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一项比较早期与晚期开始透析的随机对照试验。

A randomized, controlled trial of early versus late initiation of dialysis.

机构信息

Department of Renal Medicine, Royal North Shore Hospital, Sydney Medical School, Sydney, Australia.

出版信息

N Engl J Med. 2010 Aug 12;363(7):609-19. doi: 10.1056/NEJMoa1000552. Epub 2010 Jun 27.

Abstract

BACKGROUND

In clinical practice, there is considerable variation in the timing of the initiation of maintenance dialysis for patients with stage V chronic kidney disease, with a worldwide trend toward early initiation. In this study, conducted at 32 centers in Australia and New Zealand, we examined whether the timing of the initiation of maintenance dialysis influenced survival among patients with chronic kidney disease.

METHODS

We randomly assigned patients 18 years of age or older with progressive chronic kidney disease and an estimated glomerular filtration rate (GFR) between 10.0 and 15.0 ml per minute per 1.73 m2 of body-surface area (calculated with the use of the Cockcroft-Gault equation) to planned initiation of dialysis when the estimated GFR was 10.0 to 14.0 ml per minute (early start) or when the estimated GFR was 5.0 to 7.0 ml per minute (late start). The primary outcome was death from any cause.

RESULTS

Between July 2000 and November 2008, a total of 828 adults (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes) underwent randomization, with a median time to the initiation of dialysis of 1.80 months (95% confidence interval [CI], 1.60 to 2.23) in the early-start group and 7.40 months (95% CI, 6.23 to 8.27) in the late-start group. A total of 75.9% of the patients in the late-start group initiated dialysis when the estimated GFR was above the target of 7.0 ml per minute, owing to the development of symptoms. During a median follow-up period of 3.59 years, 152 of 404 patients in the early-start group (37.6%) and 155 of 424 in the late-start group (36.6%) died (hazard ratio with early initiation, 1.04; 95% CI, 0.83 to 1.30; P=0.75). There was no significant difference between the groups in the frequency of adverse events (cardiovascular events, infections, or complications of dialysis).

CONCLUSIONS

In this study, planned early initiation of dialysis in patients with stage V chronic kidney disease was not associated with an improvement in survival or clinical outcomes. (Funded by the National Health and Medical Research Council of Australia and others; Australian New Zealand Clinical Trials Registry number, 12609000266268.)

摘要

背景

在临床实践中,对于处于慢性肾脏病 5 期的患者,启动维持性透析的时机存在较大差异,全球范围内呈现出提前启动的趋势。在这项在澳大利亚和新西兰的 32 个中心进行的研究中,我们探讨了启动维持性透析的时机是否会影响慢性肾脏病患者的生存。

方法

我们将年龄在 18 岁及以上、估算肾小球滤过率(GFR)为 10.0 至 15.0ml/分钟/1.73m2 (使用 Cockcroft-Gault 方程计算)、进展性慢性肾脏病且预计 GFR 在 10.0 至 14.0ml/分钟(提前启动)或 5.0 至 7.0ml/分钟(延迟启动)时进入计划启动透析的患者随机分为两组,一组提前启动,另一组延迟启动。主要结局为任何原因导致的死亡。

结果

2000 年 7 月至 2008 年 11 月,共有 828 名成年人(平均年龄 60.4 岁;542 名男性和 286 名女性;355 名患有糖尿病)接受了随机分组,提前启动组的中位透析启动时间为 1.80 个月(95%置信区间 [CI],1.60 至 2.23),延迟启动组为 7.40 个月(95% CI,6.23 至 8.27)。由于出现症状,延迟启动组中有 75.9%的患者在预计 GFR 超过 7.0ml/分钟的目标值时开始透析。在中位随访 3.59 年期间,提前启动组的 404 名患者中有 152 名(37.6%)和延迟启动组的 424 名患者中有 155 名(36.6%)死亡(早期启动的风险比为 1.04;95%CI,0.83 至 1.30;P=0.75)。两组之间不良事件(心血管事件、感染或透析并发症)的发生频率没有显著差异。

结论

在这项研究中,对于处于慢性肾脏病 5 期的患者,提前启动透析并不能改善生存或临床结局。(由澳大利亚国家卫生与医学研究理事会等资助;澳大利亚和新西兰临床试验注册中心编号:12609000266268。)

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