Macleod A M, Campbell M, Cody J D, Daly C, Donaldson C, Grant A, Khan I, Rabindranath K S, Vale L, Wallace S
Medicine and Therapeutics, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, Scotland, UK, AB25 2ZD.
Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003234. doi: 10.1002/14651858.CD003234.pub2.
BACKGROUND: When the kidney fails the blood-borne metabolites of protein breakdown and water cannot be excreted. The principle of haemodialysis is that such substances can be removed when blood is passed over a semipermeable membrane. Natural membrane materials include cellulose or modified cellulose, more recently various synthetic membranes have been developed. Synthetic membranes are regarded as being more "biocompatible" in that they incite less of an immune response than cellulose-based membranes. OBJECTIVES: To assess the effects of different haemodialysis membrane material in patients with end-stage renal disease (ESRD). SEARCH STRATEGY: We searched MEDLINE, EMBASE, PreMEDLINE, HealthStar CINAHL, the Cochrane Central Register of Controlled Trials (CENTRAL), Biosis, SIGLE, CRIB, UK National Research Register and reference lists of relevant articles. We contacted biomedical companies, known investigators and handsearched selected journals and conference proceedings. Date of most recent search: June 2004. SELECTION CRITERIA: All randomised controlled trials (RCTs) or quasi-RCTs comparing different haemodialysis membrane material in patients with ESRD. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed the methodological quality of studies. Data was abstracted onto a standard form by one reviewer and checked by another. Relative Risk (RR) and weighted mean difference (WMD) with 95% confidence intervals (CI)) MAIN RESULTS: Thirty two studies were identified. Pre-dialysis ss(2) microglobulin concentrations were not significantly lower in patients treated with synthetic membranes (WMD -14.67, 95% CI -33.10 to 4.05). When analysed for change in ss(2) microglobulin, a fall was only noted with high-flux membranes. The incidence of amyloid was less in patients who were dialysed for six years with high-flux synthetic membranes (one study, RR 0.03, 95% CI 0.00 to 0.54). There was a significant difference in favour of the synthetic (high-flux) membrane in comparison to cellulose membranes for triglycerides (WMD -0.66; 95% CI -1.18 to -0.14) but not for modified cellulose membranes. Dialysis adequacy measured by Kt/V was marginally higher when cellulose membranes were used (WMD -0.10; 95% CI -0.16 to 0.04), whereas synthetic membranes achieved significantly higher Kt/V values when compared with modified cellulose membranes (WMD 0.20, 95% 0.11 to 0.29) . There were no data on quality of life measures. AUTHORS' CONCLUSIONS: We found no evidence of benefit when synthetic membranes were compared with cellulose/modified cellulose membranes in terms of reduced mortality no reduction in dialysis-related adverse symptoms. Despite the relatively large number of RCTs undertaken in this area none of the included studies reported any measures of quality of life.
背景:当肾脏衰竭时,蛋白质分解产生的血源代谢产物和水分无法排出。血液透析的原理是,当血液通过半透膜时,这些物质能够被清除。天然膜材料包括纤维素或改性纤维素,近年来已开发出各种合成膜。合成膜被认为更具“生物相容性”,因为与纤维素基膜相比,它们引发的免疫反应较小。 目的:评估不同血液透析膜材料对终末期肾病(ESRD)患者的影响。 检索策略:我们检索了MEDLINE、EMBASE、PreMEDLINE、HealthStar CINAHL、Cochrane对照试验中心注册库(CENTRAL)、Biosis、SIGLE、CRIB、英国国家研究注册库以及相关文章的参考文献列表。我们联系了生物医学公司、知名研究人员,并手工检索了选定的期刊和会议论文集。最近一次检索日期:2004年6月。 选择标准:所有比较ESRD患者不同血液透析膜材料的随机对照试验(RCT)或半随机对照试验。 数据收集与分析:两名评价员独立评估研究的方法学质量。数据由一名评价员提取到标准表格上,并由另一名评价员进行核对。相对危险度(RR)和加权均数差(WMD)及95%置信区间(CI)。主要结果:共纳入32项研究。使用合成膜治疗的患者透析前β2微球蛋白浓度无显著降低(WMD -14.67,95%CI -33.10至4.05)。在分析β2微球蛋白的变化时,仅在高通量膜组中观察到下降。使用高通量合成膜透析6年的患者淀粉样变的发生率较低(一项研究,RR 0.03,95%CI 0.00至0.54)。与纤维素膜相比,合成(高通量)膜在甘油三酯方面有显著差异(WMD -0.66;95%CI -1.18至-0.1),但与改性纤维素膜相比无差异。使用纤维素膜时,用Kt/V衡量的透析充分性略高(WMD -0.10;95%CI -0.16至0.04),而与改性纤维素膜相比,合成膜的Kt/V值显著更高(WMD 0.20,95%CI 0.11至0.29)。没有关于生活质量测量的数据。 作者结论:我们发现,在降低死亡率和减少透析相关不良症状方面,合成膜与纤维素/改性纤维素膜相比没有益处的证据。尽管该领域进行了相对大量的RCT,但纳入的研究均未报告任何生活质量测量指标。
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