Chertow Glenn M, Levin Nathan W, Beck Gerald J, Daugirdas John T, Eggers Paul W, Kliger Alan S, Larive Brett, Rocco Michael V, Greene Tom
Department of Medicine, Stanford University, Palo Alto, California;
Renal Research Institute, New York, New York;
J Am Soc Nephrol. 2016 Jun;27(6):1830-6. doi: 10.1681/ASN.2015040426. Epub 2015 Oct 14.
The Frequent Hemodialysis Network Daily Trial randomized 245 patients to receive six (frequent) or three (conventional) in-center hemodialysis sessions per week for 12 months. As reported previously, frequent in-center hemodialysis yielded favorable effects on the coprimary composite outcomes of death or change in left ventricular mass and death or change in self-reported physical health. Here, we determined the long-term effects of the 12-month frequent in-center hemodialysis intervention. We determined the vital status of patients over a median of 3.6 years (10%-90% range, 1.5-5.3 years) after randomization. Using an intention to treat analysis, we compared the mortality hazard in randomized groups. In a subset of patients from both groups, we reassessed left ventricular mass and self-reported physical health a year or more after completion of the intervention; 20 of 125 patients (16%) randomized to frequent hemodialysis died during the combined trial and post-trial observation periods in contrast to 34 of 120 patients (28%) randomized to conventional hemodialysis. The relative mortality hazard for frequent versus conventional hemodialysis was 0.54 (95% confidence interval, 0.31 to 0.93); with censoring of time after kidney transplantation, the relative hazard was 0.56 (95% confidence interval, 0.32 to 0.99). Bayesian analysis suggested a relatively high probability of clinically significant benefit and a very low probability of harm with frequent hemodialysis. In conclusion, a 12-month frequent in-center hemodialysis intervention significantly reduced long-term mortality, suggesting that frequent hemodialysis may benefit selected patients with ESRD.
频繁血液透析网络每日试验将245例患者随机分为两组,一组每周进行6次(频繁组)中心血液透析,另一组每周进行3次(传统组)中心血液透析,为期12个月。如先前报道,频繁中心血液透析对死亡或左心室质量变化以及死亡或自我报告的身体健康变化这两个共同主要复合结局产生了有利影响。在此,我们确定了为期12个月的频繁中心血液透析干预的长期效果。我们在随机分组后的中位3.6年(10% - 90%范围为1.5 - 5.3年)内确定了患者的生命状态。采用意向性分析,我们比较了随机分组组间的死亡风险。在两组患者的一个亚组中,我们在干预完成一年或更长时间后重新评估了左心室质量和自我报告的身体健康;随机分配至频繁血液透析组的125例患者中有20例(16%)在联合试验期和试验后观察期死亡,而随机分配至传统血液透析组的120例患者中有34例(28%)死亡。频繁血液透析与传统血液透析相比的相对死亡风险为0.54(95%置信区间,0.31至0.93);在肾移植后进行时间截尾分析时,相对风险为0.56(95%置信区间,0.32至0.99)。贝叶斯分析表明频繁血液透析具有临床显著益处的可能性相对较高,而造成伤害的可能性非常低。总之,为期12个月的频繁中心血液透析干预显著降低了长期死亡率,提示频繁血液透析可能使某些终末期肾病患者获益。