比较静脉腔内激光消融术与手术治疗原发性大隐静脉曲张的随机临床试验。

Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins.

作者信息

Darwood R J, Theivacumar N, Dellagrammaticas D, Mavor A I D, Gough M J

机构信息

Leeds Vascular Surgical Institute, The General Infirmary at Leeds, Great George Street, Leeds LS1 3EX, UK.

出版信息

Br J Surg. 2008 Mar;95(3):294-301. doi: 10.1002/bjs.6101.

DOI:10.1002/bjs.6101

PMID:18278775

Abstract

BACKGROUND

Endovenous laser ablation (EVLA) is a minimally invasive technique for treating varicose veins due to truncal vein incompetence. This randomized trial compared EVLA with conventional surgery in patients with primary saphenofemoral and great saphenous vein (GSV) reflux.

METHODS

Consecutive consenting patients with symptomatic varicose veins were randomized to EVLA 1 (stepwise laser withdrawal), EVLA 2 (continuous laser withdrawal) or surgery (saphenofemoral ligation, GSV stripping, multiple phlebectomies). Principal outcome measures were abolition of GSV reflux and improvement in Aberdeen Varicose Vein Symptom Score (AVVSS) 3 months after treatment.

RESULTS

GSV reflux was abolished in 41 of 42 legs treated with EVLA 1, 26 of 29 following EVLA 2 and 28 of 32 after surgery (P = 0.227). The median (interquartile range, i.q.r.) AVVSS improvement was similar: 9.38 (4.54-14.93) with EVLA 1, 10.26 (5.03-15.03) after EVLA 2 and 8.36 (4.54-13.21) following surgery (P = 0.694). Return to normal activity (median (i.q.r.) 2 (0-7) versus 7 (2-26) days; P = 0.001) and work (4 (2-7) versus 17 (7.25-33.25) days; P = 0.005) was quicker after EVLA by either method.

CONCLUSION

Abolition of reflux and improvement in disease-specific quality of life was comparable following both EVLA and surgery. The earlier return to normal activity following EVLA may confer important socioeconomic advantages.

REGISTRATION NUMBER

ISRCTN99270116 (http://www.controlled-trials.com).

摘要

背景

腔内激光消融术（EVLA）是一种用于治疗因主干静脉功能不全导致的静脉曲张的微创技术。这项随机试验比较了原发性大隐静脉股静脉反流患者接受EVLA与传统手术的疗效。

方法

连续入选的有症状静脉曲张患者被随机分为EVLA 1组（逐步回撤激光）、EVLA 2组（持续回撤激光）或手术组（大隐静脉股静脉结扎、大隐静脉剥脱术、多处静脉切除术）。主要观察指标为治疗3个月后大隐静脉反流消失及阿伯丁静脉曲张症状评分（AVVSS）改善情况。

结果

EVLA 1组治疗的42条腿中有41条大隐静脉反流消失，EVLA 2组治疗的29条腿中有26条，手术组治疗的32条腿中有28条（P = 0.227）。AVVSS改善的中位数（四分位间距，i.q.r.）相似：EVLA 1组为9.38（4.54 - 14.93），EVLA 2组为10.26（5.03 - 15.03），手术组为8.36（4.54 - 13.21）（P = 0.694）。两种EVLA方法术后恢复正常活动（中位数（i.q.r.）分别为2（0 - 7）天和7（2 - 26）天；P = 0.001）和恢复工作（分别为4（2 - 7）天和17（7.25 - 33.25）天；P = 0.005）均更快。