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透析液钙、阿法骨化醇和临床结局:J-DAVID 试验的事后分析。

Dialysate calcium, alfacalcidol, and clinical outcomes: A post-hoc analysis of the J-DAVID trial.

机构信息

Nakamura Clinic, Urasoe, Okinawa, Japan.

Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan.

出版信息

PLoS One. 2022 Sep 7;17(9):e0273195. doi: 10.1371/journal.pone.0273195. eCollection 2022.

Abstract

The selection of dialysate calcium concentration (D-Ca) is still controversial among chronic hemodialysis (HD) regimens. We examined the trajectories of CKD MBD parameters among the J-DAVID trial participants to see the effect of D-Ca and alfacalcidol. The trial was an open-label randomized clinical trial including 976 HD patients with intact PTH of 180 pg/mL or lower which compared the users of vitamin D receptor activator (oral alfacalcidol) and non-users over a median of 4 years. The main D-Ca used at baseline were 3.0 mEq/L in 70% and 2.5 mEq/L in 25%, respectively. The primary endpoint was the composite of fatal and non-fatal cardiovascular events and the secondary endpoint was all-cause mortality. Multivariable Cox proportional hazard regression analyses in which D-Ca was included as a possible effect modifier and serum laboratory data as time-varying covariates showed no significant effect modification for composite cardiovascular events or all-cause mortality. This post hoc analysis showed that the effects of alfacalcidol on cardiovascular outcomes were not significantly modified by D-Ca.

摘要

在慢性血液透析(HD)方案中,透析液钙浓度(D-Ca)的选择仍存在争议。我们检测了 J-DAVID 试验参与者的 CKD-MBD 参数轨迹,以观察 D-Ca 和阿法骨化醇的作用。该试验是一项开放性标签随机临床试验,纳入了 976 例 PTH 为 180pg/mL 或更低的 HD 患者,中位随访时间为 4 年,比较了维生素 D 受体激动剂(口服阿法骨化醇)使用者和非使用者。基线时主要使用的 D-Ca 分别为 3.0mEq/L(占 70%)和 2.5mEq/L(占 25%)。主要终点是致死性和非致死性心血管事件的复合终点,次要终点是全因死亡率。多变量 Cox 比例风险回归分析中,将 D-Ca 作为可能的效应修饰因子,将血清实验室数据作为随时间变化的协变量,结果显示复合心血管事件或全因死亡率无显著的效应修饰作用。这项事后分析表明,阿法骨化醇对心血管结局的影响不受 D-Ca 的显著影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e987/9451061/eb567e635a20/pone.0273195.g001.jpg

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