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聚多卡醇泡沫硬化疗法的疗效与安全性:一项对照临床试验。

Efficacy and safety of sclerotherapy using polidocanol foam: a controlled clinical trial.

作者信息

Alòs J, Carreño P, López J A, Estadella B, Serra-Prat M, Marinel-Lo J

机构信息

Servicio de Angiología y Cirugía Vascular, Hospital de Mataró, Mataró, Barcelona, Spain.

出版信息

Eur J Vasc Endovasc Surg. 2006 Jan;31(1):101-7. doi: 10.1016/j.ejvs.2005.08.018. Epub 2005 Oct 14.

DOI:10.1016/j.ejvs.2005.08.018
PMID:16226901
Abstract

OBJECTIVE

To assess the efficacy and safety of sclerotherapy performed with polidocanol foam compared to liquid polidocanol.

METHODS

Controlled clinical trial with 1 year follow up in which each patient acted as his/her own control. A total of 75 patients (six men and 69 women) with reticular or postoperative varices were enrolled and sclerotherapy was performed with liquid and with foam (Tessari method) using the same quantity of sclerosant for homogeneous varicose regions, to a total of 150 procedures. The sclerosant concentration was adjusted according to the vein diameter as assess by ultrasonography. The foam group was given 50% lower concentrations of sclerosant than liquid sclerosant group. Clinical assessment (pain, inflammation, pigmentation) and ultrasound examination (diameter of the lumen and length of sclerosed vein) were carried out at 15, 30, 90, and 365 days.

RESULTS

Foam allowed complete sclerosis at 90 days in 94.4% of patients compared with 53% for liquid (p<.001) and also allowed a more extensive venous sclerosis (10.1cm compared with 7.2 cm; p<.001). Pain, signs of inflammation, and pigmentation appeared more often with foam sclerosis, with significant difference. The degree of satisfaction was similar for both techniques.

CONCLUSIONS

Efficacy of venous sclerosis with foam seems to be greater than with liquid although there is a higher risk of minor secondary effects.

摘要

目的

评估聚多卡醇泡沫硬化疗法与液体聚多卡醇相比的疗效和安全性。

方法

进行为期1年随访的对照临床试验,每位患者作为自身对照。共纳入75例(6例男性和69例女性)患有网状静脉曲张或术后静脉曲张的患者,对均匀曲张区域使用相同剂量的硬化剂,分别采用液体和泡沫(泰萨里法)进行硬化治疗,共进行150次操作。根据超声评估的静脉直径调整硬化剂浓度。泡沫组使用的硬化剂浓度比液体硬化剂组低50%。在第15、30、90和365天进行临床评估(疼痛、炎症、色素沉着)和超声检查(管腔直径和硬化静脉长度)。

结果

90天时,泡沫硬化使94.4%的患者完全硬化,而液体硬化为53%(p<0.001),且泡沫硬化导致更广泛的静脉硬化(分别为10.1cm和7.2cm;p<0.001)。泡沫硬化时疼痛、炎症迹象和色素沉着出现得更频繁,差异有统计学意义。两种技术的满意度相似。

结论

泡沫硬化静脉的疗效似乎优于液体硬化,尽管出现轻微副作用的风险更高。

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