Rationale and study design of a clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia.
Rationale and study design of a clinical trial to assess the effects of LDL apheresis on proteinuria in diabetic patients with severe proteinuria and dyslipidemia.
复制标题
一项临床试验的基本原理和研究设计，旨在评估低密度脂蛋白单采术对患有严重蛋白尿和血脂异常的糖尿病患者的蛋白尿的影响。
DOI：
10.1007/s10157-017-1488-4
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发表时间：
2017
期刊：
影响因子：
2.3
通讯作者：
Terada Y,
中科院分区：
文献类型：
--
作者：
Wada T;Muso E;Maruyama S;Hara A;Furuichi K;Yoshimura K;Miyazaki M;Sato E;Abe M;Shibagaki Y;Narita I;Yokoyama H;Mori N;Yuzawa Y;Matsubara T;Tsukamoto T;Wada J;Ito T;Masutani K;Tsuruya K;Fujimoto S;Tsuda A;Suzuki H;Kasuno K;Terada Y,
背景糖尿病肾病是世界范围内终末期肾病的主要病因之一。虽然糖尿病、高血压、血脂异常等多种治疗方法改善了糖尿病肾病患者的预后和生活质量，但仍有部分糖尿病患者出现严重蛋白尿，预后不良。这项临床试验，LICENSE，旨在确认LDL血浆分离对蛋白尿表现出低反应性治疗的影响。MethodsThis正在进行的试验是一项多中心的，前瞻性的研究，糖尿病患者严重的蛋白尿。目的是检查LDL单采术对糖尿病肾病患者蛋白尿的影响。另一个主题是调查这些patients.ResultsThe主题包括糖尿病患者的血清肌酐（Cr）水平低于2 mg/dL的严重蛋白尿3 g/g Cr或3 g/天和LDL胆固醇高于120 mg/dL。登记患者的目标数量为35例患者。LDL单采治疗后24周观察尿蛋白排泄量及肾功能。结论LDL单采治疗糖尿病肾病合并严重蛋白尿及血脂异常的有效性和安全性。
BackgroundDiabetic nephropathy is a leading cause of end-stage kidney disease in the world. Although various types of treatment for diabetes, hypertension and dyslipidemia have improved prognosis and quality of life in patients with diabetic nephropathy, there still exist some diabetic patients with severe proteinuria showing poor prognosis. This clinical trial, LICENSE, aims to confirm the impact of LDL apheresis on proteinuria exhibiting hyporesponsiveness to treatment.MethodsThis ongoing trial is a multicenter, prospective study of diabetic patients with severe proteinuria. The objective is to examine the impact of LDL apheresis on proteinuria in patients with diabetic nephropathy. The other subject is to investigate safety of LDL apheresis in these patients.ResultsThe subjects consist of diabetic patients with serum creatinine (Cr) levels below 2 mg/dL who present severe proteinuria above 3 g/g Cr or 3 g/day and LDL cholesterol above 120 mg/dL. The target number of registered patients will be 35 patients. Urinary protein excretion and renal function will be observed for 24 weeks after the treatment of LDL apheresis.ConclusionThis study will determine the effectiveness and safety of LDL apheresis for diabetic nephropathy patients with severe proteinuria and dyslipidemia.