Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Medicine, University Health Network, Toronto, Ontario, Canada.
BMJ Open. 2021 Sep 13;11(9):e049557. doi: 10.1136/bmjopen-2021-049557.
After deep vein thrombosis, up to 50% of patients develop post-thrombotic syndrome (PTS). PTS is a chronic condition that reduces quality of life (QOL). Cornerstones of PTS treatment include the use of elastic compression stockings but this treatment is usually incompletely effective and is burdensome. Venoactive drugs have been reported to be effective to treat chronic venous insufficiency (CVI). However, the level of evidence supporting their use in CVI in general and in PTS in particular is low.
The MUFFIN-PTS trial is an academic, publically funded, multicentre randomised placebo-controlled trial assessing the efficacy of micronised purified flavonoid fraction (MPFF, Venixxa), a venoactive drug, to treat PTS. Eighty-six patients with PTS (Villalta score (VS) ≥5) and experiencing at least two of the following PTS manifestations among daily leg heaviness, cramps, pain or oedema will be randomised to receive 1000 mg of oral MPFF or a similar appearing placebo for 6 months, in addition to their usual PTS treatment. Total study follow-up will be 9 months, with visits at inclusion/baseline, 3, 6 and 9 months. Primary outcome is the proportion of patients with improvement in VS in each group, where improvement is defined as a decrease of at least 30% in VS or a VS <5 in the PTS-affected leg. Main secondary outcomes include QOL and patient satisfaction.
Primary ethics approval was received from Centre intégré universitaire de santé et de services sociaux (CIUSSS) West-Central Montreal Research Ethics Board. Results of the study will be disseminated via peer-reviewed publications and presentations at scientific conferences.
ClinicalTrials.gov Registry (NCT03833024); Pre-results.
深静脉血栓形成后，多达 50%的患者会发展为血栓后综合征（PTS）。PTS 是一种降低生活质量（QOL）的慢性疾病。PTS 治疗的基石包括使用弹性压缩袜，但这种治疗通常不完全有效且负担沉重。已经报道称静脉活性药物对治疗慢性静脉功能不全（CVI）有效。然而，支持其一般用于 CVI 特别是 PTS 的证据水平较低。
MUFFIN-PTS 试验是一项学术性、公共资助的、多中心随机安慰剂对照试验，评估了微米化纯化黄酮类混合物（MPFF，Venixxa）作为静脉活性药物治疗 PTS 的疗效。86 名 PTS 患者（Villalta 评分（VS）≥5），每天腿部沉重、抽筋、疼痛或肿胀至少有两种 PTS 表现，将被随机分配接受 1000 毫克口服 MPFF 或类似外观的安慰剂，为期 6 个月，同时接受常规 PTS 治疗。总研究随访时间为 9 个月，在纳入/基线、3、6 和 9 个月进行随访。主要结局是两组中 VS 改善的患者比例，改善定义为 VS 至少降低 30%或 PTS 受累腿的 VS<5。主要次要结局包括 QOL 和患者满意度。
初步伦理批准由西岛综合大学健康与社会服务中心（CIUSSS）西部中心蒙特利尔研究伦理委员会获得。研究结果将通过同行评审出版物和科学会议上的演讲进行传播。
ClinicalTrials.gov 注册表（NCT03833024）；预结果。
