Locatelli Francesco, Martin-Malo Alejandro, Hannedouche Thierry, Loureiro Alfredo, Papadimitriou Menelaos, Wizemann Volker, Jacobson Stefan H, Czekalski Stanislaw, Ronco Claudio, Vanholder Raymond
Department of Nephrology, Dialysis and Renal Transplantation, A Manzoni Hospital, Lecco, Italy.
J Am Soc Nephrol. 2009 Mar;20(3):645-54. doi: 10.1681/ASN.2008060590. Epub 2008 Dec 17.
The effect of high-flux hemodialysis membranes on patient survival has not been unequivocally determined. In this prospective, randomized clinical trial, we enrolled 738 incident hemodialysis patients, stratified them by serum albumin < or = 4 and >4 g/dl, and assigned them to either low-flux or high-flux membranes. We followed patients for 3 to 7.5 yr. Kaplan-Meier survival analysis showed no significant difference between high-flux and low-flux membranes, and a Cox proportional hazards model concurred. Patients with serum albumin < or = 4 g/dl had significantly higher survival rates in the high-flux group compared with the low-flux group (P = 0.032). In addition, a secondary analysis revealed that high-flux membranes may significantly improve survival of patients with diabetes. Among those with serum albumin < or = 4 g/dl, slightly different effects among patients with and without diabetes suggested a potential interaction between diabetes status and low serum albumin in the reduction of risk conferred by high-flux membranes. In summary, we did not detect a significant survival benefit with either high-flux or low-flux membranes in the population overall, but the use of high-flux membranes conferred a significant survival benefit among patients with serum albumin < or = 4 g/dl. The apparent survival benefit among patients who have diabetes and are treated with high-flux membranes requires confirmation given the post hoc nature of our analysis.
高通量血液透析膜对患者生存率的影响尚未明确确定。在这项前瞻性随机临床试验中,我们纳入了738例初治血液透析患者,根据血清白蛋白≤4和>4 g/dl进行分层,并将他们分配至低通量或高通量膜组。我们对患者进行了3至7.5年的随访。Kaplan-Meier生存分析显示高通量膜和低通量膜之间无显著差异,Cox比例风险模型结果一致。血清白蛋白≤4 g/dl的患者中,高通量组的生存率显著高于低通量组(P = 0.032)。此外,一项二次分析显示高通量膜可能显著提高糖尿病患者的生存率。在血清白蛋白≤4 g/dl的患者中,糖尿病患者和非糖尿病患者之间的影响略有不同,提示糖尿病状态和低血清白蛋白在高通量膜降低风险方面可能存在潜在相互作用。总之,我们在总体人群中未检测到高通量膜或低通量膜有显著的生存获益,但在血清白蛋白≤4 g/dl的患者中,使用高通量膜有显著的生存获益。鉴于我们分析的事后性质,糖尿病患者接受高通量膜治疗时明显的生存获益需要进一步证实。