Hon K L, Tsang Y C, Pong N H, Lee Vivian W Y, Luk N M, Chow C M, Leung T F
Department of Paediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.
School of Pharmacy, The Chinese University of Hong Kong, Shatin, Hong Kong.
Hong Kong Med J. 2015 Oct;21(5):417-25. doi: 10.12809/hkmj144472. Epub 2015 Aug 28.
To investigate patient acceptability, efficacy, and skin biophysiological effects of a cream/cleanser combination for childhood atopic dermatitis.
Paediatric dermatology clinic at a university teaching hospital in Hong Kong.
Consecutive paediatric patients with atopic dermatitis who were interested in trying a new moisturiser were recruited between 1 April 2013 and 31 March 2014. Swabs and cultures from the right antecubital fossa and the worst eczematous area, disease severity (SCORing Atopic Dermatitis index), skin hydration, and transepidermal water loss were obtained prior to and following 4-week usage of a cream/cleanser containing lipid complex with shea butter extract (Ezerra cream; Hoe Pharma, Petaling Jaya, Malaysia). Global or general acceptability of treatment was documented as 'very good', 'good', 'fair', or 'poor'.
A total of 34 patients with atopic dermatitis were recruited; 74% reported 'very good' or 'good', whereas 26% reported 'fair' or 'poor' general acceptability of treatment of the Ezerra cream; and 76% reported 'very good' or 'good', whereas 24% reported 'fair' or 'poor' general acceptability of treatment of the Ezerra cleanser. There were no intergroup differences in pre-usage clinical parameters of age, objective SCORing Atopic Dermatitis index, pruritus, sleep loss, skin hydration, transepidermal water loss, topical corticosteroid usage, oral antihistamine usage, or general acceptability of treatment of the prior emollient. Following use of the Ezerra cream, mean pruritus score decreased from 6.7 to 6.0 (P=0.036) and mean Children's Dermatology Life Quality Index improved from 10.0 to 8.0 (P=0.021) in the 'very good'/'good' group. There were no statistically significant differences in the acceptability of wash (P=0.526) and emollients (P=0.537) with pre-trial products. When compared with the data of another ceramide-precursor moisturiser in a previous study, there was no statistical difference in efficacy and acceptability between the two products.
The trial cream was acceptable in three quarters of patients with atopic dermatitis. Patients who accepted the cream had less pruritus and improved quality of life than the non-accepting patients following its usage. The cream containing shea butter extract did not differ in acceptability or efficacy from a ceramide-precursor product. Patient acceptability is an important factor for treatment efficacy. There is a general lack of published clinical trials to document the efficacy and skin biophysiological effects of many of the proprietary moisturisers.
研究一种用于儿童特应性皮炎的乳膏/洁面产品组合的患者接受度、疗效及皮肤生物生理学效应。
香港一所大学教学医院的儿科皮肤科诊所。
2013年4月1日至2014年3月31日期间,连续招募了有兴趣试用新保湿剂的特应性皮炎儿科患者。在使用含乳木果油提取物脂质复合物的乳膏/洁面产品(伊泽拉乳膏;马来西亚八打灵再也赫制药公司)4周之前及之后,采集右侧肘前窝和最严重湿疹部位的拭子及培养物,获取疾病严重程度(特应性皮炎评分指数)、皮肤水合作用及经表皮水分流失情况。治疗的总体或一般可接受性记录为“非常好”“好”“一般”或“差”。
共招募了34例特应性皮炎患者;74%的患者报告治疗的总体可接受性为“非常好”或“好”,而26%的患者报告为“一般”或“差”;76%的患者报告伊泽拉洁面产品治疗的总体可接受性为“非常好”或“好”,而24%的患者报告为“一般”或“差”。在年龄、客观特应性皮炎评分指数、瘙痒、睡眠障碍、皮肤水合作用、经表皮水分流失、外用糖皮质激素使用情况、口服抗组胺药使用情况或先前润肤剂治疗的总体可接受性等使用前临床参数方面,各组间无差异。在“非常好”/“好”组中,使用伊泽拉乳膏后,平均瘙痒评分从6.7降至6.0(P = 0.036),儿童皮肤病生活质量指数平均从10.0提高到8.0(P = 0.021)。与试验前产品相比,洗剂(P = 0.526)和润肤剂(P = 0.537)的可接受性无统计学显著差异。与先前一项研究中另一种神经酰胺前体保湿剂的数据相比,两种产品在疗效和可接受性方面无统计学差异。
四分之三的特应性皮炎患者可接受试验乳膏。使用该乳膏后,接受该乳膏的患者比未接受的患者瘙痒减轻,生活质量改善。含乳木果油提取物的乳膏与神经酰胺前体产品在可接受性或疗效方面无差异。患者接受度是治疗疗效的一个重要因素。普遍缺乏已发表的临床试验来记录许多专利保湿剂的疗效及皮肤生物生理学效应。