Fresenius Medical Care Deutschland GmbH, Global Research and Development, Product Engineering Center Dialyzers & Membranes, Product Development, Sankt Wendel, Germany.
Fresenius Medical Care Deutschland GmbH, Process Technology, Filter Production, Sankt Wendel, Germany.
Artif Organs. 2022 Jul;46(7):1318-1327. doi: 10.1111/aor.14216. Epub 2022 Mar 7.
Toxin removal capacity (i.e., performance) of a dialyzer is not constant but diminishes during treatment, as the adsorption of proteins to the membrane provides an additional barrier to uremic solutes. We investigated time-resolving molecular weight retention changes among synthetic high-flux dialyzers and compared the results with recent data from a randomized controlled trial.
In plasma recirculation experiments over 240 min, sieving coefficients (SC) for β2-microglobulin, myoglobin, and albumin were determined for the FX CorAL (Fresenius Medical Care), ELISIO (Nipro), and xevonta (B. Braun). Molecular weight retention (MWR) curves were generated and the shifts over 120 min were characterized. Effective pore radius was determined, and the predicted albumin loss was compared with clinical data.
SC decreased over time for all dialyzers (mean relative decrease across all dialyzers: β2-microglobulin: 8.0% (120 min); myoglobin: 56.6% (240 min); albumin: 94.1% (240 min)). FX CorAL (7.3%, 52.6% and 91.1%) and ELISIO (7.7%, 51.0%, and 93.8%) showed a lower decrease than xevonta (9.0%, 66.2%, and 97.4%). For all dialyzers, MWR curves shifted toward lower molecular weight, with the lowest shift for FX CorAL (by 0.23 nm at SC50%, 120 min) and highest for xevonta (0.50 nm). FX CorAL had the highest slope over time and the smallest decrease in the effective pore radius (2 min: 2.31 nm, 120 min: 2.08 nm). Predicted albumin loss over 4 h was highest for xevonta (609.3 mg) and comparable between ELISIO (283.6 mg) and FX CorAL (313.3 mg).
Substantial differences in the temporal performance profile of dialyzers exist. The present approach allows the characterization of dialyzer permeability changes over time using standard, clinically relevant protein markers.
由于蛋白质在膜上的吸附为尿毒症溶质提供了额外的屏障，因此透析器的毒素清除能力（即性能）并非恒定，而是在治疗过程中逐渐降低。我们研究了合成高通量透析器之间的时分辨分子量保留变化，并将结果与最近的一项随机对照试验的数据进行了比较。
在 240 分钟的血浆再循环实验中，确定了 FX CorAL（费森尤斯医疗保健公司）、ELISIO（尼普洛）和 xevonta（贝朗）的β2-微球蛋白、肌红蛋白和白蛋白的筛系数（SC）。生成分子量保留（MWR）曲线，并对 120 分钟内的变化进行特征描述。确定有效孔径，并将预测的白蛋白损失与临床数据进行比较。
所有透析器的 SC 随时间推移而降低（所有透析器的平均相对降低：β2-微球蛋白：8.0%（120 分钟）；肌红蛋白：56.6%（240 分钟）；白蛋白：94.1%（240 分钟））。FX CorAL（7.3%、52.6%和 91.1%）和 ELISIO（7.7%、51.0%和 93.8%）的下降幅度低于 xevonta（9.0%、66.2%和 97.4%）。对于所有透析器，MWR 曲线向低分子量移动，FX CorAL 的移动幅度最低（在 SC50%时为 0.23nm，120 分钟），xevonta 的移动幅度最高（0.50nm）。FX CorAL 的斜率随时间增加最快，有效孔径减小最小（2 分钟：2.31nm，120 分钟：2.08nm）。xevonta 在 4 小时内预测的白蛋白损失最高（609.3mg），ELISIO（283.6mg）和 FX CorAL（313.3mg）之间的损失相当。
透析器的时间性能存在显著差异。本方法允许使用标准的、临床相关的蛋白质标志物来描述透析器的通透性随时间的变化。
