopped using drugs and emollients.Respectively in the acute phase of the baseline,4 weeks(remission 0 weeks),remission 4 weeks and 8 weeks,and recurrence time,the severity score of this disease was evaluated by using eczema area and severity index(EASI)score,the severity of itching was evaluated by visual simulation assessment scale,and the value of trans-epidermal water loss(TWEL)and skin water content were measured by the skin barrier meter of CK company in Germany.Results The main outcome was comparison between EASI and the two groups at week 4 and 8 of remission,and the difference between the two groups was statistically significant.The secondary outcome VAS score of pruritus severity and skin water content were compared between the two groups at week 4 and 8 of the remission stage,the differences were statistically significant.TWEL value showed no statistical difference at week 4 of the maintenance period,while TWEL value showed statistical difference at week 8 of the maintenance period.Conclusion There is a correlation between continuous use of emollients and continuous improvement of the severity of skin lesions in children with AD,and it can continuously improve pruritus symptoms,reduce the trans-epidermal water loss and increase the skin water content.