蔗糖铁治疗儿童缺铁性贫血50例临床研究

Clinical study of iron sucrose injection in the treatment of iron deficiency anemia in children

目的探讨蔗糖铁注射液治疗口服铁剂治疗无效或不耐受缺铁性贫血患儿的临床效果及药物安全性。方法选取2006年3月—2014年1月确诊的50例口服铁剂治疗无效或不耐受缺铁性贫血患儿,给予蔗糖铁静脉滴注。蔗糖铁每次每公斤体重0.15 ml(3 mg铁/公斤体重),每周用药3次,1 ml本品最多只能稀释到20 ml0.9%(w/v)生理盐水中,稀释液配好后应立即使用,药液的滴注速度应为:100 mg铁滴注至少15 min;200 mg至少滴注30 min,用药次数依总缺铁量而定。监测治疗前后血红蛋白(Hb)、网织红细胞(RET)、红细胞压积(HCT)、平均红细胞容积(MCV)、平均红细胞血红蛋白量(MCH)、平均红细胞血红蛋白浓度(MCHC)、铁蛋白(SF)水平以评价疗效,观察不良反应及监测血肝肾心功能以评估安全性。结果治疗后第4天RET水平高于治疗前,提示铁剂治疗有效,治疗后第4天及11天患者Hb、HCT、MCV、MCH、MCHC指标水平均高于治疗前,治疗1周及2周SF水平均高于治疗前,差异均有统计学意义(P<0.01)。治疗1月时复查血常规均正常。50例中仅有2例(4%)出现一过性腹部不适不良反应。结论蔗糖铁注射液治疗口服铁剂治疗无效或不耐受儿童缺铁性贫血有效、安全、可靠。

Objective To investigate the clinical effect and drug safety of Iron Sucrose Injection in the treatment of children with iron deficiency anemia who were unresponsive or intolerant to oral iron therapy. Methods Fifty children confirmed in our hospital with iron deficiency anemia who were unresponsive or intolerant to oral iron therapy from March, 2006 to January,2014 were enrolled to receive Iron Sucrose Injection via vein. Each time,0.15 ml/kg wt iron sucrose was injected（ = 3 mg iron/kg wt）. Three times of injection were given in every week. For dilution of 1 ml Iron Sucrose Injection,the maximum volume of 0.9% saline was 20 ml （w/v）. After dilution, the injection was injected immediately. The speed of injection should be at least 15 minutes for 100 mg iron and at least 30 minutes for 200 mg iron. The frequency of injection was decided by the total amount of iron deficiency. Hemoglobin （Hb）, reticulocyte （RET）, hematocrit （HCT）, mean corpuscular volume （ MCV ）, mean corpuscular hemoglobin （ MCH ）, mean corpuscular hemoglobin concentration （MCHC） and ferritin（ SF ） before and after treatment were monitored to evaluate the therapeutic effect. Adverse reactions were observed and blood liver, kidney and cardiac functions were monitored to evaluate drug safety. Results There was a significant rising in the level of RET in on the 4th day after treatment compared to the levels before treatment which indi- cated effectiveness of the iron treatment. There were significant rising in the levels of Hb, HCT, MCV, MCH, MCHC on the 4th and 11 th days after treatment compared to that before treatment. There were significant rising in the levels of SF at the end of the 1 st and 2nd weeks after treatment compared to the levels before treatment. There were statistic significance in both differences （P 〈 0.01 ）. The blood routine examinations rechecked after 1 month treatment were all in normal ranges. Among the 50 children, there were only 2 adverse reactions reported which manifested as transient abdominal discomfort. Conclusion Iron Sucrose Injection was effective, safe and reliable to treat children with iron deficiency anemia who were unresponsive or intolerant to oral iron therapy.