Comprimidos mastigáveis de ferro carbonila para tratamento da anemia ferropriva de crianças menores de seis anos

Abstract

The objective this study is verify the efficiency and occurrence of collateral effects with the use of carbonyl iron powder, in the form of chewable tablets, in order to enable the use of an alternative to the conventional treatment of iron deficiency anemia with ferrous sulfate, for children under 6 years of age. The intervention proposed for the treatment of iron deficiency anemia in children almost always consists of ferrous sulfate drops that do not have the desired effectiveness. Several studies have proven the low adherence to the treatment due to collateral effects of the medication (gastrointestinal intolerance, alterations in color and consistency of stools, impregnation of iron in diapers and teeth), to the prolonged daily administration in the form of drops, to the metallic taste, as well as to socio-cultural aspects. In choosing the preparation, the content of the iron ion, tolerance, absorption, effectiveness and cost must all be considered. Carbonyl iron powder is obtained by decomposition of Fe pentacarbonyl at high temperatures, resulting in extremely pure elemental Fe (Fe0), in the form of non-toxic micro-spheres of 4-7/μm, with bioavailability in relation to 58-70% ferrous sulfate and it does not confer a metallic taste to the preparation. An open randomized clinical assay was carried out. The group studied (CA) received Carbonyl Iron and the control group (SF) received a solution of Ferrous Sulfate, both at a dose of 5mg/Kg/day, for 90 days. Seventy-three children from Family Health Units (FHU) of Santa Maria, Brazil, participated in the study. Blood was collected at 0, 30 and 90 days of treatment. The hemograms were carried out in STKS (Coulter, USA), serum iron and TIBC, by colorimetric assay and ferritin by immunometric assay. The data was analyzed with the EpiInfo program, version 3.3.2, from CDC/USA. The increase in Hb after 30 days of treatment was of 1.3g/dl (SD 0.92) for group CA and of 1.2g/dl (SD 1.13) for group SF (p>0.05). After 90 days of treatment, CA had favorable results for Ht, MCV, MCH, TIBC and ferritin (p<0.05). None of the children from group CA presented side effects, in group SF, 62% of the children presented diarrhea and/or experienced vomiting. The number of children from the control group who continued to present a level of Hb lower than 11g/dl was two-fold that of the group that received carbonyl iron. Based on the results demonstrating the same effectiveness at 30 days as for the standard ferrous sulfate and the superior results at 90 days of treatment, together with the safety (low toxicity) and excellent acceptance, carbonyl iron should be considered an important option for the therapeutic treatment of iron deficiency anemia in children under the age of six.