Moore R Andrew, Gaskell Helen, Rose Peter, Allan Jonathan
Pain Research, Nuffield Department of Anaesthetics, University of Oxford, Oxford Radcliffe Hospitals, The Churchill, Oxford, OX3 7LJ, UK.
BMC Blood Disord. 2011 Sep 24;11:4. doi: 10.1186/1471-2326-11-4.
Recommendations given for intravenous iron treatment are typically not supported by a high level of evidence. This meta-analysis addressed this by summarising the available date from clinical trials of ferric carboxymaltose using clinical trial reports and published reports.
Clinical trial reports were supplemented by electronic literature searches comparing ferric carboxymaltose with active comparators or placebo. Various outcomes were sought for efficacy (attainment of normal haemoglobin (Hb), increase of Hb by a defined amount, for example), together with measures of harm, including serious adverse events and deaths.
Fourteen studies were identified with 2,348 randomised patients exposed to ferric carboxymaltose, 832 to oral iron, 762 to placebo, and 384 to intravenous iron sucrose. Additional data were available from cohort studies. Intravenous ferric carboxymaltose was given up to the calculated iron deficit (up to 1,000 mg in one week) for iron deficiency anaemia secondary to chronic kidney disease, blood loss in obstetric and gynaecological conditions, gastrointestinal disease, and other conditions like heart failure. The most common comparator was oral iron, and trials lasted 1 to 24 weeks. Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin saturation levels; the mean end-of-trial increase over oral iron was, for Hb 4.8 (95% confidence interval 3.3 to 6.3) g/L, for ferritin 163 (153 to 173) μg/L, and for transferrin saturation 5.3% (3.7 to 6.8%). Ferric carboxymaltose was significantly better than comparator in achievement of target Hb increase (number needed to treat (NNT) 6.8; 5.3 to 9.7) and target Hb NNT (5.9; 4.7 to 8.1). Serious adverse events and deaths were similar in incidence in ferric carboxymaltose and comparators; rates of constipation, diarrhoea, and nausea or vomiting were lower than with oral iron.
This review examined the available trials of intravenous ferric carboxymaltose using details from published papers and unpublished clinical trial reports. It increases the evidence available to support recommendations given for intravenous iron treatment, but there are limited trial data comparing different intravenous iron preparations.
关于静脉注射铁剂治疗的推荐意见通常缺乏高水平证据的支持。本荟萃分析通过使用临床试验报告和已发表报告总结羧基麦芽糖铁临床试验的现有数据来解决这一问题。
通过电子文献检索补充临床试验报告，将羧基麦芽糖铁与活性对照剂或安慰剂进行比较。寻求各种疗效结果（如达到正常血红蛋白（Hb）水平、Hb升高一定量等）以及危害指标，包括严重不良事件和死亡情况。
确定了14项研究，共有2348例随机分组患者接受羧基麦芽糖铁治疗，832例接受口服铁剂治疗，762例接受安慰剂治疗，384例接受静脉注射蔗糖铁治疗。队列研究提供了更多数据。对于慢性肾脏病继发的缺铁性贫血、妇产科疾病失血、胃肠道疾病以及心力衰竭等其他疾病，静脉注射羧基麦芽糖铁的剂量可达计算出的铁缺乏量（一周内最高可达1000mg）。最常见的对照剂是口服铁剂，试验持续1至24周。静脉注射羧基麦芽糖铁可改善平均Hb水平、血清铁蛋白水平和转铁蛋白饱和度水平；与口服铁剂相比，试验结束时平均升高幅度为：Hb 4.8（95%置信区间3.3至6.3）g/L，铁蛋白163（153至173）μg/L，转铁蛋白饱和度5.3%（3.7至6.8%）。在实现目标Hb升高方面（治疗所需人数（NNT）为6.8；5.3至9.7）以及目标Hb NNT（5.9；4.7至8.1）方面，羧基麦芽糖铁显著优于对照剂。羧基麦芽糖铁和对照剂的严重不良事件和死亡发生率相似；便秘、腹泻以及恶心或呕吐的发生率低于口服铁剂。
本综述利用已发表论文和未发表临床试验报告中的详细信息，对静脉注射羧基麦芽糖铁的现有试验进行了研究。它增加了支持静脉注射铁剂治疗推荐意见的可用证据，但比较不同静脉注射铁剂制剂的试验数据有限。
