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羧基麦芽糖铁与蔗糖铁治疗围绝经期月经过多妇女缺铁性贫血的比较分析:一项随机对照试验

Comparative analysis of ferric carboxymaltose and iron sucrose in treating iron deficiency anemia in perimenopausal women with heavy menstrual bleeding: a randomized controlled trial.

作者信息

Chaturvedi Jaya, K Rupendra, Bahadur Anupama, Heda Ayush, Mundhra Rajlaxmi

机构信息

Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, Rishikesh, India.

出版信息

Obstet Gynecol Sci. 2024 Nov;67(6):565-573. doi: 10.5468/ogs.24065. Epub 2024 Nov 4.

Abstract

OBJECTIVE

To evaluate the impact of intravenous ferric carboxymaltose (FCM) compared to iron sucrose (ISC) in perimenopausal women with heavy menstrual bleeding (HMB) and anemia.

METHODS

This prospective, open-label, randomized controlled trial enrolled perimenopausal women (40-50 years) with HMB and hemoglobin levels between 6-10 g/dL, intolerant or non-compliant to oral iron therapy. The study compared FCM and ISC by assessing hematological parameters, including hemoglobin, ferritin, and iron levels, over a 12-week period. The patients were followed up at 3, 6, and 12 weeks after initiation. The adverse effects were also evaluated.

RESULTS

The study included 60 perimenopausal women, with 30 in each group. The baseline patient characteristics were comparable. FCM demonstrated a statistically significant higher mean increase in hemoglobin (4.97 g/dL) than ISC (4.63 g/dL) over 12 weeks. The proportion of patients achieving correction of anemia (hemoglobin ≥12 g/dL) was higher in the FCM group (75.9% vs. 65.5%). Serum ferritin levels were significantly higher in the FCM group after 3 weeks. Adverse effects were minimal and comparable between the groups. Although the direct cost of FCM is high, its ability to be administered in larger doses may result in lower total costs.

CONCLUSION

In perimenopausal women with heavy menstrual bleeding and iron deficiency anemia, FCM and ISC show comparable efficacy in increasing hemoglobin levels with similar side effect profiles. This study highlights the potential benefits of FCM and calls for further exploration of these therapies in diverse patient populations.

摘要

目的

评估与蔗糖铁(ISC)相比,静脉注射羧基麦芽糖铁(FCM)对围绝经期月经过多(HMB)和贫血女性的影响。

方法

这项前瞻性、开放标签、随机对照试验纳入了年龄在40 - 50岁、患有HMB且血红蛋白水平在6 - 10 g/dL、不耐受或不依从口服铁剂治疗的围绝经期女性。该研究通过在12周内评估血液学参数,包括血红蛋白、铁蛋白和铁水平,来比较FCM和ISC。在开始治疗后的3周、6周和12周对患者进行随访。同时也评估了不良反应。

结果

该研究纳入了60名围绝经期女性,每组30名。两组患者的基线特征具有可比性。在12周内,FCM组血红蛋白的平均升高幅度(4.97 g/dL)在统计学上显著高于ISC组(4.63 g/dL)。FCM组实现贫血纠正(血红蛋白≥12 g/dL)的患者比例更高(75.9%对65.5%)。3周后FCM组的血清铁蛋白水平显著更高。不良反应轻微,两组之间相当。尽管FCM的直接成本较高,但其能够以更大剂量给药可能会导致总成本降低。

结论

在围绝经期月经过多和缺铁性贫血的女性中,FCM和ISC在提高血红蛋白水平方面显示出相似的疗效,且副作用相似。本研究强调了FCM的潜在益处,并呼吁在不同患者群体中进一步探索这些疗法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/582f/11581812/569f734380cb/ogs-24065f1.jpg

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