Department of Neuroradiology, University Hospital Freiburg, Breisacher Str. 64, 79106 Freiburg, Germany.
Eur J Radiol. 2011 Dec;80(3):e366-72. doi: 10.1016/j.ejrad.2010.12.074. Epub 2011 Apr 1.
To study the efficacy and safety of a new sclerosing gel of absolute ethanol in the percutaneous treatment of venous malformations (VM).
In this prospective, non-randomized multicenter study patients with clinically and by magnetic resonance imaging diagnosed VM were treated. Efficacy and safety of the gel was evaluated. Therapeutic outcome was judged at day 56 after the last sclerosing therapy. Blood ethanol levels of ethanol were measured after each infusion. Local and systemic adverse events were recorded.
Seventy-five (75) patients (age 4-46 y, mean 26 y) were treated in 172 sessions. Compared to no treatment, ethanol gel showed a complete cure rate of about 15% per session (p<0.00001). At the end of the last session, therapeutic outcome was complete (score 2) and partial (score 1) in 28 (37%) and 42 patients (56%), respectively, whereas treatment failure (score 0) was observed in 5 patients (7%). The plasmatic ethanol levels were very low (mean±SEM 0.03±0.06 g L(-1)), with only one patient above the legal 0.5 g L(-1) intoxication limit (0.6 g L(-1)). Forty-six (46) product-related adverse events (all local, none systemic) were reported. They included temporary mild isolated pain (N=21), inflammatory reactions (N=4), and local complications (7 skin necroses, 7 compressive neuropathies, 4 product leakage/fistula, 2 intralesional fibrous or granulomatous tissue, 1 dense node; 12.2% of the infusions). All local complications resolved spontaneously, except for 2 skin necroses requesting surgical paring.
Ethanol gel is an embosclerosing substance that provides high efficiency and improves safety of ethanol in the treatment of VM lesions.
研究新型无水乙醇硬化胶在静脉畸形（VM）经皮治疗中的疗效和安全性。
本前瞻性、非随机多中心研究纳入经临床和磁共振成像诊断为 VM 的患者。评估凝胶的疗效和安全性。治疗结果在最后一次硬化治疗后 56 天进行评估。每次输注后测量乙醇的血乙醇水平。记录局部和全身不良事件。
75 例（年龄 4-46 岁，平均 26 岁）患者在 172 次治疗中接受了治疗。与未治疗相比，乙醇凝胶的每次治疗完全治愈率约为 15%（p<0.00001）。最后一次治疗结束时，28 例（37%）和 42 例（56%）患者的治疗结果分别为完全（评分 2）和部分（评分 1），而 5 例（7%）患者治疗失败（评分 0）。血浆乙醇水平非常低（平均值±SEM 0.03±0.06 g L(-1)），只有 1 例患者的乙醇水平高于法定的 0.5 g L(-1)中毒限值（0.6 g L(-1)）。报告了 46 例（46%）与产品相关的不良事件（均为局部，无全身性）。包括暂时性轻度孤立性疼痛（N=21）、炎症反应（N=4）和局部并发症（7 例皮肤坏死、7 例压迫性神经病、4 例产品漏出/瘘管、2 例腔内纤维或肉芽肿组织、1 例致密节点；占输注的 12.2%）。除 2 例皮肤坏死需要手术切除外，所有局部并发症均自行缓解。
乙醇凝胶是一种硬化胶，可提高乙醇治疗 VM 病变的效率和安全性。
