Locatelli F, Mastrangelo F, Redaelli B, Ronco C, Marcelli D, La Greca G, Orlandini G
Division of Nephrology and Dialysis, Ospedale di Lecco, Italy.
Kidney Int. 1996 Oct;50(4):1293-302. doi: 10.1038/ki.1996.441.
There is increasing evidence that the biochemical and cellular phenomena induced by blood/ membrane/dialysate interactions contribute to dialysis-related intradialytic and long-term complications. However, there is a lack of large, prospective, randomized trials comparing biocompatible and bioincompatible membranes, and convective and diffusive treatment modalities. The primary aim of this prospective, randomized trial was to evaluate whether the use of polysulfone membrane with bicarbonate dialysate offers any advantage (in terms of treatment tolerance, nutritional parameters and pre-treatment beta-microglobulin levels) over a traditional membrane (Cuprophan). A secondary aim was to assess whether the use of more sophisticated methods consisting of a biocompatible synthetic membrane with different hydraulic permeability at different ultrafiltration rate (high-flux hemodialysis and hemodiafiltration) offers any further advantages. Seventy-one Centers were involved and stratified according to the availability of only the first two or all four of the following techniques: Cuprophan hemodialysis (Cu-HD), low-flux polysulfone hemodialysis (LfPS-HD), high-flux polysulfone high-flux hemodialysis (HfPS-HD), and high-flux polysulfone hemodiafiltration (HfPS-HDF). The 380 eligible patients were randomized to one of the two or four treatments (132 to Cu-HD, 147 to LfPS-HD, 51 to HfPS-HD and 50 to HfPS-HDF). The follow-up was 24 months. No statistical difference was observed in the algebraic sum of the end points between bicarbonate dialysis with Cuprophan or with low-flux polysulfone, or among the four dialysis methods under evaluation. There was a significant decrease in pre-dialysis plasma beta 2-microglobulin levels in high-flux dialysis of 9.04 +/- 10.46 mg/liter (23%) and in hemodiafiltration of 6.35 +/- 12.28 mg/liter (16%), both using high-flux polysulfone membrane in comparison with Cuprophan and low-flux polysulfone membranes (P = 0.032). The significant decrease in pre-dialysis plasma beta 2-microglobulin levels could have a clinical impact when one considers that beta 2-microglobulin accumulation and amyloidosis are important long-term dialysis-related complications.
越来越多的证据表明，血液/膜/透析液相互作用所引发的生化和细胞现象会导致与透析相关的透析过程中及长期并发症。然而，目前缺乏大型、前瞻性、随机试验来比较生物相容性和生物不相容性膜，以及对流和扩散治疗方式。这项前瞻性随机试验的主要目的是评估使用聚砜膜与碳酸氢盐透析液相比传统膜（铜仿膜）是否具有任何优势（在治疗耐受性、营养参数和治疗前β-微球蛋白水平方面）。次要目的是评估使用更复杂的方法，即由具有不同水力通透性的生物相容性合成膜在不同超滤率下组成的方法（高通量血液透析和血液透析滤过）是否具有进一步的优势。71个中心参与了研究，并根据是否仅具备以下两种或全部四种技术进行分层：铜仿膜血液透析（Cu-HD）、低通量聚砜血液透析（LfPS-HD）、高通量聚砜高通量血液透析（HfPS-HD）和高通量聚砜血液透析滤过（HfPS-HDF）。380名符合条件的患者被随机分配到两种或四种治疗方法之一（132人接受Cu-HD，147人接受LfPS-HD，51人接受HfPS-HD，50人接受HfPS-HDF）。随访期为24个月。在使用铜仿膜或低通量聚砜进行碳酸氢盐透析之间，以及在所评估的四种透析方法之间，终点的代数和未观察到统计学差异。与铜仿膜和低通量聚砜膜相比，使用高通量聚砜膜进行高通量血液透析时，透析前血浆β2-微球蛋白水平显著降低9.04±10.46毫克/升（23%），进行血液透析滤过时降低6.35±12.28毫克/升（16%）（P = 0.032）。考虑到β2-微球蛋白蓄积和淀粉样变性是重要的与长期透析相关的并发症，透析前血浆β2-微球蛋白水平的显著降低可能具有临床意义。
