静脉曲张封闭胶套件治疗大隐静脉功能不全的安全性和有效性分析

Safety and efficacy analysis of a varicose vein sealant kit in the treatment of great saphenous vein dysfunction

目的探讨静脉曲张封闭胶套件治疗大隐静脉功能不全的安全性和有效性。方法随机对照试验。前瞻性纳入2022年6至10月海军军医大学第二附属医院、同济大学附属上海东方医院、首都医科大学宣武医院、河北医科大学第一医院、赣州市人民医院、山西白求恩医院、浙江大学医学院附属第二医院、浙江大学医学院附属第四医院、厦门大学附属中山医院共9家医院血管外科拟行手术治疗的大隐静脉功能不全患者180例。采用随机数字表法分为试验组和对照组,每组90例。试验组患者接受静脉曲张封闭胶套件治疗,对照组患者接受射频消融术治疗。主要观察指标为两组患者术后3个月大隐静脉完全闭合率。次要观察指标为两组患者术后即刻及术后6个月大隐静脉完全闭合率、大隐静脉主干闭合操作时间、疼痛评分、手术前后不同时间静脉临床严重程度评分(VCSS)和阿伯丁静脉曲张问卷(AVVQ)评分以及并发症情况。两种治疗方法的非劣效界值设定为“-10.00%”。结果最终入组177例患者。试验组89例,男38例,女51例,年龄[M(Q_(1),Q_(3))]为59.7(49.6,66.7)岁;对照组88例,男30例,女58例,年龄为57.2(46.9,65.9)岁。174例患者完成3个月随访,167例患者完成6个月随访。试验组大隐静脉主干闭合操作时间为(22.1±11.1)min,长于对照组的(18.7±9.8)min(P=0.031)。试验组、对照组术后即刻大隐静脉完全闭合率均为100%;术后3个月大隐静脉完全闭合率分别为98.8%(85/86)、98.9%(87/88),两组差值的95%CI下限为-3.19%,大于非劣效界值-10.00%(非劣效性P<0.001);术后6个月大隐静脉完全闭合率分别为97.6%(81/83)、100%(84/84),两组差值的95%CI下限为-5.71%,大于非劣效界值-10.00%(非劣效性P<0.001)。试验组、对照组在麻醉完全清醒后的即刻疼痛评分[M(Q_(1),Q_(3))]均为1.0(0,2.0)分,差异无统计学意义(P=0.365)。试验组与对照组术后1周瘀斑发生率分别为61.2%(52/85)、67.1%(57/85),差异无统计学意义(P=0.181);术前及术后1、3、6个月VCSS和AVVQ评分的组间差异均无统计学意义(均P>0.05);术后3个月下肢深静脉血栓形成、静脉炎、疼痛、皮下血肿等并发症发生率差异均无统计学意义(均P>0.05)。结论静脉曲张封闭胶套件治疗大隐静脉功能不全安全有效,能够实现不劣于传统射频消融术的大隐静脉完全闭合率。

Objective To investigate the safety and efficacy of a varicose vein sealant kit in the treatment of great saphenous vein dysfunction.Methods It was a randomized controlled trial.A total of 180 patients with great saphenous vein dysfunction were enrolled prospectively,and scheduled for surgical treatment in 9 hospitals,including the Second Affiliated Hospital of Naval Medical University,Shanghai Oriental Hospital Affiliated to Tongji University,Xuanwu Hospital Capital Medical University,the First Hospital of Hebei Medical University,Ganzhou People′s Hospital,Shanxi Bethune Hospital,the Second Affiliated Hospital of Zhejiang University School of Medicine,the Fourth Affiliated Hospital of Zhejiang University School of Medicine,and Zhongshan Hospital Affiliated to Xiamen University,from June to October 2022.Using a random number table method,the subjects were divided into an experimental group and a control group,with 90 cases in each group.The patients of experimental group received treatment with varicose vein sealant kit,while the patients of control group received radiofrequency ablation.The main outcome measure was the complete closure rate of the great saphenous vein in both groups of patients 3 months after surgery.The secondary outcome measures were the complete closure rate of the great saphenous vein in both groups of patients immediately after surgery and 6 months after surgery,the operation time for closing the main trunk of the great saphenous vein,pain score,venous clinical severity score(VCSS),Aberdeen varicose veins questionnaire(AVVQ)at different times before and after surgery,and the incidence of complications in both groups of patients.The non inferiority threshold for the two treatment methods is set at"-10.00%".Results A total of 177 patients were ultimately enrolled.There were 89 cases in the experimental group,including 38 males and 51 females,with a median age[M(Q_(1),Q_(3))]of 59.7(49.6,66.7)years,and 88 cases in the control group,including 30 males and 58 females,with a median age of 57.2(46.9,65.9)years.A total of 174 patients completed a 3-month follow-up,and 167 patients completed a 6-month follow-up.The closure time of the main saphenous vein in the experimental group was(22.1±11.1)min,which was longer than the control group,which was(18.7±9.8)min(P=0.031).The complete closure rate of the great saphenous vein immediately after surgery in both the experimental group and the control group was 100%.The complete closure rates of the great saphenous vein at 3 months after surgery were 98.8%(85/86)and 98.9%(87/88),respectively.The lower limit of the 95%CI for the difference between the two groups was-3.19%,which was greater than the non-inferiority threshold of-10.00%(non-inferiority P<0.001).The complete closure rates of the great saphenous vein at 6 months after surgery were 97.6%(81/83)and 100%(84/84),the lower limit of the 95%CI for the difference between the two groups was-5.71%,which was greater than the non-inferiority threshold of-10.00%(non-inferiority P<0.001).The immediate pain scores after complete anesthesia awakening of the experimental group and the control group were both 1.0(0,2.0),with no statistically significant difference(P=0.365).The incidence of bruising in the experimental group and the control group one week after surgery was 61.2%(52/85)and 67.1%(57/85),respectively,with no statistically significant difference(P=0.181).There was no statistically significant difference in VCSS and AVVQ scores between groups before surgery and at 1,3,and 6 months after surgery(all P>0.05).There was no statistically significant difference in the incidence of complications such as deep vein thrombosis,phlebitis,pain,and subcutaneous hematoma in the lower limbs 3 months after surgery(all P>0.05).Conclusion The varicose vein sealant kit is safe and effective in treating great saphenous vein dysfunction,and can achieve a complete closure rate of great saphenous vein that is not inferior to traditional radiofrequency ablation.