外科理论与实践2025，Vol.30Issue(4)：302-309,8.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
Randomized controlled multicenter trial of N-butyl cyanoacrylate endovenous ablation and radiofrequency endo-venous ablation for incompetent great saphenous veins
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
作者信息
- 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
- 折叠
摘要
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.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Key words
Great saphenous vein(GSV)insufficiency/N-butyl cyanoacrylate(NBCA)/Endovenous nonthermal ablation/Radiofrequency ablation(RFA)分类
医药卫生引用本文复制引用
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(4):302-309,8.
