改善桡动脉-头静脉内瘘成熟度：脂质体泼尼松龙改善血液透析内瘘成熟度（LIPMAT）研究的原理与设计——一项随机对照试验
Improvement of radiocephalic fistula maturation: rationale and design of the Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study - a randomized controlled trial.
作者信息
Voorzaat Bram M, van Schaik Jan, van der Bogt Koen E A, Vogt Liffert, Huisman Laurens, Gabreëls Bas A Th F, van der Meer Irene M, van Eps Randolph G S, Eefting Daniël, Weijmer Marcel C, Groeneveld Han O, van Nieuwenhuizen Roos C, Boom Henk, Verburgh Cornelis A, van der Putten Karien, Rotmans Joris I
机构信息
Departments of Internal Medicine and Vascular Surgery, Leiden University Medical Center, Leiden - The Netherlands.
Department of Vascular Surgery, Haaglanden Medical Center, The Hague - The Netherlands.
出版信息
J Vasc Access. 2017 Mar 6;18(Suppl. 1):114-117. doi: 10.5301/jva.5000673. Epub 2017 Mar 5.
BACKGROUND
Non-maturation is a frequent complication of radiocephalic arteriovenous fistulas (RCAVF). In an animal model, liposomal prednisolone improved maturation of experimental fistulas. The Liposomal Prednisolone to Improve Hemodialysis Fistula Maturation (LIPMAT) study investigates if liposomal prednisolone improves RCAVF maturation.
METHODS AND RESULTS
The LIPMAT study is an investigator-initiated, multicenter, double-blinded, placebo-controlled randomized controlled trial with 1:1 randomization to liposomal prednisolone or placebo. Eighty patients receiving an RCAVF will be included. The primary outcome is the cephalic vein diameter six weeks after surgery, measured by ultrasound. The LIPMAT study started in May 2016. Enrollment is expected to be completed by the end of 2017.
CONCLUSIONS
The LIPMAT study is the first to evaluate the efficacy of liposomal prednisolone to enhance RCAVF maturation.
背景
未成熟是桡动脉头静脉动静脉内瘘（RCAVF）常见的并发症。在动物模型中，脂质体泼尼松龙可改善实验性内瘘的成熟情况。脂质体泼尼松龙改善血液透析内瘘成熟（LIPMAT）研究旨在探究脂质体泼尼松龙是否能改善RCAVF的成熟情况。
方法与结果
LIPMAT研究是一项由研究者发起的、多中心、双盲、安慰剂对照的随机对照试验，按1:1随机分为脂质体泼尼松龙组或安慰剂组。将纳入80例接受RCAVF手术的患者。主要结局指标是术后六周通过超声测量的头静脉直径。LIPMAT研究于2016年5月开始。预计2017年底完成入组。
结论
LIPMAT研究是首个评估脂质体泼尼松龙增强RCAVF成熟疗效的研究。
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