Hamel-Desnos Claudine, Desnos Philippe, Wollmann Jan-Christoph, Ouvry Pierre, Mako Serge, Allaert François-Andre
Center Hospitalier Privé Saint Martin, 18 Rue des Rocquemonts, 14050 Caen-Cedex, France.
Dermatol Surg. 2003 Dec;29(12):1170-5; discussion 1175. doi: 10.1111/j.1524-4725.2003.29398.x.
Foamed sclerosing agents have been used with enthusiasm by phlebologists for more than 5 decades. Any type of varicose veins can and has been treated with this technique. Numerous publications have stressed the advantages of foamed sclerosing agents on the basis of empiric and experimental criteria and have described various individual techniques to prepare foams. Until now, however, no comparative study for the treatment of large varicose veins with foam or liquid exists.
The purpose of this first randomized, prospective, multicenter trial was to study the elimination of reflux, the rate of recanalization, and possible side effects of foam sclerotherapy (FS) compared with conventional liquid sclerotherapy for the greater saphenous vein (GSV).
Eighty-eight patients were randomized into two groups: One group was treated with sclerosing foam (45 patients) and the other with sclerosing liquid (43 cases). Sclerotherapy was performed with direct puncture of the vessel under duplex guidance. The reference sclerosing agent was polidocanol in a 3% solution. The foam was prepared using the Double Syringe System (DSS) method. Only one injection of 2.0 or 2.5 mL liquid or foam was allowed, depending on the diameter of the GSV. Results were assessed according to the protocol.
Follow-up after 3 weeks showed 84% elimination of reflux in the GSV with DSS foam versus 40% with liquid sclerosant (P < 0.01). At 6 months, six recanalizations were found in the liquid group versus two in the foam group. After 1 year, no additional recanalization was observed with either foam or liquid. Longer term studies are underway. Side effects did not differ between both groups.
The efficacy of sclerosing foam (DSS) compared with sclerosing liquid in therapy of the GSV is superior, a finding that had already gained empirical recognition but for which there has not been any clinical evidence to date.
泡沫硬化剂已被静脉病学家积极使用超过50年。任何类型的静脉曲张都可以且已经采用这种技术进行治疗。众多出版物基于经验和实验标准强调了泡沫硬化剂的优势，并描述了制备泡沫的各种个体化技术。然而，迄今为止，尚无关于用泡沫或液体治疗大隐静脉曲张的比较研究。
这项首个随机、前瞻性、多中心试验的目的是研究与传统液体硬化疗法相比，泡沫硬化疗法（FS）治疗大隐静脉（GSV）时反流的消除情况、再通率及可能的副作用。
88例患者随机分为两组：一组用硬化泡沫治疗（45例患者），另一组用硬化液体治疗（43例患者）。在双功超声引导下直接穿刺血管进行硬化治疗。参考硬化剂为3%溶液的聚多卡醇。使用双注射器系统（DSS）方法制备泡沫。根据GSV的直径，仅允许注射一次2.0或2.5 mL液体或泡沫。根据方案评估结果。
3周后的随访显示，使用DSS泡沫时GSV反流消除率为84%，而使用液体硬化剂时为40%（P<0.01）。6个月时，液体组发现6例再通，泡沫组为2例。1年后，泡沫组和液体组均未观察到额外的再通情况。正在进行长期研究。两组的副作用无差异。
与硬化液体相比，硬化泡沫（DSS）治疗GSV的疗效更佳，这一发现虽已获得经验认可，但迄今为止尚无任何临床证据。
