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

doi:10.16139/j.1007-9610.2025.04.03

外科理论与实践 ›› 2025, Vol. 30 ›› Issue (04): 302-309.doi: 10.16139/j.1007-9610.2025.04.03

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¹(), 吴昊¹, 王欣叶², 解荡², 王昌明³, 方欣⁴, 何春水⁵, 刘震杰⁶

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

收稿日期:2024-09-23 出版日期:2025-07-25 发布日期:2025-10-23
通讯作者: 蒋劲松，E-mail: 654614713@qq.com

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

JIANG Jinsong¹(), WU Hao¹, WANG Xinye², XIE Dang², WANG Changming³, FANG Xin⁴, HE Chunshui⁵, LIU Zhenjie⁶

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:2024-09-23 Online:2025-07-25 Published:2025-10-23

摘要/Abstract

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

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)

中图分类号:

R654.4

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.

JIANG Jinsong, WU Hao, WANG Xinye, XIE Dang, WANG Changming, FANG Xin, HE Chunshui, LIU Zhenjie. Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endovenous ablation for incompetent great saphenous veins[J]. Journal of Surgery Concepts & Practice, 2025, 30(04): 302-309.

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参考文献 32

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Clinical data	NBCA group （n=78）	RFA group （n=77）	Statistical value	P value
Gender			χ²=0.50	0.48
Male	30（38.5）	34（44.2）
Female	48（61.5）	43（55.8）
Age(years)	58.1±11.6	58.0±11.2	t=0.08	0.94
CEAP classification				<0.001
C2	23（29.5）	18（23.4）
C3	6（7.7）	21（27.3）
C4a	35（44.9）	36（46.8）
C4b	5（6.4）	1（1.3）
C5	9（11.5）	1（1.3）
VCSS	4.1±2.6	3.7±1.9	U=2650.5	0.21
AVVQ	5.0±4.0	4.2±3.4	U=2699.0	0.27
GSV diameter（mm）	8.0±2.3	7.6±2.1	t=1.34	0.18
Reflux time（s）	5.3±3.6	5.1±2.4	t=1.61	0.11

Closure rates	NBCA group	RFA group	P value
at 3 months	98.6%(70/71)	98.5%(67/68)	1.00
at 6 months	97.1%(66/68)	98.5%(64/65)	0.62
at 12 months	98.1%(52/53)	95.9%(47/49)	0.61

Item	NBCA group	RFA group	χ² value	P value
CEAP grade at 3 months			1.67	0.43
C0-C1	53（74.6）	54（79.4）
C2-C3	8（11.3）	9（13.2）
C4a	10（14.1）	5（7.4）
CEAP grade at 6 months			0.60	0.74
C0-C1	60（87.0）	60（90.9）
C2-C3	2（2.9）	1（1.5）
C4a	7（10.1）	5（7.6）

Item	NBCA group	RFA group	P value
Thrombus	3.8(3/78)	2.6(2/77)	1.00
Petechia	1.3(1/78)	5.2(4/77)	0.21
Pain	2.6(2/78)	2.6(2/77)	1.00
Numbness	0	2.6(2/77)	0.24
Infection	3.8(3/78)	2.6(2/77)	1.00
Pigment	2.6(2/78)	0	0.24

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

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

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Hospital	NBCA group	RFA group	Total
Zhejiang Provincial People’s Hospital	33	32	65
Peking University Third Hospital	14	14	28
Hospital of Chengdu University of Traditional Chinese Medicine	3	2	5
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine	13	13	26
The Second Affiliated Hospital, Zhejiang University School of Medicine	15	16	31

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