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激光和射频消融研究(LARA 研究):一项比较射频消融和静脉内激光消融(810nm)的随机研究。

Laser and radiofrequency ablation study (LARA study): a randomised study comparing radiofrequency ablation and endovenous laser ablation (810 nm).

机构信息

Department of Vascular and Endovascular Surgery, E Floor, West Block, Queens Medical Centre, Nottingham NG7 2UH, UK.

出版信息

Eur J Vasc Endovasc Surg. 2010 Aug;40(2):246-53. doi: 10.1016/j.ejvs.2010.02.026.

Abstract

OBJECTIVES

There have been few randomised studies comparing Radiofrequency Ablation(RFA) with other endovenous techniques. The primary aim of this study was to determine whether RFA of the great saphenous vein (GSV) was associated with less pain and bruising than endovenous laser ablation (EVLA).

MATERIALS AND METHODS

This trial had two cohorts--patients with bilateral GSV incompetence causing varicose veins (VV) and those with unilateral GSV VVs. In total 87 legs were treated in this study. Limbs in the bilateral group were treated with RFA in one leg and EVLA in the other. In the unilateral group limbs were randomised to RFA or EVLA. RFA was performed using the Celon RFiTT system (Teltow, Germany). EVLA was performed using an 810nm Laser (Biolitec AG, Germany). Phlebectomies were performed as required. Primary endpoints were patient assessed pain and bruising measured by visual analogue scale (VAS). Secondary endpoints were patency assessed by duplex ultrasound at 6 weeks and 6 months.

RESULTS

In the bilateral group, RFA resulted in significantly less pain than EVLA on days 2-11 postoperatively. RFA also resulted in significantly less bruising than EVLA on days 3-9. There were no significant differences in mean post operative pain, bruising and activity scores in the unilateral group. Both RFA and EVLA resulted in occlusion rates of 95% at 10 days postoperatively.

CONCLUSIONS

RFA was less painful for patients than EVLA and produced less bruising in the postoperative period with comparable success rates but there was no difference in the unilateral group.

摘要

目的

比较射频消融(RFA)与其他静脉内技术的随机研究较少。本研究的主要目的是确定射频消融治疗大隐静脉(GSV)是否比静脉内激光消融(EVLA)引起的疼痛和瘀斑更少。

材料和方法

本试验有两个队列 - 双侧 GSV 功能不全引起静脉曲张(VV)和单侧 GSV VV 的患者。本研究共治疗 87 条肢体。在双侧组中,一条腿采用 RFA 治疗,另一条腿采用 EVLA 治疗。在单侧组中,肢体随机分为 RFA 或 EVLA。RFA 使用 Celon RFiTT 系统(德国 Teltow)进行。EVLA 使用 810nm 激光(Biolitec AG,德国)进行。需要时进行静脉切除术。主要终点是通过视觉模拟量表(VAS)评估患者的疼痛和瘀斑。次要终点是在 6 周和 6 个月时通过双功能超声评估通畅性。

结果

在双侧组中,RFA 在术后第 2-11 天的疼痛明显低于 EVLA。RFA 在术后第 3-9 天的瘀斑也明显少于 EVLA。在单侧组中,术后平均疼痛、瘀斑和活动评分无显著差异。RFA 和 EVLA 均在术后 10 天达到 95%闭塞率。

结论

与 EVLA 相比,RFA 对患者更疼痛,在术后期间产生的瘀斑更少,成功率相当,但在单侧组中无差异。

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