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前瞻性随机临床试验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疗效:2 年随访。

Prospective randomized trial comparing endovenous laser ablation and surgery for treatment of primary great saphenous varicose veins with a 2-year follow-up.

机构信息

Division of Cardiovascular Surgery, Venous Centre, University Hospital of Geneva and Faculty of Medicine, Geneva University, Geneva, Switzerland.

出版信息

J Vasc Surg. 2010 Nov;52(5):1234-41. doi: 10.1016/j.jvs.2010.06.104.

DOI:10.1016/j.jvs.2010.06.104
PMID:20801608
Abstract

BACKGROUND

Endovenous laser therapy (EVLT) for ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity compared with high ligation and stripping (HL/S). Only a few randomized trials have reported early results. This prospective randomized trial compared EVLT (980 nm) and HL/S results at 1 and 2 years after the intervention.

METHOD

Patients with symptomatic varicose veins due to GSV insufficiency were randomized to HL/S (100 limbs) or EVLT (104 limbs). Four EVLT procedures failed primarily and were excluded. Phlebectomy and ligature of incompetent perforators were performed whenever indicated in both groups. Patients were re-examined clinically and by duplex ultrasound imaging preoperatively and at 12 days and at 1 and 2 years after treatment. Closure rate, complication rate, time to return to normal activity, the Aberdeen Varicose Vein Symptom Severity Score (AVVSS), the Varicose Venous Clinical Severity Score (VVCSS), and the Medical Outcome Study Short Form-36 scores were also recorded.

RESULTS

There were no differences in patient demographics, CEAP class, Widmer class, or severity scores between the groups. Simultaneous interventions did not differ between the groups. Similar times for the return to normal activity and scores for postoperative pain were reported. No major complications after treatment were recorded. HL/S limbs had significantly more postoperative hematomas than EVLT limbs, and EVLT patients reported more bruising. Follow-up at 1 year was 100% for HL/S and 99% for EVLT. Two GSVs in the EVLT group reopened and three partially reopened. No open GSVs occurred in HL/S limbs. Ninety-eight percent of the limbs in both groups were free of symptoms. VCSS, AVVSS, and Short Form-36 scores did not reveal any group differences. At 2 years, no differences compared with 1-year results were observed, except that two more GSVs in the EVLT group were partially reopened.

CONCLUSIONS

Abolition of GSV reflux and improvement in quality of life was similar after HL/S and EVLT. After EVLT, however, two GSVs were found completely reopened and five were partially reopened, which was significantly higher than after HL/S. A prolonged follow-up is ongoing.

摘要

背景

与高位结扎和剥脱术(HL/S)相比,静脉内激光治疗(EVLT)消融大隐静脉(GSV)被认为可最大程度降低术后发病率。仅有少数随机试验报告了早期结果。本前瞻性随机试验比较了干预后 1 年和 2 年时 EVLT(980nm)和 HL/S 的结果。

方法

患有 GSV 功能不全性静脉曲张症状的患者被随机分为 HL/S(100 条肢体)或 EVLT(104 条肢体)组。4 条 EVLT 主要操作失败,被排除在外。两组均行曲张静脉切除术和功能不全交通支结扎术。患者在术前、治疗后 12 天以及 1 年和 2 年时进行临床和双功能超声检查。还记录了闭合率、并发症发生率、恢复正常活动的时间、Aberdeen 静脉疾病症状严重程度评分(AVVSS)、静脉临床严重程度评分(VVCSS)和医疗结局研究 36 项简明健康调查问卷(SF-36)评分。

结果

两组患者的人口统计学特征、CEAP 分级、Widmer 分级或严重程度评分均无差异。同时干预在两组间无差异。报告了恢复正常活动的时间和术后疼痛评分相似。治疗后无重大并发症。HL/S 肢体的术后血肿明显多于 EVLT 肢体,EVLT 患者的瘀斑更多。HL/S 组的随访率为 100%,EVLT 组为 99%。EVLT 组有两条 GSV 再通,三条部分再通。HL/S 肢体无 GSV 再开放。两组肢体 98%均无症状。VVCSS、AVVSS 和 SF-36 评分均未显示任何组间差异。2 年时,除 EVLT 组有两条 GSV 部分再通外,与 1 年结果相比无差异。

结论

与 HL/S 相比,GSV 反流消除和生活质量改善在 HL/S 和 EVLT 后相似。然而,在 EVLT 后,两条 GSV 完全再通,五条部分再通,明显高于 HL/S。正在进行长期随访。

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