重组人类促红细胞生成素防治早产儿贫血的临床研究

Clinical evaluation of recombinant human erythropoietin in prevention and treatment of anemia of preterm infants

目的 应用不同剂量国产重组人类促红细胞生成素 (rhu EPO)防治早产儿贫血 ,探讨其最适剂量和疗效。方法 83例孕周 <36周 ,出生体重 <2 5 0 0克早产儿 ,以入院顺序按rhu EPO剂量随机分为第 1组 2 5例 (rhu EPO 75 0IU·kg-1·w-1) ,第 2组 18例 (45 0IU·kg-1·w-1) ,第 3组 2 0例(30 0IU·kg-1·w-1) ,分为每周 3次 ,静脉注射 ,疗程 4周。另设第 4组 2 0例为对照组。结果 4组早产儿生后血红蛋白 (Hb)、红细胞压积 (Hct)渐行下降。第 1组下降最轻 ,第 2组次之 ,对照组最明显 ,经方差分析有显著性差异 (P <0 0 1) ;网织红细胞 (Ret)明显增高 ,且Ret升高程度和rhu EPO剂量有关 ;治疗后血清EPO浓度以第 1组最高 ,对照组最低 ,有显著性差异 (P <0 0 1) ,但第 3组与对照组比较无显著性差异 (P >0 0 5 ) ;血清铁 (Fe)生后均逐渐下降 ,治疗各组略低于对照组 ,无显著性差异。结论 早期rhu EPO治疗可提高Hb、Hct、Ret,并且疗效和剂量有关 ,体内充足的铁储备是确保rhu EPO疗效的重要因素。

Objective To evaluate the efficacy and optimal dose of recombinant human erythropoietin (rhuEPO) in prevention and treatment of anemia of preterm infants.Methods 83 preterm infants born at less than 36 weeks of gestation and less than 2*#500gm of birth weight were randomly assigned to receive intravenous rhu EPO 750IU·kg -1 ·w -1 group ( n= 25),450IU·kg -1 ·w -1 group ( n= 18),300IU ·kg -1 ·w -1 group ( n= 20) respectively,three times per week,and control group ( n= 20) for 4 weeks.Results Postnatal decline of hemoglobin (Hb) and hematocrit (Hct) lessened in the rhu EPO 750IU ·kg -1 ·w -1 and rhu EPO 450IU ·kg -1 ·w -1 group,particularly in the former group.There were significant difference in each group by analysis of variance ( P< 0 01).We found no difference between rhu EPO 300IU ·kg -1 · w -1 group and control group ( P> 0 05).Treated infants had significantly higher reticulocyte (Ret),moreover rhu EPO therapy enhanced Ret in a dose dependent manner.After treatment,serum levels of EPO were higher in rhu EPO 750IU·kg -1 ·w -1 group than that in rhu EPO 450IU·kg -1 ·w -1 and rhu EPO 300IU·kg -1 ·w -1 and control group ( P< 0 01).There were no significant differences between the rhu EPO 300IU·kg -1 ·w -1 and control group ( P> 0 05).Serum ferritin concentrations dropped in each group,but it remained similar between treated and control group ( P> 0 05).Conclusion Our study suggested that early administration of rhu EPO stimulated endogenous erythropoiesis and enhanced Ret,Hct and level of Hb in premature infants.The therapy was more efficient when given in higher dosages.Enough iron supplementation increased the efficacy of rhu EPO.