Iron Protein Succinylate Research Articles

ЛЕЧЕНИЕ ЖЕЛЕЗОДЕФИЦИТНОЙ АНЕМИИ И ДЕФИЦИТА ФОЛАТОВ У ДЕТЕЙ РАННЕГО ВОЗРАСТА

Anemia is a global health problem worldwide associated with high morbidity and mortality rates and an increase in the number of hospitalizations. The article reflects the prevalence of grade 1 iron deficiency anemia and folate deficiency in children from 0 to 36 months of age, presents the latest data on the clinical efficacy of a drug containing iron protein succinylate and calcium folinate pentahydrate in this category of children in the treatment of grade 1 iron deficiency anemia and folate deficiency. The study monitored blood changes in children from 0 to 36 with grade 1 iron deficiency anemia and folate deficiency before and after treatment with a drug containing iron protein succinylate and calcium folinate pentagiomrate, and justified the pharmacoeconomical expediency of prescribing this drug from the point of view of the patient and the doctor.

Retracted: Changes of Serum Ferritin, Hemoglobin, and Serum Iron (SI) and Treatment Effect of Iron Proteinsuccinylate Oral Solution Combined with Vitamin A and D Drops on Children with Nutritional Iron Deficiency Anemia.

[This retracts the article DOI: 10.1155/2022/2972617.].

Efficacy of polysaccharide iron complex in IDA rats: A comparative study with iron protein succinylate and ferrous succinate

Iron deficiency anemia (IDA) is the most common nutrient-related health problem in the world. There is still a lack of comprehensive comparative study on the efficacies of commonly used iron supplements such as polysaccharide iron complex (PIC), iron protein succinylate (IPS) and ferrous succinate (FS) for IDA. In this study, we compared the PIC, IPS and FS efficacies in IDA rats via intragastric administration. The results showed that the three iron supplements had similar efficacies. PIC/IPS/FS at a dose of 15 mg Fe/kg/d for 10 d increased the hematological and serum biochemical parameters to 2.15/2.12/2.18 (Hb), 1.71/1.67/1.69 (RBC), 2.10/2.11/2.12 (HCT), 1.26/1.22/1.22 (MCV), all 1.34 (MCH), 1.15/1.15/1.14 (MCHC), 1.94/1.82/1.91 (SF), 9.75/9.67/9.53 (SI), and 23.30/22.68/21.64 (TS) times, and reduced TIBC to 0.42/0.43/0.44 times, compared to untreated IDA rats. PIC performed slightly better than IPS and FS in restoring MCV level. Meanwhile, the heart, spleen and kidney coefficients reduced to 67%/74%/65% (heart), all 59% (spleen) and 87%/88%/88% (kidney), and the liver coefficient increased to 116%/115%/116%, compared to untreated IDA rats. The liver iron content was found to be more affected by IDA than the spleen iron content. PIC/IPS/FS at 15 mg Fe/kg/d increased organ iron contents to 4.20/3.97/4.03 times (liver) and 1.36/1.24/1.41 times (spleen) within 10 d compared to untreated IDA rats, and PIC-H and FS were slightly better than IPS in restoring spleen iron content. The results of this study can provide useful data information for the comparison of three iron supplements, PIC, IPS and FS.

Development and validation of RP HPLC method for the estimation of methyl paraben sodium and propyl paraben sodium in iron protein succinylate syrup

AbstractA new precise, selective and reliable reversed phase high performance liquid chromatographic (RP-HPLC) method has been developed and validated for the determination of Methyl paraben sodium (MPS) and Propyl paraben sodium (PPS) (preservatives) in Iron protein succinylate syrup. Optimized conditions were; Methanol: Water (65: 35) as mobile phase, UV/Vis detector at the wavelength of 254 nm and flow rate was set at 1.3 ml min−1. By applying the set of conditions, separation of components was carried out in less than 7 min for both the analytes. The method was validated according to International conference of Harmonization (ICH) guidelines and the analytical characteristic parameters of validation included specificity, limit of detection (LOD), limit of quantification, linearity, accuracy, precision and robustness were evaluated. The calibration curve was found to be linear in the range of 0.045 mg mL−1 to 0.075 mg mL−1 for Methyl paraben sodium and 0.015 mg mL−1 to 0.025 mg mL−1 for propyl paraben sodium with a correlation coefficient r2 > 0.999. Accuracy; reported as percentage recovery was found to be in the range of 98.71%–101.64% for Methyl paraben sodium and 99.85%–101.47% for Propyl paraben sodium at 80%, 100% and 120% concentration for both the analytes. The proposed method was found to be precise and robust when evaluated by variations in wavelength, mobile phase composition, temperature and analyst. The limit of detection (LOD) was found 0.001 mg mL−1 (3 ppm) for Methyl paraben sodium and 0.001 mg mL−1 (1 ppm) for Propyl paraben sodium.

Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study.

To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world. A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to the treatment drugs. The overall adverse reaction rate was 15.4%, and the main adverse reaction site was the digestive system. The incidence of all kinds of oral iron adverse reactions from high to low in order: compound ferrous sulfate and folic acid tablets (21.88%); iron proteinsuccinylate oral solution (20.90%); ferrous succinate tablets (19.76%); ferrous succinate sustained-release tablets (18.00%); iron polysaccharide complex capsule (12.06%); and iron dextran oral solution (6.94%). It was found that there was a significant difference in the incidence of adverse reactions among the six drugs (p < 0.05). Pairwise comparison showed that the incidence of adverse reactions was higher in the iron proteinsuccinylate oral solution than that in the iron polysaccharide complex capsule (p < 0.05). There was no significant difference in the incidence of adverse reactions in different ages (p > 0.05), but there was a significant difference in the incidence of adverse reactions in different gestational ages (p < 0.05). In Adverse Drug Reaction (ADR) patients, the adverse reaction result of most patients is recovery or improvement, and there was no serious adverse reaction outcome such as sequela and death. All the adverse reactions of oral iron were mainly gastrointestinal adverse reactions, and no heavy adverse reactions were found. Iron proteinsuccinylate oral solution has a higher incidence of adverse reactions than iron polysaccharide complex capsule. The results showed that oral iron was safer for anemia patients during pregnancy.

Fe(III)-Rhamnoxylan-A Novel High Spin Fe(III) Octahedral Complex Having Versatile Physical and Biological Properties.

An iron (III) complex with rhamnoxylan, a hemicellulose from Salvia plebeia seeds, was synthesized and characterized by elemental analysis, spectroscopic and magnetic susceptibility measurements, thermal analysis and scanning electron microscopy. The rhamnoxylan was found to be a branched hemicellulose consisting of β-1,4-linked xylose main chain and rhamnose attached to the chain at β-1,3 positions. The complex was found to contain 18.8% w/w iron. A high-spin octahedral geometry of Fe3+ was indicated by the electronic absorption spectrum of the complex. In other experiments, the complex exhibited good electrical and magnetic properties. In vivo efficacy, as hematinic, of the complex in induced anemia was demonstrated equivalent to that of iron protein succinylate (taken as standard) as evidenced by raised red blood cell count, hemoglobin, hematocrit and total iron in rabbit. The complex was found to be non-toxic with LD50 > 5000 mg kg−1 body weight in rabbit. Thus, iron(III)-rhamnoxylan hold the potential for application as hematinic for treatment of iron deficiency anemia.

Changes of Serum Ferritin, Hemoglobin, and Serum Iron (SI) and Treatment Effect of Iron Proteinsuccinylate Oral Solution Combined with Vitamin A and D Drops on Children with Nutritional Iron Deficiency Anemia.

Objective The purpose was to evaluate the treatment effect of iron proteinsuccinylate oral solution combined with vitamin A and D drops on children with nutritional iron deficiency anemia. Methods 124 children treated in the outpatient department of our hospital from January 2017 to January 2020 were selected as the study subjects. They were randomly divided into control and observation two groups. The control group was treated with iron proteinsuccinylate oral solution (1.5 mL/kg) in the morning and evening, respectively. The observation group received adjuvant treatment with oral vitamin A and D drops based on the treatment of the control group. The treatment effect of proteinsuccinylate oral solution combined with vitamin A and D drops was evaluated by the serum iron (SI), serum ferritin (SF), and transferrin (TRF) levels, the values of CD3+, CD4+, and CD4+/CD8+, and other evaluation indicators. Results After treatment, the SI and SF levels of children in both groups significantly increased (P < 0.01) while the TRF level significantly decreased (P < 0.01), and the SI and SF levels in the observation group increased more significantly, and the TRF level decreased more significantly compared with those in the control group (P < 0.01). After treatment, the values of CD3+, CD4+, and CD4+/CD8+ of children in both groups significantly increased compared with those before treatment (P < 0.01), and the values of CD3+, CD4+, and CD4+/CD8+ increased more significantly in the observation group compared with those in the control group (P < 0.01). In addition, the evaluation results of treatment effect showed that the markedly effective rate in the observation group was significantly higher than that in the control group (P < 0.01). Conclusion Iron proteinsuccinylate oral solution combined with vitamin A and D drops can better improve the anemia symptoms in children, with high application value.

STUDY OF THE SAFETY OF ANTIANEMIC PREPARATIONS BY METHOD OF THE SYSTEM OF PROBLEMS RELATED TO MEDICINAL PREPARATIONS

Iron deficiency is the most common micronutrient deficiency worldwide. Prevention and treatment of iron deficiency conditions are some of the most important health problems in many countries of the world. At the same time, the main problems for it remain the timely diagnosis, elimination of the cause, as well as the choice of replacement therapy with iron-containing drugs and correction of adverse reactions (ADR) that occur during their use.The aim. This research aims to study the peculiarities of the development of antianaemic drugs ADRs in patients living in the territory of the Republic of Crimea.Materials and methods. The objects of research were cases of ADR occurrence associated with the use of a group of antianaemic drugs and revealed during the 2009-2018 period in the territory of the Republic of Crimea. The main tasks in the analysis of notification forms were the study of the ADR severity, the causality assessment for suspected drugs and ADRs, as well as analysis of particular problems associated with the use of antianaemic drugs (Drug-related problems, DRP).Results. Iron supplements in combination with other drugs became the leaders in the incidence of ADR among antianaemic drugs (28 cases, 42.4% of all cases of ADR). The largest number of cases was registered in patients aged from 18 to 30 years, with female patients prevailing. Among the clinical manifestations of ADR, the most cases were drug hypersensitivity reactions of varying severity (40 cases) and disorders of the gastrointestinal tract (18 cases). The study of the problems associated with the use of antianaemic drugs made it possible to determine that the highest rates of DRP values were observed with the use of iron preparations for parenteral use and cyanocobalamine. The minimal DRP values were observed when prescribing iron protein succinylate preparations.Conclusion. The basis of pharmacotherapy for various types of anemias is the replenishment of iron and vitamin B12 (cyanocobalamin) depots. The effectiveness of the treatment in these cases largely depends on the patient's adherence to treatment, which is, in turn, depends on the frequency and severity of ADRs that occur during the use of antianaemic drugs.

Iron Protein Succinylate in the Management of Iron Deficiency Anemia: A Comparative Study with Ferrous Sulphate at Low and High Therapeutic Doses.

Oral iron supplementation constitutes the first line treatment for iron deficiency anemia (IDA), with daily doses between 80 mg and 200 mg of elemental iron. Ferrous salts, such as ferrous sulphate (FeSO4), while efficacious, frequently give rise to gastrointestinal side effects. In the present paper we attempted to directly compare the efficacy of an alternative to the FeSO4 formulation, which presents a better tolerability profile, iron protein succinylate (Ferplex®). In a diet-induced anemia model, rats were treated by oral gavage with vehicle, FeSO4, or Ferplex® at a human-dose equivalent of 80 mg and 200 mg of elemental iron. We evaluated the change in anemia-related hematological and biochemical parameters, conducting a histological examination of the intestine at sacrifice. Results indicate that both types of iron supplementation are equally effective in the treatment of IDA, restoring hemoglobin, hematocrit, erythrocytes, free iron and transferrin levels in 15 days, with no statistical differences between treated groups and control. The impact of anemia on body weight was also attenuated following treatment with both iron supplements. Thrombocyte and reticulocyte levels, altered by the anemic condition, returned to homeostasis after 15 days of either FeSO4 or Ferplex® treatment. Importantly, the lower and higher doses of iron were equally effective, thus supporting the current school of thought which states that lower therapeutic doses are sufficient for management of IDA. In addition, the study shows for the first time that oral treatment with Ferplex® does not increase serum hepcidin. Finally, Ferplex® induced minimal iron depositions in the intestinal tissue compared to FeSO4.

Adverse effects of iron deficiency anemia on pregnancy outcome and offspring development and intervention of three iron supplements

Iron deficiency anemia (IDA) is a common micronutrient deficiency among pregnant women with severe consequences including impaired immuno-inflammatory system, premature birth, fetal death etc. The present study aimed to investigate the effects of three iron supplements on IDA female rats and their offspring. The IDA female rat model was established with low iron diet and the rats were then mated. After pregnancy, rats were fed diets containing different iron supplements (iron polysaccharide complex, iron protein succinylate and ferrous sulfate) until their offspring were 42 days old. Pregnancy outcomes, haematological, iron metabolism, physical and neurological development indexes were determined. The results showed that all three iron supplements improved the levels of hematological parameters of both mother and offspring rats. After iron supplementation, serum iron, transferrin saturation and serum ferritin levels were increased compared with the IDA group. The level of ferritin light chain in the liver and spleen of both mother and offspring rats in iron supplemented groups was significantly higher than that of the IDA group. The average number of born alive per litter in the iron treatment groups was significantly higher than that in the IDA group. Iron supplements also improved the physical growth and neurobehavioral development of offspring rats. It was also found that iron supplementation improved the expression of ferritin light chain and the synaptic growth associated proteins in the brain and hippocampus. No significant difference was found in the efficacy of three iron supplements. These results suggest that pregnant and postpartum IDA affects pregnancy outcomes, offspring physical development and causes neural impairment. Sufficient iron supplementation can significantly improve IDA and its adverse effects on both mother and offspring.

Efficacy and Tolerability of Oral Iron Protein Succinylate in the Treatment of Iron Deficiency Anemia in Adults with Diverse Pathologies

An increasing number of prevalent conditions in the adult population associated with absolute or/and functional iron deficiencies (ID) may predispose to iron deficiency anemia (IDA). Oral iron formulations, especially ferrous salts, are generally regarded as the first line therapies for adult-onset ID and IDA according to several current guidelines. However, they have been frequently associated with gastrointestinal side effects, and with a subsequent high treatment discontinuation. Iron protein succinylate (IPS) is an iron complex containing 5% of ferric iron engulfed in a succinylated casein shell that precipitates in acid pH and becomes soluble at neutral to alkaline pH, gradually releasing iron into the intestinal lumen, and, hence, overcoming the gastric and intestinal problems of the ferrous compounds, as well as improving intestinal iron absorption. Besides, IPS has shown to prevent the up regulation of the expression of hepcidin or to induce its expression at a smaller extent when compared with ferrous sulphate (FS). This narrative review addresses the efficacy and safety profiles of IPS for the treatment of ID and IDA in adult patients with a wide range of clinical conditions, such as preoperative and postoperative ID, elderly ID, Chronic Kidney Disease (CKD), Hypothyroidism, regular blood donors, and ID developed in young athletes. In conclusion, IPS compares favorably in efficacy and safety with other currently available oral iron preparations, showing a fast and steady improvement in hematologic parameters (that reflect a better iron absorption), and a lower incidence of adverse events.

Efficacy and Tolerability of Oral Iron Protein Succinylate in the Treatment of Iron Deficiency Anemia in Adults with Gastrointestinal Diseases

Iron deficiency anemia (IDA) is commonly associated with several pathological gastrointestinal (GI) conditions in adults, being induced through different mechanisms, such as chronic bleeding, chronic inflammation, malabsorption, autoimmune re-actions, or, quite frequently, as a combination of different mechanisms. All patients must be treated with iron supplementation with the aim of restoring normal hemoglobin levels and iron status. Oral iron compounds are the first line treatment options for ID clinical conditions, according to International Guidelines, as they have proven to be efficacious, safe, and relatively inexpensive. However, ferric salts are scarcely absorbed, and ferrous compounds present a poor GI tolerability. Iron-protein succinylate (IPS), an iron complex that keeps ferric iron bonded to the protein content of a succinylated casein shell at acid pH values, has been shown to release gradually iron into the intestinal lumen, protecting the gastrointestinal mucosa from eventual damage, an ensuring an optimal intestinal iron absorption. This review focuses on IPS in the treatment of IDA associated to a variety of GI medical conditions in adults. Results from diverse studies including IDA due to acute and chronic GI conditions, as well as IDA associated to gastric surgery, confirm a consistent improvement in hematologic parameters and clinical symptoms, and an optimal tolerability profile.

Substitution of hemoglobin levels in pregnant women with iron supplement: A prospective randomized clinical study

Introduction: Iron deficiency anemia (IDA) is the most common form of anemia. Women who are pregnant or lactating and young children are the most affected. Iron protein acetyl aspartilate is a ferroprotein complex that is more efficient versus iron protein succinylate in relatively short periods of time, for example 30 days. Objective: The aim of this clinical study was to investigate the efficacy of acetyl aspartate iron protein supplement in the treatment of anemia in pregnant women after the first trimester. This is the first real-time clinical study testing the usage of an iron protein supplement in a specific population, as there are not sufficient data for such studies in the literature. Study Design: 28 pregnant women with hemoglobin &lt; 10.5 gr/dL and after completing the 12th week of pregnancy, initiated acetyl aspartate protein iron at a daily dose yielding 80g of elemental iron in two uptakes. Similarly, 35 women were studied who received different iron supplements at the same daily dose. After 30 days, hemoglobin values were measured. Inclusion criteria included: age &gt; 18, gestational week &gt; 12, Hb &lt; 10.5 g/dL, Ht &lt; 32%. Exclusion criteria included: age &lt;18, pregnancy &lt; 12 weeks, many pregnancies, history: allergy to iron preparations, ulcer, cirrhosis, hemodialysis, hemochromatosis, aplastic anemia, chronic disease anemia, pancreatitis, renal disease. Results: Treatment with acetyl aspartylated iron lead to higher levels of hemoglobin after four weeks of treatment. Following successive measurements of hemoglobin levels in the 28 women of the study group, Hb levels increased from an initial mean Hb value of 10.04 gr/dL to 10.69 gr/dL. In the control group of 35 pregnant women, an increase in the mean hemoglobin from Hb was observed from 9.99 gr/dL to 10.46 gr/dL. The difference was statistically significant with p &lt; 0.0001. Conclusions: The use of acetyl aspartate iron protein is a very promising option, as there has been an increase in hemoglobin levels to 0.5 gr/dL.

Effect of Iron Supplementation on the Modulation of Iron Metabolism, Muscle Damage Biomarkers and Cortisol in Professional Cyclists.

Background: The intense efforts made during 3-week stage races may reduce iron metabolism and hematological parameters. These efforts may increase the levels of circulating muscle damage markers and some hormones. All of these physiological changes may have negative consequences not only for the performance of athletes but also for their health. The main aim of this study was to evaluate the effects of supplementation with 80 mg/day of iron on haematological parameters, serum cortisol and biochemical muscle indicators on elite male cyclists during the 3-week stage race the Vuelta a España. Our secondary aim was to examine whether the hematological profile is associated with muscular damage parameters and cortisol. Methods: Eighteen elite male cyclists from two teams were randomly assigned to one of two groups: (1) control group (CG, n = 9; age: 26.1 ± 4.6 years; maximum oxygen uptake per kg: 78.0 ± 5.4 mL/kg/min) or (2) group treated with 80 mg/day iron (800 mg of iron protein succinylate, ITG, n = 9; age: 25.7 ± 6.4 years; maximum oxygen uptake per kg: 77.6 ± 6.5 mL/kg/min). The cyclists were subjected to blood tests one week before the start of the race (T1) and after 4 weeks of treatment, coinciding with the end of the competition (T2). Iron metabolism parameters, muscle damage indicators and serum cortisol were assessed. Repeated-measures ANOVA with group as a factor (GC and ITG) were used to examine the differences between groups throughout the study (time × group) after iron supplementation treatment. Results: Significant differences were observed between groups throughout the study in the group-by-time interaction and changes in serum iron (GC: −8.93 ± 10.35% vs. ITG: 0.60 ± 8.64%; p = 0.018), ferritin (GC: −13.88 ± 23.53% vs. ITG: 91.08 ± 118.30%; p = 0.004), haemoglobin (GC: 10.00 ± 3.32% vs. ITG: 13.04 ± 5.64%; p < 0.001), haematocrit (GC: −1.17 ± 3.78% vs. ITG: 7.32 ± 3.92%; p < 0.001) and cortisol (GC: 24.74 ± 25.84% vs. ITG: –13.54 ± 13.61%; p = 0.005). However, no significant group-by-time interaction was observed for the circulating muscle biomarkers. Additionally, significant negative correlations of serum iron, haemoglobin and haematocrit with muscle circulating biomarkers and cortisol (p < 0.05) were observed. Conclusions: Oral iron supplementation with 80 mg/day iron (800 mg of iron protein succinylate) effectively prevented a decline in haematological parameters (serum iron, ferritin, haemoglobin and haematocrit) and maintained optimal levels of recovery in elite cyclists during the Vuelta a España. Moreover, the hematological values were shown to have relationship with muscular recovery parameters.

Preparation of succinylated sodium caseinate–iron complex by adopting ultrafiltration technology: A novel food fortificant

Abstract Iron has several functions in the human body and its deficiency leads to severe health problems. Food fortification is considered as the most acceptable strategy to combat iron deficiency, but the fortification of soluble iron salts induces many technological problems. Succinylated milk proteins can bind sufficient amount of iron. Many varieties of iron protein succinylates are also available in the market as iron supplements, not as food fortificants. Therefore, the present study was intended to prepare succinylated sodium caseinate (succ. NaCas)–iron complex suitable for food fortification purposes by adopting ultrafiltration technology. Level of iron required for the preparation of complex was standardized on the basis of maximum iron binding ability of succ. NaCas. Diafiltration carried out during the manufacturing process not only removed free iron but also reduced excess succinic acid from the complex. The obtained complex also showed better stability under different conditions encountered during processing. Industrial relevance Centrifugation and ultrafiltration (UF) technologies were adopted in the study, the former used to remove the insoluble iron and latter was used to remove free iron. The presence of both insoluble and free iron may be unacceptable for the food processing. The freeze drying technology was also used to facilitate the availability of iron protein succinylate in the powder form for wide range of food application. The proposed method will help industries to adopt the suitable conditions to produce a novel food fortificant commercially.

Are any iron supplement formulations better tolerated than ferrous sulfate?

Evidence-Based Answer Iron (III) polymaltose complex (IPC) has fewer gastrointestinal adverse effects than ferrous sulfate (FeSO4) (SOR: A, meta-analysis). Women report fewer adverse effects with iron protein succinylate (IPS) than with FeSO4, but men report no difference (SOR: B, meta-analysis of small RCTs). Neither sustainedrelease FeSO4 nor carbonyl iron is better tolerated than rapidly disintegrated FeSO4 (SOR: B, comparison RCTs).

Iron complex, dabigatran and toxic epidermal necrolysis syndrome: a case-report

Toxic Epidermal Necrolysis Syndrome falls in the spectrum of acute idiosyncratic bullous disorders with medications being the major aetiological factor. The authors review the relevant literature and report a case of Toxic Epidermal Necrolysis Syndrome where two medications, iron protein succinylate and dabigatran, not previously associated with the disorder might have acted as precipitants to it. An 86-year-old female recently introduced to iron protein succinylate and dabigatran, presented with a widespread rash consisting of erythematous macules symmetrically distributed on her torso and both upper and lower limbs, down to her extremities. She was diagnosed with Toxic Epidermal Necrolysis Syndrome. None of the drugs previously implicated with the disorder were listed in her recent prescriptions. It was therefore concluded that the two most recently initiated medications, iron protein succinylate and dabigatran, might have been the cause. They were both discontinued to good effect for our patient. Although neither iron protein succinylate nor dabigatran has been incriminated as causative of Toxic Epidermal Necrolysis Syndrome, we believe that either one of these or their interaction might have acted as the precipitant to this condition. We suggest that the possibilities of the above associations should be further explored.

Incidence of sideropenia and effects of iron repletion treatment in women with subclinical hypothyroidism.

Sideropenia affects ca. 20% of the world population, and iron dependent anemia is the most frequent type of anemia worldwide. The aim of the study was to investigate the incidence of sideropenia and dependent anemia in patients with subtle changes of the thyroid function, such as subclinical hypothyroidism (SH). 57 women with SH and 61 euthyroid controls (CG) were studied. Serum concentrations of T4, T3, TSH, anti-TPO, anti-Tg, ferrum (Fe), ferritin (Frt) total iron binding capacity (TIBC) and blood count were determined. In SH 17 patients (29.8%) presented low Fe levels (<50 microg/dl). 9 (15.7%) also had decreased Frt, confirming iron deficiency, whereas 8 patients presented additionally diminished hematocrit and hemoglobin levels, suggesting manifested sideropenic anemia. In CG, 10 persons (16%) had sideropenia, 6 (9.8%) had low Fe and Frt and only 3 (4.9%) had blood count alterations suggesting manifested sideropenic anemia. In SH, anti-TPO were positive in 39 patients (68%), whereas, in CG only 2 (3.2%) were positive. 8 patients with SH and manifested sideropenic anemia were treated with ironproteinsuccinylate (I-PSL), (80 mg Fe /day, for three months), a new iron compound. The repletion treatment safely led to the clinical and laboratory correction of sideropenia and showed a good tolerability. Furthermore, iron treatment provoked a minor increase of T4 and a mild decline of TSH, but the levels were not significant. These results suggest that sideropenia is a common finding in patients with slightly decreased thyroid activity, and that determination of Frt should be routinely advised. Finally, in the assessment of sideropenia and dependent anemia, evaluation of the thyroid function must be taken into account.

Safety and Usefulness of Intravenous Iron Sucrose in the Management of Preoperative Anemia in Patients with Menorrhagia: A Phase IV, Open-Label, Prospective, Randomized Study

Background: The aim of this study was to compare the efficacy, safety and achievement of the target hemoglobin level (Hb ≥10 g/dl) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management. Methods: Seventy-six patients with Hb levels <9.0 g/dl who were scheduled to undergo surgical treatment were randomized to receive either intravenous iron sucrose (based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week, beginning 3 weeks before surgery) or oral iron (80 mg/day of oral iron protein succinylate daily). Results: The intravenous iron group had higher increases in Hb (3.0 vs. 0.8 g/dl; p < 0.0001) and ferritin levels (170.1 vs. 4.1 μg/l; p < 0.0001) than the oral iron group. Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group (76.7 vs. 11.5%; p < 0.0001). There were tolerable adverse events in both groups. Conclusion: Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia.

Acute allergic reaction to an iron compound in a milk‐allergic patient

A child allergic to cow's milk developed a mild systemic allergic reaction after the first dose of Ferplex 40 (iron proteinsuccinylate). Skin tests and in vitro studies were performed in the child, in three cow's milk-allergic controls and in a non-allergic control. Milk, casein and iron proteinsuccinylate (Ferplex 40) were used for skin tests, specific immunoglobulin E (IgE) determination, sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), immunoblotting and enzyme allergo sorbent test (EAST) inhibition. A review of the drug information sheet and contact with the manufacturer were also performed. Although proteinsuccinylate is indeed a succinylated casein (each dose containing about 575 mg of casein) there was no indication of the milk protein content in the prescribing information provided by the manufacturer. Skin tests and specific IgE were positive in the case and in all allergic controls, except for EAST to iron proteinsuccinylate in one control. In EAST, iron proteinsuccinylate in solid phase was 100% inhibited by casein and casein in solid phase was inhibited 74% by iron proteinsuccinylate. SDS-PAGE of iron proteinsuccinylate showed a broad 46 kDa band and a blur of aggregated material. On immunoblot, the patient's IgE reacted to this heavily aggregated material and in the native casein extract recognized a 35-kDa band. The allergenicity of succinylated casein (proteinsuccinylate) among milk-allergic children is demonstrated. The protein source used in drug-protein conjugates should always be indicated by the manufacturer (as it should be in foods) to avoid potential risks to allergic patients.