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如何为全面的临床试验测试“增量血液透析”做好准备。

How to set the stage for a full-fledged clinical trial testing 'incremental haemodialysis'.

机构信息

Clinical Research Branch, Division of Nephrology, Miulli General Hospital, Acquaviva delle Fonti, Italy.

Dialysis Centre SM2, Potenza, Italy.

出版信息

Nephrol Dial Transplant. 2018 Jul 1;33(7):1103-1109. doi: 10.1093/ndt/gfx225.

DOI:10.1093/ndt/gfx225
PMID:28992335
Abstract

Most people who make the transition to maintenance haemodialysis (HD) therapy are treated with a fixed dose of thrice-weekly HD (3HD/week) regimen without consideration of their residual kidney function (RKF). The RKF provides an effective and naturally continuous clearance of both small and middle molecules, plays a major role in metabolic homeostasis, nutritional status and cardiovascular health, and aids in fluid management. The RKF is associated with better patient survival and greater health-related quality of life. Its preservation is instrumental to the prescription of incremental (1HD/week to 2HD/week) HD. The recently heightened interest in incremental HD has been hindered by the current limitations of the urea kinetic model (UKM), which tend to overestimate the needed dialysis dose in the presence of a substantial RKF. A recent paper by Casino and Basile suggested a variable target model (VTM), which gives more clinical weight to the RKF and allows less frequent HD treatments at lower RKF as opposed to the fixed target model, based on the wrong concept of the clinical equivalence between renal and dialysis clearance. A randomized controlled trial (RCT) enrolling incident patients and comparing incremental HD (prescribed according to the VTM) with the standard 3HD/week schedule and focused on hard outcomes, such as survival and health-related quality of life of patients, is urgently needed. The first step in designing such a study is to compute the 'adequacy lines' and the associated fitting equations necessary for the most appropriate allocation of the patients in the two arms and their correct and safe follow-up. In conclusion, the potentially important clinical and financial implications of the incremental HD render it highly promising and warrant RCTs. The UKM is the keystone for conducting such studies.

摘要

大多数接受维持性血液透析(HD)治疗的患者均接受每周 3 次的固定剂量透析方案(3HD/周),而不考虑其残余肾功能(RKF)。RKF 可有效且持续清除小分子和中分子物质,在代谢平衡、营养状况和心血管健康方面发挥着重要作用,并有助于液体管理。RKF 与更好的患者生存率和更高的健康相关生活质量相关。保留 RKF 对于递增式(每周增加 1 次至 2 次 HD)HD 的处方至关重要。最近,人们对递增式 HD 的兴趣日益浓厚,但受到尿素动力学模型(UKM)的当前局限性的阻碍,在存在大量 RKF 的情况下,UKM 往往会高估所需的透析剂量。最近,Casino 和 Basile 的一篇论文提出了可变目标模型(VTM),该模型更重视 RKF,并允许在较低的 RKF 下进行较少的 HD 治疗,而不是基于肾清除率和透析清除率之间临床等效性的错误概念的固定目标模型。急需一项纳入新发病例患者的随机对照试验(RCT),比较递增式 HD(根据 VTM 处方)与标准的 3HD/周方案,并重点关注生存和患者健康相关生活质量等硬结局。设计此类研究的第一步是计算“充足线”及其相关拟合方程,以最适当地将患者分配到两个治疗组中,并对其进行正确和安全的随访。总之,递增式 HD 具有潜在的重要临床和经济意义,因此非常有前景,值得进行 RCT。UKM 是开展此类研究的关键。

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引用本文的文献

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Trials. 2024 Jun 28;25(1):424. doi: 10.1186/s13063-024-08281-9.
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Twice Weekly versus Thrice Weekly Hemodialysis-A Pilot Cross-Over Equivalence Trial.每周两次与每周三次血液透析——一项交叉等效性试验的初步研究
Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1159-1168. doi: 10.2215/CJN.0000000000000507. Epub 2024 Jun 26.
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Incremental hemodialysis, a valuable option for the frail elderly patient.
递增式血液透析,为体弱老年患者提供的宝贵选择。
J Nephrol. 2019 Oct;32(5):741-750. doi: 10.1007/s40620-019-00611-4. Epub 2019 Apr 19.
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IHDIP: a controlled randomized trial to assess the security and effectiveness of the incremental hemodialysis in incident patients.IHDIP:一项评估增量血液透析在新发病例患者中的安全性和有效性的对照随机试验。
BMC Nephrol. 2019 Jan 9;20(1):8. doi: 10.1186/s12882-018-1189-6.
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Prescribing Hemodialysis or Hemodiafiltration: When One Size Does Not Fit All the Proposal of a Personalized Approach Based on Comorbidity and Nutritional Status.开具血液透析或血液滤过治疗处方:当一种方案并不适用于所有人时——基于合并症和营养状况的个性化方法建议
J Clin Med. 2018 Oct 8;7(10):331. doi: 10.3390/jcm7100331.
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Residual Function Effectively Controls Plasma Concentrations of Secreted Solutes in Patients on Twice Weekly Hemodialysis.每周两次血液透析患者中,残余肾功能可有效控制溶质的血中浓度。
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