VNUS ClosureFAST 射频消融与激光治疗静脉曲张的随机临床试验。

Randomized clinical trial of VNUS ClosureFAST radiofrequency ablation versus laser for varicose veins.

机构信息

Imperial Vascular Unit, Department of Surgery, Division of Surgery and Cancer, Imperial College, Charing Cross Hospital, London, UK.

出版信息

Br J Surg. 2010 Jun;97(6):810-8. doi: 10.1002/bjs.7091.

DOI:10.1002/bjs.7091

PMID:20473992

Abstract

BACKGROUND

Endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) are both associated with excellent technical, clinical and patient-reported outcomes for the treatment of varicose veins. The aim of this study was to compare the techniques in a randomized clinical trial.

METHODS

Consecutive patients with primary great saphenous vein reflux were randomized to EVLA (980 nm) or RFA (VNUS ClosureFAST) at a single centre. The primary outcome measure was postprocedural pain after 3 days. Secondary outcome measures were quality of life at 6 weeks, determined by the Aberdeen Varicose Vein Questionnaire (AVVQ) and Short Form 12 (SF-12), and clinical improvement assessed by the Venous Clinical Severity Score (VCSS). Analyses were performed on the basis of intention to treat using multivariable linear regression.

RESULTS

Some 131 patients were randomized to EVLA (64 patients) or RFA (67). Mean(s.d.) pain scores over 3 days were 26.4(22.1) mm for RFA and 36.8(22.5) mm for EVLA (P = 0.010). Over 10 days, mean(s.d.) pain scores were 22.0(19.8) mm versus 34.3(21.1) mm for RFA and EVLA respectively (P = 0.001). The mean(s.d.) number of analgesic tablets used was lower for RFA than for EVLA over 3 days (8.8(9.5) versus 14.2(10.7); P = 0.003) and 10 days (20.4(22.6) versus 35.9(29.4) respectively; P = 0.001). Changes in AVVQ, SF-12 and VCSS scores at 6 weeks were similar in the two groups: AVVQ (P = 0.887), VCSS (P = 0.993), SF-12 physical component score (P = 0.276) and mental component score (P = 0.449).

CONCLUSION

RFA using VNUS ClosureFAST was associated with less postprocedural pain than EVLA. However, clinical and quality-of-life improvements were similar after 6 weeks for the two treatments.

摘要

背景

静脉内激光消融术（EVLA）和射频消融术（RFA）在治疗静脉曲张方面均具有出色的技术、临床和患者报告的结果。本研究的目的是在一项随机临床试验中比较这两种技术。

方法

在一家单中心，将患有原发性大隐静脉反流的连续患者随机分配至 EVLA（980nm）或 RFA（VNUS ClosureFAST）。主要的结局测量是术后 3 天的疼痛程度。次要结局测量是 6 周时的生活质量，通过阿伯丁静脉曲张问卷（AVVQ）和 12 项简短健康调查量表（SF-12）进行评估，临床改善情况通过静脉临床严重程度评分（VCSS）进行评估。采用多变量线性回归对基于意向治疗的分析进行了分析。

结果

131 例患者被随机分配至 EVLA（64 例）或 RFA（67 例）。RFA 组的 3 天平均（标准差）疼痛评分是 26.4（22.1）mm，EVLA 组是 36.8（22.5）mm（P = 0.010）。10 天内，RFA 组和 EVLA 组的平均（标准差）疼痛评分分别为 22.0（19.8）mm 和 34.3（21.1）mm（P = 0.001）。3 天内，RFA 组比 EVLA 组使用的镇痛药片数少（8.8（9.5）片与 14.2（10.7）片；P = 0.003）和 10 天内（20.4（22.6）片与 35.9（29.4）片；P = 0.001）。6 周时，两组的 AVVQ、SF-12 和 VCSS 评分变化相似：AVVQ（P = 0.887），VCSS（P = 0.993），SF-12 生理成分评分（P = 0.276）和心理成分评分（P = 0.449）。