[Comparison of the efficacy and safety between high-dose intravenous iron and oral iron in treating iron deficiency anemia: a multicenter, prospective, open-label, randomized controlled study].

Objective: This study aimed to compare the efficacy and safety between high-dose intravenous iron and oral iron in treating iron deficiency anemia (IDA) . Methods: This prospective randomized controlled study (1∶1) enrolled 338 patients with IDA at The First Affiliated Hospital of Soochow University, Suzhou Hongci Hematology Hospital, and Huai'an Second People's Hospital from June 1, 2022, to January 19, 2024. Of all the patients, 169 received high-dose intravenous iron therapy and 169 received oral iron treatment for 12 weeks of observation. Focus on the hemoglobin (HGB) change from baseline to week 4, secondary focus was on the HGB and iron metabolism parameters (serum iron [SI], transferrin saturation [TSAT], total iron binding force [TIBC], serum ferritin [SF]), and changes in the fatigue score, efficacy, and treatment-related adverse effects were monitored throughout in the two treatment groups. Results: The HGB levels were improved in both treatments, but the HGB improved faster in the intravenous group compared with the oral group. HGB increased from (76.8±15.0) g/L to (118.0±13.3) g/L in the intravenous group and from (77.9±11.6) g/L to (104.3±15.0) g/L in the oral group after 4 weeks of treatment. The increase from baseline in the intravenous group (40.7±17.3) g/L was significantly higher than that in the oral group (27.2±17.5) g/L (P<0.001). The intravenous group demonstrated a more significant early effect than the oral group in terms of iron metabolism parameter improvement. SI, TSAT, TBIC, and SF increased better from baseline at 4 weeks in the intravenous group than in the oral group (P<0.001). Additionally, the intravenous group exhibited better fatigue scores for early improvement than the oral group (P<0.001). The incidence of total adverse effects was similar in the intravenous group as compared to the oral group (3.5% [6/169] vs 5.9% [10/169], P=0.442) . Conclusion: High doses of intravenous iron quickly boost HGB early, causing rapid improvement in SI, TSAT, TBIC, SF, and patient fatigue scores. The patient was well tolerated.