随机临床试验：不同绷带方案在泡沫硬化疗法治疗静脉曲张后的应用。

Randomized clinical trial of different bandage regimens after foam sclerotherapy for varicose veins.

机构信息

Department of Vascular Surgery, Gloucestershire Royal Hospital, Great Western Road, Gloucester GL1 3NN, UK.

出版信息

Br J Surg. 2010 May;97(5):650-6. doi: 10.1002/bjs.6951.

DOI:10.1002/bjs.6951

PMID:20306530

Abstract

BACKGROUND

This trial compared outcomes after foam sclerotherapy in patients wearing compression bandaging for 24 h or 5 days after treatment.

METHODS

Consecutive patients with primary uncomplicated varicose veins were randomized after foam sclerotherapy treatment. The primary endpoint was 6-week Aberdeen Varicose Vein Severity Score (AVVSS) and Burford pain score.

RESULTS

Some 124 legs were randomized, 61 to 24 h and 63 to 5 days of bandaging. Target vein occlusion rates at 6-week duplex imaging were 90 and 89 per cent respectively (P = 0.842). There was no significant difference in phlebitis after 2 weeks (P = 0.445) or skin discoloration after 6 weeks (46 versus 40 per cent; P = 0.546). There was no significant difference in the change in AVVSS from baseline to 2 weeks (-0.29 versus -0.80; P = 0.717) or to 6 weeks (-5.89 versus -5.14; 95 per cent confidence interval (c.i.) for the difference -3.29 to 1.80; P = 0.563), or in change in Burford pain score from baseline to 2 weeks (-9.04 versus -2.80; P = 0.248) or to 6 weeks (-17.32 versus -8.46; 95 per cent c.i. for the difference -19.06 to 1.33; P = 0.088), or in change in Short Form 36 score from baseline to 6 weeks (2.02 versus 1.74; P = 0.903).

CONCLUSION

There was no advantage to compression bandaging for more than 24 h when thromboembolus deterrent stockings were worn for the remainder of 14 days.

REGISTRATION NUMBER

NCT00991497 (http://www.clinicaltrials.gov).

摘要

背景

本试验比较了接受泡沫硬化治疗后，分别使用加压绷带包扎 24 小时和 5 天患者的治疗结果。

方法

连续入选的原发性单纯性静脉曲张患者，在接受泡沫硬化治疗后进行随机分组。主要终点为治疗后 6 周时的 Aberdeen 静脉疾病严重程度评分（AVVSS）和 Burford 疼痛评分。

结果

共有 124 条肢体被随机分组，61 条肢体绷带包扎 24 小时，63 条肢体绷带包扎 5 天。6 周时双功能超声检查提示目标静脉闭塞率分别为 90%和 89%（P=0.842）。2 周时静脉炎发生率（P=0.445）和 6 周时皮肤色素沉着发生率（46%比 40%；P=0.546）均无显著差异。从基线到 2 周时 AVVSS 评分的变化（-0.29 比-0.80；P=0.717）和到 6 周时的变化（-5.89 比-5.14；差值的 95%置信区间为-3.29 至 1.80；P=0.563），以及从基线到 2 周时 Burford 疼痛评分的变化（-9.04 比-2.80；P=0.248）和到 6 周时的变化（-17.32 比-8.46；差值的 95%置信区间为-19.06 至 1.33；P=0.088），以及从基线到 6 周时的健康调查简表 36 项评分的变化（2.02 比 1.74；P=0.903）均无显著差异。