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多中心随机临床试验比较手术后使用弹性袜与绷带对静脉曲张的压迫效果。

Multicenter randomized trial comparing compression with elastic stocking versus bandage after surgery for varicose veins.

机构信息

Department of General Surgery, University of Siena, Siena, Italy.

出版信息

J Vasc Surg. 2011 Jan;53(1):115-22. doi: 10.1016/j.jvs.2010.08.033. Epub 2010 Nov 3.

DOI:10.1016/j.jvs.2010.08.033
PMID:21050700
Abstract

OBJECTIVES

Postoperative limb compression is widely used after venous surgery to prevent thromboembolism and to reduce hemorrhage, edema, hematoma, and pain. Only limited studies have been published regarding the most adequate postoperative compression therapy after varicose vein surgery. This study evaluated the effectiveness of a new stocking kit used for postoperative limb compression.

METHODS

The study compared the clinical practicability, ease to use, effectiveness, and safety of a postoperative stocking system (23 to 32 mmHg at the ankle) with compression bandages (control group). This prospective, randomized, open-label clinical trial, was performed in three Italian centers specializing in venous surgery. Sixty consecutive patients (classification CEAP C₂,(S)) underwent unilateral varicose vein surgery at one of the three centers. After surgery, patients were randomized for postoperative compression therapy with a new stocking system (Sigvaris Postoperative Kit; Ganzoni Sigvaris Corp, Winterthur, Switzerland) or standard stretch bandages (30 patients per group). Primary end points were incidence of venous thromboembolism, hemorrhage, limb hematoma, or edema.

RESULTS

No episodes of venous thromboembolism were observed. The mean area of thigh hematoma on postoperative days 7 and 14 was 75.70 cm² and 2.93 cm², respectively, for the stocking group, and 92.97 cm² and 5.42 cm² for the bandage group (not significant). On postoperative day 7, edema was found in 50% of the patients wearing bandages and in 20% of the patients wearing the stocking kit, which was a significant reduction. No statistical difference was recorded for postoperative pain; however, better patient acceptance and quality of life after the operation were recorded in the stocking group.

CONCLUSION

Patients can be effectively treated with the Sigvaris Postoperative Kit. Patients treated with stockings have less edema compared with standard bandaging, and the application of the stocking kit improves patient quality of life and compliance with postoperative compression therapy.

摘要

目的

静脉手术后广泛使用肢体加压来预防血栓栓塞,并减少出血、水肿、血肿和疼痛。只有有限的研究发表了关于静脉曲张手术后最适当的术后加压治疗。本研究评估了一种新的用于术后肢体加压的弹力袜套件的有效性。

方法

本研究比较了一种术后弹力袜系统(踝部 23 至 32mmHg)与加压绷带(对照组)的临床实用性、易用性、有效性和安全性。这是一项前瞻性、随机、开放标签的临床试验,在三个专门从事静脉手术的意大利中心进行。60 例连续患者(CEAP C₂,(S) 级)在三个中心之一进行单侧静脉曲张手术。手术后,患者随机接受新的弹力袜系统(Sigvaris 术后套件;Ganzoni Sigvaris 公司,温特图尔,瑞士)或标准弹力绷带(每组 30 例)的术后加压治疗。主要终点是静脉血栓栓塞、出血、肢体血肿或水肿的发生率。

结果

未观察到静脉血栓栓塞事件。在术后第 7 天和第 14 天,弹力袜组大腿血肿面积分别为 75.70cm²和 2.93cm²,绷带组分别为 92.97cm²和 5.42cm²(无显著性差异)。在术后第 7 天,绷带组 50%的患者出现水肿,而弹力袜组仅 20%的患者出现水肿,这是显著减少。术后疼痛无统计学差异;然而,在弹力袜组记录到更好的患者接受度和术后生活质量。

结论

患者可以用 Sigvaris 术后套件进行有效治疗。与标准绷带相比,使用弹力袜的患者水肿更少,而且弹力袜套件的应用提高了患者的生活质量和对术后加压治疗的依从性。

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