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IDEAL 试验中计划开始腹膜透析的患者开始透析时间对临床结局的影响。

Effect of timing of dialysis commencement on clinical outcomes of patients with planned initiation of peritoneal dialysis in the IDEAL trial.

机构信息

Centre for Kidney Disease Research, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia.

出版信息

Perit Dial Int. 2012 Nov-Dec;32(6):595-604. doi: 10.3747/pdi.2012.00046.

Abstract

BACKGROUND

Since the mid-1990s, early dialysis initiation has dramatically increased in many countries. The Initiating Dialysis Early and Late (IDEAL) study demonstrated that, compared with late initiation, planned early initiation of dialysis was associated with comparable clinical outcomes and increased health care costs. Because residual renal function is a key determinant of outcome and is better preserved with peritoneal dialysis (PD), the present pre-specified subgroup analysis of the IDEAL trial examined the effects of early-compared with late-start dialysis on clinical outcomes in patients whose planned therapy at the time of randomization was PD.

METHODS

Adults with an estimated glomerular filtration rate (eGFR) of 10 - 15 mL/min/1.73 m(2) who planned to be treated with PD were randomly allocated to commence dialysis at an eGFR of 10 - 14 mL/min/1.73 m(2) (early start) or 5 - 7 mL/min/1.73 m(2) (late start). The primary outcome was all-cause mortality.

RESULTS

Of the 828 IDEAL trial participants, 466 (56%) planned to commence PD and were randomized to early start (n = 233) or late start (n = 233). The median times from randomization to dialysis initiation were, respectively, 2.03 months [interquartile range (IQR):1.67 - 2.30 months] and 7.83 months (IQR: 5.83 - 8.83 months). Death occurred in 102 early-start patients and 96 late-start patients [hazard ratio: 1.04; 95% confidence interval (CI): 0.79 - 1.37]. No differences in composite cardiovascular events, composite infectious deaths, or dialysis-associated complications were observed between the groups. Peritonitis rates were 0.73 episodes (95% CI: 0.65 - 0.82 episodes) per patient-year in the early-start group and 0.69 episodes (95% CI: 0.61 - 0.78 episodes) per patient-year in the late-start group (incidence rate ratio: 1.19; 95% CI: 0.86 - 1.65; p = 0.29). The proportion of patients planning to commence PD who actually initiated dialysis with PD was higher in the early-start group (80% vs 70%, p = 0.01).

CONCLUSION

Early initiation of dialysis in patients with stage 5 chronic kidney disease who planned to be treated with PD was associated with clinical outcomes comparable to those seen with late dialysis initiation. Compared with early-start patients, late-start patients who had chosen PD as their planned dialysis modality were less likely to commence on PD.

摘要

背景

自 20 世纪 90 年代中期以来,许多国家的早期透析治疗已显著增加。IDEAL 研究表明,与晚期开始相比,计划中的早期开始透析与可比的临床结果相关,并增加了医疗保健成本。由于残余肾功能是结果的关键决定因素,并且腹膜透析(PD)更好地保留,因此本 IDEAL 试验的预先指定亚组分析检查了与晚期开始透析相比,早期开始透析对随机分配时计划治疗为 PD 的患者的临床结果的影响。

方法

肾小球滤过率(eGFR)估计为 10-15 mL/min/1.73 m(2)的成年人计划接受 PD 治疗,随机分配至 eGFR 为 10-14 mL/min/1.73 m(2)(早期开始)或 5-7 mL/min/1.73 m(2)(晚期开始)时开始透析。主要结局为全因死亡率。

结果

在 828 名 IDEAL 试验参与者中,466 名(56%)计划开始 PD,并被随机分配至早期开始(n=233)或晚期开始(n=233)。从随机分组到开始透析的中位时间分别为 2.03 个月[四分位距(IQR):1.67-2.30 个月]和 7.83 个月(IQR:5.83-8.83 个月)。102 例早期开始治疗的患者和 96 例晚期开始治疗的患者死亡[风险比:1.04;95%置信区间(CI):0.79-1.37]。两组之间未观察到心血管复合事件、感染性死亡或与透析相关的并发症的差异。早期开始组的腹膜炎发生率为 0.73 例(95%CI:0.65-0.82 例)/患者年,晚期开始组为 0.69 例(95%CI:0.61-0.78 例)/患者年(发生率比:1.19;95%CI:0.86-1.65;p=0.29)。在早期开始组中,计划开始 PD 的患者中实际开始 PD 的比例更高(80%比 70%,p=0.01)。

结论

计划开始 PD 的 5 期慢性肾脏病患者的早期透析治疗与晚期开始透析治疗的临床结果相当。与早期开始治疗的患者相比,选择 PD 作为计划透析方式的晚期开始治疗的患者开始 PD 的可能性较小。

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