前瞻性双盲随机对照试验研究射频与激光治疗静脉曲张患者大隐静脉的效果。
A prospective double-blind randomized controlled trial of radiofrequency versus laser treatment of the great saphenous vein in patients with varicose veins.
机构信息
St George's Vascular Institute, St James' Wing, St George's Hospital, London, United Kingdom.
出版信息
Ann Surg. 2011 Dec;254(6):876-81. doi: 10.1097/SLA.0b013e318230af5a.
BACKGROUND
Endovenous ablation of varicose veins using radiofrequency ablation (RFA) and endovenous laser therapy (EVLT) has reported advantages over traditional open surgical treatment. There is little evidence comparing the efficacy and patient-reported outcomes between the 2 endovenous solutions. This study compares the RFA and EVLT strategies in a prospective double-blind clinical trial.
METHODS
Consecutive patients with primary unilateral great saphenous vein (GSV) reflux undergoing endovenous treatment were randomized to RFA (VNUS ClosureFAST) or EVLT (810-nm diode laser). The primary outcome measure was GSV occlusion at 3 months after treatment. Secondary outcome measures were occlusion at 7 days, postoperative pain, analgesic requirement, and bruising, assessed at day 7 after surgery. Quality of life (QoL) was assessed preoperatively and 3 months after surgery using the Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D.
RESULTS
A total of 159 patients were randomized to RFA (79 patients) or EVLT (80 patients). Groups were well matched for demographics, disease extent, severity, and preoperative QoL. Duplex scanning confirmed 100% vein occlusion at 1 week in both groups. At 3 months, occlusion was 97% for RFA and 96% for EVLT; P = 0.67. Median (interquartile range) percentage above-knee bruise area was greater after EVLT 3.85% (6.1) than after RFA 0.6% (2); P = 0.0001. Postoperative pain assessed at each of the first 7 postoperative days was less after RFA (P = 0.001). Changes in the AVVQ (P = 0.12) and EQ-5D (P = 0.66) at 3 months were similar in both groups.
CONCLUSIONS
RFA and EVLT offer comparable venous occlusion rates at 3 months after treatment of primary GSV varices; with neither modality proving superior. RFA is associated with less periprocedural pain, analgesic requirement, and bruising.
REGISTRATION NUMBER
ISRCTN63135694 (http://www.controlled-trials.com).
背景
射频消融（RFA）和静脉内激光治疗（EVLT）治疗静脉曲张的静脉内消融已报道优于传统的开放式手术治疗。很少有证据比较这两种静脉内解决方案的疗效和患者报告的结果。本研究在一项前瞻性双盲临床试验中比较了 RFA 和 EVLT 策略。
方法
连续患有原发性单侧大隐静脉曲张（GSV）反流的患者接受静脉内治疗，随机分为 RFA（VNUS ClosureFAST）或 EVLT（810nm 二极管激光）。主要观察指标为治疗后 3 个月 GSV 闭塞。次要观察指标为术后 7 天闭塞、术后疼痛、镇痛需求和瘀斑，术后第 7 天评估。使用阿伯丁静脉曲张问卷（AVVQ）和 EQ-5D 在术前和术后 3 个月评估生活质量（QoL）。
结果
共 159 例患者随机分为 RFA 组（79 例）或 EVLT 组（80 例）。两组在人口统计学、疾病范围、严重程度和术前 QoL 方面均匹配良好。两组在 1 周时均通过双能扫描确认 100%静脉闭塞。3 个月时，RFA 组闭塞率为 97%，EVLT 组为 96%；P=0.67。EVLT 组术后 3 个月以上膝部瘀斑面积中位数（四分位距）为 3.85%（6.1），高于 RFA 组 0.6%（2）；P=0.0001。RFA 术后第 1 至 7 天每天评估的术后疼痛较轻（P=0.001）。两组在 3 个月时 AVVQ（P=0.12）和 EQ-5D（P=0.66）的变化相似。
结论
在原发性 GSV 静脉曲张治疗后 3 个月，RFA 和 EVLT 的静脉闭塞率相似；两种方法均无优势。RFA 与围手术期疼痛较轻、镇痛需求较少和瘀斑较少相关。
注册号
ISRCTN63135694（http://www.controlled-trials.com）。
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