Effect of dialysis dose and membrane flux in maintenance hemodialysis.
Effect of dialysis dose and membrane flux in maintenance hemodialysis.
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DOI：
10.1056/nejmoa021583
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发表时间：
2002-12-19
影响因子：
158.5
通讯作者：
Toto, R
中科院分区：
文献类型：
--
作者：
Eknoyan, G;Beck, GJ;Toto, R
背景：透析剂量和透析膜通量水平对维持性血液透析患者死亡率和发病率的影响尚不确定。方法：我们对1846例每周3次透析的患者进行了随机临床试验，采用2×2析因设计，将患者随机分配到标准剂量或高剂量透析器，以及低通量或高通量透析器。结果：标准剂量组平均(+/-SD)尿素降解率为66.3+/-2.5%，单池Kt/V为1.32+/-0.09，平衡Kt/V为1.16+/-0.08；高剂量组分别为75.2+/-2.5%、1.71+/-0.11、1.53+/-0.09。根据β(Sub2)-微球蛋白清除量估算的流量，低流量组为3+/-7毫升/分钟，高流量组为34+/-11毫升/分钟。高剂量组与标准剂量组相比死亡的相对危险度为0.96(95%可信区间为0.84~1.10；P=0.53)，高剂量组与低剂量组相比死亡的相对危险度为0.92(95%可信区间0.81~1.05；P=0.23)。主要的次要结果(首次因心脏原因或任何原因死亡住院，首次因感染或任何原因死亡住院，血清白蛋白水平首次下降15%或任何原因死亡，以及所有与血管通畅无关的住院)在剂量组或流量组之间也没有显著差异。剂量或通量干预在7个预先指定的亚组患者中有2个被建议了可能的益处。结论：每周三次的血液透析患者似乎没有从高于当前美国指南推荐的透析剂量或使用高通量膜中获得重大好处。
Background: The effects of the dose of dialysis and the level of flux of the dialyzer membrane on mortality and morbidity among patients undergoing maintenance hemodialysis are uncertain.Methods: We undertook a randomized clinical trial in 1846 patients undergoing thrice-weekly dialysis, using a two-by-two factorial design to assign patients randomly to a standard or high dose of dialysis and to a low-flux or high-flux dialyzer.Results: In the standard-dose group, the mean (+/-SD) urea-reduction ratio was 66.3+/-2.5 percent, the single-pool Kt/V was 1.32+/-0.09, and the equilibrated Kt/V was 1.16+/-0.08; in the high-dose group, the values were 75.2+/-2.5 percent, 1.71+/-0.11, and 1.53+/-0.09, respectively. Flux, estimated on the basis of beta(sub 2)-microglobulin clearance, was 3+/-7 ml per minute in the low-flux group and 34+/-11 ml per minute in the high-flux group. The primary outcome, death from any cause, was not significantly influenced by the dose or flux assignment: the relative risk of death in the high-dose group as compared with the standard-dose group was 0.96 (95 percent confidence interval, 0.84 to 1.10; P=0.53), and the relative risk of death in the high-flux group as compared with the low-flux group was 0.92 (95 percent confidence interval, 0.81 to 1.05; P=0.23). The main secondary outcomes (first hospitalization for cardiac causes or death from any cause, first hospitalization for infection or death from any cause, first 15 percent decrease in the serum albumin level or death from any cause, and all hospitalizations not related to vascular access) also did not differ significantly between either the dose groups or the flux groups. Possible benefits of the dose or flux interventions were suggested in two of seven prespecified subgroups of patients.Conclusions: Patients undergoing hemodialysis thrice weekly appear to have no major benefit from a higher dialysis dose than that recommended by current U.S. guidelines or from the use of a high-flux membrane.