Academic Vascular Surgical Unit, University of Hull, Hull, UK.
Br J Surg. 2011 Apr;98(4):501-10. doi: 10.1002/bjs.7394. Epub 2011 Jan 31.
Endovenous laser ablation (EVLA) is a popular minimally invasive treatment for varicose veins. Surgical treatment, featuring junctional ligation and inversion stripping, has shown excellent clinical and cost effectiveness. The clinical effectiveness of both treatments was compared within a randomized trial.
Some 280 patients were randomized equally into groups receiving either surgery or EVLA. Participants had primary, symptomatic, unilateral venous insufficiency, with isolated saphenofemoral junction incompetence, leading to reflux into the great saphenous vein. Outcomes included: quality of life (QoL), Venous Clinical Severity Score (VCSS), pain scores and time taken to return to normal function. Owing to the nature of the procedures, blinding was not possible.
Both groups had significant improvements in VCSS after treatment (P < 0.001), which resulted in improved disease-specific QoL (Aberdeen Varicose Vein Questionnaire, P < 0.001) and quality-adjusted life year (QALY) gain (P < 0.001). The pain and disability following surgery impaired normal function, with a significant decline in five of eight Short Form 36 (SF-36(®)) domains (P < 0.001 to P = 0.029). Periprocedural QoL was relatively preserved following EVLA, leading to a significant difference between the two treatments in pain scores (P < 0.001), six of eight SF-36(®) domains (P = 0.004 to P = 0.049) and QALYs (P = 0.003). As a result, surgical patients took longer to return to work and normal activity (14 versus 4 days; P < 0.001). Complications were rare.
EVLA was as effective as surgery for varicose veins, but had a less negative impact on early postintervention QoL.
NCT00759434 (http://www.clinicaltrials.gov).
静脉内激光消融术（EVLA）是一种治疗静脉曲张的微创方法。手术治疗，具有交界结扎和反转剥离，已显示出优异的临床和成本效益。在一项随机试验中比较了这两种治疗方法的临床效果。
将 280 名患者均等随机分为接受手术或 EVLA 治疗的两组。参与者患有原发性、有症状的单侧静脉功能不全，伴有孤立的隐股交界处功能不全，导致大隐静脉反流。结局包括：生活质量（QoL）、静脉临床严重程度评分（VCSS）、疼痛评分和恢复正常功能所需的时间。由于治疗方法的性质，无法进行盲法。
两组患者治疗后 VCSS 均有显著改善（P<0.001），导致疾病特异性 QoL（阿伯丁静脉曲张问卷，P<0.001）和质量调整生命年（QALY）获益（P<0.001）。手术引起的疼痛和残疾影响了正常功能，八个 SF-36（®）领域中的五个领域（P<0.001 至 P=0.029）显著下降。EVLA 后围手术期 QoL 相对保留，导致两种治疗方法之间疼痛评分（P<0.001）、八个 SF-36（®）领域中的六个（P=0.004 至 P=0.049）和 QALY（P=0.003）存在显著差异。因此，手术患者需要更长的时间才能返回工作和正常活动（14 天与 4 天；P<0.001）。并发症罕见。
EVLA 治疗静脉曲张与手术同样有效，但对早期干预后 QoL 的负面影响较小。
NCT00759434（http://www.clinicaltrials.gov）。
