多糖铁胶囊治疗妊娠合并缺铁性贫血的临床疗效

Clinical observation of the pregnant women with iron deficient anemia treated by polyferose capsules

目的探讨多糖铁胶囊(商品名:红源达)治疗妊娠合并缺铁性贫血(IDA)的疗效及其安全性。方法采用多中心、临床试验,在广州市内4家医院按入选标准选择480例妊娠合并缺铁性贫血的患者,给予多糖铁胶囊治疗(口服,150mg/次,2次/d),同时服维生素C片0.3g。治疗第2、4和8周后复查血常规和铁代谢,比较治疗前后红细胞(RBC)计数、血红蛋白(Hb)、血清铁蛋白(SF)、血清铁(SI)及可溶性血清铁蛋白受体(sTfR)变化及安全性。结果多糖铁胶囊治疗2周后SF、sTfR较治疗前改善(P<0.05);治疗4周后RBC计数、Hb、SF、sTfR较治疗前显著升高(P<0.05);治疗8周后RBC计数、Hb、SF及sTfR较治疗前升高非常明显(P<0.01),但SI在各检测时间的复查结果差异无统计学意义(P>0.05)。治疗过程中患者均未发生明显的不良发应。结论多糖铁胶囊治疗妊娠合并IDA效果好,无明显不良反应。

Objective This study is to evaluate the efficacy and safety of polyferose capsules （Hong-yuan-da） in treating the pregnant women with iron deficient anemia（IDA）. Methods An randomized, multicenter clinical study was undertaken in 480 pregnant women, who were assigned to receive daily （2×150 mg polyferose capsules）and （2×0.3 g vitamin C）. Red blood cells count （RBC-count）, hemoglobin （Hb）, serum iron （SI ）, serum ferritin （SF） and soluble transferring receptor （sTfR） were evaluated before and 2, 4, 8 weeks after the polyferose capsules treatment. All data were analyzed with the statistical softwares. Results After 2 week treatment with polyferose capsules, there were significant changes in SF and sTfR from baseline（P0.05）. After 4 weeks, RBC-count, Hb, SF and sTfR were significantly increased （P0.05）, while （P0.01）. After 8 weeks, RBC-count, Hb, SF and sTfR obviously increased （P0.01）. SI had no significant difference at various time points. No significant adverse reactions were observed during the treatment. Conclusion As less adverse effect and good prognosis, polyferose capsules is a good choice as the iron-supplementation for the pregnant women with IDA.