Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.
Drugs. 2023 Sep;83(14):1309-1314. doi: 10.1007/s40265-023-01935-z. Epub 2023 Sep 2.
Birch bark extract (Filsuvez; also known as the developmental name Oleogel-S10), a topical gel consisting of 10% dry birch bark extract and 90% sunflower oil, is the first therapy approved in the EU and UK for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged ≥ 6 months old. In the pivotal double-blind, randomized, vehicle-controlled, phase III EASE trial in patients with EB, the primary endpoint was met, in which birch bark extract relative to control gel significantly increased the proportion of patients with first complete target wound closure within 45 days. Moreover, patients treated with birch bark extract demonstrated several other positive findings in improving wound burden and wound-associated symptoms. The clinical benefits of birch bark extract were maintained in the 24-month open-label extension period of the EASE trial. Birch bark extract was generally well tolerated in patients with EB, with the tolerability profile being similar to that of control gel. Current evidence indicates that birch bark extract is an effective, emerging treatment option for patients with dystrophic and junctional EB.
桦树皮提取物（Filsuvez；也称为开发名称 Oleogel-S10），一种由 10%干桦树皮提取物和 90%葵花籽油组成的局部凝胶，是欧盟和英国批准的第一种用于治疗与营养不良性和交界性大疱性表皮松解症（EB）相关的部分厚度创面的疗法，适用于年龄≥6 个月的患者。在针对 EB 患者的关键、双盲、随机、对照凝胶的 III 期 EASE 试验中，主要终点达到，与对照凝胶相比，桦树皮提取物显著增加了 45 天内首次完全目标伤口闭合的患者比例。此外，接受桦树皮提取物治疗的患者在改善伤口负担和与伤口相关的症状方面也有其他一些积极发现。EASE 试验的 24 个月开放标签扩展期内维持了桦树皮提取物的临床益处。桦树皮提取物在 EB 患者中通常具有良好的耐受性，其耐受性与对照凝胶相似。现有证据表明，桦树皮提取物是营养不良性和交界性 EB 患者的一种有效、新兴的治疗选择。
