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大疱性表皮松解症患者换药负担的减轻——油凝胶-S10的影响

Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa-Impact of Oleogel-S10.

作者信息

Bruckner Anna L, Murrell Dédée, Lee Lara Wine, Sprecher Eli, Kiritsi Dimitra, Maher Laura, Löwe Sandra, Donovan Maryanne, Kern Johannes S

机构信息

Department of Dermatology, University of Colorado School of Medicine, Aurora, Colorado, USA.

Department of Dermatology, St. George Hospital, University of new South Wales, Sydney, New South Wales, Australia.

出版信息

J Dermatol. 2025 Sep;52(9):1447-1451. doi: 10.1111/1346-8138.17884. Epub 2025 Aug 1.

DOI:10.1111/1346-8138.17884
PMID:40908727
Abstract

Epidermolysis bullosa (EB) is a severe genetic disorder marked by skin fragility and blistering from minimal trauma. Management relies on frequent and painful dressing changes. The EASE study (NCT03068780), the largest to date in EB, previously demonstrated accelerated wound healing and reduced wound burden for Oleogel-S10 (birch triterpenes) versus control gel. This post hoc analysis focused on dressing change frequency and related time and cost savings among patients with daily dressing changes at baseline (Oleogel-S10 n = 47, control gel n = 53). By Day 90, 35.6% of Oleogel-S10 patients required fewer daily changes versus 10.6% in the control group (p = 0.005). Weekly dressing changes reduced by 1.36 ± 0.24 with Oleogel-S10 compared to 0.41 ± 0.23 for control (difference -0.95 ± 0.33; p = 0.005). This translated to almost three fewer dressing changes every 2 weeks for Oleogel-S10 versus nearly one change for the control gel. The estimated time saved per week was 10.7 h with Oleogel-S10 (6.4 h patient, 4.3 h caregiver) versus 4.0 h with control (2.4 h patient, 1.6 h caregiver). Estimated dressing costs reduced by 59%, from $63.4 k to $25.9 k per patient over 27 months. Oleogel-S10 significantly reduced dressing frequency and time burden, with potential to ease the intensive demands of EB wound care.

摘要

大疱性表皮松解症(EB)是一种严重的遗传性疾病,其特征是皮肤脆弱,轻微创伤即可导致水疱形成。治疗依赖于频繁且痛苦的换药。EASE研究(NCT03068780)是迄今为止关于EB的最大规模研究,此前已证明与对照凝胶相比,Oleogel-S10(桦木三萜)可加速伤口愈合并减轻伤口负担。这项事后分析聚焦于基线时每天换药的患者(Oleogel-S10组n = 47,对照凝胶组n = 53)的换药频率以及相关的时间和成本节省情况。到第90天时,35.6%使用Oleogel-S10的患者每日换药次数减少,而对照组为10.6%(p = 0.005)。与对照组每周换药次数减少0.41±0.23次相比,使用Oleogel-S10后每周换药次数减少1.36±0.24次(差异为-0.95±0.33;p = 0.005)。这意味着Oleogel-S10每2周的换药次数比对照凝胶几乎少三次。使用Oleogel-S10每周估计节省的时间为10.7小时(患者6.4小时,护理人员4.3小时),而对照凝胶为4.0小时(患者2.4小时,护理人员1.6小时)。估计换药成本降低了59%,每位患者在27个月内从63.4千美元降至25.9千美元。Oleogel-S10显著降低了换药频率和时间负担,有可能缓解EB伤口护理的高强度需求。

相似文献

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本文引用的文献

1
Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the phase III EASE study.Oleogel-S10(桦树皮提取物)治疗大疱性表皮松解症的长期安全性和有效性:III期EASE研究的24个月结果
Br J Dermatol. 2025 May 19;192(6):1007-1017. doi: 10.1093/bjd/ljaf022.
2
Oleogel-S10 in Dystrophic Epidermolysis Bullosa: A Case Series Evaluating the Impact on Wound Burden Over Two Years.用于营养不良性大疱性表皮松解症的油凝胶-S10:一项评估两年内对伤口负担影响的病例系列研究
Adv Ther. 2024 Feb;41(2):867-877. doi: 10.1007/s12325-023-02749-x. Epub 2024 Jan 3.
3
Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study.
Oleogel-S10(桦木三萜)治疗大疱性表皮松解症的疗效和安全性:EASE 研究 III 期随机双盲阶段的结果。
Br J Dermatol. 2023 Jan 23;188(1):12-21. doi: 10.1093/bjd/ljac001.
4
A systematic literature review of the disease burden in patients with recessive dystrophic epidermolysis bullosa.隐性营养不良型大疱性表皮松解症患者疾病负担的系统文献回顾。
Orphanet J Rare Dis. 2021 Apr 13;16(1):175. doi: 10.1186/s13023-021-01811-7.
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Consensus reclassification of inherited epidermolysis bullosa and other disorders with skin fragility.遗传性大疱性表皮松解症及其他皮肤脆性疾病的共识性重新分类
Br J Dermatol. 2020 Oct;183(4):614-627. doi: 10.1111/bjd.18921. Epub 2020 Mar 11.
6
The challenges of living with and managing epidermolysis bullosa: insights from patients and caregivers.患有大疱性表皮松解症和对其进行管理的挑战:来自患者和护理者的见解。
Orphanet J Rare Dis. 2020 Jan 3;15(1):1. doi: 10.1186/s13023-019-1279-y.
7
Assessment of the Timing of Milestone Clinical Events in Patients With Epidermolysis Bullosa From North America.评估北美的大疱性表皮松解症患者里程碑临床事件的发生时间。
JAMA Dermatol. 2019 Feb 1;155(2):196-203. doi: 10.1001/jamadermatol.2018.4673.
8
Epidemiology of Inherited Epidermolysis Bullosa Based on Incidence and Prevalence Estimates From the National Epidermolysis Bullosa Registry.基于全国大疱性表皮松解症登记处的发病率和患病率估计的遗传性大疱性表皮松解症的流行病学。
JAMA Dermatol. 2016 Nov 1;152(11):1231-1238. doi: 10.1001/jamadermatol.2016.2473.
9
Pain care for patients with epidermolysis bullosa: best care practice guidelines.大疱性表皮松解症患者的疼痛护理:最佳护理实践指南。
BMC Med. 2014 Oct 9;12:178. doi: 10.1186/s12916-014-0178-2.
10
Living in dressings and bandages: findings from workshops with people with Epidermolysis bullosa.穿着敷料和绷带生活:大疱性表皮松解症患者研讨会的发现。
Int Wound J. 2013 Jun;10(3):274-84. doi: 10.1111/j.1742-481X.2012.00973.x. Epub 2012 Apr 4.