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用于恶性疾病患者的促红细胞生成素。

Erythropoietin for patients with malignant disease.

作者信息

Bohlius J, Langensiepen S, Schwarzer G, Seidenfeld J, Piper M, Bennet C, Engert A

机构信息

Department I of Internal Medicine, University of Cologne, Kerpener Str. 15, Cologne, Germany, 50924.

出版信息

Cochrane Database Syst Rev. 2004(3):CD003407. doi: 10.1002/14651858.CD003407.pub2.

Abstract

BACKGROUND

Anaemia associated with cancer and cancer therapy is an important clinical factor in the treatment of malignant diseases. Therapeutic alternatives are recombinant human erythropoietin (EPO) and red blood cell transfusions.

OBJECTIVES

The aim of this systematic review was to assess the effect of erythropoietin to either prevent or treat anaemia in cancer patients.

SEARCH STRATEGY

We searched the Central Register of Controlled Trials, MEDLINE (01/1985 to 12/2001), EMBASE (01/1985 to 12/2001), other databases and reference lists of articles. We also contacted experts in the field and pharmaceutical companies.

SELECTION CRITERIA

Randomised controlled trials comparing the use of recombinant human erythropoietin (plus transfusion if needed) with red blood cell transfusions alone for the treatment or prevention of anaemia in cancer patients.

DATA COLLECTION AND ANALYSIS

Two reviewers independently assessed trial quality and extracted data. All authors from included studies were contacted for additional information.

MAIN RESULTS

Twenty seven trials with 3,287 adults were included. Use of erythropoietin significantly reduced the relative risk of red blood cell transfusions (RR 0.67; 95% CI 0.62 to 0.73, 25 trials, n = 3,069). On average participants in the erythropoietin group received one unit of blood less than the control group (WMD -1.00; 95% CI-1.31 to -0.70, 13 trials, n = 2,056). For participants with baseline haemoglobin below 10 g/dL haematological response was observed more often in participants receiving EPO (RR 3.60; 95% CI 3.07 to 4.23, 14 trials, n = 2,347). There was inconclusive evidence whether EPO improves tumour response (fixed effect RR 1.36; 95% CI 1.07 to 1.72, seven trials, n = 1,150; random effects: RR 1.21; 95% CI 0.92 to 1.59) and overall survival (adjusted data: HR 0.81; 95% CI 0.67 to 0.99; unadjusted data: HR 0.84; 95% CI 0.69 to 1.02, 19 trials, n = 2,865). There were no statistically significant adverse effects. Evidence was inconclusive with respect to quality of life and fatigue.

REVIEWERS' CONCLUSIONS: There is consistent evidence that the administration of erythropoietin reduces the risk for blood transfusions and the number of units transfused in cancer patients. For patients with baseline haemoglobin below 10 g/dL there is strong evidence that erythropoietin improves haematological response. There is inconclusive evidence whether erythropoietin improves tumour response and overall survival. Research on side effects is inconclusive.

摘要

背景

与癌症及癌症治疗相关的贫血是恶性疾病治疗中的一个重要临床因素。治疗选择包括重组人促红细胞生成素(EPO)和红细胞输血。

目的

本系统评价的目的是评估促红细胞生成素预防或治疗癌症患者贫血的效果。

检索策略

我们检索了Cochrane对照试验中心注册库、MEDLINE(1985年1月至2001年12月)、EMBASE(1985年1月至2001年12月)、其他数据库以及文章的参考文献列表。我们还联系了该领域的专家和制药公司。

选择标准

比较重组人促红细胞生成素(必要时加输血)与单纯红细胞输血用于治疗或预防癌症患者贫血的随机对照试验。

数据收集与分析

两名评价员独立评估试验质量并提取数据。联系纳入研究的所有作者以获取更多信息。

主要结果

纳入了27项涉及3287名成年人的试验。使用促红细胞生成素显著降低了红细胞输血的相对风险(RR 0.67;95%CI 0.62至0.73,25项试验,n = 3069)。促红细胞生成素组的参与者平均比对照组少接受1个单位的血液(WMD -1.00;95%CI -1.31至-0.70,13项试验,n = 2056)。对于基线血红蛋白低于10 g/dL的参与者,接受EPO的参与者更常观察到血液学反应(RR 3.60;95%CI 3.07至4.23,14项试验,n = 2347)。关于EPO是否改善肿瘤反应(固定效应RR 1.36;95%CI 1.07至1.72,7项试验,n = 1150;随机效应:RR 1.21;95%CI 0.92至1.59)和总生存期(校正数据:HR 0.81;95%CI 0.67至0.99;未校正数据:HR 0.84;95%CI 0.69至1.02,19项试验,n = 2865),证据尚无定论。没有统计学上显著的不良反应。关于生活质量和疲劳的证据尚无定论。

评价员结论

有一致的证据表明,给予促红细胞生成素可降低癌症患者输血的风险和输血量。对于基线血红蛋白低于10 g/dL的患者,有强有力的证据表明促红细胞生成素可改善血液学反应。关于促红细胞生成素是否改善肿瘤反应和总生存期,证据尚无定论。关于副作用的研究尚无定论。

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