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  

Evaluation of Clinical Effect of Ferric Derisomaltose on Postpartum Iron Deficiency Anemia:Prospective,Randomized,Single-Center Clinical Trial with Oral Iron as a Positive Control

作　　者：方灵漪 王亚娟 李洁[2] 高晓丽[2] FANG Lingyi;WANG Yajuan;LI Jie(Graduate School,Tianjin Medical University,Tianjin 300070,China;Department of Gynecology and Obstetrics,Tianjin Medical University General Hospital,Tianjin Key Laboratory of Female Reproductive Health and Eugenics,Tianjin 300052,China)

机构地区：[1]天津医科大学研究生院,天津300070 [2]天津医科大学总医院妇产科天津市女性生殖健康与优生重点实验室,天津300052

出　　处：《实用妇产科杂志》2025年第1期54-59,共6页Journal of Practical Obstetrics and Gynecology

基　　金：白求恩基金会菲凡补铁-缺铁性诊疗提升项目(编号:ffbt-B-2022-003)。

摘　　要：目的:以口服铁剂为阳性对照,探讨静脉应用异麦芽糖酐铁在治疗产后中度缺铁性贫血(IDA)方面的有效性、安全性及纠正贫血对产后患者的疲劳程度及心理状况的影响。方法:采用单中心、前瞻性、随机对照试验,选择2022年4月1日至2023年6月30日在天津医科大学总医院产科分娩的84例产褥期中度IDA患者为研究对象,按照1∶1随机分组并排除失访病例,最终分为静脉组(37例)和口服组(39例)。静脉组于产后1~3 d内一次性静脉滴注异麦芽糖酐铁(1000 mg);口服组从产后1 d开始口服铁剂(150 mg/d,持续至少4周)。比较两组产后6~8周的贫血改善疗效及不良反应发生情况,同时通过电子问卷方式进行生活质量评估[多维疲劳量表(MFI)]和产后抑郁评估[爱丁堡产后抑郁量表评分(EPDS)]。结果:①治疗后,产后6~8周随访显示,静脉组的Hb水平(129.1±6.4 g/L vs.119.4±9.6 g/L)、Hb增长值(49.8±9.4 g/L vs.39.8±11.8 g/L)、Hb增长百分比(62.7%vs.49.3%)、Hb增加≥40 g/L占比(89.2%vs.53.8%)、血细胞比容(HCT)值(34.8%vs.29.4%)、平均红细胞体积(MCV)值(97.6 fl vs.92.5 fl)均高于口服组,差异有统计学意义(P<0.05)。②组内比较:与治疗前比较,静脉组和口服组治疗后的MFI评分均显著降低(P<0.05);而两组治疗前后EPDS评分差异无统计学意义(P>0.05)。组间比较:治疗前后两组的MFI评分和EPDS评分差异均无统计学意义(P>0.05)。③静脉组和口服组均无3级及以上不良反应发生。结论:静脉注射异麦芽糖酐铁较口服铁剂可以快速改善产褥期中度IDA患者的Hb水平,对疲劳程度的改善与口服铁剂相似,对产后IDA是有效和安全的。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 assigned 1∶1 to the intravenous group(37cases)or the oral iron group(39cases).The intravenous 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 assessment[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 psychological 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 group

关 键 词：异麦芽糖酐铁 产褥期中度贫血 产后贫血 缺铁性贫血 产后抑郁 生活质量评估 

分 类 号：R714.6[医药卫生—妇产科学]