背景:VEINSTEP旨在收集有关慢性静脉疾病(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。
方法:这个国际,观察,prospective,纵向,队列研究招募了有症状的CVD咨询的成年门诊患者。主要目标是保守治疗对症状的有效性,使用一系列患者报告的结果指标评估现实生活中的体征和生活质量:症状变化的10厘米视觉模拟和患者总体印象量表;用于医师体征评估的静脉临床严重程度评分;以及用于生活质量的14项ChronIc静脉功能不全问卷(CIVIQ-14)。在纳入时,根据医师的常规惯例,对患者进行保守治疗.后续访问在第2周和第4周进行,可选的第8周访问。
结果: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/m2。最常见的CEAP分类是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),包括微粉化的纯化类黄酮部分(MPFF75.5%)和地奥司明(18.8%),压缩(52.0%),和局部化学品(31.5%)。保守治疗导致2周后89%的患者和4周后96%的患者整体症状改善。疼痛,腿沉重,抽筋,肿胀的感觉改善了82%,71%,45.5%,46%的患者,分别。保守治疗与患者评估的总体症状强度降低相关:-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强度的最大降低相关。所有治疗均观察到CIVIQ-14的改善,但MPFF的改善最大。
结论:在现实世界中进行的这项前瞻性研究中,保守治疗,特别是MPFF,与有意义的改善CVD患者的临床体征和症状以及生活质量相关。
背景:ClinicalTrials.gov标识符NCT04574375。
目的:VEINSTEP研究旨在收集有关慢性静脉疾病(CVD)管理的全球数据,并评估保守(非手术)治疗对改善CVD体征和症状的有效性。
方法:研究组中有症状的CVD患者正在门诊就诊。主要目的是衡量治疗改善症状的程度,疾病的身体迹象,和生活质量。使用不同的方法来测量这些方面,例如以10分制对症状进行评分,并使用患者和医生填写的问卷。
结果:来自9个国家的6084名参与者参加了这项研究。他们大多是女性(78%),平均年龄在50岁左右。常见症状包括腿部疼痛和腿部沉重。治疗主要包括对静脉功能有活性的药物,比如MPFF和Diosmin,随着压缩丝袜和面霜。保守治疗导致2周后89%的患者症状改善,4周后96%。大多数患者的疼痛和腿部疼痛得到改善(同期为82%和71%),而痉挛,和肿胀显示改善在45.5%和46%的患者,分别。患者报告症状强度显著下降,医生观察到疾病严重程度降低。MPFF与症状强度的最大降低相关。所有治疗均观察到生活质量的改善,但MPFF的改善最大。
结论:这项研究强调了保守治疗,尤其是MPFF,与CVD患者的临床体征和症状以及生活质量的显着改善有关。
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/m2. 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.
OBJECTIVE: The VEIN STEP
study aimed to gather global data on managing chronic venous disease (CVD) and evaluate the usefulness of conservative (non-surgical) treatments for improving CVD signs and symptoms.
METHODS: Persons included in the
study group had symptomatic CVD and were visiting outpatient clinics. The main aim was to measure how well treatments improved symptoms, physical signs of the illness, and quality of life. Different methods were used to measure these aspects, such as rating symptoms on a 10-point scale and using questionnaires completed by patients and doctors.
RESULTS: 6084 participants from nine countries joined the
study. They were mostly women (78%) with an average age of around 50. Common symptoms included leg pain and leg heaviness. Treatments consisted mainly of drugs active on vein function, like MPFF and diosmin, along with compression stockings and creams. Conservative treatment led to symptom improvement in 89% of patients after 2 weeks and 96% at 4 weeks. Pain and leg heaviness improved in most patients (82% and 71% over the same period) while cramps, and swelling showed improvement in 45.5% and 46% of patients, respectively. Patients reported a significant decrease in symptom intensity, and doctors observed a reduction in disease severity. MPFF was associated with the highest reduction in symptom intensity. Improvements in quality of life were observed with all treatments but were greatest for MPFF.
CONCLUSIONS: The study highlights that conservative treatments, especially MPFF, are associated with significant improvements in the clinical signs and symptoms of patients with CVD as well as in their quality of life.