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重组人促红细胞生成素用于透析前慢性肾衰竭患者的贫血治疗

Recombinant human erythropoietin for chronic renal failure anaemia in pre-dialysis patients.

作者信息

Cody J, Daly C, Campbell M, Donaldson C, Khan I, Rabindranath K, Vale L, Wallace S, Macleod A

机构信息

Cochrane Incontinence Review Group, University of Aberdeen, Health Services Research Unit, Polwarth Building, Foresterhill, Aberdeen, UK, AB25 2ZD.

出版信息

Cochrane Database Syst Rev. 2005 Jul 20(3):CD003266. doi: 10.1002/14651858.CD003266.pub2.

DOI:10.1002/14651858.CD003266.pub2
PMID:16034896
Abstract

BACKGROUND

Treatment with recombinant human erythropoietin (rHu EPO) in dialysis patients has been shown to be highly effective in terms of correcting anaemia and improving quality of life. There is debate concerning the benefits of rHu EPO use in pre-dialysis patients which may accelerate the deterioration of renal function. However the opposing view is that if rHu EPO is as effective in pre-dialysis patient's, improving the patients sense of well-being may result in the onset of dialysis being delayed.

OBJECTIVES

To assess the effects of rHu EPO use in pre-dialysis patients with renal anaemia.

SEARCH STRATEGY

The initial search included 13 electronic databases (1980 to May 2001) an internet search (August 1997), handsearching of Kidney International (1983 to May 1997), contact with known investigators and biomedical companies, and reference list of relevant articles. For this update we searched the Cochrane Renal Group's specialised register (June 2004) and The Cochrane Library (Issue 3, 2004).

SELECTION CRITERIA

Randomised controlled trials (RCTs) or quasi-RCTs comparing the use of rHu EPO with no treatment or placebo in pre-dialysis patients.

DATA COLLECTION AND ANALYSIS

Only published data were used. Quality assessment was performed by two assessors independently. Data were abstracted by a single author onto a standard form, a sample of which was checked by another author. Results were expressed as relative risk (RR) or weighted mean difference (WMD) with 95% confidence intervals (CI).

MAIN RESULTS

Fifteen trials (461 participants) were included. There was a marked improvement in haemoglobin (WMD 1.82 g/dL, 95% CI 1.35 to 2.28) and haematocrit (WMD 9.85%, 95% CI 8.35 to 11.34) with treatment and a decrease in the number of patients requiring blood transfusions (RR 0.32, 95% CI 0.12 to 0.83). The data from studies reporting quality of life or exercise capacity demonstrated an improvement in the treatment group. Most of the measures of progression of renal disease showed no statistically significant difference. No significant increase in adverse events was identified.

AUTHORS' CONCLUSIONS: Treatment with rHu EPO in pre-dialysis patients corrects anaemia, avoids the requirement for blood transfusions and also improves quality of life and exercise capacity. We were unable to assess the effects of rHu EPO on progression of renal disease, delay in the onset of dialysis or adverse events. Based on the current evidence, decisions on the putative benefits in terms of quality of life are worth the extra costs of pre-dialysis rHu EPO need careful evaluation.

摘要

背景

已证明,对透析患者使用重组人促红细胞生成素(rHu EPO)在纠正贫血和改善生活质量方面非常有效。对于在透析前患者中使用rHu EPO是否有益存在争议,这可能会加速肾功能恶化。然而,相反的观点是,如果rHu EPO对透析前患者同样有效,改善患者的幸福感可能会导致透析开始时间延迟。

目的

评估在透析前肾性贫血患者中使用rHu EPO的效果。

检索策略

最初的检索包括13个电子数据库(1980年至2001年5月)、一次互联网检索(1997年8月)、对《国际肾脏杂志》的手工检索(1983年至1997年5月)、与知名研究者和生物医学公司联系以及相关文章的参考文献列表。为了本次更新,我们检索了Cochrane肾脏组的专门注册库(2004年6月)和《Cochrane图书馆》(2004年第3期)。

选择标准

比较在透析前患者中使用rHu EPO与不治疗或安慰剂的随机对照试验(RCT)或半随机对照试验。

数据收集与分析

仅使用已发表的数据。由两名评估者独立进行质量评估。数据由一名作者提取到标准表格上,另一名作者对其中一个样本进行了检查。结果以相对危险度(RR)或加权均数差(WMD)及95%置信区间(CI)表示。

主要结果

纳入了15项试验(461名参与者)。治疗后血红蛋白(WMD 1.82 g/dL,95% CI 1.35至2.28)和血细胞比容(WMD 9.85%,95% CI 8.35至11.34)有显著改善,需要输血的患者数量减少(RR 0.32,95% CI 0.12至0.83)。报告生活质量或运动能力的研究数据显示治疗组有改善。大多数肾病进展指标无统计学显著差异。未发现不良事件有显著增加。

作者结论

在透析前患者中使用rHu EPO可纠正贫血、避免输血需求,还可改善生活质量和运动能力。我们无法评估rHu EPO对肾病进展、透析开始延迟或不良事件的影响。基于目前的证据,关于在生活质量方面假定益处的决策是否值得透析前使用rHu EPO的额外费用,需要仔细评估。

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