Maggioli Arnaud, Carpentier Patrick
Laboratoires Servier, Nevilly sur Seine, France -
Grenoble University Hospital, Grenoble cedex, France.
Int Angiol. 2019 Apr;38(2):83-89. doi: 10.23736/S0392-9590.18.04054-3.
To show the efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg in the mild cases of chronic venous disorders (CVD), i.e. in C0s-C1 patients according to the CEAP classification.
In an international, randomized, double-blind, parallel-group study, symptomatic C0s to C4 patients according to the Clinical Etiological Anatomic Pathophysiologic (CEAP) were treated for 8 weeks by either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis is focused on the efficacy of MPFF at the daily doses of 1000 mg in the population of mild cases of the CVD (C0s-C1 patients) on lower limb discomfort, leg pain and leg heaviness using a 10-cm Visual Analog Scale (VAS), and on quality of life (QoL) using CIVIQ-20.
In the 256 patients of the C0s-C1 subset of the study patients, lower limb discomfort improvement measured on VAS was clinically and statistically significant: -2.87±2.38 cm in the MPFF 1000 mg group and -3.30±2.36 cm in the MPFF 500 mg group (P<0.001 in both groups). Leg pain and leg heaviness VAS improved similarly: -2.77±2.58 cm in the MPFF 1000 mg group and -3.45±2.38 cm in the MPFF 500 mg group (P<0.001 in both groups), and -2.91±2.47 cm in the MPFF 1000 mg group and -3.47±2.33 cm in the MPFF 500 mg group (P<0.001 in both groups). The quality of life assessed by the CIVIQ-20 questionnaire improved significantly in both treatment groups from baseline to W8 with a mean changes of global index score of -16.53±14.18 in the MPFF 1000 mg group and -18.78±18.14 in the MPFF 500 mg group (P<0.001).
MPFF at the daily dose of 1000 mg was shown to have a similar efficacy in mild CVD cases (C0s-C1 patients) as in the whole spectrum of patients from the main study, with a very good safety profile. These result further illustrates the interest of MPFF in the management of the mild cases of the disease at a daily dose of 1000 mg.
为了证明微粒化纯化黄酮类化合物组分（MPFF）1000毫克在慢性静脉疾病（CVD）轻症病例中的疗效，即根据CEAP分类法，在C0s-C1患者中的疗效。
在一项国际、随机、双盲、平行组研究中，根据临床病因解剖病理生理学（CEAP）分类为症状性C0s至C4的患者，分别接受每日一次1000毫克MPFF或每日两次500毫克MPFF治疗8周。本次事后分析聚焦于每日剂量1000毫克的MPFF对CVD轻症患者（C0s-C1患者）群体下肢不适、腿痛和腿部沉重感的疗效，使用10厘米视觉模拟量表（VAS）进行评估，以及使用CIVIQ-20评估生活质量（QoL）。
在研究患者的C0s-C1亚组的256例患者中，通过VAS测量的下肢不适改善在临床和统计学上均具有显著意义：MPFF 1000毫克组为-2.87±2.38厘米，MPFF 500毫克组为-3.30±2.36厘米（两组P均<0.001）。腿痛和腿部沉重感的VAS改善情况类似：MPFF 1000毫克组为-2.77±2.58厘米，MPFF 500毫克组为-3.45±2.38厘米（两组P均<0.001），以及MPFF 1000毫克组为-2.91±2.47厘米，MPFF 500毫克组为-3.47±2.33厘米（两组P均<0.001）。从基线到第8周，两个治疗组通过CIVIQ-20问卷评估的生活质量均有显著改善，MPFF 1000毫克组的总体指数评分平均变化为-16.53±14.18，MPFF 500毫克组为-18.78±18.14（P<0.001）。
每日剂量1000毫克的MPFF在CVD轻症病例（C0s-C1患者）中显示出与主要研究的全谱患者相似的疗效，且安全性良好。这些结果进一步说明了每日剂量1000毫克的MPFF在该疾病轻症管理中的价值。
