Hoenich N A, Woffindin C, Brennan A, Cox P J, Matthews J N, Goldfinch M
Department of Medicine, University of Newcastle, United Kingdom.
J Am Soc Nephrol. 1996 Jun;7(6):871-6. doi: 10.1681/ASN.V76871.
A prospective clinical crossover study comparing the functional performance and biocompatibility of three brands of polysulfone membranes (Fresenius Polysultone (Fresenius Ag, Bad Homburg, Germany), Polyphen (Minntech Corp., Minneapolis, MN), and Biosulfane (WR Grace Inc., Danvers, MA)) incorporated in ethylene oxide-sterilized dialyzers of comparable surface area (1.3 to 1.35 m2) was undertaken. The clearance of small molecules by each membrane was comparable. Plasma levels of beta 2 microglobulin fell to 49.9% of pretreatment values by 210 min when using the Fresenius Polysulfone membrane, 60.2% with the Polyphen membrane, and 63.1% with the Biosulfane membrane. The reduction achieved by the Fresenius Polysulfone membrane was superior (P = 0.003). The plasma reductions were associated with the recovery of 195 mg beta 2 microglobulin from the dialysate for the Fresenius Polysulfone membrane and 158 mg for the Polyphen membrane, but no beta 2 microglobulin was recovered from the dialysate with the Biosulfane membrane. The dialysate collected with the Fresenius Polysulfone membrane also contained a mean of 6853 mg of total protein, compared with 5490 mg with the Polyphen membrane and 8422 mg with the Biosulfane (P = 0.04) membrane. The neutropenia was slight and independent of membrane brand, as were the changes in C3a des arg and SC5b-9 complement components. The reduction in platelet counts was higher for the Biosulfane membrane than for the other brands (P = 0.003). This study indicates that whereas the polymer base of the membrane is the same, its production and subsequent handling during dialyzer production induce changes that attain statistical significance, most notably in the way that the membrane removes beta 2 microglobulin and interacts with proteins. The differences observed are a consequence of the different alloying polymers used during manufacture and, consequently, the membranes cannot be considered equivalent.
开展了一项前瞻性临床交叉研究，比较三种品牌聚砜膜（德国巴德洪堡费森尤斯公司的费森尤斯聚砜、美国明尼苏达州明尼阿波利斯市明泰克公司的Polyphen、美国马萨诸塞州丹弗斯市WR Grace公司的Biosulfane）在环氧乙烷灭菌且表面积相当（1.3至1.35平方米）的透析器中的功能性能和生物相容性。各膜对小分子的清除率相当。使用费森尤斯聚砜膜时，210分钟时β2微球蛋白的血浆水平降至预处理值的49.9%；使用Polyphen膜时为60.2%；使用Biosulfane膜时为63.1%。费森尤斯聚砜膜实现的降低效果更优（P = 0.003）。血浆降低与从透析液中回收的β2微球蛋白量相关，费森尤斯聚砜膜回收了195毫克β2微球蛋白，Polyphen膜回收了158毫克，但使用Biosulfane膜时未从透析液中回收β2微球蛋白。用费森尤斯聚砜膜收集的透析液中总蛋白平均含量为6853毫克，而Polyphen膜为5490毫克，Biosulfane膜为8422毫克（P = 0.04）。中性粒细胞减少轻微且与膜品牌无关，C3a去精氨酸和SC5b - 9补体成分的变化也是如此。Biosulfane膜导致的血小板计数降低高于其他品牌（P = 0.003）。这项研究表明，尽管膜的聚合物基质相同，但在透析器生产过程中其生产及后续处理会引发具有统计学意义的变化，最显著的是膜清除β2微球蛋白及与蛋白质相互作用的方式。观察到的差异是制造过程中使用的合金聚合物不同所致，因此，这些膜不能被视为等效。
