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静脉铁剂过敏反应的比较:异麦芽糖铁 1000(Monofer)与羧基麦芽糖铁(Ferinject)。单中心、队列研究。

Comparison of hypersensitivity reactions of intravenous iron: iron isomaltoside-1000 (Monofer ) versus ferric carboxy-maltose (Ferinject ). A single center, cohort study.

机构信息

Department of Clinical Pharmacy, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.

Central Hospital Pharmacy, The Hague, The Netherlands.

出版信息

Br J Clin Pharmacol. 2019 Feb;85(2):385-392. doi: 10.1111/bcp.13805. Epub 2018 Dec 11.

Abstract

AIMS

Intravenous iron supplementation is widely used to treat iron deficiency and iron deficiency anemia when oral iron administration is ineffective or poorly tolerated. Hypersensitivity reactions (HSRs) during infusions are rare, but can be life-threatening. This study aimed to compare the risk for HSRs with the intravenous administration of iron isomaltoside-1000 and ferric carboxymaltose for the treatment of iron deficiency and iron deficiency anemia.

METHODS

This was a single-centre cohort study. Nurses and physicians were instructed to fill out an HSR registration form with every administration of intravenous iron. HSRs were distinguished into serious and non-serious HSRs using the Ring and Messmer classification.

RESULTS

HSRs occurred in 18/836 (2.1%) ferric carboxymaltose and 43/496 (8.7%) iron isomaltoside-1000 administrations. The crude risk for HSRs was 75% lower after ferric carboxymaltose treatment (RR = 0.248, 95% CI: 0.145-0.426, P < 0.0001). The risk for grade II HSRs was 88% lower after ferric carboxymaltoside (RR = 0.123, 95% CI: 0.051-0.294). The likelihood of HSRs was 3.4 times higher after the administration of iron isomaltoside-1000 (95% CI: 1.910-6.093, P < 0.0001). Regardless of the type of intravenous iron, patients with comorbidities have a factor 3.6 higher risk (95% CI: 1.899-6.739, P < 0.0001).

CONCLUSIONS

Ferric carboxymaltose is associated with a 75% lower risk for HSRs compared with iron isomaltoside-1000 in our population. The presence of a comorbidity raises the likelihood of an HSR by a factor of three regardless of the type of intravenous iron infusion. Further research is needed to clarify the underlying mechanism in various patient groups.

摘要

目的

当口服铁剂无效或不能耐受时,静脉铁剂补充广泛用于治疗缺铁和缺铁性贫血。输液过程中的过敏反应(HSR)很少见,但可能危及生命。本研究旨在比较静脉注射异麦芽糖铁-1000 和羧基麦芽糖铁治疗缺铁和缺铁性贫血的 HSR 风险。

方法

这是一项单中心队列研究。护士和医生被指示在每次静脉注射铁剂时填写 HSR 登记表。根据 Ring 和 Messmer 分类,HSR 分为严重和非严重 HSR。

结果

在羧基麦芽糖铁治疗中,HSR 发生在 18/836(2.1%)和 43/496(8.7%)的异麦芽糖铁-1000 给药中。羧基麦芽糖铁治疗后 HSR 的风险降低了 75%(RR=0.248,95%CI:0.145-0.426,P<0.0001)。二级 HSR 的风险降低了 88%(RR=0.123,95%CI:0.051-0.294)。在给予异麦芽糖铁-1000 后,HSR 的可能性增加了 3.4 倍(95%CI:1.910-6.093,P<0.0001)。无论使用哪种静脉铁剂,合并症患者的风险增加了 3.6 倍(95%CI:1.899-6.739,P<0.0001)。

结论

与我们人群中的异麦芽糖铁-1000 相比,羧基麦芽糖铁与 HSR 风险降低 75%相关。无论静脉铁剂输注类型如何,合并症的存在使 HSR 的可能性增加了三倍。需要进一步研究以阐明不同患者群体中潜在的机制。

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