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泡沫硬化疗法与传统硬化疗法的疗效和安全性比较:一项对照临床试验。

Comparison of efficacy and safety between foam sclerotherapy and conventional sclerotherapy: a controlled clinical trial.

作者信息

Ukritmanoroat Teerachai

机构信息

Department of Surgery, Rajavithi Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.

出版信息

J Med Assoc Thai. 2011 Mar;94 Suppl 2:S35-40.

PMID:21717876
Abstract

BACKGROUND

Conventional sclerotherapy of varicose vein is performed by injection of a sclerosing substance into the vein. The modern use of foam in sclerotherapy in which sclerosants can be transformed into fine-bubbled foam by special techniques is developed. Many studies report about the better efficacy of foam therapy than conventional liquid therapy.

OBJECTIVE

To assess the efficacy of sclerosant Polidocanol in foam form compared to liquid form and to determine safety profile by monitoring the complications (Pain, inflammation and pigmentation).

MATERIAL AND METHOD

Randomized controlled trial study, fifty patients with symptomatic varicose veins underwent duplex ultrasonography for measurement of the diameter of the varices. All patients underwent one session of sclerotherapy with both sclerosants (foam and liquid Polidocanol). Efficacy was assessed at 15, 30 and 90 days after the sclerotherapy by duplex ultrasound and the safety was evaluated at 15, 30, 90 days.

RESULTS

The efficacy of sclerosis was reported in total occlusion of 46 sites (92.0%) in foam therapy and of 38 sites (76.0%) in Polidocanol liquid therapy after 90 days. The differences of occlusion for the two groups were statistically significant, foam therapy showed greater results than that of Polidocanol liquid therapy at 15 days, 30 days and 90 days after therapy Pain and hyperpigmentation were significantly higher in foam group than that in liquid group at 15 days and 30 days.

CONCLUSION

Foam sclerotherapy has greater efficacy for treating varicose veins comparing to conventional liquid sclerotherapy. However Pain, inflammation, and hyperpigmentation appeared more often with foam Polidocanol therapy.

摘要

背景

传统的静脉曲张硬化疗法是将硬化剂注入静脉。现代硬化疗法中使用泡沫,通过特殊技术可将硬化剂转化为细泡状泡沫。许多研究报告称泡沫疗法比传统液体疗法疗效更好。

目的

评估泡沫形式的聚多卡醇硬化剂与液体形式相比的疗效,并通过监测并发症(疼痛、炎症和色素沉着)来确定安全性。

材料与方法

随机对照试验研究,50例有症状的静脉曲张患者接受双功超声检查以测量静脉曲张的直径。所有患者均接受两种硬化剂(泡沫和液体聚多卡醇)的一次硬化治疗。在硬化治疗后15、30和90天通过双功超声评估疗效,并在15、30、90天评估安全性。

结果

90天后,泡沫疗法中46个部位(92.0%)完全闭塞,聚多卡醇液体疗法中38个部位(76.0%)完全闭塞。两组闭塞情况的差异具有统计学意义,泡沫疗法在治疗后15天、30天和90天的效果均优于聚多卡醇液体疗法。在15天和30天时,泡沫组的疼痛和色素沉着明显高于液体组。

结论

与传统液体硬化疗法相比,泡沫硬化疗法治疗静脉曲张的疗效更佳。然而,聚多卡醇泡沫疗法中疼痛、炎症和色素沉着出现得更频繁。

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