a Russian Scientific Research Medical University named after N. I. Pirogova , Department of Faculty Surgery , Moscow , Russia.
b Institute for Cardiovascular Diseases , Clinic for Vascular Surgery , Beograd , Serbia.
Curr Med Res Opin. 2019 Mar;35(3):553-557. doi: 10.1080/03007995.2018.1499508. Epub 2018 Aug 14.
To investigate the clinical efficacy of micronized purified flavonoid fraction (MPFF) 1000 mg given as a single 1000 mg tablet once daily in patients suffering from chronic venous disease (CVD) vs MPFF 500 mg twice daily.
In an international, randomized, double-blind, parallel-group study, patients classified C0s to C4 according to Clinical Etiological Anatomic Pathophysiologic [CEAP] classification and with leg pain graded as superior to 4 cm on a 10-cm visual analog scale (VAS), were treated for 8 weeks with either MPFF 1000 mg once daily or MPFF 500 mg twice daily. The present post-hoc analysis focuses on the effect of treatment over time in patients randomized to the MPFF 1000 mg group. Leg pain was assessed at each follow-up visit by VAS. VAS scores over time were compared between each visit using paired Student t-tests.
In total, 87 patients out of 174 were randomized to the MPFF 1000 mg group. Mean age ± SD was 49.1 ± 12.2 years, most of the patients were female (81.6%), the main CEAP classes of the most affected leg were C1 (20.7%), C2 (39.1%), C3 (33.33%), and the mean duration of CVD was 14.6 ± 10.9 years. Patients with previous CVD treatment represent 27.6% of the patients. A MPFF 1000 mg tablet once daily was associated with a significant and continuous reduction in leg pain throughout the treatment period: -1.54 cm (±1.45) from baseline to week 2 (p < .01), -1.11 cm (±1.06) from week 2 to week 4 (p < .01), -1.57 cm (±1.05) from week 4 to week 8 (p < .01).
The new MPFF 1000 mg dose regimen in once daily tablets was associated with a rapid and continuous reduction in leg pain throughout the 8-week treatment period.
评估每日一次给予 1000 毫克微粒化纯化黄酮（MPFF）与每日两次给予 500 毫克 MPFF 治疗慢性静脉疾病（CVD）患者的临床疗效。
在一项国际性、随机、双盲、平行分组研究中，根据临床病因解剖病理生理（CEAP）分类将患者分为 C0 至 C4 级，腿部疼痛程度根据 10 厘米视觉模拟量表（VAS）评为高于 4 厘米，患者接受为期 8 周的治疗，每日一次给予 1000 毫克 MPFF 或每日两次给予 500 毫克 MPFF。本事后分析重点关注随机分配至 MPFF 1000 毫克组患者的治疗随时间的变化。每次随访时均通过 VAS 评估腿部疼痛。使用配对学生 t 检验比较每次就诊时的 VAS 评分随时间的变化。
总共 174 名患者中有 87 名随机分配至 MPFF 1000 毫克组。平均年龄±标准差为 49.1±12.2 岁，大多数患者为女性（81.6%），最受影响的腿部的主要 CEAP 类别为 C1（20.7%）、C2（39.1%）、C3（33.33%），CVD 平均病程为 14.6±10.9 年。有 27.6%的患者之前接受过 CVD 治疗。每日一次给予 1000 毫克 MPFF 可显著且持续减轻腿部疼痛：与基线相比，治疗第 2 周时疼痛减轻 1.54 厘米（±1.45）（p<.01），第 4 周时疼痛减轻 1.11 厘米（±1.06）（p<.01），第 8 周时疼痛减轻 1.57 厘米（±1.05）（p<.01）。
每日一次给予 1000 毫克 MPFF 新剂量方案可在 8 周治疗期间迅速且持续减轻腿部疼痛。
