Institut de Recherche Pierre Fabre, Pierre Fabre Innovation, 3 Avenue Hubert Curien, Toulouse Cedex 1, France.
Eur J Nutr. 2012 Mar;51(2):221-9. doi: 10.1007/s00394-011-0210-7. Epub 2011 Jun 4.
Iron deficiency anaemia (IDA) is the last stage of iron deficiency, consecutive to an imbalance between iron supply through food intake and iron loss through physiological or pathological processes. As well as by haemoglobin levels, IDA is diagnosed by measuring biomarkers of iron stores. Women are most affected by IDA since their teenage years, as menstruation constitutes a chronic iron loss. Oral supplementation with ferrous sulphate is an effective therapy, but gastrointestinal side effects may impair treatment compliance.
The present multicentric randomised controlled trial was designed to assess the non-inferiority of a ferrous sulphate prolonged release formulation called V0355 with the referential ferrous sulphate Ferrograd® in a population of Italian women aged 18-50 years diagnosed for IDA. Three hundred and ninety-nine patients were randomised to receive V0355 (80 mg Fe/day) or Ferrograd® (105 mg Fe/day).
After 12 weeks of treatment, the difference in the mean haemoglobin level between the two groups was 0.081 g/dL ([-2.986;1.361], p = 0.54), which confirmed the hypothesis of non-inferiority. All the other biochemical parameters (serum iron, serum ferritin, transferrin, and soluble transferrin receptor) and haematological parameters (erythrocytes count, reticulocytes count, haematocrit, and mean corpuscular volume), as well as patient's anaemia-related symptoms, were not different between treatment groups throughout the study. Furthermore, the incidence of gastrointestinal adverse events of moderate and severe intensity was significantly lower (p = 0.007) in the V0355 group (5.6%) than in the Ferrograd® group (13.9%).
V0355 was as efficient as Ferrograd® in the treatment of anaemia and exhibited a better gastrointestinal tolerance profile.
缺铁性贫血（IDA）是缺铁的最后阶段，是由于通过食物摄入的铁供应与通过生理或病理过程的铁损失之间的不平衡引起的。除了血红蛋白水平外，还通过测量铁储存的生物标志物来诊断 IDA。女性受 IDA 的影响最大，因为她们在十几岁时就开始月经，这构成了慢性铁损失。口服硫酸亚铁补充剂是一种有效的治疗方法，但胃肠道副作用可能会影响治疗的依从性。
本项多中心随机对照试验旨在评估一种名为 V0355 的硫酸亚铁控释制剂在诊断为 IDA 的意大利 18-50 岁女性人群中的非劣效性，与参比药物 Ferrograd®相比。399 名患者被随机分配接受 V0355（80mgFe/天）或 Ferrograd®（105mgFe/天）。
治疗 12 周后，两组间平均血红蛋白水平的差异为 0.081g/dL（[-2.986；1.361]，p=0.54），证实了非劣效性假设。所有其他生化参数（血清铁、血清铁蛋白、转铁蛋白和可溶性转铁蛋白受体）和血液学参数（红细胞计数、网织红细胞计数、血细胞比容和平均红细胞体积）以及患者的贫血相关症状在整个研究期间在治疗组之间均无差异。此外，V0355 组中度和重度胃肠道不良事件的发生率明显低于 Ferrograd®组（5.6%比 13.9%，p=0.007）。
V0355 在治疗贫血方面与 Ferrograd®同样有效，且具有更好的胃肠道耐受性。
