Clinical study of iron protein succinylate oral solution for preventing and treating anemia of prematurity

Abstract:

Objective To evaluate the efficacy and safety of iron protein succinylate(IPS) oral solution in preventing and treating anemia of prematurity(AOP). Methods Sixty premature infants less than 35 weeks of gestation were randomly divided into IPS(n=30) and polysaccharide iron complex(PIC) groups (n=30). Treatment began at two weeks after birth. The infants received IPS or PIC in addition to recombinant human erythropoietin. On days 14, 28, 42, and 60 after treatment, hemoglobin(Hb), red blood cell count (RBC), hematocrit(HCT), percentage of reticulocytes, serum iron, and serum ferritin were determined. Liver and renal functions were evaluated before and after treatment. Results There were significant differences in the changing trends of RBC and HCT between the two groups(P<0.05). In the IPS group, RBC and HCT gradually decreased after birth, but began to rise gradually on days 28 and 42 of treatment; in the PIC group, RBC and HCT kept decreasing from birth to day 60 of treatment. On day 60 of treatment, the IPS group had significantly higher levels of Hb, RBC, HCT, serum iron, and serum ferritin than the PIC group(P<0.05). No notable adverse events occurred in either group. Conclusions IPS oral solution has good efficacy and tolerability in preventing and treating AOP.