Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.
Department of Surgery and Orthopedics of Botucatu Medical School, São Paulo State University Júlio de Mesquita Filho, UNESP, Botucatu, SP, Brazil.
Eur J Vasc Endovasc Surg. 2021 Jan;61(1):128-135. doi: 10.1016/j.ejvs.2020.07.007. Epub 2020 Aug 7.
The aim of this study was to compare the effectiveness and safety of two sclerosing agents used to treat telangiectasias in the lower limbs: 0.2% polidocanol + 70% hypertonic glucose (HG) vs. 75% HG alone.
A prospective, randomised, triple blind, controlled, parallel group trial with patients randomly assigned in a 1:1 ratio between January and December 2015, with a two month follow up, from a single academic medical centre in Brazil, was carried out. Participants were women aged 18-65 years with telangiectasias on the lateral aspect of one thigh, classified as C1EpAsPn who underwent sclerotherapy in a single session with 0.2% polidocanol + 70% HG or 75% HG alone to treat the telangiectasias on an area limited by a rectangular template. The primary effectiveness endpoint was elimination of 75% of the telangiectasias within 60 days vs. the pre-treatment pattern. The length of vessels was measured on images obtained before and after treatment using ImageJ software. Safety outcomes were analysed immediately, 7 days, and 60 days after the treatment, and included pigmentation.
A total of 115 patients were included, 98 of whom completed the study. Sclerotherapy with 0.2% polidocanol + 70% HG was significantly more effective than with 75% HG alone to treat telangiectasias in the target area (82.2% vs. 63.9%; p < .001); considering a minimum improvement of 75%, there was a 0.49 risk reduction (95% confidence interval 0.24-0.98; p = .047). No severe adverse events occurred in either group. Pigmentation was the most common minor adverse event and was significantly shorter in length in the group treated with 0.2% polidocanol + 70% HG (median 0 cm vs. 0.5 cm, respectively; p = .033).
Polidocanol 0.2% plus 70% HG had better results than 75% HG alone in sclerosing telangiectasias. No severe adverse events occurred. Pigmentation occurred in both groups and was shorter in length in the group treated with 0.2% polidocanol + 70% HG.
本研究旨在比较两种用于治疗下肢毛细血管扩张症的硬化剂的有效性和安全性：0.2%聚多卡醇+70%高渗葡萄糖（HG）与单独使用 75%HG。
这是一项前瞻性、随机、三盲、对照、平行组试验，于 2015 年 1 月至 12 月在巴西的一家学术医疗中心进行，将患者按 1:1 的比例随机分配，随访时间为 2 个月。参与者为年龄在 18-65 岁之间的女性，患有外侧大腿毛细血管扩张症，C1EpAsPn 级，在一次治疗中接受 0.2%聚多卡醇+70%HG 或单独使用 75%HG 进行硬化治疗，治疗范围限制在矩形模板内。主要有效性终点为治疗后 60 天内 75%的毛细血管扩张症消除率与治疗前模式相比。使用 ImageJ 软件在治疗前后的图像上测量血管长度。安全性结果在治疗后立即、7 天和 60 天进行分析，包括色素沉着。
共有 115 名患者入组，其中 98 名完成了研究。与单独使用 75%HG 相比，0.2%聚多卡醇+70%HG 治疗靶区毛细血管扩张症的效果明显更好（82.2%对 63.9%；p<0.001）；考虑最小改善 75%，风险降低 0.49（95%置信区间 0.24-0.98；p=0.047）。两组均未发生严重不良事件。色素沉着是最常见的轻微不良事件，在 0.2%聚多卡醇+70%HG 组中长度明显更短（中位数分别为 0cm 对 0.5cm；p=0.033）。
与单独使用 75%HG 相比，0.2%聚多卡醇+70%HG 治疗毛细血管扩张症的效果更好。两组均未发生严重不良事件。两组均出现色素沉着，0.2%聚多卡醇+70%HG 组色素沉着长度更短。
