Double-blind Randomized Dose Controlled Multicenter Study on Prevention of Anemia in VLBW Premature Infants Treated with High Dose rhEPO (recombinant human erythropoietin)

ABSTRACT

PURPOSE: Very low birth weight infants frequently suffer severe anemia. This study was designed to evaluate the effectiveness of rhEPO for prevention of anemia of prematurity and for reduction of the need for transfusion in very low birth weight infants. METHODS: Eighty very low birth weight infants(<1.5 kg) whose gestational age was under 33 weeks were enrolled at 9 university hospital in Korea. This study was conducted as a double-blind randomized, dose-controlled study. In high dose EPO group, 500 IU/kg of rhEPO was subcutaneously administered every other day for 17 times. In low dose EPO group, 250 IU/kg of rhEPO was subcutaneously administered every other day for 17 times. In control group, placebo was administered in the same manner. The effectiveness of rhEPO was evaluated for multiple parameters. RESULTS: 1) Infants receiving high dose rhEPO showed a significant increase in hemoglobin and hematocrit by 3 weeks(P<0.05). 2) Infants receiving high & low dose rhEPO showed an increase in reticulocyte count by 1 week(P<0.05). 3) There were no significant changes in platelet, WBC count, and ANC in each group. 4) Serum concentration of erythropoietin, iron, TIBC and ferritin were highly variable in study patients.5) Incidence of anemia k transfusion in high dose rhEPO group was lower than low dose and control group(P<0.05). 6) Number of patients who did not receive transfusion and whose hematocrit did not fall below 30% in high dose rhEPO group was significantly higher than in low dose and control group(P<0.01). CONCLUSION: High dose recombinant human erythropoietin(rhEPO) treatment for anemia of prematurity may minimize the decrease in hemoglobin and hematocrit, rapidly increase reticulocyte count and reduce the need for transfusion.