Evaluation of Clinical Effect of Ferric Derisomaltose on Postpartum Iron Defi-ciency Anemia:Prospective,Randomized,Single-Center Clinical Trial with Oral Iron as a Positive Control
- VernacularTitle:异麦芽糖酐铁应用于产后缺铁性贫血的前瞻性、随机、单中心临床试验的效果评估
- Author:
Lingyi FANG
1
;
Yajuan WANG
;
Jie LI
;
Xiaoli GAO
Author Information
1. 天津医科大学研究生院,天津 300070
- Publication Type:Journal Article
- Keywords:
Ferric derisomaltose;
Moderate anemia in puerperium;
Postpartum anemia;
Iron deficiency anemi-a;
Postpartum depression;
Quality of life assessment
- From:
Journal of Practical Obstetrics and Gynecology
2025;41(1):54-59
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Using oral iron preparations as the positive control,this study explores the efficacy and safety of intravenous iron isomaltoside in the treatment of moderate postpartum iron deficiency anemia(IDA),as well as the impact of anemia correction on fatigue levels and psychological status among postpartum patients.Methods:Eighty-four patients with moderate iron deficiency anemia during puerperium who were delivered at the Tianjin Medical University General Hospital from April 1,2022,to June 30,2023,were included and randomly as-signed1∶1 to the intravenous group(37cases)or the oraliron group(39cases).Theintravenous group received a one-time infusion of ferric derisomaltose(1000 mg)within 1-3 days after delivery.In the oral group,oral iron(150 mg/day for at least 4 weeks)was administered from postpartum day 1.The improvement effect of anemia and the occurrence of adverse reactions were compared between groups.At the same time,the quality of life assess-ment[Multidimensional Fatigue Inventory(MFI)]and postpartum depression assessment[Edinburgh Postnatal Depression Scale(EPDS)]were self-evaluated by electronic questionnaire,and the degree of fatigue and psy-chological condition were compared.Results:①After treatment,6-8 weeks postpartum follow-up showed that the Hb level(129.1±6.4 g/L vs.119.4±9.6 g/L),Hb growth value(49.8±9.4 g/L vs.39.8±11.8 g/L),and Hb growth percentage(62.7%vs.49.3%)Hb increase≥40 g/L(89.2%vs.53.8%),hematocrit level(34.8%vs.29.4%),mean corpuscular volume(97.6 fl vs.92.5 fl)in the intravenous group were significantly higher than those in the control group(P<0.05).②Comparison within groups:compared with the pre-treatment,the MFI scores of the intravenous group and the oral group were significantly lower after treatment(P<0.05),while the difference between the EPDS scores of the two groups before and after treatment was not statistically significant(P>0.05).Comparison between groups:there was no statistically significant difference in MFI scores and EPDS scores between the two groups before and after treatment(P>0.05).③There were no grade 3 or above adverse events occurred in either group.Conclusions:Intravenous ferric derisomaltose is effective and safe for the treat-ment of postpartum anemia,improving hemoglobin levels more rapidly than oral iron,with similar improvements in fatigue levels and no significant impact on postpartum depression as assessed by EPDS.
