Cohort Study on Benefit of Martial Supplementation with EDTA Sodium Iron in Management of Gravidic Anemia at the University Clinics of Kinshasa

Background: Anemia is mainly attributed to nutritional deficiency, especially iron deficiency, which predominates during pregnancy, and is associated with parasitic diseases such as malaria and intestinal parasitosis, acute or chronic diseases such as sickle cell disease, tuberculosis, HIV infection and various micronutrients disorders. It is associated with an increased risk of low birth weight and prematurity and can contribute to impaired cognitive development in early childhood, as well as to maternal mortality. The impact on the fetus is even greater if maternal anemia onset is at an early stage, or prior to pregnancy. Iron salts, such as sulfate or fumarate, are widely used in the treatment of gravidic anemia, but due to various gastrointestinal side effects, many pregnant women are not compliant with treatment. Sodium iron EDTA, on the other hand, is highly absorbable and bioavailable. The latter improves hematological values and appears to be free from the usual iron-related side effects, hence compliance with this supplementation. Objectives: To evaluate the evolution of hemoglobin levels after sodium iron EDTA supplementation at the university Clinics of Kinshasa, to determine the frequency of gravidic anemia, the dose-dependent benefit of sodium iron EDTA supplementation in pregnant women and to identify factors associated with insufficient hemoglobin gain after supplementation. Methods: This longitudinal cohort will take place in the gynecology department of the University Clinics of Kinshasa from September 2022 to August 2023 and will include at least 54 pregnant women with anemia. Conclusion: The study will enable us to better assess the benefits of sodium iron EDTA in improving hematological values, as well as its tolerability in pregnant women suffering from anemia during pregnancy in our environment.

Benefit of Iron Supplementation with Ferric Sodium EDTA (NaFe ³⁺-EDTA) in the Treatment of Anemia during Pregnancy in Democratic Republic of Congo (FERARI Study)

Background: Oral iron supplements, usually in the form of ferrous salts, are associated with gastric side effects, poor compliance and failure of anemia treatment. To make iron more bioavailable, reduce the gastric side effects and increase the patient compliance, newer iron form, Ferric Sodium EDTA, has become available on the market. Objective: To assess the change in hemoglobin level after iron supplementation with Ferric Sodium EDTA during pregnancy. Materials and Methods: This is a longitudinal study concerning 337 women attending antenatal care in maternity hospitals in the Democratic Republic of Congo from May to December 2020. The study included sociodemographic and anthropometric variables along with type of feed, hemoglobin level at recruitment and after three weeks of taking iron supplement with Ferric Sodium EDTA (Hemoforce Plus Zinc® syrup). For statistical analysis, we used t-test or ANOVA and chi-square test, the significance being stated at p < 0.05. Results: The frequency of pregnancy anemia was 51.4%. The mean hemoglobin value of the overall study group was 8.7 ± 0.5 g/dL. The mean maternal age and weight were 28.9 ± 6.2 years and 65.3 ± 11.7 kg, respectively. Most pregnant women (83.1%) had a diet consisting of food of plant and animal origin in equal proportions. Mean of Body Mass Index (BMI) was 24.6 ± 4.6 Kg/m2 and 44.3% were overweight and obese. The co-morbidities associated were malaria and intestinal parasitosis found in 45% and 5.9% of cases, respectively. After iron treatment with Ferric Sodium EDTA, the average hemoglobin level increased to 11.2 g/dL with mean gain of 2.5 g/dL (p < 0.001). Pregnant women with excess weight (≥90 kg) and malaria as a comorbidity achieved a significantly lower mean hemoglobin gain (p = 0.014 and p = 0.022, respectively). Majority of women (91.2%) had not experienced the metallic taste of the syrup. Conclusion: Ferric Sodium EDTA as a novel iron formulation (Hemoforce Plus Zinc®) has shown a rapid increase in hemoglobin levels in pregnant women suffering from anemia. The speedy rise in hemoglobin is related to the property of Ferric Sodium EDTA to enhance the iron absorption by inhibiting the dietary iron inhibitors. Thus, Ferric Sodium EDTA should be used as an effective and promising iron supplement in pregnant women with iron deficiency anemia.

EDTA铁钠的制备与应用

本文研究了用FeC13和Na2EDTA、EDTA、NaOH、NaHCO3为原料,制备乙二胺四乙酸铁钠的不同方法,其中用NaHCO3调pH值合成工艺简单,温度低易控制,易过滤,易形成工业化生产,所制得的产品红外光谱图与文献相吻合。本文还介绍了乙二胺四乙酸铁钠在食品、照相、农业、工业、印染等行业的广泛用途。

乙二胺四乙酸铁钠(NaFeEDTA)的国内外法规情况研究

研究了国内外关于NaFeEDTA的法规标准情况。在安全及毒理学方面,其使用量不超过铁的暂定每日最大耐受摄入量(PMTDI)0.8mg/kg bw,以及EDTA不超过1.9mg/kg.bw时,NaFeEDTA在食品中应用是安全的。从质量技术指标上,各个国家主要参考JECFA 2006的质量标准为制订依据;相较其他国家,美国食品化学品法典(FCC 6&FCC 7)又补充了部分指标要求,而且对铁、EDTA和pH的指标也做了更严格的限定。在使用范围方面,各国要求各异,大多局限于食物强化中应用,但根据欧盟最新批准状况,NaFeEDTA已经批准应用于食品补充剂和特殊营养用食品中。

乙二胺四乙酸铁钠(NaFeEDTA)在改善铁营养状况和预防铁缺乏性贫血方面的研究

临床数据表明婴幼儿和少年儿童缺铁性贫血发病率较高,而常用口服铁剂由于其铁腥味、胃肠刺激和生物利用率差等原因,限制了其在特殊人群中的应用。本文重点介绍了新型铁剂乙二胺四乙酸铁钠(NaFeEDTA)的特性、毒理安全性和人体吸收代谢过程等。国内外许多营养专家通过在食物中添加铁营养强化剂NaFeEDTA的方式,明显有效的改善婴幼儿、3～8岁儿童和11～17岁学生等人群的铁营养状况,而对铜、锌、钙等离子代谢没有影响,同时还能促进人体的锌吸收和铅排出;因此,NaFeEDTA被推荐用于改善人群铁营养状况和预防缺铁性贫血的最佳铁剂之一。

EDTA络合滴定法测定铁矿石中钙和镁

在微氨性溶液中，采用硫化钠及铜试剂使铜、铅、锌、铁、钴、镍、锰、铬、镉、铋等生成硫化物沉淀和铜试剂内络盐沉淀与钙镁分离，然后以盐酸羟胺将微量的锰还原成低价消除其干扰，用三乙醇胺和L-半胱氨酸掩蔽残留的其他金属离子。在pH10氨水-氯化铵缓冲溶液中，以酸性铬蓝K-萘酚绿B为指示剂，用EDTA络合滴定法测定钙、镁合量；另在氢氧化钾溶液中，用钙试剂为指示剂，以EDTA络合滴定法测定钙量，用差减法计算镁的含量。该方法对铁矿石标准样品中的钙和镁进行多次测定，结果与认定值相符，相对标准偏差在0.99％—3.4％（n=6）之间，加标回收率在98％—101％之间。

含苯酚危险废物的改进型Fenton氧化处理研究

建立以EDTA钠铁作为催化剂的改进型Fenton氧化体系,研究改进型Fenton氧化处理含高浓度苯酚危险废物的影响因素、处理效果和控制参数。研究结果表明,针对含苯酚污染土壤的自配样,当EDTA钠铁投加量为2μmol/g,15%H2O2投加量为0.1 mL/g,体系含水率为33%左右,反应时间60 min时,苯酚(含量为2 mg/g)的氧化降解率可达90%以上,反应后的体系pH约为5.7,便于直接进行固化稳定化等后续处理。该处理过程较传统型Fenton体系温和、安全,且适用于中性pH的体系,可应用于高苯酚含量且以固相无机质为主体的危险废物的快速应急处理。

不同铁剂强化面粉在家庭制作面条中的留存

为考察不同铁剂强化面粉制作的面条在煮面时营养素铁进入面汤的情况,按家庭制作方式,将基础面粉和电解质铁、羰基铁粉、硫酸亚铁、NaFeEDTA四种铁强化面粉手工制成湿面条,并以煮面的方式制熟,测定熟面条中总铁含量,计算铁和添加铁剂的留存率。试验结果表明这五种熟面条中铁大部分保留,留存率都在80%以上,分别为94.3%、96.1%、96.2%、93.9%、80.6%;推算得到四种熟面条中电解质铁、羰基铁粉、硫酸亚铁、NaFeEDTA的留存率则分别为96.8%、97.0%、93.6%、74.8%。溶解性铁剂硫酸亚铁的留存率与水和稀酸不溶性铁剂电解质铁和羰基铁粉基本相同,而与NaFeEDTA有较大差异,表明硫酸亚铁经面条烹调后,其在熟面条中存在的形式可能已经发生很大改变。

方波伏安法检测酱油和食盐中乙二胺四乙酸铁钠

采用方波伏安法建立乙二胺四乙酸铁钠(NaFeEDTA)的检测方法。用pH值为3.0的磷酸缓冲溶液作为底液;电化学条件为扫描增量10mV、方波频率2.5kHz、方波振幅100mV,可实现对NaFeEDTA的检测。试液中NaFeEDTA的质量浓度在10～200mg/L范围内,标准曲线相关系数为0.9997,检出限为4mg/L。对铁强化酱油和食盐中的NaFeEDTA检测的回收率为(93.5±2.1)%和(96.8±2.8)%。

加权平均法测定RH炉顶渣改质剂中的金属铝

RH炉顶渣改质剂中细颗粒铝经硫酸铁溶液进行浸取,以二苯胺磺酸钠为指示剂,用重铬酸钾标准溶液滴定,计算出筛下试样金属铝的含量;粗颗粒铝用氢氧化钠溶解,用苦杏仁酸掩蔽钛,以二甲酚橙为指示剂,先用乙酸锌标准溶液滴定过量的EDTA,再用氟盐取代法计算出筛上试样金属铝的含量,运用加权平均法求出金属铝总量。

乙二胺四乙酸铁钠的制备

研究了用FeC13·6H20和Na2EDTA、EDTA、NaOH、NaHCO3为原料,制备乙二胺四乙酸铁钠的方法,并对不同制法做了分析对比。将乙二胺四乙酸在80℃以上加热溶解,分次加入固体碳酸氢钠和三氯化铁,加完后80℃保温反应20 min,调整溶液pH值小于5,冷却、抽滤、洗涤、干燥即可。此法容易操作,产品质量好。