
蛋白琥珀酸铁口服溶液防治早产儿贫血的临床研究
Clinical study of iron protein succinylate oral solution for preventing and treating anemia of prematurity
目的 评价蛋白琥珀酸铁口服溶液防治早产儿贫血的疗效和安全性。方法 将60例胎龄小于35周的早产儿随机分为两组:蛋白琥珀酸铁组和多糖铁组。生后2周在应用促红细胞生成素的基础上,分别应用蛋白琥珀酸铁和多糖铁,于治疗后的14、28、42和60 d测定Hb、RBC、HCT、Ret、血清铁及铁蛋白等指标,并评价治疗前后肝肾功能的变化。结果 治疗后两组间RBC和HCT变化趋势差异有统计学意义(P<0.05),蛋白琥珀酸铁组RBC和HCT均自生后逐渐降低,但分别从28 d和42 d时间点后又开始逐渐回升,而多糖铁组RBC和HCT均自生后呈现逐渐降低的趋势。在治疗后60 d,蛋白琥珀酸铁组的Hb、RBC、HCT、血清铁及铁蛋白均高于多糖铁组(P<0.05)。两组均未发生明显的不良反应。结论 蛋白琥珀酸铁口服溶液在防治早产儿贫血中疗效显著,耐受性好。
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.