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羧基麦芽糖铁:印度女性产后贫血治疗的一次变革。

Ferric carboxymaltose: A revolution in the treatment of postpartum anemia in Indian women.

作者信息

Rathod Setu, Samal Sunil K, Mahapatra Purna C, Samal Sunita

机构信息

Department of Obstetrics and Gynaecology, SCB Medical College, Cuttack, Odisha, India.

Department of Obstetrics and Gynaecology, Mahatma Gandhi Medical College and Research Institute, Puducherry, India.

出版信息

Int J Appl Basic Med Res. 2015 Jan-Apr;5(1):25-30. doi: 10.4103/2229-516X.149230.

Abstract

OBJECTIVES

The objective of the present study is to compare the safety and efficacy of ferric carboxymaltose (FCM), intravenous (IV) iron sucrose and oral iron in the treatment of post = partum anemia (PPA).

MATERIALS AND METHODS

A total of 366 women admitted to SCB Medical College, Cuttack between September 2010 and August 2012 suffering from PPA hemoglobin (Hb) <10 g/dL were randomly assigned to receive either oral iron or IV FCM or iron sucrose. FCM, IV iron sucrose, and oral iron were given as per the protocol. Changes in hemoglobin (Hb) and serum ferritin levels at 2 and 6 weeks after treatment were measured and analyzed using ANOVA. Adverse effects to drug administration were also recorded.

RESULTS

A statistically significant increase in Hb and serum ferritin level were observed in all three groups, but the increase in FCM group was significantly higher (P < 0.0001) than conventional iron sucrose and oral iron group. The mean increase in Hb after 2 weeks was 0.8, 2.4, and 3.2 g/dL and 2.1, 3.4, and 4.4 g/dL at 6 weeks in oral iron, iron sucrose and FCM groups, respectively. The mean increase in serum ferritin levels after 2 weeks was 2.5, 193.1, and 307.1 and 14.2, 64, and 106.7 ng/mL after 6 weeks in oral iron, iron sucrose and FCM groups, respectively. Adverse drug reactions were significantly less (P < 0.001) in FCM group when compared with other two groups.

CONCLUSION

Ferric carboxymaltose elevates Hb level and restores iron stores faster than IV iron sucrose and oral iron, without any severe adverse reactions. There was better overall satisfaction reported by the patients who received FCM treatment.

摘要

目的

本研究的目的是比较羧基麦芽糖铁(FCM)、静脉注射蔗糖铁和口服铁剂治疗产后贫血(PPA)的安全性和有效性。

材料与方法

2010年9月至2012年8月期间,共有366名因PPA且血红蛋白(Hb)<10 g/dL而入住SCB医学院(位于库塔克)的女性被随机分配接受口服铁剂、静脉注射FCM或蔗糖铁。FCM、静脉注射蔗糖铁和口服铁剂均按方案给药。使用方差分析测量并分析治疗后2周和6周时血红蛋白(Hb)和血清铁蛋白水平的变化。还记录了药物给药的不良反应。

结果

在所有三组中均观察到Hb和血清铁蛋白水平有统计学意义的升高,但FCM组的升高明显高于传统蔗糖铁和口服铁剂组(P<0.0001)。口服铁剂组、蔗糖铁组和FCM组在2周时Hb的平均升高分别为0.8、2.4和3.2 g/dL,在6周时分别为2.1、3.4和4.4 g/dL。口服铁剂组、蔗糖铁组和FCM组在2周时血清铁蛋白水平的平均升高分别为2.5、193.1和307.1,在6周时分别为14.2、64和106.7 ng/mL。与其他两组相比,FCM组的药物不良反应明显更少(P<0.001)。

结论

与静脉注射蔗糖铁和口服铁剂相比,羧基麦芽糖铁能更快地提高Hb水平并恢复铁储备,且无任何严重不良反应。接受FCM治疗的患者总体满意度更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3cce/4318097/ac0008c91b91/IJABMR-5-25-g002.jpg

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