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成人及儿童慢性肾脏病患者的肠外与口服铁剂治疗

Parenteral versus oral iron therapy for adults and children with chronic kidney disease.

作者信息

Albaramki Jumana, Hodson Elisabeth M, Craig Jonathan C, Webster Angela C

机构信息

Centre for Kidney Research, The Children’sHospital atWestmead,Westmead, Australia.

出版信息

Cochrane Database Syst Rev. 2012 Jan 18;1:CD007857. doi: 10.1002/14651858.CD007857.pub2.

Abstract

BACKGROUND

The anaemia seen in chronic kidney disease (CKD) may be exacerbated by iron deficiency. Iron can be provided through different routes, with advantages and drawbacks of each route. It remains unclear whether the potential harms and additional costs of intravenous (IV) compared with oral iron are justified.

OBJECTIVES

To determine the benefits and harms of IV iron supplementation compared with oral iron for anaemia in adults and children with CKD.

SEARCH METHODS

In March 2010 we searched the Cochrane Renal Group's specialised register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE and EMBASE without language restriction.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) and quasi-RCTs in which oral and IV routes of iron administration were compared in adults and children with CKD.

DATA COLLECTION AND ANALYSIS

Two authors independently assessed study eligibility, risk of bias, and extracted data. Results were reported as risk ratios (RR) or risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes and for continuous outcomes the mean difference (MD) was used or standardised mean difference (SMD) if different scales had been used. Statistical analyses were performed using the random-effects model. Subgroup analysis and univariate meta-regression were performed to investigate between study differences.

MAIN RESULTS

Twenty eight studies (2098 participants) were included. Risk of bias attributes were poorly performed and/or reported with low risk of bias reported in 12 (43%) studies for sequence generation, incomplete outcome reporting and selective outcome reporting and in 6 (16%) studies for allocation concealment. No study was blinded for participants, investigators and outcome assessors but all were considered at low risk of bias because the primary outcome of haemoglobin was a laboratory outcome and unlikely to be influenced by lack of blinding. Haemoglobin (22 studies, 1862 patients: MD 0.90 g/dL, 95% CI 0.44 to 1.37); ferritin (24 studies, 1751 patients: MD 243.25 μg/L, 95% CI 188.74 to 297.75); and transferrin saturation (18 studies, 1457 patients: MD 10.20%, 95% CI 5.56 to 14.83) were significantly increased by IV iron compared with oral iron. There was a significant reduction in erythropoiesis-stimulating agent (ESA) dose in patients receiving dialysis who were treated with IV iron (9 studies, 487 patients: SMD -0.76, 95% CI -1.22 to -0.30). There was a high level of heterogeneity in all analyses. Mortality and cardiovascular morbidity did not differ significantly, but were reported in few studies. Gastrointestinal side effects were more common with oral iron, but hypotensive and allergic reactions were more common with IV iron.

AUTHORS' CONCLUSIONS: The included studies provide strong evidence for increased ferritin and transferrin saturation levels, together with a small increase in haemoglobin, in patients with CKD who were treated with IV iron compared with oral iron. From a limited body of evidence, we identified a significant reduction in ESA requirements in patients treated with IV iron, and found no significant difference in mortality. Adverse effects were reported in only 50% of included studies. We therefore suggest that further studies that focus on patient-centred outcomes are needed to determine if the use of IV iron is justified on the basis of reductions in ESA dose and cost, improvements in patient quality of life, and with few serious adverse effects.

摘要

背景

慢性肾脏病(CKD)患者中出现的贫血可能因缺铁而加重。铁可以通过不同途径提供,每种途径都有其优缺点。静脉注射(IV)铁与口服铁相比,其潜在危害和额外成本是否合理仍不明确。

目的

确定与口服铁相比,静脉注射铁补充剂对CKD成人和儿童贫血的益处和危害。

检索方法

2010年3月,我们检索了Cochrane肾脏组的专业注册库、Cochrane图书馆中的Cochrane对照试验中心注册库(CENTRAL)、MEDLINE和EMBASE,无语言限制。

入选标准

我们纳入了随机对照试验(RCT)和半随机对照试验,这些试验比较了CKD成人和儿童口服和静脉注射铁的给药途径。

数据收集与分析

两位作者独立评估研究的合格性、偏倚风险并提取数据。结果以风险比(RR)或风险差(RD)及95%置信区间(CI)报告二分结局,对于连续结局,使用平均差(MD),如果使用了不同量表则使用标准化平均差(SMD)。采用随机效应模型进行统计分析。进行亚组分析和单变量meta回归以研究研究间差异。

主要结果

纳入了28项研究(2098名参与者)。偏倚风险属性执行不佳和/或报告存在低偏倚风险,在12项(43%)研究中序列生成、结局报告不完整和选择性结局报告存在低偏倚风险,在6项(16%)研究中分配隐藏存在低偏倚风险。没有研究对参与者、研究者和结局评估者进行盲法,但所有研究都被认为偏倚风险较低,因为血红蛋白的主要结局是实验室结局,不太可能受到缺乏盲法的影响。与口服铁相比,静脉注射铁显著提高了血红蛋白(22项研究,1862例患者:MD 0.90 g/dL,95% CI 0.44至1.37);铁蛋白(24项研究,1751例患者:MD 243.25 μg/L,95% CI 188.74至297.75);转铁蛋白饱和度(18项研究,1457例患者:MD 10.20%,95% CI 5.56至$14.83)。接受静脉注射铁治疗的透析患者促红细胞生成素(ESA)剂量显著降低(9项研究,487例患者:SMD $-0.76,95% CI -1.22至-0.30)。所有分析中均存在高度异质性。死亡率和心血管发病率无显著差异,但报告的研究较少。胃肠道副作用在口服铁时更常见,但低血压和过敏反应在静脉注射铁时更常见。

作者结论

纳入的研究提供了有力证据,表明与口服铁相比,接受静脉注射铁治疗的CKD患者铁蛋白和转铁蛋白饱和度水平升高,血红蛋白也略有升高。从有限的证据中,我们发现接受静脉注射铁治疗的患者ESA需求显著降低,且死亡率无显著差异。仅50%的纳入研究报告了不良反应。因此,我们建议需要进一步开展以患者为中心结局的研究,以确定基于ESA剂量降低、成本、患者生活质量改善以及严重不良反应较少,使用静脉注射铁是否合理。

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