Department of Dermatology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Department of Dermatology, Center of Pediatric Dermatology, Sophia Children's Hospital, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands.
Br J Dermatol. 2024 Feb 16;190(3):342-354. doi: 10.1093/bjd/ljad437.
Increased Staphylococcus aureus (SA) colonization is considered an important factor in the pathogenesis of atopic dermatitis (AD). Antibacterial therapeutic clothing aims to reduce SA colonization and AD inflammation; however, its role in the management of AD remains poorly understood.
To investigate the effectiveness of antibacterial therapeutic clothing + standard topical treatment in patients with moderate-to-severe AD vs. standard therapeutic clothing + standard topical treatment; and, if effectiveness was demonstrated, to demonstrate its cost-effectiveness.
A pragmatic double-blinded multicentre randomized controlled trial (NCT04297215) was conducted in patients of all ages with moderate-to-severe AD. Patients were centrally randomized 1 : 1 : 1 to receive standard therapeutic clothing or antibacterial clothing based on chitosan or silver. The primary outcome was the between-group difference in Eczema Area and Severity Index (EASI) measured over 52 weeks. Secondary outcomes included patient-reported outcomes (PROs), topical corticosteroid (TCS) use, SA colonization, safety and cost-effectiveness. Outcomes were assessed by means of (generalized) linear mixed-model analyses.
Between 16 March 2020 and 20 December 2021, 171 patients were enrolled. In total, 159 patients were included (54 in the standard therapeutic clothing group, 50 in the chitosan group and 55 in the silver group). Adherence was high [median 7 nights a week wear (interquartile range 3-7)]. Median EASI scores at baseline and at 4, 12, 26 and 52 weeks were 11.8, 4.3, 4.6, 4.2 and 3.6, respectively, in the standard therapeutic clothing group vs. 11.3, 5.0, 3.0, 3.0 and 4.4, respectively, in the chitosan group, and 11.6, 5.0, 5.4, 4.6 and 5.8, respectively, in the silver group. No differences in EASI over 52 weeks between the standard therapeutic clothing group, the chitosan group [-0.1, 95% confidence interval (CI) -0.3 to 0.2; P = 0.53] or the silver group (-0.1, 95% CI -0.3 to 0.2; P = 0.58) were found. However, a small significant group × time interaction effect between the standard and silver groups was found (P = 0.03), in which the silver group performed worse after 26 weeks. No differences between groups were found in PROs, TCS use, SA skin colonization and healthcare utilization. No severe adverse events or silver absorption were observed.
The results of this study suggest no additional benefits of antibacterial agents in therapeutic clothing in patients with moderate-to-severe AD.
金黄色葡萄球菌（SA）定植增加被认为是特应性皮炎（AD）发病机制中的一个重要因素。抗菌治疗性衣物旨在减少 SA 定植和 AD 炎症；然而，其在 AD 管理中的作用仍知之甚少。
研究中重度 AD 患者使用抗菌治疗性衣物+标准局部治疗与使用标准治疗性衣物+标准局部治疗相比的疗效；如果证明有效，则证明其成本效益。
在所有年龄段的中重度 AD 患者中进行了一项实用的双盲、多中心随机对照试验（NCT04297215）。患者按 1:1:1 的比例接受中央随机分组，分别接受标准治疗性衣物或基于壳聚糖或银的抗菌衣物。主要结局为在 52 周内 Eczema Area and Severity Index（EASI）的组间差异。次要结局包括患者报告的结局（PROs）、局部皮质类固醇（TCS）使用、SA 定植、安全性和成本效益。采用（广义）线性混合模型分析进行评估。
在 2020 年 3 月 16 日至 2021 年 12 月 20 日期间，共纳入了 171 名患者。共纳入 159 名患者（标准治疗性衣物组 54 名，壳聚糖组 50 名，银组 55 名）。依从性很高[中位数每周 7 晚佩戴（四分位距 3-7）]。标准治疗性衣物组基线和第 4、12、26 和 52 周的 EASI 中位数分别为 11.8、4.3、4.6、4.2 和 3.6，壳聚糖组分别为 11.3、5.0、3.0、3.0 和 4.4，银组分别为 11.6、5.0、5.4、4.6 和 5.8。在 52 周内，标准治疗性衣物组、壳聚糖组[-0.1，95%置信区间（CI）-0.3 至 0.2；P = 0.53]或银组（-0.1，95%CI-0.3 至 0.2；P = 0.58）之间的 EASI 差异无统计学意义。然而，发现标准组和银组之间存在一个小的显著组×时间交互效应（P = 0.03），在该效应中，银组在 26 周后表现更差。在 PROs、TCS 使用、SA 皮肤定植和医疗保健利用方面，各组之间无差异。未观察到严重不良事件或银吸收。
本研究结果表明，在中重度 AD 患者中，治疗性衣物中的抗菌剂没有额外的益处。
