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3.
Adv Ther ; 40(11): 5016-5036, 2023 11.
Artículo en Inglés | MEDLINE | ID: mdl-37728696

RESUMEN

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT04574375.


STUDY AIM: 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. STUDY FINDINGS: 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. CONCLUSION: 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.


Asunto(s)
Enfermedades Vasculares , Insuficiencia Venosa , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Crónica , Estudios de Cohortes , Tratamiento Conservador , Estudios Prospectivos , Calidad de Vida , Resultado del Tratamiento , Enfermedades Vasculares/tratamiento farmacológico , Insuficiencia Venosa/tratamiento farmacológico , Estudios Longitudinales
4.
Phlebology ; 38(5): 322-333, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37078365

RESUMEN

INTRODUCTION: To date, the problem of venous thromboembolism and its consequences remains relevant, despite significant progress in the development of phlebology and technologies. AIM: In our study, we tried to assess the "danger" of floating DVTs, methods and features of conservative and surgical treatment of patients with floating DVTs, analyze the results of treatment of this group of patients, and draw conclusions based on our data. MATERIALS AND METHODS: The results of treatment of 1297 patients with venous thromboembolism for the period 2011-2022 were analyzed. 104 patients were treated with floating deep vein thrombosis, 1193 patients had occlusive proximal venous thrombosis. RESULTS: In our study, we determined the danger of floating DVT by comparing the facts of the migration of thrombotic masses in the proximal direction according to the results of treatment in two groups of patients. The first group consisted of 10 patients with proximal floating venous thromboses who were implanted with cava filters, the second group consisted of 28 patients with occlusive proximal venous thrombosis who were implanted with cava filters. Embolism occurred in 40.0% of cases floating DVT, while no cases of embolism were detected in occluding DVT (p < 0.01). Groups of patients with the length of the floating part of the thrombus up to 5 cm were analyzed. Anticoagulant therapy was used in 42 cases; thrombectomy was performed in 52 cases. There was no case of pulmonary embolism when treated with both conservative and surgical methods. CONCLUSIONS: Based on our research, it can be stated that floating thrombosis of deep veins of proximal venous segments is a type of thrombosis that has an increased risk of thromboembolic complications when the length of the floating part is 5 cm or more.


Asunto(s)
Embolia Pulmonar , Trombosis , Filtros de Vena Cava , Tromboembolia Venosa , Trombosis de la Vena , Humanos , Tromboembolia Venosa/complicaciones , Trombosis de la Vena/cirugía , Embolia Pulmonar/etiología , Trombectomía/efectos adversos , Filtros de Vena Cava/efectos adversos
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