外科理论与实践

外科理论与实践 >

2025 , Vol. 30 >Issue 04: 302 - 309

DOI: https://doi.org/10.16139/j.1007-9610.2025.04.03

论著

氰基丙烯酸正丁酯与射频消融腔内闭合治疗大隐静脉功能不全的随机对照多中心临床研究

  • 蒋劲松 ,
  • 吴昊 ,
  • 王欣叶 ,
  • 解荡 ,
  • 王昌明 ,
  • 方欣 ,
  • 何春水 ,
  • 刘震杰
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  • 1.浙江省人民医院（附属人民医院）血管外科，杭州医学院，浙江 杭州 310014
    2.上海玮沐医疗科技有限公司，上海 201422
    3.北京大学第三医院介入血管外科，北京 100191
    4.西湖大学医学院附属杭州市第一人民医院血管外科，浙江 杭州 310006
    5.成都中医药大学附属医院血管外科，四川 成都 610075
    6.浙江大学医学院附属第二医院血管外科，浙江 杭州 310009
蒋劲松，E-mail: 654614713@qq.com

收稿日期: 2024-09-23

  网络出版日期: 2025-10-23

收起

Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endovenous ablation for incompetent great saphenous veins

  • JIANG Jinsong ,
  • WU Hao ,
  • WANG Xinye ,
  • XIE Dang ,
  • WANG Changming ,
  • FANG Xin ,
  • HE Chunshui ,
  • LIU Zhenjie
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  • 1. Department of Vascular Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Zhejiang Hangzhou 310014, China
    2. Shanghai Weimu Medical Technology Co., Ltd, Shanghai 201422, China
    3. Department of Interventional Radiology and Vascular Surgery, Peking University Third Hospital, Beijing 100191, China
    4. Department of Vascular Surgery, Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine, Zhejiang Hangzhou 310006, China
    5. Department of Vascular Surgery, Hospital of Chengdu University of Traditional Chinese Medicine, Sichuan Chengdu 610075, China
    6. Department of Vascular Surgery, the Second Affiliated Hospital, Zhejiang University School of Medicine, Zhejiang Hangzhou 310009, China

Received date: 2024-09-23

  Online published: 2025-10-23

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摘要

目的：比较氰基丙烯酸正丁酯（NBCA）与射频消融（RFA）治疗大隐静脉（GSV）功能不全12个月的治疗效果。方法：将来自5个中心的155例GSV功能不全的病人随机分为NBCA组和RFA组，观察术后有效性及安全性。结果：术后即刻两组GSV主干闭合率均为100%，NBCA组与RFA组术后3个月闭合率分别为98.6%和98.5%，术后6个月闭合率分别为97.1%和98.5%，术后12个月闭合率分别为98.1%和95.9%，差异均无统计学意义（P>0.05）。两组病人经治疗后CEAP分级较基线均显著改善。在安全性方面，NBCA组出现1例静脉炎、1例消融相关血栓延伸及2例小腿肌间静脉血栓(CMVT)，RFA组出现2例肢体麻木、1例持续性大腿疼痛及2例CMVT。两组出现的严重不良事件均与器械或实验无关。结论：NBCA相比RFA，治疗GSV功能不全12个月的有效性与安全性非劣。

关键词： 大隐静脉功能不全; 氰基丙烯酸正丁酯; 腔内常温闭合; 射频消融

本文引用格式

蒋劲松 , 吴昊 , 王欣叶 , 解荡 , 王昌明 , 方欣 , 何春水 , 刘震杰 . 氰基丙烯酸正丁酯与射频消融腔内闭合治疗大隐静脉功能不全的随机对照多中心临床研究[J]. 外科理论与实践, 2025 , 30(04) : 302 -309 . DOI: 10.16139/j.1007-9610.2025.04.03

Abstract

Objective To compare the 12-month efficacy and safety of N-butyl cyanoacrylate (NBCA) versus radiofrequency ablation (RFA) in treating great saphenous vein (GSV) insufficiency. Methods A total of 155 patients with GSV insufficiency from five centers were randomly allocated to the NBCA group or RFA group. Postoperative efficacy and safety outcomes were evaluated. Results Immediate postoperative closure rates of the GSV trunk were 100% in both groups. The closure rates of NBCA and RFA group were 98.6% and 98.5% at 3 months, 97.1% and 98.5% at 6 months, 98.1% and 95.9% at 12 months, with no statistically significant differences (P>0.05). After treatment, CEAP classification improved significantly from baseline in both groups. In terms of safety, 1 case of phlebitis, 1 case of ablation-related thrombus extension (ARTE) and 2 cases of calf muscle venous thrombosis(CMVT) occurred in the NBCA group, while 2 cases of limb numbness, 1 case of persistent thigh pain and 2 cases of CMVT in the RFA group. All reported serious adverse events in both groups were assessed as unrelated to the medical device or the trial procedure. Conclusions NBCA demonstrates non-inferior efficacy and safety compared to RFA for treating GSV insufficiency over 12 months.

Key words： Great saphenous vein(GSV) insufficiency; N-butyl cyanoacrylate(NBCA); Endovenous nonthermal ablation; Radiofrequency ablation (RFA)

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