国产新型静脉射频闭合治疗系统与进口系统应用效果的随机对照研究

Randomized controlled study on the application effect of a new type of intravenous radiofrequency closed therapy system made in China and an imported system

目的比较国产新型静脉射频闭合治疗系统与进口系统治疗原发性下肢静脉曲张的应用效果。方法本研究为单中心、前瞻性、非劣效性随机对照试验。纳入2021年1月至2022年1月浙江大学医学院附属第四医院血管外科收治的符合纳入和排除标准的原发性下肢静脉曲张患者,按1∶1随机分为两组,分别接受国产新型静脉射频闭合治疗系统和进口静脉射频闭合治疗系统治疗。对两组的技术成功率、系统操作性能、术后6个月内的不良事件和严重不良事件(SAE)发生率、术后6个月目标静脉闭合率等进行比较。定量资料的比较采用Mann-Whitney U检验,分类资料的比较采用χ^(2)检验、Fisher确切概率法或非劣效性检验。结果研究共纳入80例患者,试验组41例,对照组39例。其中男性27例,女性53例;年龄[M(IQR)]55(23)岁(范围:40~78岁);左下肢48例,右下肢32例。两组技术成功率均为100%,术中均未出现系统操作故障。试验组和对照组术后6个月内不良事件发生率[58.5%(24/41)比61.5%(24/39),χ^(2)=0.075,P=0.784]、SAE发生率[7.3%(3/41)比5.1%(2/39),χ^(2)=0.163,P=0.686]的差异均无统计学意义。两组各发生1例器械相关不良事件,试验组1例患者术后发生静脉内热致血栓,口服利伐沙班片后痊愈;对照组1例术后右大腿上段疼痛1 d余,外用镇痛、消肿药物后痊愈。未发生器械相关SAE。试验组术后6个月血管闭合率为100%(38/38),对照组为97.4%(37/38),试验组与对照组术后6个月目标静脉闭合率差值为2.6%(95%CI:-3.19~8.45,Z=4.865,P<0.01),差值的95%CI低限大于非劣效界值-10.0%。结论国产新型静脉射频闭合治疗系统在原发性下肢静脉曲张患者中的早期应用效果不劣于进口静脉射频闭合治疗系统。

Objective To compare the application effect of domestic and imported intravenous radiofrequency closure system in the treatment of primary varicose veins of lower extremities.Methods This single-center prospective,non-inferiority randomized controlled trial was performed in the Department of Vascular Surgery,the Fourth Affiliated Hospital,Zhejiang University School of Medicine from January 2021 to January 2022.Patients with primary varicose veins of lower extremities who met the ataxation criteria were randomly assigned to the experimental group(domestic novel venous radiofrequency closure system)or the control group(imported venous radiofrequency closure system)in a ratio of 1∶1.The two groups of subjects were compared in terms of target vein closure rate,technical success rate,system operation performance,incidence of adverse events and incidence of serious adverse events(SAE)within 6 months after surgery.Quantitative data were compared by Mann-Whitney U test,and categorical data were compared byχ^(2) test and non-inferiority test.Results A total of 80 subjects were included in the trial(41 in the experimental group and 39 in the control group),including 27 males and 53 females,aged(M(IQR))55(23)years(range:40 to 78 years).There were 48 cases of left lower limb and 32 cases of right lower limb.The technical success rate and system control performance between the groups were 100%.The incidence of adverse events(58.5%(24/41)vs.61.5%(24/39),χ^(2)=0.075,P=0.784),and the incidence of SAE(7.3%(3/41)vs.5.1%(2/39),χ^(2)=0.163,P=0.686)within 6 months after surgery in experimental group and control group had no statistical significance.There was one device-related adverse event in each of the two groups.In the experimental group,one patient developed endovenous heat-induced thrombosis after surgery and recovered after taking rivaroxaban tablets.One patient in the control group had pain in the upper right thigh for more than 1 day after operation,which was cured after using analgesic cream.No device-related SAE occurred.The venous closure rate of the experimental group was 100%(38/38)at 6 months after surgery,and that of the control group was 97.4%(37/38).The difference between the two groups was 2.63%(95%CI:-3.19 to 8.45,Z=4.865,P<0.01),and the 95%CI lower limit of the difference in target venous closure rate between two groups was greater than the non-inferiority threshold of-10.00%.Conclusion The early application effect of the new domestic intravenous radiofrequency closure system in patients with primary varicose veins of lower extremities is in line with expectations,it is not inferior to the imported system.