Prospective Randomized Study of Ultrasound-Guided Foam Sclerotherapy Combined with Great Saphenous Vein High Ligation in the Treatment of Severe Lower Extremity Varicosis
Prospective Randomized Study of Ultrasound-Guided Foam Sclerotherapy Combined with Great Saphenous Vein High Ligation in the Treatment of Severe Lower Extremity Varicosis
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DOI：
10.1016/j.avsg.2016.06.027
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发表时间：
2017-02-01
影响因子：
1.5
通讯作者：
Chang, Guangqi
中科院分区：
文献类型：
--
作者：
Yin, Henghui;He, Haipeng;Chang, Guangqi
背景资料：评价超声引导泡沫硬化治疗（UGFS）联合大隐静脉（GSV）高位结扎治疗C4-C6严重下肢静脉曲张的疗效，并与GSV剥脱加多刺撕脱术或透照动力静脉切除术（TIPP）进行比较。方法：从2012年1月至2014年12月，177例原发性GSV功能不全（分类为C4-C6）患者被随机分配到UGFS组或对照组。UGFS组在超声监测下采用GSV高位结扎加泡沫硬化治疗，对照组采用GSV高位结扎加剥脱加多刺撕脱或TIPP治疗。分别于治疗后1、6、12个月进行随访。结果评估包括反流复发率、手术相关不良事件、血流动力学参数、修订的静脉临床严重程度评分（VCSS）和Aberdeen静脉曲张问卷（AVVQ）评分。结果：73例患者接受UGFS，90例患者接受传统手术。UGFS组65例患者（89.0%）和对照组74例患者（82.2%）完成随访。在12个月结束时，UGFS组和对照组的累积反流复发率分别为13.8%和13.5%（P = 0.955）。在UGFS组和对照组中，轻微并发症（27.7% vs. 21.6%，P = 0.406）和严重并发症（3.1% vs. 2.7%，P = 0.895）无显著差异。两组治疗后静脉充盈指数、VCSS、AVVQ评分均较治疗前明显改善（P < 0.001）。与对照组相比，UGFS组的平均手术和恢复时间更短（分别为38.3 vs. 81.2 min，5.4 vs. 9.6 d，P < 0.001），平均住院费用更低（853美元vs. 1，575美元，P < 0.001）。术后12个月，UGFS组患者满意率为92.3%，对照组为89.2%（P = 0.270）。
Background: To evaluate the effect of ultrasound-guided foam sclerotherapy (UGFS) in a single session combined with great saphenous vein (GSV) high ligation for severe lower extremity varicosis classified as C4-C6, compared with GSV stripping plus multistab avulsion or transilluminated powered phlebectomy (TIPP).Methods: From January 2012 to December 2014, 177 patients with primary GSV insufficiency, classified as C4-C6, were randomized into the UGFS group or the control group. The UGFS group was managed by GSV high ligation and foam sclerotherapy in one session under the surveillance of ultrasonography, whereas the control group received GSV high ligation and stripping combined with multistab avulsion or TIPP. The patients were followed up at 1, 6, and 12 months after treatment. Outcome assessments included reflux recurrence rate, procedure-related adverse events, hemodynamic parameters, revised Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ) score. The medical cost and operating time of the 2 groups were also compared.Results: In total, 73 patients received UGFS, whereas 90 patients underwent traditional surgery. Sixty-five patients in the UGFS group (89.0%) and 74 patients in the control group (82.2%) completed the follow-up. At the end of 12 months, the cumulative reflux recurrence rate was 13.8% in the UGFS group and 13.5% in the control group (P = 0.955). In the UGFS and control groups, minor complications (27.7% vs. 21.6%, P = 0.406) and major complications (3.1% vs. 2.7%, P = 0.895) were not significantly different. Compared with baseline values, obvious improvements of the venous filling index, VCSS, and AVVQ scores after treatment were confirmed in both groups (P < 0.001). The average operating and recovery times were much shorter (38.3 vs. 81.2 min, 5.4 vs. 9.6 days, P < 0.001, respectively), and the average hospital cost was much lower ($853 vs. $1,575, P < 0.001) in the UGFS group than in the control group. The patient satisfaction rate reached 92.3% in the UGFS group and 89.2% in the control group 12 months after operation (P = 0.270).Conclusions: Our outcomes indicated that UGFS combined with GSV high ligation was safe and effective for severe lower extremity varicosis.