Hirokawa Masayuki, Ogawa Tomohiro, Sugawara Hiromitsu, Shokoku Shintaro, Sato Shoji
Ochanomizu Vascular and Vein Clinic, Tokyo, Japan.
Cardiovascular Center, Fukushima Daiichi Hospital, Koriyama, Fukushima, Japan.
Ann Vasc Dis. 2015;8(4):282-9. doi: 10.3400/avd.oa.15-00084. Epub 2015 Sep 9.
The aim of this study is to compare the clinical efficacy and safety of two laser wavelengths and fiber types in endovenous laser ablation (EVLA) of saphenous varicose veins of the lower limb.
Multi-center prospective randomized non-blind clinical trial.
From January 2007 to December 2011, 113 patients (113 limbs) with primary varicose veins were randomized into two groups. They were treated with radial 2ring fiber and 1470 nm laser in Group I (57 limbs) and bare-tip fiber and 980 nm laser in Group E (56 limbs) in order to ablate the saphenous vein. Vein occlusion rates at 12 weeks and pain in treated region were recorded as primary endpoint. Visual analogue scale (VAS) for assessment of pain, rates of bruising, complications and equipment failure were recorded as secondary endpoint of safety.
Occlusion rates at 12 weeks were 100% in both groups. Rates of pain (0% vs. 25.0%) and bruising (7.0% vs. 57.1%) were significantly lower in Group I (p <0.0001). VAS of pain was significantly lower on postoperative day 1, day 5 and 2nd week in Group I.
Treatment of saphenous varicose veins by EVLA using a 1470 nm laser and a radial 2ring fiber resulted in comparable occlusion rates at 12 weeks and less postoperative pain and bruising than EVLA with a 980 nm laser and a bare-tip fiber. (This article is a translation of Jpn J Vasc Surg 2014; 23: 964-971.).
本研究旨在比较两种激光波长和光纤类型在下肢大隐静脉曲张腔内激光消融术(EVLA)中的临床疗效和安全性。
多中心前瞻性随机非盲临床试验。
2007年1月至2011年12月,113例原发性静脉曲张患者(113条肢体)被随机分为两组。第一组(57条肢体)采用径向2环光纤和1470nm激光治疗,第二组(56条肢体)采用裸端光纤和980nm激光治疗,以消融大隐静脉。记录12周时的静脉闭塞率和治疗区域的疼痛作为主要终点。采用视觉模拟评分法(VAS)评估疼痛、瘀斑发生率、并发症和设备故障作为安全性的次要终点。
两组12周时的闭塞率均为100%。第一组的疼痛发生率(0%对25.0%)和瘀斑发生率(7.0%对57.1%)显著较低(p<0.0001)。第一组术后第1天、第5天和第2周的疼痛VAS显著较低。
使用1470nm激光和径向2环光纤进行EVLA治疗大隐静脉曲张,在12周时闭塞率相当,且术后疼痛和瘀斑比使用980nm激光和裸端光纤的EVLA更少。(本文是对《日本血管外科学杂志》2014年;23:964 - 971的翻译。)