Rognoni Carla, Venturini Sergio, Meregaglia Michela, Marmifero Melania, Tarricone Rosanna
Centre for Research on Health and Social Care Management (CERGAS), Bocconi University, Via Roentgen 1, 20136, Milan, Italy.
Transfusion Medicine, San Lazzaro Hospital, Alba, Italy.
Clin Drug Investig. 2016 Mar;36(3):177-94. doi: 10.1007/s40261-015-0361-z.
Iron deficiency is very common in a number of medical conditions. Ferric carboxymaltose is a new stable iron preparation that can be administered in single infusions over short periods of time. The aim of this study was to conduct a systematic review of randomised controlled trials (RCTs) regarding the efficacy and safety of the novel complex compared with other iron formulations. In addition, the feasibility of a network meta-analysis for indirect comparisons was investigated.
A systematic literature review was performed for published RCTs on the use of ferric carboxymaltose in iron deficiency between July and October 2014. Indirect comparisons were also addressed using terms referring to competing iron formulations. We further supported the qualitative results of the systematic review by a network meta-analysis that allows pooling the evidence around different intervention outcomes in the absence of trials involving a direct comparison.
The initial search yielded 1027 citations, which was decreased to 21 studies eligible for inclusion in the review. Studies were heterogeneous in the number of patients randomised, iron deficiency-related conditions addressed, trial inclusion criteria, time horizon, treatment dosage and outcomes assessed. Six studies with the same time horizon (i.e. 6 weeks) were included in the network meta-analysis. Considering the differences between final and initial outcome values for each iron formulation, the mean difference of these differences (delta) was estimated for each couple of treatments involving ferric carboxymaltose. Significant improvements in serum ferritin (µg/l) were obtained with ferric carboxymaltose compared to oral iron (delta 172.8; 95 % CI 66.7-234.4) and in haemoglobin (g/dl) with respect to ferric gluconate (delta 0.6; 95 % CI 0.2-0.9), oral iron (delta 0.8; 95 % CI 0.6-0.9) and placebo (delta 2.1; 95 % CI 1.2-3.0).
All currently available intravenous iron preparations appear to be safe and effective, but ferric carboxymaltose seems to provide a better and quicker correction of haemoglobin and serum ferritin levels in iron-deficient patients.
缺铁在多种医学状况中非常常见。羧基麦芽糖铁是一种新型稳定的铁制剂，可在短时间内单次输注给药。本研究的目的是对随机对照试验（RCT）进行系统评价，比较这种新型复合物与其他铁制剂在疗效和安全性方面的差异。此外，还研究了进行网络荟萃分析以进行间接比较的可行性。
对2014年7月至10月间发表的关于羧基麦芽糖铁用于缺铁治疗的RCT进行系统文献综述。还使用提及竞争性铁制剂的术语进行间接比较。我们通过网络荟萃分析进一步支持了系统评价的定性结果，该分析能够在缺乏直接比较试验的情况下汇总不同干预结果的证据。
初步检索得到1027条引文，最终纳入综述的合格研究有21项。这些研究在随机分组的患者数量、所涉及的缺铁相关状况、试验纳入标准、观察期、治疗剂量和评估的结局方面存在异质性。网络荟萃分析纳入了6项观察期相同（即6周）的研究。考虑每种铁制剂最终和初始结局值的差异，对涉及羧基麦芽糖铁的每对治疗估计这些差异的平均差值（δ）。与口服铁剂相比，羧基麦芽糖铁使血清铁蛋白（μg/l）有显著改善（δ 172.8；95%CI 66.7 - 234.4）；与葡萄糖酸铁相比，血红蛋白（g/dl）有显著改善（δ 0.6；95%CI 0.2 - 0.9）；与口服铁剂相比（δ 0.8；95%CI 0.6 - 0.9）以及与安慰剂相比（δ 2.1；95%CI 1.2 - 3.0）血红蛋白也有显著改善。
所有目前可用的静脉铁制剂似乎都是安全有效的，但羧基麦芽糖铁似乎能更好、更快地纠正缺铁患者的血红蛋白和血清铁蛋白水平。
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