Administration of Micronized Purified Flavonoid Fraction During Sclerotherapy of Reticular Veins and Telangiectasias: Results of the National, Multicenter, Observational Program VEIN ACT PROLONGED-C1

在网状静脉和毛细血管扩张症硬化治疗期间应用微粒化纯化类黄酮组分:国家多中心观察性研究项目 VEIN ACT PROLONGED-C1 的结果

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Abstract

INTRODUCTION: 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. METHODS: 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. RESULTS: 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(2). 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. CONCLUSION: 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. FUNDING: Servier.

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