Department of Faculty Surgery No. 2, Pirogov Russian National Research Medical University, Moscow, Russia.
Adv Ther. 2018 Jul;35(7):1001-1008. doi: 10.1007/s12325-018-0731-z. Epub 2018 Jun 15.
Sclerotherapy is a common technique for the removal of intradermal veins. This study examined the rationale for prescribing micronized purified flavonoid fraction (MPFF) in clinical, etiological, anatomic, pathophysiologic (CEAP) class C1 patients with dilated intradermal veins scheduled for sclerotherapy.
In a national, multicenter, observational program, physicians recruited CEAP C1s patients scheduled for sclerotherapy. The decision to prescribe adjuvant MPFF (1000 mg/day for 6 weeks beginning 2 weeks before sclerotherapy) was made according to usual practice. Disease severity and treatment outcomes were assessed at baseline and 4 weeks post-sclerotherapy using a visual analog scale (VAS) as well as quality-of-life (CIVIQ-14) and patient satisfaction (Darvall) questionnaires.
A total of 70 physicians recruited 1150 patients: 1071 (93%) women, 79 (7%) men. Mean age (± SD) was 40.7 ± 10.7 years (range 18-74) and mean body mass index was 23.6 ± 3.3 kg/m. Reticular veins were observed in 42.1% of patients and 57.9% had telangiectasias. MPPF was prescribed to 905 patients (79%). Sclerotherapy was associated with statistically significant decreases in mean VAS scores for leg heaviness, pain, sensation of swelling, night cramps, and itching. For each symptom, MPFF-treated patients showed a more pronounced improvement than those undergoing sclerotherapy alone: mean VAS pain score with MPFF decreased from 1.90 ± 2.30 to 0.30 ± 0.62 versus 1.72 ± 1.93 to 0.52 ± 0.99 with sclerotherapy alone; mean VAS leg heaviness score with MPFF decreased from 2.80 ± 2.43 to 0.47 ± 1.07 versus 2.38 ± 2.23 to 0.76 ± 0.85 with sclerotherapy alone. Patient quality-of-life indicators improved with symptom resolution, particularly pain, and for each indicator the observed improvement was greater with MPFF. The outcomes of treatment exceeded patient expectations. Fewer patients experienced sclerotherapy-induced hyperpigmentation with adjunctive MPFF versus sclerotherapy alone (33.9% versus 41.2%, respectively, P = 0.034). No adverse events related to MPFF were observed.
Resolution of venous symptoms post-sclerotherapy was greater in patients treated with MPFF compared with those undergoing sclerotherapy alone, supporting the rationale for use of MPFF in patients undergoing sclerotherapy.
Servier.
硬化疗法是一种去除真皮内静脉的常用技术。本研究旨在探讨在接受硬化疗法治疗的真皮内扩张静脉的 CEAP C1 级（临床、病因、解剖、病理生理学[CEAP]）患者中，开具微粉化纯化黄酮类混合物（MPFF）的合理性。
在一项全国性、多中心、观察性研究中，医生招募了计划接受硬化疗法治疗的 CEAP C1 患者。根据常规实践，决定是否开具辅助性 MPFF（1000mg/天，共 6 周，在硬化疗法前 2 周开始）。在硬化疗法后 4 周，使用视觉模拟量表（VAS）以及生活质量（CIVIQ-14）和患者满意度（Darvall）问卷，评估疾病严重程度和治疗结果。
共有 70 名医生招募了 1150 名患者：1071 名（93%）为女性，79 名（7%）为男性。平均年龄（±标准差）为 40.7±10.7 岁（范围 18-74 岁），平均体重指数为 23.6±3.3kg/m。网状静脉见于 42.1%的患者，57.9%的患者存在毛细血管扩张。905 名患者（79%）开具了 MPFF。硬化疗法与腿部沉重感、疼痛、肿胀感、夜间抽筋和瘙痒等平均 VAS 评分的显著降低相关。对于每种症状，接受 MPFF 治疗的患者比单独接受硬化疗法的患者改善更为明显：MPFF 治疗组的平均 VAS 疼痛评分从 1.90±2.30 降至 0.30±0.62，而单独接受硬化疗法的患者从 1.72±1.93 降至 0.52±0.99；MPFF 治疗组的平均 VAS 腿部沉重感评分从 2.80±2.43 降至 0.47±1.07，而单独接受硬化疗法的患者从 2.38±2.23 降至 0.76±0.85。随着症状的缓解，患者的生活质量指标得到改善，尤其是疼痛，对于每个指标，观察到的改善都因使用 MPFF 而更为显著。治疗结果超出了患者的预期。与单独接受硬化疗法相比，接受辅助性 MPFF 的患者发生硬化疗法诱导性色素沉着的比例更低（分别为 33.9%和 41.2%，P=0.034）。未观察到与 MPFF 相关的不良反应。
与单独接受硬化疗法相比，接受 MPFF 治疗的患者静脉症状缓解更为明显，这支持在接受硬化疗法的患者中使用 MPFF 的合理性。
Servier。
