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乳铁蛋白加健康教育与低分子右旋糖酐铁总剂量输注治疗妊娠期缺铁性贫血的随机对照试验

Lactoferrin plus health education versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating iron deficiency anemia (IDA) in pregnancy: a randomized controlled trial.

作者信息

Darwish A M, Fouly H A, Saied W H, Farah E

机构信息

a Department of Obstetrics and Gynecology, Faculty of Medicine , Woman's Health University Hospital , Assiut , Egypt.

b Faculty of Nursing , Assiut University , Assiut , Egypt.

出版信息

J Matern Fetal Neonatal Med. 2019 Jul;32(13):2214-2220. doi: 10.1080/14767058.2018.1429396. Epub 2018 Jan 25.

DOI:10.1080/14767058.2018.1429396
PMID:29338568
Abstract

BACKGROUND

Iron deficiency anemia (IDA) is one of the most common medical disorder disturbing pregnancies particularly in low resources countries, and contributes significantly to morbidities and mortalities. Thus, early diagnosis and prompt management of IDA is highly recommended.

AIM

To Test the efficacy and safety of oral lactoferrin plus health education provided by a nurse versus total dose infusion (TDI) of low-molecular weight (LMW) iron dextran for treating IDA in the second and third trimester of pregnancy.

DESIGN

A prospective interventional, randomized, parallel-group, single-center longitudinal study.

SETTING

Woman's Health Assiut University Hospital, Assiut, Egypt, at the outpatient clinic and inpatient unit. It comprised 120 cases divided into two groups as pineapple flavored lactoferrin oral sachets 100 mg twice daily with health education (group A) and TDI of LMW iron dextran (group B).

MAIN OUTCOME MEASURES

The primary efficacy parameter was clinical improvement and the amount of increase in hemoglobin concentration by 4 weeks after therapy, secondary outcome measures included measurement of the rest of RBC, and iron indices, the adverse effects related to iron therapy and the patient compliance to the treatment.

RESULTS

There was insignificant difference between both groups regarding sociodemographic data, parity and mean gestational age. Both groups showed a significant clinical improvement of anemia 4 weeks post-therapy. There was no statistically significant difference in mean Hb level improvement in both groups after 1 month of therapy. However, mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) improved significantly more in group B than A while iron indices (serum iron and serum ferritin) were significantly more in group A than group B.

CONCLUSIONS

Pineapple flavored lactoferrin oral sachets plus health education can be widely used as an alternative to TDI iron dextran supplementation due to clinical as well as laboratory improvement of IDA during pregnancy after 1 month of treatment. Proper health education of the pregnant women with nurse recommendations of balanced diet containing good sources of iron would increase awareness of pregnant women and help eradicate IDA with its serious sequel during pregnancy.

摘要

背景

缺铁性贫血(IDA)是困扰孕期的最常见医学病症之一,在资源匮乏国家尤为如此,且对发病率和死亡率有重大影响。因此,强烈建议对缺铁性贫血进行早期诊断和及时治疗。

目的

比较口服乳铁蛋白加护士提供的健康教育与低分子右旋糖酐铁全剂量输注(TDI)治疗妊娠中晚期缺铁性贫血的疗效和安全性。

设计

一项前瞻性干预、随机、平行组、单中心纵向研究。

地点

埃及阿斯尤特女子健康大学医院门诊和住院部。该研究纳入120例患者,分为两组,A组为每日两次口服100mg菠萝味乳铁蛋白冲剂并接受健康教育,B组为低分子右旋糖酐铁全剂量输注。

主要观察指标

主要疗效参数为治疗4周后的临床改善情况及血红蛋白浓度增加量,次要观察指标包括其余红细胞指标和铁指标的测量、铁治疗相关不良反应以及患者对治疗的依从性。

结果

两组在社会人口统计学数据、产次和平均孕周方面无显著差异。两组在治疗4周后贫血均有显著临床改善。治疗1个月后,两组血红蛋白水平平均改善情况无统计学显著差异。然而,B组平均红细胞体积(MCV)和平均红细胞血红蛋白含量(MCH)改善程度显著高于A组,而A组铁指标(血清铁和血清铁蛋白)显著高于B组。

结论

治疗1个月后,菠萝味乳铁蛋白口服冲剂加健康教育由于在孕期缺铁性贫血的临床及实验室指标改善方面效果良好,可广泛用作低分子右旋糖酐铁补充剂的替代方法。对孕妇进行适当的健康教育,并由护士推荐富含优质铁源的均衡饮食,将提高孕妇的认知,有助于消除孕期缺铁性贫血及其严重后果。

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