Efficacy of Sideral in the early stage of iron deficiency in children

K.I. Pshenichnaya, T.N. Kasatkina

SPb GPMU

In the structure of microelement diseases leading to the development of hematological diseases of non-oncohematological nature in children the main place belongs to iron deficiency [1,2,5]. According to the pathogenetic mechanisms, we distinguish between iron deficiency states (IDS) that developed due to absolute iron deficiency in the body, including depletion of its depot, and functional iron deficiency and iron deposition syndrome, which is not accompanied by a true deficiency of this trace element in general [7]. Anatomical and physiological features of the growing organism in general, and features of iron metabolism in particular predispose to the development of absolute iron deficiency primarily in young children. This type of pathology includes latent iron deficiency (LAD), as an earlier stage of the formation of the pathological process, and iron deficiency anemia (IDA) itself [3]. LAD is known to account for about 70% of all absolute iron deficiency states, whereas EAD, which has typical characteristics in the form of microcytosis and hypochromia, accounts for about 30%, respectively… The treatment of children with LAD and early stages of EAD (mild anemia) is the only possible way to prevent the formation of severe iron deficiency states.

Sideral drops

Clinical medicine has a large variety of therapeutic agents containing iron. Modern trivalent iron preparations are a priority among them in most cases, due to their ability to be absorbed actively, that is, on demand in the presence of iron deficiency, as well as the lack of dependence on food intake, better compliance and a significantly less likely oxidative effect at the level of the intestinal wall [3]. One possible use of trivalent iron is the prescription of a specialized therapeutic and prophylactic nutritional product for anemia, Sideral drops. The peculiarity of this product is the content of iron inside liposomes, which are absorbed in the intestine through the M-cells of the apical part of the Peyer's plaque into the lymph. The data available in the literature on the efficacy of liposomal iron in GAD are isolated and refer mainly to adult patients, often suffering from concomitant chronic pathology. In this regard, we have analyzed the efficacy of Sideral drops in children in outpatient settings according to the results of an observational study conducted in some children's polyclinics in St. Petersburg.

Objective — evaluation of hematological efficacy and tolerability of the specialized therapeutic and preventive nutrition product for anemia "Sideral drops" in children with GAD.

Material and methods. We followed up 44 children: 26 boys and 18 girls. The children's age was from 6 months to 1 year in 20 children, from 1 to 3 years in 19 children, from 3 to 5 years in 5 children. All patients were under observation by district pediatricians and had risk factors for iron deficiency. Absolute risk factors: prematurity and/or low birth weight had 14 children. With a birth weight of more than 4 kg followed by high gains, there were 10. The remaining 20 children had known anamnestic risk factors [4,6] in the form of maternal pregnancy pathology: maternal anemia, second half gestosis, and exacerbations of chronic diseases. Of the 44 patients, 38 (86.3%) had mild GAD in the form of microcytic hypochromic and, as a rule, regenerative anemia. In 6 children (13.7%) hemoglobin and erythrocyte values remained within normal limits, but there were microcytosis and hypochromia, which in combination with the above anamnestic factors allowed to diagnose LHD. Selectively, some children were determined biochemical parameters: serum iron and ferritin, a decrease in which confirmed the presence of iron deficiency. Patients were prescribed a specialized therapeutic and prophylactic nutritional product for anemia "Sideral drops" containing trivalent iron in liposomal form, in a dose according to the enclosed instructions: 1-2 drops (0.7-1.4 mg of iron) per kilogram of weight per day. The results of patient follow-up and monitoring of blood tests over the next 2 months are reported in this report. Clinical blood tests with determination of red blood cell count (RBC), hemoglobin (Hb), erythrocyte volume (MCV) and mean erythrocyte hemoglobin content (MCH) were performed before treatment, after 1 month of treatment and after 2 months on continued use of Sideral drops.

Treatment tolerance was assessed by recording all adverse events over time that coincided with treatment with Sideral drops.

Results and discussion. Before treatment, hemoglobin values in the children ranged from 76-111 g/l, averaging 90.8±8.4 g/l, and erythrocyte count from 3.0-4.7 x 10¹²/l, averaging 3.7±0.3 x 10¹²/l (Table 1). All patients had characteristic for WBC, microcytosis and hypochromia.

Table 1. Dynamics of clinical blood values in children treated with Sideral drops

The average volume of erythrocytes, MCV, was 61-73 fl, on the average 65.0±3.5 fl, the average content of hemoglobin in erythrocytes, MSN, was 16-28 pg, on the average 21.5±2.9 pg. In clinical blood tests performed after 2 weeks from the start of Sideral drops intake no distinct changes of the indicators were noted, only in some patients there was an increase in hemoglobin levels by 1-3 g/l. A month later the total number of erythrocytes increased slightly and was 3.1-4.7 x 10¹²/l, on the average slightly above the initial index - 4.4±0.3 x 10¹²/l. The increase of hemoglobin level to 109.8±6.2 g/l, MCV to 76.5±3.9 pg and MSN to 24.7±2.5 fl (Table 1) indicates the efficiency of ferrotherapy, similar to that of other iron medications. The analysis of the examined blood parameters after 2 months of the treatment showed their complete normalization. The number of erythrocytes in children was in the range of 3.6-5.2 x 10¹²/l, being on the average 4.3±0.2 x 10¹²/l. The hemoglobin level remained low in two children of the first year of life, 103 g/l, and in the remaining children it ranged from 111 g/l to 128 g/l, averaging 118±0.5 g/l. Mean erythrocyte volume, normalized in all, and, ranging from 71-93fl, averaged 81.6±5.0fl. Erythrocyte hypochromia was absent in all children, as indicated by MSN fluctuations in the group of 23.0-33.0 pg, averaging 28.0±2.3 pg. Thus, in the group of children with WBC in the form of LAD and mild type of WBC in 44 patients a complete normalization of clinical blood count was registered after 2 months of using a specialized product of therapeutic and prophylactic nutrition for anemia "Sideral drops". In two children hemoglobin parameters were within the age subnormal range. The timing of the hematological effect corresponds to that of the use of iron medications and is conditioned by the lifetime of red blood cells and, accordingly, by the time required for new red blood cells, sufficiently saturated with hemoglobin under iron correction, to constitute a major part of the circulating red blood cells [4].

Tolerability of treatment in all cases was good, no complications or side effects were noted.

Conclusion. Sideral drops, being a specialized therapeutic and preventive nutrition product for anemia, containing trivalent iron in liposomal form, leads to normalization of clinical blood test parameters in children with latent iron deficiency and a mild form of iron deficiency anemia within at least two months from the beginning of treatment. This indicates a likely positive effect on the correction of iron deficiency and allows us to recommend the appointment of Sideral drops in young children in outpatient settings with the necessary monitoring of effectiveness monthly until complete recovery of laboratory parameters. The total duration of use of Sideral drops, as well as treatment with other iron drugs, is determined by the initial severity of iron deficiency and should be for at least 2 months for prevention and at least 3 months for the treatment of mild forms of iron deficiency anemia on generally accepted indications. At the same time a significant advantage of Sideral drops is very good tolerability, even in long-term treatment of anemia.

List of references

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