一种新的中性 pH 值、低 GDP 的腹膜透析液。

A new neutral-pH low-GDP peritoneal dialysis fluid.

机构信息

Fresenius Medical Care North America, Waltham, Massachusetts, USA.

出版信息

Perit Dial Int. 2012 Jul-Aug;32(4):444-52. doi: 10.3747/pdi.2011.00072. Epub 2012 Mar 1.

DOI:10.3747/pdi.2011.00072

PMID:22383632

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3524839/

Abstract

BACKGROUND

Conventional peritoneal dialysis fluids (PDFs) consist of ready-to-use solutions with an acidic pH. Sterilization of these fluids is known to generate high levels of glucose degradation products (GDPs). Although several neutral-pH, low-GDP PD solutions have been developed, none are commercially available in the United States. We analyzed pH and GDPs in Delflex Neutral pH (Fresenius Medical Care North America, Waltham, MA, USA), the first neutral-pH PDF to be approved by the US Food and Drug Administration.

METHODS

We evaluated whether patients (n = 26; age range: 18 - 78 years) could properly mix the Delflex Neutral pH PDF after standardized initial training. We further analyzed the concentrations of 10 different glucose degradation products in Delflex Neutral pH PDF and compared the results with similar analyses in other commercially available biocompatible PDFs.

RESULTS

All pH measurements (n = 288) in the delivered Delflex Neutral pH solution consistently fell within the labeled range of 7.0 ± 0.4. Analysis of mixing errors showed no significant impact on the pH results. Delflex Neutral pH, Balance (Fresenius Medical Care, Bad Homburg, Germany), BicaVera (Fresenius Medical Care), and Gambrosol Trio (Gambro Lundia AB, Lund, Sweden) exhibited similar low total GDP concentrations, with maximums in the 4.25% solutions of 88 μmol/L, 74 μmol/L, 74 μmol/L, and 79 μmol/L respectively; the concentration in Physioneal (Baxter Healthcare Corporation, Deerfield, IL, USA) was considerably higher at 263.26 μmol/L. The total GDP concentration in Extraneal (Baxter Healthcare Corporation) was 63 μmol/L, being thus slightly lower than the concentrations in the 4.25% glucose solutions, but higher than the concentrations in the 1.5% and 2.5% glucose solutions.

CONCLUSIONS

The new Delflex Neutral pH PDF consistently delivers neutral pH with minimal GDPs.

摘要

背景

传统的腹膜透析液（PDF）由即用型溶液组成，呈酸性 pH 值。已知这些溶液的消毒会产生大量的葡萄糖降解产物（GDPs）。尽管已经开发了几种中性 pH 值、低 GDP 的 PD 溶液，但在美国都没有商业用途。我们分析了 Delflex Neutral pH（美国弗雷森纽斯医疗保健公司，马萨诸塞州沃尔瑟姆）的 pH 值和 GDP 值，这是第一个获得美国食品和药物管理局批准的中性 pH 值 PDF。

方法

我们评估了经过标准化初始培训的患者（n = 26；年龄范围：18-78 岁）是否能够正确混合 Delflex Neutral pH PDF。我们进一步分析了 Delflex Neutral pH PDF 中 10 种不同葡萄糖降解产物的浓度，并将结果与其他商业上可用的生物相容性 PDF 的类似分析进行了比较。

结果

在交付的 Delflex Neutral pH 溶液中，所有 pH 值测量（n = 288）均始终保持在 7.0±0.4 的标签范围内。混合误差分析表明，这对 pH 值结果没有显著影响。Delflex Neutral pH、Balance（德国弗雷森纽斯医疗保健公司）、BicaVera（德国弗雷森纽斯医疗保健公司）和 Gambrosol Trio（瑞典甘布罗隆迪亚公司）的总 GDP 浓度相似，均为 4.25%溶液中的最大值分别为 88 μmol/L、74 μmol/L、74 μmol/L 和 79 μmol/L；Physioneal（美国百特医疗保健公司）的浓度则高得多，为 263.26 μmol/L。Extraneal（美国百特医疗保健公司）的总 GDP 浓度为 63 μmol/L，略低于 4.25%葡萄糖溶液中的浓度，但高于 1.5%和 2.5%葡萄糖溶液中的浓度。