Reeves J D, Yip R
Pediatrics. 1985 Feb;75(2):352-5.
An evaluation was made of 278 healthy-appearing 1-year-old infants who were tested for iron deficiency to determine the relative frequency of adverse side effects attributable to oral iron treatment. After obtaining parental informed consent, laboratory tests of iron status were performed on venous blood and infants with hemoglobin level greater than 10.5 g/dL were randomly chosen to receive 1.2 mL of ferrous sulfate (FeSO4) drops (about 3 mg of iron per kilogram per day) or equal volume of placebo for 3 months. After 3 months of treatment, infants were to return to the clinic for repeat blood testing, compliance estimation, and evaluation for possible adverse side effects. There was no significant difference (P greater than .50) in the frequency of vomiting, diarrhea, or fussiness in iron-treated infants (6%) compared with placebo-treated infants (9%). Constipation was slightly more frequently reported (P = .03) in placebo-treated infants (9%) than in iron-treated infants (1%). Compliance with therapy was confirmed in 179 completely evaluated infants by the lack of remaining medication at 3 months, the higher incidence (P less than .0001) of dark stools reported among iron-treated infants, and the changes in laboratory tests of iron status. No parents reported dark stools as an adverse effect of therapy. It is concluded that once daily, moderate-dose FeSO4 therapy given to fasting 1-year-old infants results in no more gastrointestinal side effects than placebo therapy.
对278名看似健康的1岁婴儿进行了评估，这些婴儿接受了缺铁测试，以确定口服铁剂治疗所致不良副作用的相对发生率。在获得家长知情同意后，采集静脉血进行铁状态实验室检测，血红蛋白水平高于10.5 g/dL的婴儿被随机选择接受1.2 mL硫酸亚铁（FeSO4）滴剂（约每日每千克3 mg铁）或等体积安慰剂，为期3个月。治疗3个月后，婴儿返回诊所进行重复血液检测、依从性评估以及可能出现的不良副作用评估。与接受安慰剂治疗的婴儿（9%）相比，接受铁剂治疗的婴儿出现呕吐、腹泻或烦躁不安的频率无显著差异（P大于0.50）（6%）。接受安慰剂治疗的婴儿（9%）报告便秘的频率略高于接受铁剂治疗的婴儿（1%）（P = 0.03）。在179名完成评估的婴儿中，通过3个月时无剩余药物、铁剂治疗婴儿中报告黑便的发生率较高（P小于0.0001）以及铁状态实验室检测结果的变化，证实了治疗依从性。没有家长报告黑便是治疗的不良反应。结论是，每天一次给予空腹1岁婴儿中等剂量的FeSO4治疗，与安慰剂治疗相比，不会导致更多的胃肠道副作用。
