UNASSIGNED:雷诺现象(RP)和数字溃疡(DU)是系统性硬化症(SSc)的常见表现。尽管在SSc患者中非常常见,事实证明,这两种情况都非常难以研究。很少有可用的批准药物具有不同的功效。已经表明,DU的存在与增加的全血黏度(WBV)相关。Rheopheresis(RheoP)是一种体外血液分离技术,用于通过改善血液粘度来治疗微循环障碍。在单个病例报告中已经报道了RheoP治疗后改善的血流和伤口愈合。
UNASSIGNED:我们报告了“一项针对系统性硬化症(RHEACT)中雷诺综合征和数字溃疡的随机对照前瞻性单中心可行性研究”的临床试验方案。“RHEACT旨在研究RheoP对雷诺状态评分(RCS)的疗效,作为从基线开始16周后的主要疗效结局指标。30名患者将以1:1:1的比例随机分配到两个RheoP治疗组之一,或分配到标准护理(SoC)对照组(静脉注射伊洛前列素)。次要终点包括DU的变化,甲叠视频毛细管镜检查和患者报告结果的变化(硬皮病健康评估问卷,FACIT-疲劳,和手臂的残疾,肩膀,手,快速版本)。
未经证实:在SSc中已经研究了单采技术,但主要是观察性的,回顾性研究,或单个病例报告。RheoP是一种病理生理驱动的潜在新疗法,适用于患有或不患有DU的SSc相关继发性RP的负担沉重患者。
UNASSIGNED:该研究已在clinicaltrials.gov注册(标识符:NCT05204784)。此外,该研究已在德国系统性硬化症网络的网站上公开提供。\"
UNASSIGNED: Raynaud\'s phenomenon (RP) and digital ulcers (DU) are frequent manifestations of Systemic Sclerosis (SSc). Despite being very common in SSc patients, both conditions have proven to be notoriously difficult to
study. There are very few available approved drugs with varying efficacy. It has been shown that the presence of DU is associated with increased whole blood viscosity (WBV). Rheopheresis (RheoP) is an extracorporeal apheresis technique used to treat microcirculatory disorders by improving blood viscosity. Improved blood flow and wound healing after RheoP treatments have been reported in single case reports.
UNASSIGNED: We report the clinical
trial protocol of \"A randomized controlled prospective single-center feasibility
study of Rheopheresis for Raynaud\'s syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT).\" RHEACT aims to investigate the efficacy of RheoP on the Raynaud Condition Score (RCS) as the primary efficacy outcome measure after 16 weeks from baseline. Thirty patients will be randomized in a 1:1:1 ratio to one of two RheoP treatment groups or assigned to the standard of care (SoC) control group (intravenous iloprost). Secondary endpoints include changes in DU, changes in nailfold video capillaroscopy and patient-reported-outcomes (Scleroderma Health Assessment Questionnaire, FACIT-Fatigue, and the Disability of Arm, Shoulder, and Hand, quick version).
UNASSIGNED: Apheresis techniques have been investigated in SSc but mainly in observational, retrospective studies, or single case reports. RheoP is a pathophysiologically driven potential new therapy for heavily burdened patients with SSc-associated secondary RP with or without DU.
UNASSIGNED: The
study was registered at clinicaltrials.gov (Identifier: NCT05204784). Furthermore, the
study is made publicly available on the website of the German network of Systemic Sclerosis \"Deutsches Netzwerk Systemische Sklerodermie (DNSS).\"