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静脉注射高剂量羧甲麦芽糖铁与蔗糖铁治疗产后贫血的安全性和疗效。

Safety and efficacy of high-dose intravenous iron carboxymaltose vs. iron sucrose for treatment of postpartum anemia.

机构信息

Department of Obstetrics and Gynecology, University Hospital Bern, University of Bern, Bern, Switzerland.

出版信息

J Perinat Med. 2012 Apr 2;40(4):397-402. doi: 10.1515/jpm-2011-0239.

Abstract

OBJECTIVE

The purpose of this study is to compare the safety and efficacy of intravenous (IV) high-dose iron carboxymaltose (ICM) with iron sucrose (IS) for the treatment of postpartum anemia.

STUDY DESIGN

We performed a retrospective cohort study with 210 anemic inpatient women in the postpartum period who received IV high-dose ICM (15 mg/kg; maximum, 1000 mg) or IS (2×200 mg), respectively. Safety and tolerability of both groups were compared on the basis of reported systemic and local adverse events. The cohorts were matched for baseline characteristics and their initial hemoglobin (Hb) values. The secondary endpoint included drug efficacy assessment by measurement of Hb level increase up to 8 days after treatment.

RESULTS

Rapid administration of high ICM doses was as well tolerated as IS with overall adverse events of 5% (ICM) vs. 6% (IS). The most common complaint was burning and pain at the injection site. ICM was as effective as IS in changing Hb levels from the baseline. There was no difference in the mean daily Hb increase between the groups. Women with severe anemia showed the most effective responsiveness.

CONCLUSIONS

IV ICM is as safe as IS in the management of postpartum (IDA) iron deficiency anemia despite five times of higher dosage. Both drugs are effective and offer a rapid normalization of Hb after delivery. The single application of ICM shows advantages of lower incidence of side effects at the injection site, a shorter treatment period, and better patient compliance.

摘要

目的

本研究旨在比较静脉注射(IV)高剂量铁羧麦芽糖(ICM)与蔗糖铁(IS)治疗产后贫血的安全性和疗效。

研究设计

我们进行了一项回顾性队列研究,纳入了 210 名产后贫血住院女性患者,分别接受 IV 高剂量 ICM(15mg/kg;最大剂量 1000mg)或 IS(2×200mg)治疗。根据报告的全身和局部不良事件比较两组的安全性和耐受性。两组在基线特征及其初始血红蛋白(Hb)值方面相匹配。次要终点包括治疗后 8 天内 Hb 水平升高的药物疗效评估。

结果

高剂量 ICM 的快速给药与 IS 一样耐受良好,总不良事件发生率为 5%(ICM)与 6%(IS)。最常见的不良反应是注射部位灼热和疼痛。ICM 与 IS 一样有效,可改变基线时的 Hb 水平。两组的平均 Hb 日增长率无差异。重度贫血女性的反应最有效。

结论

尽管 ICM 的剂量是 IS 的五倍,但在管理产后(IDA)缺铁性贫血方面,IV ICM 与 IS 一样安全。两种药物均有效,可在分娩后迅速使 Hb 正常化。ICM 的单次应用具有不良反应发生率较低、治疗周期较短和更好的患者依从性等优势。

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