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[Clinical study of iron protein succinylate oral solution for preventing and treating anemia of prematurity]
1Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China. tongxm2007@126.com.
Insights
Iron protein succinylate (IPS) oral solution effectively treats anemia of prematurity (AOP) in premature infants. IPS demonstrated superior efficacy and good tolerability compared to polysaccharide iron complex (PIC).
Area of Science:
- Neonatal Medicine
- Hematology
- Pediatric Pharmacology
Background:
- Anemia of prematurity (AOP) is a common complication in preterm infants.
- Early and effective treatment is crucial for optimal infant development.
- Iron supplementation is a cornerstone of AOP management.
Purpose of the Study:
- To assess the efficacy and safety of iron protein succinylate (IPS) oral solution for AOP.
- To compare IPS with polysaccharide iron complex (PIC) in premature infants.
- To evaluate key hematological parameters and iron status.
Main Methods:
- A randomized controlled trial involving 60 premature infants (<35 weeks gestation).
- Infants received either IPS or PIC alongside recombinant human erythropoietin.
- Hematological markers (Hb, RBC, HCT), reticulocyte percentage, and iron indices were monitored over 60 days.
Main Results:
- Significant differences in red blood cell count (RBC) and hematocrit (HCT) trends between groups.
- IPS group showed increasing RBC and HCT from day 28 onwards.
- On day 60, the IPS group exhibited significantly higher Hb, RBC, HCT, serum iron, and serum ferritin levels than the PIC group.
Conclusions:
- Iron protein succinylate (IPS) oral solution is effective in preventing and treating AOP.
- IPS demonstrates good tolerability in premature infants.
- IPS offers a promising therapeutic option for managing AOP.
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.
