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lrj107hn鐵桿木蟲(chóng) (著名寫(xiě)手)
路人甲-肥龍
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【轉(zhuǎn)帖】早期透析與晚期透析比較的隨機(jī)、對(duì)照試驗(yàn)
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早期透析與晚期透析比較的隨機(jī)、對(duì)照試驗(yàn) 摘要 背景: 在臨床實(shí)踐中，對(duì)于CKD5期病人，維持性透析開(kāi)始的時(shí)間有相當(dāng)大的不同觀點(diǎn)，現(xiàn)在的趨勢(shì)是早啟動(dòng)進(jìn)行維持新透析。在本研究，在澳大利亞和新西蘭有32個(gè)中心進(jìn)行了該研究。我們分析了維持新透析餓開(kāi)始時(shí)間對(duì)CKD患者生存的影響。 方法: 我們隨機(jī)分配了≥18歲的進(jìn)展性CKD患者，且eGFR在10.0到15.0ml/min（Cockcroft-Gault 公式計(jì)算）。當(dāng)eGFR在10.0到14.0ml/min時(shí)（早期）啟動(dòng)透析，或者eGFR在5.0到7.0（晚期）進(jìn)行透析。有部分患者的主要結(jié)果是死亡。 結(jié)果: 在2000年7月到2008年11月，828名成人患者（平均年齡60.4歲；男：542名，女286名；糖尿�。�355名）通過(guò)隨機(jī)化，在早期透析組，平均透析啟動(dòng)時(shí)間1.8月（95%CI，1.60——2.23），晚期透析組為7.4月（95%CI，6.23——8.27）。 在晚期透析組，有75.9%的患者因?yàn)榘Y狀的原因，在eGFR大于7.0ml/min時(shí)啟動(dòng)透析。在平均3.59年的隨訪中，在早期透析組的404名患者中，有152名死亡(占37.6%)；在晚期透析組424名患者中，155名患者死亡（占36.6%）（早期啟動(dòng)透析危險(xiǎn)比是1.04；95%CI，0.83——1.30；P=0.75）。在不良事件的發(fā)生上（包括心血管事件、感染、透析的并發(fā)癥)，沒(méi)有明顯的差異。 結(jié)論:在本研究中，在CKD5期患者，早期啟動(dòng)透析與患者的生存和臨床結(jié)果的改善無(wú)關(guān)。 ( （該研究被澳大利亞和其他國(guó)家的國(guó)家衛(wèi)生和醫(yī)療研究委員會(huì)資助）澳大利亞、新西蘭臨床試驗(yàn)注冊(cè)編號(hào)：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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