大隐静脉传统剥脱术与泡沫硬化剂注射术的随机对照研究

目的 比较大隐静脉传统剥脱术与泡沫硬化剂注射联合高位结扎术治疗大隐静脉曲张的临床效果.方法 本研究为单中心前瞻性随机对照研究.2009年3月至11月,连续录入60例大隐静脉曲张患者,其中男性26例,女性34例,年龄37～66岁,中位年龄49岁.随机分为两组,每组30例,一组行大隐静脉剥脱术(手术组),另一组行高位结扎联合泡沫硬化剂注射治疗(硬化剂组).主要临床观察指标为患者术后恢复时间、术后疼痛程度和术后复发率,次要观察指标为围手术期并发症发生率.结果 1例患者术前退出研究,余59例手术按计划完成.硬化剂组手术时间短于手术组(43 min比65 min,P＜0.01),术后镇痛药应用少于手术组,术后平均恢复时间也少于手术组(3 d比6 d,P＜0.01).术后3个月随访,两组CEAP分级为C1,均较术前的C4明显改善(P＜0.01).术后6个月随访,硬化剂组大隐静脉闭塞率80.0%,手术组为89.5%,差异无统计学意义(P＞0.05).结论 与大隐静脉剥脱术相比,大隐静脉高位结扎联合泡沫硬化剂注射术可以缩短手术时间,减少术后疼痛和术后恢复时间.

Foam sclerotherapy of the great saphenous vein with sapheno-femoral ligation compared to standard stripping: a prospective randomized controlled trial

Objective To compare the clinical outcome of foam sclerotherapy of the great saphenous vein (GSV) combined with sapheno-femoral junction (SFJ) ligation to standard stripping surgery. Methods As a prospective randomized controlled trial, 60 consecutive patients with incompetence of the GSV resulting in varicose veins were prospectively randomized into 2 groups, treated by SFJ ligation and either foam sclerotherapy or standard stripping of the GSV. There were 26 male and 34 female with a median age of 49 years ( ranging 37 to 66 years). Primary end points were patient recovery period, postoperative pain, quality of life and recurrence rate. Secondary end points were frequency of complications on the two arms of the trial. Results All treatments were completed as intended. The time taken to complete treatment was shorter in the foam sclerotherapy plus SFJ ligation group than the standard stripping (43 min vs. 65 min,P ＜0. 01 ).Less analgesic use postoperatively was recorded in the foam sclerotherapy group. Median time to return to normal activities was significantly reduced in the foam sclerotherapy group compared to the surgical group (3 d vs. 6 d, P ＜0. 01 ). After 3 months, median CEAP class dropped from four pre-operatively to one following treatment in both groups (P ＜0. 01 ). After 6 months, in the foam sclerotherapy group, 5 patients needed further sessions of foam sclerotherapy, resulting in a short-term closure rate of 80. 0%. And the short-term obliteration rate was 89. 5% in the conventional surgery group. Conclusions Foam sclerotherapy combined with sapheno-femoral ligation involves a shorter treatment time, less postoperative discomfort and results in more rapid recovery compared to conventional GSV stripping.