Efficacy and safety of ferric citrate hydrate compared with sodium ferrous citrate in Japanese patients with iron deficiency anemia: a randomized, double-blind, phase 3 non-inferiority study
Efficacy and safety of ferric citrate hydrate compared with sodium ferrous citrate in Japanese patients with iron deficiency anemia: a randomized, double-blind, phase 3 non-inferiority study
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DOI：
10.1007/s12185-021-03123-9
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发表时间：
2021-03-15
影响因子：
2.1
通讯作者：
Hanaki, Koji
中科院分区：
文献类型：
--
作者：
Komatsu, Norio;Arita, Kojo;Hanaki, Koji
口服铁制剂被用作缺铁性贫血(IDA)的一线治疗，但其胃肠道副作用阻碍了患者的适当依从性。我们最近进行了一项随机、双盲、3期非劣势研究，以评估两种剂量的柠檬酸铁(FC)与柠檬酸亚铁钠(SF)治疗IDA患者的疗效和安全性。从第7周开始的血红蛋白浓度变化来看，500和1000 mg/d的FC并不比100 mg/d的SF差。Logistic回归分析显示，在服用FC 1000 mg/d组、其次是SF 100 mg/d组和FC 500 mg/d组中，在第7周达到目标血红蛋白浓度(男性患者为13.0g/dL，女性患者为12.0g/dL)的累积比例最高。IDA患者对两种剂量的FC耐受性良好。FC治疗组恶心呕吐发生率明显低于SF组。总之，FC有可能成为一种口服铁制剂，具有足够的疗效和较低的恶心和呕吐风险。
Oral iron preparations are used as first-line treatment for iron deficiency anemia (IDA), but their gastrointestinal side effects prevent patients from appropriate adherence. We recently conducted a randomized, double-blind, phase 3 non-inferiority study to evaluate the efficacy and safety of two dosages of ferric citrate hydrate (FC) compared with sodium ferrous citrate (SF) in patients with IDA. FC at both 500 and 1000 mg/day was non-inferior to SF at 100 mg/day in terms of the change in the hemoglobin concentration at Week 7 from baseline. Logistic regression analysis suggested that the cumulative proportion of patients who achieved the target hemoglobin concentration (>= 13.0 g/dL in male patients and >= 12.0 g/dL in female patients) at Week 7 was highest among those treated with FC at 1000 mg/day, followed by SF at 100 mg/day and FC at 500 mg/day. Both dosages of FC were well tolerated in patients with IDA. The incidences of nausea and vomiting were significantly lower in the FC treatment groups than in the SF group. In conclusion, FC has potential to be an oral iron preparation with sufficient efficacy for the treatment of IDA and a lower risk of nausea and vomiting.