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一项口服铁治疗失败或不耐受后铁缺乏性贫血中铁异麦芽糖和羧基麦芽糖铁的系统文献回顾和间接比较。

A systematic literature review and indirect comparison of iron isomaltoside and ferric carboxymaltose in iron deficiency anemia after failure or intolerance of oral iron treatment.

机构信息

a Health Economics , Covalence Research Ltd , London , UK.

b International Market Access , Pharmacosmos A/S , Holbæk , Denmark.

出版信息

Expert Rev Hematol. 2019 Feb;12(2):129-136. doi: 10.1080/17474086.2019.1575202. Epub 2019 Feb 19.

Abstract

OBJECTIVES

The efficacy of oral iron in treating iron deficiency anemia (IDA) can be limited by poor gastrointestinal (GI) absorption and adverse GI symptoms; intravenous (IV) iron is a well-established alternative. The present study compared the efficacy of two IV iron formulations in patients with IDA: iron isomaltoside (IIM) and ferric carboxymaltose (FCM).

METHODS

A systematic literature review (SLR) was conducted to identify randomized controlled trials (RCTs) of IIM and FCM in patients with IDA. An adjusted indirect treatment comparison (ITC) of IIM and FCM was then conducted to evaluate differences in change from baseline hemoglobin and the proportion of patients achieving a clinically-relevant response.

RESULTS

The SLR identified no completed RCTs of IIM versus FCM, 5 RCTs of IIM (4 versus oral iron and 1 versus iron sucrose), and 14 RCTs of FCM (11 versus oral iron and 3 versus iron sucrose). In an ITC via iron sucrose, IIM resulted in a significantly larger increase from baseline hemoglobin with a mean difference of +0.249 g/dL with IIM relative to FCM, but there was no significant difference in the proportion of patients with a clinically-relevant response.

CONCLUSIONS

IIM resulted in a larger increase from baseline hemoglobin than FCM in patients with IDA, but with no difference in the proportion of patients responding. Studies comparing IIM and FCM directly would be needed to confirm these findings.

摘要

目的

口服铁剂治疗缺铁性贫血(IDA)的疗效可能受到胃肠道(GI)吸收不良和不良 GI 症状的限制;静脉(IV)铁是一种成熟的替代疗法。本研究比较了两种 IV 铁制剂在 IDA 患者中的疗效:低分子右旋糖酐铁(IIM)和羧基麦芽糖铁(FCM)。

方法

进行了系统文献综述(SLR),以确定 IIM 和 FCM 治疗 IDA 患者的随机对照试验(RCT)。然后进行了调整后的间接治疗比较(ITC),以评估 IIM 和 FCM 在从基线血红蛋白变化和达到临床相关反应的患者比例方面的差异。

结果

SLR 未发现 IIM 与 FCM 的完成 RCT,5 项 IIM 的 RCT(4 项与口服铁剂和 1 项与蔗糖铁)和 14 项 FCM 的 RCT(11 项与口服铁剂和 3 项与蔗糖铁)。通过蔗糖铁进行 ITC 显示,与 FCM 相比,IMM 使血红蛋白从基线的增加显著更大,平均差异为+0.249g/dL,但在具有临床相关反应的患者比例方面无显着差异。

结论

在 IDA 患者中,IMM 比 FCM 使血红蛋白从基线的增加更大,但在反应患者的比例方面没有差异。需要比较 IIM 和 FCM 的直接研究来证实这些发现。

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