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静脉内机械化学闭塞术后基于微粉化纯化黄酮类成分的静脉活性治疗的疗效:前瞻性比较研究

Efficacy of Micronized Purified Flavonoid Fraction-Based Venoactive Therapy After Endovenous Mechanochemical Obliteration: Prospective Comparative Study.

作者信息

Khryshchanovich Vladimir Y, Nebylitsin Yuri S, Kosinets Vladimir A

机构信息

Belarusian State Medical University, Dzerzhinski Ave., 83, Minsk, 220116, Republic of Belarus.

Vitebsk State Order of Peoples Friendship Medical University, Vitebsk, Republic of Belarus.

出版信息

Drugs Real World Outcomes. 2021 Sep;8(3):349-358. doi: 10.1007/s40801-021-00249-4. Epub 2021 Apr 28.

Abstract

BACKGROUND

Endovenous interventions and minimally invasive open procedures are effective in the management of varicose veins, but can result in post-operative pain/discomfort.

OBJECTIVE

The objective of this study was to evaluate the clinical efficacy of micronized purified flavonoid fraction venoactive therapy for postoperative pain, vein-specific symptoms, and quality of life in patients with varicose veins following an endovenous mechanochemical ablation procedure.

METHODS

This prospective, observational, single-center study allocated patients into two groups: Group A, micronized purified flavonoid fraction 1000 mg once daily for 30 days; Group B, no venoactive drug prescribed (control). The Clinical-Etiology-Anatomy-Pathophysiology classification system for chronic venous disorders was used to assess varicose veins; a 10-point Visual Analog Scale assessed pain syndrome intensity; the Venous Clinical Severity Score measured overall varicose vein severity; and the Chronic Venous Insufficiency QoL Questionnaire measured total quality of life.

RESULTS

The study enrolled 58 patients (mean age 36.9 ± 4.1 years; 24 men) with varicose veins of C2-C4 who underwent truncal mechanochemical ablation plus mini-phlebectomy or foam sclerotherapy. Group A had significantly lower pain syndrome at days 14 and 30 compared with Group B (1.76 vs 2.20, p = 0.039; 1.38 vs 2.07, p = 0.003, respectively), and clinical symptom severity at day 30 (2.67 vs 3.13, p = 0.05). Significant differences in quality-of-life scores existed between groups at days 14 and 30 (15.21 vs 18.75, p = 0.008; 12.98 vs 16.33, p = 0.001). No micronized, purified flavonoid, fraction-related adverse effects were observed.

CONCLUSIONS

Micronized purified flavonoid fraction-based venoactive adjuvant therapy after mechanochemical ablation alleviated pain, reduced the severity of symptoms, and improved the quality of life in patients with varicose veins.

摘要

背景

静脉内干预和微创开放手术在治疗静脉曲张方面有效,但可能导致术后疼痛/不适。

目的

本研究旨在评估微粉化纯化黄酮类化合物静脉活性疗法对接受静脉内机械化学消融术后的静脉曲张患者的术后疼痛、静脉特异性症状及生活质量的临床疗效。

方法

这项前瞻性、观察性、单中心研究将患者分为两组:A组,微粉化纯化黄酮类化合物1000毫克,每日一次,共30天;B组,未开具静脉活性药物(对照组)。采用慢性静脉疾病的临床-病因-解剖-病理生理分类系统评估静脉曲张;用10分视觉模拟量表评估疼痛综合征强度;用静脉临床严重程度评分衡量静脉曲张的总体严重程度;用慢性静脉功能不全生活质量问卷测量生活质量总分。

结果

该研究纳入了58例C2-C4级静脉曲张患者(平均年龄36.9±4.1岁;24例男性),他们接受了主干机械化学消融加小隐静脉切除术或泡沫硬化疗法。与B组相比,A组在第14天和第30天的疼痛综合征明显更低(分别为1.76对2.20,p = 0.039;1.38对2.07,p = 0.003),且在第30天的临床症状严重程度更低(2.67对3.13,p = 0.05)。两组在第14天和第30天的生活质量评分存在显著差异(15.21对18.75,p = 0.008;12.98对16.33,p = 0.001)。未观察到与微粉化纯化黄酮类化合物相关的不良反应。

结论

机械化学消融术后基于微粉化纯化黄酮类化合物的静脉活性辅助治疗减轻了静脉曲张患者的疼痛,降低了症状严重程度,并改善了生活质量。

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