静脉溃疡患者的溃疡下泡沫硬化疗法:随机对照试验。

Toni Pihlaja, Pasi Ohtonen, Pekka Romsi, Matti Pokela
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引用次数: 0

摘要

目的:本试验分析了溃疡下泡沫硬化疗法对腿部静脉溃疡(VLU)患者的治疗效果:方法:随机对照试验:该试验招募了静脉性腿部溃疡患者,让他们接受溃疡下泡沫硬化疗法和压力疗法(研究组)或仅接受压力疗法(对照组)。研究的主要结果是静脉溃疡面积在4周后的变化。研究记录了溃疡下泡沫硬化疗法的可行性、安全性和并发症:在纳入的 23 名患者中,12 人被随机分配到研究组,11 人被随机分配到对照组。术前,两组患者的平均溃疡面积均为 5.8 平方厘米。4 周后,研究组溃疡面积平均缩小 4.0 平方厘米(标清 3.1)(95% CI 2.0 至 5.9,p = .001),对照组缩小 2.0 平方厘米(标清 3.1)(95% CI:-0.1 至 4.1,p = .051)。并发症方面无差异:结论:溃疡下泡沫硬化剂治疗和加压疗法在 1 个月后可显著减少溃疡面积,而单独使用加压疗法则无法减少溃疡面积。溃疡下泡沫硬化剂疗法可作为VLU患者浅静脉功能不全治疗的良好补充。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Sub-ulcer foam sclerotherapy in patients with venous ulceration: A randomized controlled trial.

Purpose: This trial analyzed the effect of sub-ulcer foam sclerotherapy in patients with venous leg ulcer (VLU).

Design: Randomized controlled trial.

Methods: This trial recruited patients with VLUs to receive either sub-ulcer foam sclerotherapy and compression therapy (study group) or compression therapy only (control group). The primary outcome of this study was the change in the venous ulcer area at 4 weeks. The feasibility, safety, and complications of the sub-ulcer foam sclerotherapy were recorded.

Results: Of 23 patients included, 12 were randomized to study group and 11 to control group. Preoperatively, the average ulcer areas were 5.8 cm2 in both groups. At 4 weeks, the average reductions in ulcer areas were 4.0 cm2 (SD 3.1) in the study group (95% CI 2.0 to 5.9, p = .001) and 2.0 cm2 (SD 3.1) in the control group (95% CI: -0.1 to 4.1, p = .051). No differences in complications were recorded.

Conclusions: At 1-month sub-ulcer foam sclerotherapy and compression therapy reduced the ulcer area statistically significantly, whereas compression therapy alone did not. Sub-ulcer foam sclerotherapy could be a good addition to superficial venous insufficiency treatment in patients with VLU.ClinicalTrials.gov identifier NCT03795064.

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