Effect of a Carbonaceous Oral Adsorbent on the Progression of CKD: A Multicenter, Randomized, Controlled Trial
Effect of a Carbonaceous Oral Adsorbent on the Progression of CKD: A Multicenter, Randomized, Controlled Trial
复制标题
DOI：
10.1053/j.ajkd.2009.05.011
复制
发表时间：
2009-09-01
影响因子：
13.2
通讯作者：
Kurokawa, Kiyoshi
中科院分区：
文献类型：
--
作者：
Akizawa, Tadao;Asano, Yasushi;Kurokawa, Kiyoshi
背景：含碳口服吸附剂AST-120可减缓晚期慢性肾病（CKD）患者的肾功能恶化。研究设计：随机对照试验，地点和参与者：75家医疗机构，460名血清肌酐（sCr）浓度低于5.0 mg/dL的CKD患者（未接受透析）。干预：随机分配到低蛋白饮食和抗高血压药物的对照组或治疗结合AST-120（6 g/d）。复合主要终点：sCr水平加倍，sCr水平升高至6.0 mg/dL或更高，需要透析或移植，或死亡。次要结局：不良事件和估计肌酐清除率（CCr），蛋白尿（蛋白毫克每天），和生活quality.Results的变化：平均sCr水平为2.66毫克/分升，估计CCr为22.4毫升/分钟，在两组。在56周内，两组间主要终点事件（对照组43例，AST-120组42例）和无事件生存率（P = 0.9）无差异。对照组中胃肠道不良事件的发生率低于AST-120组（2 vs 32起事件）。对照组的估计CCr下降幅度大于AST-120组（-0.15 vs-0.12 mL/min/y; P = 0.001）。中位蛋白尿从1，162到1，167 mg/d的蛋白质在对照组与1，102到906 mg/d在AST-120组（P = 0.2）.限制：罕见的主要终点事件.结论：AST-120并没有实质上减缓肾脏疾病的进展在中度至重度CKD患者在1年。美国肾脏病杂志54：459-467。(C)2009年，美国国家肾脏基金会（National Kidney Foundation，Inc.）
Background: The carbonaceous oral adsorbent AST-120 slows the deterioration of kidney function in patients with advanced chronic kidney disease (CKD). However, information about AST-120 in patients with less severe stages of CKD is lacking.Study Design: Randomized controlled trial.Setting & Participants: 75 medical facilities, 460 patients with CKD with serum creatinine (sCr) concentrations less than 5.0 mg/dL (not undergoing dialysis).Intervention: Random assignment to either a low-protein diet and anti hypertensive medication in the control group or that treatment combined with AST-120 (6 g/d).Outcomes & Measurements: Composite primary end point: doubling of sCr level, increase in sCr level to 6.0 mg/dL or more, need for dialysis or transplantation, or death. Secondary outcomes: adverse events and changes in estimated creatinine clearance (CCr) rate, proteinuria (protein in milligrams per day), and quality of life.Results: Mean sCr level was 2.66 mg/dL and estimated CCr was 22.4 mL/min in both groups. During 56 weeks, numbers of primary end-point events (43 for control versus 42 for AST-120) and event-free survival (P = 0.9) did not differ between groups. Gastrointestinal adverse events were less common in the control group than the AST-120 group (2 versus 32 events). Estimated CCr decreased more in the control group than in the AST-120 group (-0.15 versus -0.12 mL/min/y; P = 0.001). Median proteinuria changed from protein of 1,162 to 1,167 mg/d in the control group versus 1,102 to 906 mg/d in the AST-120 group (P = 0.2).Limitation: Infrequent primary end-point events.Conclusion: AST-120 did not substantially slow the progression of kidney disease in patients with moderate to severe CKD during 1 year. Am J Kidney Dis 54:459-467. (C) 2009 by the National Kidney Foundation, Inc.