A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction
A Randomized, Controlled Trial of Oral Intestinal Sorbent AST-120 on Renal Function Deterioration in Patients with Advanced Renal Dysfunction
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DOI：
10.2215/cjn.12011214
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发表时间：
2016-04-01
影响因子：
9.8
通讯作者：
Kim, Yon Su
中科院分区：
文献类型：
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作者：
Cha, Ran-hui;Kang, Shin Wook;Kim, Yon Su
背景和目的口服肠道吸附剂AST-120减缓肾脏疾病进展的概念尚未得到彻底的评价。在这项研究中，我们研究了AST-120对肾脏疾病进展的长期影响。（血清肌酐加倍、eGFR降低> 50%或开始RRT）。设计、设置、参与者和测量我们前瞻性招募了579名患者从2009年3月4日至2010年8月31日从韩国的11个医疗中心获得的慢性肾脏病3期或4期患者，并将他们随机分为AST-120组和对照组。AST-120组的患者每天分三次给予6 g AST-120，结果治疗组和对照组的血清和尿硫酸吲哚酚和β 2-微球蛋白水平在整个研究期间均下降，但AST-120和对照组的尿毒症毒素变化无显著差异。两组在复合主要结局的发生率方面没有差异（AST-120组272例受试者发生100起事件，对照组266例受试者发生100起事件;风险比为1.12; 95%置信区间为0.85 - 1.48;对数秩P=0.45）。随时间推移，两个治疗组的eGFR下降和蛋白尿变化相似（分别为P随机化-时间=0.64和P随机化-时间=0.16）。两个治疗组的死亡率（AST-120组9例死亡，对照组11例死亡;对数秩P=0.73）或计划外住院（AST-120组102例，对照组109例;对数秩P=0.76）无差异。两组间健康相关生活质量评分无显著差异。结论长期使用AST-120加标准治疗并不改变晚期肾功能不全患者的肾脏疾病进展、蛋白尿、死亡率和健康相关生活质量。
Background and objectives The notion that oral intestinal sorbent AST-120 slows renal disease progression has not been evaluated thoroughly. In this study, we investigated the long-term effect of AST-120 on renal disease progression (doubling of serum creatinine, eGFR decrease >50%, or initiation of RRT) in patients with advanced CKD.Design, setting, participants, & measurements We prospectively recruited 579 patients (CKD stage 3 or 4) from 11 medical centers in Korea from March 4, 2009 to August 31, 2010 and randomized them into an AST-120 arm and a control arm. Patients in the AST-120 arm were given 6 g AST-120 in three divided doses per day, and those in the control arm received only standard conventional treatment (open-label design) for 36 months or until the occurrence of primary outcomes.Results Levels of serum and urine indoxyl sulfate and beta 2-microglobulin decreased throughout the study period in both treatment arms; however, there was not a significant difference in change in uremic toxins in the AST-120 and control arms. The two arms were not different in the occurrence of composite primary outcomes (100 events in 272 individuals in the AST-120 arm and 100 events in 266 individuals in the control arm; hazard ratio, 1.12; 95% confidence interval, 0.85 to 1.48; log-rank P=0.45). The decline in eGFR and change in proteinuria were similar in the two treatment arms over time (Prandomization-time=0.64 and Prandomization-time=0.16, respectively). There was no difference in mortality (nine deaths in the AST-120 arm and 11 deaths in the control arm; log-rank P=0.73) or unplanned hospitalizations (102 in the AST-120 arm and 109 in the control arm; log-rank P=0.76) in the two treatment arms. There was no significant difference of the health-related quality of life score between the two arms.Conclusions Long-term use of AST-120 added to standard treatment did not change renal disease progression, proteinuria, mortality, and health-related quality of life in patients with advanced renal dysfunction.