Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.
J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
Many case series have been published on treatments of varicose veins, but comparative randomized controlled trials remain sparse.
To compare the anatomic success rate, frequency of major complications, and quality-of-life improvement of endovenous laser ablation (EVLA), ultrasound-guided foam sclerotherapy (UGFS), and conventional surgery (CS), after 1-year follow-up.
A total of 240 consecutive patients with primary symptomatic great saphenous vein reflux were randomized to EVLA, UGFS, or CS, consisting of high ligation and short stripping. Primary outcome was anatomic success defined as obliteration or absence of the treated vein on ultrasound examination after 1 year. Secondary outcomes were complications, improvement of the "C" class of the CEAP classification, and improvement of disease-specific (Chronic Venous Insufficiency Quality-of-Life Questionnaire) and general (EuroQol 5) quality-of-life scores.
More than 80% of the study population was classified as C2 or C3 venous disease. After 1 year, the anatomic success rate was highest after EVLA (88.5%), followed by CS (88.2%) and UGFS (72.2%) (P < .001). The complication rate was low and comparable between treatment groups. All groups showed significant (P < .001) improvement of EuroQol 5 and Chronic Venous Insufficiency Quality-of-Life Questionnaire scores after therapy; 84.3% of all treated patients showed an improvement of the "C" of the CEAP classification.
After 1-year follow-up, EVLA is as effective as CS and superior to UGFS according to occlusion on ultrasound duplex. Quality of life improves after treatment in all groups significantly.
已经发表了许多关于静脉曲张治疗的病例系列,但比较性随机对照试验仍然很少。
比较静脉内激光消融术(EVLA)、超声引导泡沫硬化疗法(UGFS)和传统手术(CS)治疗后 1 年的解剖成功率、主要并发症发生率和生活质量改善。
共纳入 240 例原发性有症状大隐静脉反流的连续患者,随机分为 EVLA、UGFS 或 CS 组,包括高位结扎和短段剥脱术。主要结局为 1 年后超声检查显示治疗静脉闭塞或缺失的解剖成功率。次要结局为并发症、CEAP 分类“C”级的改善以及疾病特异性(慢性静脉功能不全生活质量问卷)和一般(EuroQol 5)生活质量评分的改善。
超过 80%的研究人群被归类为 C2 或 C3 静脉疾病。1 年后,EVLA 的解剖成功率最高(88.5%),其次是 CS(88.2%)和 UGFS(72.2%)(P<.001)。治疗组的并发症发生率低且相似。所有组在治疗后 EuroQol 5 和慢性静脉功能不全生活质量问卷评分均显著改善(P<.001);所有治疗患者中有 84.3%的患者 CEAP 分类的“C”级得到改善。
在 1 年随访后,EVLA 在超声双功能检查显示闭塞的情况下与 CS 一样有效,优于 UGFS。所有组在治疗后生活质量均显著改善。