Service de Médecine Interne, Hématologie Clinique, Centre Hospitalo-Universitaire Ibn Sina, Université Mohammed V de Rabat, Rabat, Morocco.
Vascularte Interdisciplinar Clinics SRL, Bucharest, Romania.
Adv Ther. 2023 Nov;40(11):5016-5036. doi: 10.1007/s12325-023-02643-6. Epub 2023 Sep 20.
VEIN STEP was conducted to collect international data on the management of chronic venous disease (CVD) and to assess the effectiveness of conservative treatments for the relief of CVD signs and symptoms.
This international, observational, prospective, longitudinal, cohort study recruited adult outpatients consulting for symptomatic CVD. The primary objective was the effectiveness of conservative treatments on symptoms, signs and quality of life in a real-life setting assessed using a range of patient-reported outcome measures: 10-cm Visual Analog and Patient Global Impression of Change scales for symptoms; Venous Clinical Severity Score for physician assessment of signs; and 14-item ChronIc Venous Insufficiency Questionnaire (CIVIQ-14) for quality of life. At inclusion, patients were prescribed conservative treatment according to the physicians' usual practice. Follow-up visits took place at weeks 2 and 4, with an optional week 8 visit.
The analysis set comprised 6084 subjects (78% female) from nine countries with a mean age of 50.6 ± 13.8 years and BMI of 28.0 ± 4.9 kg/m. The most common CEAP classifications were C1 (23.0%), C2 (31.6%), and C3 (30.7%). Conservative therapy consisted of oral venoactive drugs (VADs; 95.8% of subjects) including micronized purified flavonoid fraction (MPFF 75.5%) and diosmin (18.8%), compression (52.0%), and topicals (31.5%). Conservative therapy led to global symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain, leg heaviness, cramps, and sensation of swelling were improved in 82%, 71%, 45.5%, and 46% of patients, respectively. Conservative therapy was associated with a decrease over time in patient-assessed global symptom intensity: - 2.37 ± 1.73 (P < 0.001) and physician-assessed disease severity - 1.83 ± 2.82 (P < 0.001). Among the VADs, MPFF-based conservative therapy was associated with the greatest reduction in symptom and sign intensity. Improvements in CIVIQ-14 were observed with all treatments but were greatest for MPFF.
In this prospective study conducted in the real-world setting, treatment with conservative therapy, in particular MPFF, was associated with meaningful improvements in the clinical signs and symptoms of disease as well as in quality of life in patients with CVD.
ClinicalTrials.gov identifier NCT04574375.
VEIN STEP 旨在收集关于慢性静脉疾病（CVD）管理的国际数据，并评估保守治疗缓解 CVD 体征和症状的有效性。
这是一项国际性、观察性、前瞻性、纵向队列研究，招募了因有症状的 CVD 而就诊的成年门诊患者。主要目的是评估保守治疗在真实环境下对症状、体征和生活质量的有效性，使用一系列患者报告的结局测量指标进行评估：10 厘米视觉模拟和患者整体变化印象量表用于症状评估；静脉临床严重程度评分用于医生评估体征；14 项慢性静脉功能不全问卷（CIVIQ-14）用于生活质量评估。入组时，根据医生的常规治疗为患者开具保守治疗方案。在第 2 周和第 4 周进行随访，第 8 周可进行可选随访。
分析集包括来自 9 个国家的 6084 名受试者（78%为女性），平均年龄为 50.6±13.8 岁，BMI 为 28.0±4.9kg/m。最常见的 CEAP 分类为 C1（23.0%）、C2（31.6%）和 C3（30.7%）。保守治疗包括口服静脉活性药物（VAD；95.8%的受试者），包括微粒化纯化黄酮类化合物（MPFF 75.5%）和地奥司明（18.8%）、压缩（52.0%）和局部治疗（31.5%）。治疗 2 周后，89%的患者出现全身性症状改善，4 周后为 96%。疼痛、腿部沉重感、痉挛和肿胀感分别改善了 82%、71%、45.5%和 46%的患者。保守治疗与患者评估的全球症状严重程度随时间的降低相关：-2.37±1.73（P<0.001）和医生评估的疾病严重程度-1.83±2.82（P<0.001）。在 VAD 中，基于 MPFF 的保守治疗与症状和体征严重程度的最大降低相关。所有治疗均观察到 CIVIQ-14 的改善，但 MPFF 的改善最大。
在这项在真实环境中进行的前瞻性研究中，保守治疗，特别是基于 MPFF 的保守治疗，与 CVD 患者的临床体征和症状以及生活质量的显著改善相关。
ClinicalTrials.gov 标识符 NCT04574375。
