羧基麦芽糖铁与蔗糖铁治疗缺铁性贫血女性的有效性和安全性比较:IV期临床试验

Effectiveness and safety of ferric carboxymaltose compared to iron sucrose in women with iron deficiency anemia: phase IV clinical trials.

作者信息

Naqash Amreen, Ara Rifat, Bader Ghulam N

机构信息

Department of Pharmaceutical Sciences, University of Kashmir, Srinagar, J&K, 190006, India.

Department of Obstetrics and Gynecology, SKIMS Medical College and Hospital, Srinagar, J&K, 190017, India.

出版信息

BMC Womens Health. 2018 Jan 5;18(1):6. doi: 10.1186/s12905-017-0506-8.

Abstract

BACKGROUND

Iron deficiency anemia (IDA) is a significant problem worldwide particularly in women. The aim of the study was to evaluate the effectiveness and safety of intravenous ferric carboxymaltose (FCM) in comparison to iron sucrose (IS) in women with IDA.

METHOD

Two hundred patients at Department of Obstetrics and Gynaecology, Sher-i-Kashmir Institute of Medical Sciences Medical College and Hospital, Jammu & Kashmir, India identified with IDA were enrolled for the study. Intravenous FCM and IS were both given as per the protocol. Change in the laboratory parameters such as hemoglobin (Hb), mean corpuscular value, and serum ferritin levels at two weeks and four weeks interval after the treatment was recorded.

RESULT

A significant increase in the mean Hb was observed from 7.76 ± 0.709 to 13.25 ± 0.606 in patients treated with FCM and 7.64 ± 0.710 to 11.59 ± 0.733 g/dL (P < 0.001) in patients treated with IS after four weeks of therapy. The rise in mean corpuscular volume was from 66.82 ± 5.24 to 86.76 ± 3.765 and 68.05 ± 5.56 to 93.80 ± 3.80 and rise in serum ferritin levels were from 8.32 ± 1.787 to 38.94 ± 6.095 μg/L and 8.16 ± 1.540 to 27 ± 8.175 μg/L in patients treated with FCM and IS respectively after four weeks of therapy. No serious adverse effects were reported.

CONCLUSION

Parenteral therapy is effective in IDA, but FCM elevates hemoglobin level and restored iron stores faster than IS with minimum adverse drug reactions.

TRIAL REGISTRATION NUMBER

ISRCTN14484575 Dated: 15-12-2017 retrospectively registered. https://doi.org/10.1186/ISRCTN14484575.

摘要

背景

缺铁性贫血(IDA)是一个全球性的重大问题,在女性中尤为突出。本研究的目的是评估静脉注射羧基麦芽糖铁(FCM)与蔗糖铁(IS)相比,治疗IDA女性患者的有效性和安全性。

方法

印度查谟和克什米尔谢里 - 克什米尔医学科学研究所医学院及医院妇产科的200例确诊为IDA的患者被纳入本研究。静脉注射FCM和IS均按照方案给药。记录治疗后两周和四周时血红蛋白(Hb)、平均红细胞体积和血清铁蛋白水平等实验室参数的变化。

结果

治疗四周后,接受FCM治疗的患者平均Hb从7.76±0.709显著升至13.25±0.606,接受IS治疗的患者从7.64±0.710升至11.59±   0.733 g/dL(P < 0.001)。接受FCM治疗的患者平均红细胞体积从66.82±5.24升至86.76±3.765,接受IS治疗的患者从68.05±5.56升至93.80±3.80;血清铁蛋白水平在接受FCM和IS治疗的患者中分别从8.32±1.787升至38.94±6.095 μg/L和从8.16±1.540升至27±8.175 μg/L。未报告严重不良反应。

结论

肠外治疗对IDA有效,但FCM比IS能更快地提高血红蛋白水平并恢复铁储备,且药物不良反应最小。

试验注册号

ISRCTN14484575,日期:2017年12月15日,追溯注册。https://doi.org/10.1186/ISRCTN14484575

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