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静脉注射铁剂与口服铁剂治疗炎症性肠病贫血的疗效比较:一项随机对照试验的系统评价与荟萃分析

Intravenous Versus Oral Iron for the Treatment of Anemia in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

作者信息

Bonovas Stefanos, Fiorino Gionata, Allocca Mariangela, Lytras Theodore, Tsantes Argirios, Peyrin-Biroulet Laurent, Danese Silvio

机构信息

From the IBD Center, Department of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy (SB, GF, MA, SD); Humanitas University, Rozzano, Milan, Italy (SD); Department of Experimental and Health Sciences, Pompeu Fabra University, Barcelona, Spain (TL); Centre for Research in Environmental Epidemiology, Barcelona, Spain (TL); Hellenic Center for Disease Control and Prevention, Athens, Greece (TL); Laboratory of Hematology and Blood Bank Unit, "Attikon" University Hospital, School of Medicine, University of Athens, Athens, Greece (AT); and Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France (LP-B).

出版信息

Medicine (Baltimore). 2016 Jan;95(2):e2308. doi: 10.1097/MD.0000000000002308.

DOI:10.1097/MD.0000000000002308
PMID:26765407
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4718233/
Abstract

Anemia is the most prevalent extraintestinal complication of inflammatory bowel disease (IBD). Our aim was to evaluate the comparative efficacy and harm of intravenous (IV) versus oral iron supplementation for correcting anemia in adult IBD patients.We conducted a systematic review and meta-analysis to integrate evidence from randomized controlled trials having enrolled adults with IBD, and comparing IV versus oral iron (head-to-head) for correcting iron-deficiency anemia. Medline, Embase, Scopus, and the Web of Science database were searched through July 2015. The Cochrane Central Register of Controlled Trials, the WHO International Clinical Trials Registry Platform, the ClinicalTrials.gov, and international conference proceedings were also investigated. Two reviewers independently abstracted study data and outcomes, and rated each trial's risk-of-bias. Pooled odds ratio (OR) estimates with their 95% CIs were calculated using fixed- and random-effects models.Five eligible studies, including 694 IBD patients, were identified. In meta-analysis, IV iron demonstrated a higher efficacy in achieving a hemoglobin rise of ≥2.0 g/dL as compared to oral iron (OR: 1.57, 95% CI: 1.13, 2.18). Treatment discontinuation rates, due to adverse events or intolerance, were lower in the IV iron groups (OR: 0.27, 95% CI: 0.13, 0.59). Similarly, the occurrence of gastrointestinal adverse events was consistently lower in the IV iron groups. On the contrary, serious adverse events (SAEs) were more frequently reported among patients receiving IV iron preparations (OR: 4.57, 95% CI: 1.11, 18.8); however, the majority of the reported SAEs were judged as unrelated or unlikely to be related to the study medication. We found no evidence of publication bias, or between-study heterogeneity, across all analyses. Risk of bias was high across primary studies, because patients and personnel were not blinded to the intervention.IV iron appears to be more effective and better tolerated than oral iron for the treatment of IBD-associated anemia.

摘要

贫血是炎症性肠病(IBD)最常见的肠外并发症。我们的目的是评估静脉注射(IV)与口服铁剂补充对纠正成年IBD患者贫血的相对疗效和危害。我们进行了一项系统评价和荟萃分析,以整合来自纳入成年IBD患者的随机对照试验的证据,并比较静脉注射与口服铁剂(直接比较)对纠正缺铁性贫血的效果。检索了截至2015年7月的Medline、Embase、Scopus和科学引文索引数据库。还调查了Cochrane对照试验中心注册库、世界卫生组织国际临床试验注册平台、ClinicalTrials.gov和国际会议论文集。两名评价者独立提取研究数据和结果,并对每个试验的偏倚风险进行评分。使用固定效应模型和随机效应模型计算合并比值比(OR)及其95%置信区间(CI)。共纳入5项符合条件的研究,包括694例IBD患者。在荟萃分析中,与口服铁剂相比,静脉注射铁剂在使血红蛋白升高≥2.0g/dL方面显示出更高的疗效(OR:1.57,95%CI:1.13,2.18)。静脉注射铁剂组因不良事件或不耐受导致的治疗中断率较低(OR:0.27,95%CI:0.13,0.59)。同样,静脉注射铁剂组胃肠道不良事件的发生率始终较低。相反,接受静脉注射铁剂制剂的患者中严重不良事件(SAE)的报告更为频繁(OR:4.57,95%CI:1.11,18.8);然而,大多数报告的SAE被判定与研究药物无关或不太可能相关。在所有分析中,我们未发现发表偏倚或研究间异质性的证据。由于患者和研究人员未对干预措施进行盲法处理,所有主要研究的偏倚风险都很高。静脉注射铁剂在治疗IBD相关性贫血方面似乎比口服铁剂更有效且耐受性更好。

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