Cha Ran-Hui, Kang Shin Wook, Park Cheol Whee, Cha Dae Ryong, Na Ki Young, Kim Sung Gyun, Yoon Sun Ae, Han Sang Youb, Chang Jae Hyun, Park Sue K, Lim Chun Soo, Kim Yon Su
Due to the number of contributing authors, the affiliations are provided in the Supplemental Material.
Clin J Am Soc Nephrol. 2016 Apr 7;11(4):559-67. doi: 10.2215/CJN.12011214. Epub 2016 Feb 9.
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.
Levels of serum and urine indoxyl sulfate and β2-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.
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.
口服肠道吸附剂AST-120可减缓肾病进展这一观点尚未得到充分评估。在本研究中，我们调查了AST-120对晚期慢性肾脏病（CKD）患者肾病进展（血清肌酐翻倍、估算肾小球滤过率（eGFR）下降>50%或开始肾脏替代治疗（RRT））的长期影响。
设计、地点、参与者及测量方法：2009年3月4日至2010年8月31日，我们从韩国11个医疗中心前瞻性招募了579例患者（CKD 3或4期），并将他们随机分为AST-120组和对照组。AST-120组患者每天分三次服用6g AST-120，对照组患者仅接受标准常规治疗（开放标签设计），为期36个月或直至出现主要结局。
在整个研究期间，两个治疗组的血清和尿液硫酸吲哚酚及β2-微球蛋白水平均下降；然而，AST-120组和对照组中尿毒症毒素的变化没有显著差异。两个组在复合主要结局的发生率上没有差异（AST-120组272例中有100例发生事件，对照组266例中有100例发生事件；风险比，1.12；95%置信区间，0.85至1.48；对数秩检验P=0.45）。随着时间的推移，两个治疗组的eGFR下降和蛋白尿变化相似（随机化-时间P分别为0.64和0.16）。两个治疗组在死亡率（AST-120组9例死亡，对照组11例死亡；对数秩检验P=0.73）或非计划住院率（AST-120组102例，对照组109例；对数秩检验P=0.76）方面没有差异。两组之间与健康相关的生活质量评分没有显著差异。
在标准治疗基础上加用AST-120进行长期治疗，并未改变晚期肾功能不全患者的肾病进展、蛋白尿、死亡率及与健康相关的生活质量。
