单独使用1%胶态燕麦片乳膏可有效减轻轻至中度特应性皮炎的症状：两项临床研究结果
A 1% Colloidal Oatmeal Cream Alone is Effective in Reducing Symptoms of Mild to Moderate Atopic Dermatitis: Results from Two Clinical Studies.
作者信息
Lisante Toni Anne, Nunez Chris, Zhang Paul, Mathes Barbara M
出版信息
J Drugs Dermatol. 2017 Jul 1;16(7):671-676.
BACKGROUND: The epidermal barrier in patients with atopic dermatitis (AD) is deficient in ceramides and cathelicidins. Such epidermal defects may be a trigger for AD, thereby encouraging research toward development of skin-barrier-targeted preventive strategies.
METHODS: Two single-center, single-arm clinical trials were conducted (study 1, age greater than equal to 8 years and study 2, greater than equal to 10 years) in patients with mild to moderate AD to evaluate the effects of an over-the-counter 1% colloidal oatmeal cream administered for 14 days. Study 1 assessed the Eczema Area and Severity Index (EASI) and Investigator's Global Atopic Dermatitis Assessment (IGADA) on day 3, and itch severity using a Visual Analogue Scale (VAS) immediately after application as primary efficacy endpoints. In study 2, the primary efficacy endpoint was change from baseline in patients' assessment of itch. Both studies assessed safety through adverse event (AE) recording.
RESULTS: Study 1: 29 patients were enrolled (mean age [range], 27.07 [8 -67]). Comparing to baseline, EASI, IGADA, and itch were improved after the application, and improvements were maintained until day 14. Improvements of greater than/equal to 20% over baseline were noted in 53.6% and 25.0% patients at day 3 for EASI and IGADA scores, respectively, and in 37.9% patients for itch score immediately after the product application. On day 14, these percentages were 82.8%, 62.1%, and 85.7%, respectively.
STUDY 2: 30 patients were enrolled (mean age [range], 32.9 [10-80]). Itch severity and EASI score were significantly improved after product application and improvements were maintained until day 14. Transepidermal water loss values were significantly reduced and skin hydration was significantly increased at all assessment time points. No adverse events (AEs) were reported in study 2 and 2 AEs were reported by 1 patient in study 1.
CONCLUSIONS: The colloidal oatmeal cream was well tolerated and clinically effective in patients with mild to moderate AD.
J Drugs Dermatol. 2017;16(7):671-676.
.背景
特应性皮炎（AD）患者的表皮屏障中神经酰胺和cathelicidins缺乏。这种表皮缺陷可能是AD的触发因素，从而促使人们开展针对皮肤屏障的预防策略的研究。
方法
在轻度至中度AD患者中进行了两项单中心、单臂临床试验（研究1，年龄大于等于8岁；研究2，年龄大于等于10岁），以评估非处方1%胶态燕麦片乳膏使用14天的效果。研究1在第3天评估湿疹面积和严重程度指数（EASI）、研究者整体特应性皮炎评估（IGADA），并在用药后立即使用视觉模拟量表（VAS）评估瘙痒严重程度作为主要疗效终点。在研究2中，主要疗效终点是患者瘙痒评估相对于基线的变化。两项研究均通过记录不良事件（AE）来评估安全性。
结果
研究1：纳入29例患者（平均年龄[范围]，27.07[8 - 67]）。与基线相比，用药后EASI、IGADA和瘙痒情况均有改善，且改善持续至第14天。在第3天，EASI和IGADA评分较基线改善大于等于20%的患者分别为53.6%和25.0%，用药后立即瘙痒评分改善的患者为37.9%。在第14天，这些百分比分别为82.8%、62.1%和85.7%。
研究2：纳入30例患者（平均年龄[范围]，32.9[10 - 80]）。用药后瘙痒严重程度和EASI评分显著改善，且改善持续至第14天。在所有评估时间点，经表皮水分流失值显著降低，皮肤水合作用显著增加。研究2未报告不良事件，研究1有1例患者报告了2起不良事件。
结论
胶态燕麦片乳膏在轻度至中度AD患者中耐受性良好且临床有效。
《皮肤药物学杂志》。2017；16(7):671 - 676。
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