Abstract

DONATO, Hugo; RAPETTI, María C; MORAN, Lorena  and  CAVO, Marcela. Comparación entre hierro polimaltosa y sulfato ferroso para el tratamiento de la anemia ferropénica: estudio prospectivo aleatorizado. Arch. argent. pediatr. [online]. 2007, vol.105, n.6, pp.491-497. ISSN 0325-0075.

Introduction. The usefulness of iron polymaltose (IP) for the treatment of iron deficiency anemia is still controversial. The aim of this prospective, randomized study was to compare efficacy and tolerability of IP and ferrous sulfate (FS). Patients, materials y methods. Children aged 6-48 months, with hemoglobin <11.0 g/dl, mean corpuscular volume <72 fl and transferrin saturation ≤15% or ferritin <16 ng/ml were stratified in age groups and randomized to receive IP or FS (5 mg/kg per day) throughout 90 days. Hemoglobin, hematocrit, mean corpuscular volume, serum iron, transferrin saturation, and ferritin were determined. Tolerability to oral administration was classified as good, intermediate or poor, according to the percentage of the total daily iron dose received. Results. Fifty-nine patients (23 IP, 36 FS) were included. Hemoglobin and hematocrit showed significantly higher values in group FS than in group IP from day 30 to the end of the study (p <0.05). Serum iron, saturation and ferritin at day 90 were significantly higher in group FS (p <0.05). The difference between initial and final values was significantly higher in group FS for every determination. Normal values for hemoglobin, hematocrit, mean corpuscular volume, serum iron and saturation were achieved by significantly more patients in group FS (p <0.05). Only one patient in group FS (due to poor tolerance) and another in group IP (due to hemoglobin fall >1 g/dl) had to discontinue treatment. Conclusions. The first choice for treatment is FS, since it is more effective, with similar safety, tolerability and compliance profiles than IP.

Keywords : Iron; Ferrous sulfate; Iron polymaltose; Anemia; Iron deficiency.

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