一项评价新护肤方案对埃塞俄比亚疣状足患者皮肤屏障功能影响的随机对照试验。

A randomized controlled trial to evaluate the effect of a new skincare regimen on skin barrier function in those with podoconiosis in Ethiopia.

机构信息

University of Hull, Hull, U.K.

Department of Health Sciences, University of York, York, U.K.

出版信息

Br J Dermatol. 2017 Nov;177(5):1422-1431. doi: 10.1111/bjd.15543. Epub 2017 Nov 1.

DOI:10.1111/bjd.15543

PMID:28374907

Abstract

BACKGROUND

Podoconiosis affects an estimated 3 million people in Ethiopia with a further 19 million at risk. Volcanic soil and pathogens enter skin breaches in the feet causing inflammation, lymphoedema and hyperkeratosis. There is no robust evidence on optimal podoconiosis skincare regimens to improve skin barrier function (SBF).

OBJECTIVES

To evaluate the effectiveness of a new, low-cost, evidence-based intervention to improve SBF in the lower limbs of those with podoconiosis.

METHODS

A randomized controlled trial (NCT02839772) was conducted over 3 months in two podoconiosis clinics (n = 193). The intervention comprised 2% (v/v) glycerine added to a reduced volume of soaking water. The control group received the current skincare regimen. Primary outcome measures were transepidermal water loss (TEWL) and stratum corneum hydration (SCH) at four specific sites on the lower limbs.

RESULTS

Improvement in SBF was observed in both groups across all measurement sites and time points, although this was significantly greater in the experimental group. TEWL reduced in both groups at all sites. For example, on top of the foot the estimated group difference in TEWL at visit 4 was 1·751 [standard error (SE) = 0·0390] in favour of the experimental group [t = 3·15, degrees of freedom (df) = 189·58, P = 0·002, 95% confidence interval (CI) 0·066-2·85], indicating a greater reduction in TEWL in the experimental group. Similarly, at the same site the estimated group difference in SCH at visit 4 was -2·041 (SE = 0·572) in favour of the experimental group (t = -3·56, df = 186·74, P < 0·001, 95% CI -3·16 to -0·91), indicating a greater increase in SCH in the experimental group. There were also significantly greater reductions in odour, number of wounds and largest foot circumference in the experimental vs. the control group.

CONCLUSIONS

The addition of 2% (v/v) glycerol to a reduced volume (83% reduction) of soaking water significantly improved SBF.

摘要

背景

在埃塞俄比亚，约有 300 万人受到 Podoconiosis 的影响，另有 1900 万人面临风险。火山土和病原体通过脚部的皮肤裂口进入，引起炎症、淋巴水肿和过度角化。目前没有强有力的证据表明哪种 Podoconiosis 皮肤护理方案最能改善皮肤屏障功能（SBF）。

目的

评估一种新的、低成本、基于证据的干预措施对改善 Podoconiosis 患者下肢 SBF 的有效性。

方法

在两家 Podoconiosis 诊所（n = 193）进行了一项为期 3 个月的随机对照试验（NCT02839772）。干预措施包括在减少的浸泡水中加入 2%（v/v）甘油。对照组接受当前的皮肤护理方案。主要结局指标是下肢四个特定部位的经皮水分丢失（TEWL）和角质层水合作用（SCH）。

结果

两组在所有测量部位和时间点的 SBF 均有改善，但实验组的改善更为显著。两组在所有部位的 TEWL 均降低。例如，在足背，第 4 次就诊时实验组 TEWL 的估计组间差异为 1.751（标准误 [SE] = 0.0390）[t = 3.15，自由度（df）= 189.58，P = 0.002，95%置信区间（CI）0.066-2.85]，表明实验组 TEWL 降低更多。同样，在同一部位，第 4 次就诊时实验组 SCH 的估计组间差异为 -2.041（SE = 0.572）[t = -3.56，df = 186.74，P < 0.001，95%CI -3.16 至 -0.91]，表明实验组 SCH 增加更多。实验组在气味、伤口数量和最大脚围方面的减少也明显大于对照组。