随机对照临床试验观察隐静脉和穿通支静脉射频消融对静脉性溃疡愈合的影响（VUERT 试验）。
A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).
机构信息
Vascular and Endovascular Surgery Division, Department of Surgery, Universidade de São Paulo (USP), São Paulo, Brazil.
Surgical Division, Hospital Israelita Albert Einstein, São Paulo, Brazil.
出版信息
Phlebology. 2021 Apr;36(3):194-202. doi: 10.1177/0268355520951697. Epub 2020 Sep 14.
OBJECTIVES
To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence.
METHOD
This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS).
RESULTS
Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT).
CONCLUSIONS
RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome. Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.
目的
研究射频静脉内消融（RFA）治疗大隐静脉和交通静脉是否能提高静脉性溃疡（VLU）的愈合率并预防溃疡复发。
方法
这项前瞻性、开放标签、随机、对照、单中心试验纳入了 56 例 VLU 患者，分为：单纯加压治疗组（CR，N=29）和 RFA 联合加压治疗组（RF，N=27）。主要终点为 12 个月时的溃疡复发率；次要终点为 6、12 和 24 周时的溃疡愈合率、溃疡愈合速度和静脉临床严重程度评分（VCSS）。
结果
RF 组的复发率较低（p<0.001），治疗后 VCSS 均值也较低（p=0.001）。两组之间的愈合率没有显著差异。RF 组的愈合速度较快（p=0.049）。RF 组有 2 例出现 1 型静脉内热诱导血栓形成（EHIT）。
结论
RFA 联合加压治疗是 VLU 的一种极好的治疗方法，因为它安全、有效，能降低溃疡复发率和改善临床结局。clinicaltrials.gov，NCT03293836。
Zotero 插件