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【转帖】早期透析与晚期透析比较的随机、对照试验
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早期透析与晚期透析比较的随机、对照试验 摘要 背景: 在临床实践中,对于CKD5期病人,维持性透析开始的时间有相当大的不同观点,现在的趋势是早启动进行维持新透析。在本研究,在澳大利亚和新西兰有32个中心进行了该研究。我们分析了维持新透析饿开始时间对CKD患者生存的影响。 方法: 我们随机分配了≥18岁的进展性CKD患者,且eGFR在10.0到15.0ml/min(Cockcroft-Gault 公式计算)。当eGFR在10.0到14.0ml/min时(早期)启动透析,或者eGFR在5.0到7.0(晚期)进行透析。有部分患者的主要结果是死亡。 结果: 在2000年7月到2008年11月,828名成人患者(平均年龄60.4岁;男:542名,女286名;糖尿病:355名)通过随机化,在早期透析组,平均透析启动时间1.8月(95%CI,1.60——2.23),晚期透析组为7.4月(95%CI,6.23——8.27)。 在晚期透析组,有75.9%的患者因为症状的原因,在eGFR大于7.0ml/min时启动透析。在平均3.59年的随访中,在早期透析组的404名患者中,有152名死亡(占37.6%);在晚期透析组424名患者中,155名患者死亡(占36.6%)(早期启动透析危险比是1.04;95%CI,0.83——1.30;P=0.75)。在不良事件的发生上(包括心血管事件、感染、透析的并发症),没有明显的差异。 结论:在本研究中,在CKD5期患者,早期启动透析与患者的生存和临床结果的改善无关。 ( (该研究被澳大利亚和其他国家的国家卫生和医疗研究委员会资助)澳大利亚、新西兰临床试验注册编号:12609000266268。 A randomized, controlled trial of early versus late initiation of dialysis. Cooper BA, Branley P, Bulfone L, Collins JF, Craig JC, Fraenkel MB, Harris A, Johnson DW, Kesselhut J, Li JJ, Luxton G, Pilmore A, Tiller DJ, Harris DC, Pollock CA; IDEAL Study. Collaborators (59)Kerr P, Krum H, Pitt A, Dawborn J, Forbes A, McNeil J, Tonkin A, Cooper BA, Kesselhut J, Davis M, Pilmore A, Martin A, Helyar J, Dempster J, Bisscheroux P, Kesselhut J, Milne A, Prasad R, Bohte H, Parag V, Holloway T, Jenkins M, Menahem S, Fraenkel MB, Harris DC, Mantha M, McIver M, Gillies A, Fassett R, Mathew M, Suranyi M, Brown F, Gray NA, Wyndham R, Shannon G, Johnson DW, Russ G, Elias T, Healy H, Kirkland G, Jose M, Cooper BA, Pollock CA, Irish A, Hutchison B, Brown M, Langham R, May S, Chowdhury S, Swao J, Lonergan M, Collins JF, Walker R, Voss D, Panlilio N, Madhan K, Fisher M, Matheson P, Walker J. Department of Renal Medicine, Royal North Shore Hospital, Sydney Medical School, Sydney, Australia. bcooper@med.usyd.edu.au N Engl J Med. 2010 Aug 12;363(7):678-80. 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.) |
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