PDF(Pubmed)
Abstract：
Our study aims to validate safety and efficacy of Feroglobin capsule compared with different iron supplementations in adult subjects diagnosed with non-anemic to mild anemic iron deficiency and fatigue. Enrolled 302 participants diagnosed with non-anemic to mild anemic iron deficiency and fatigue. Group A (n = 147) received Feroglobin, Group B (n = 146) received standard of care [Haem Up Gems capsules (Ferrous fumarate) or Fericip tablets (Ferrous ascorbate)]. 293 subjects completed the study with follow-up visits on days 30, 60, and 90. Feroglobin treatment significantly increased hemoglobin levels from mean 12.43 g/dl to 13.24 g/dl in 90 days. Ferritin levels improved significantly by 442.87% compared to the standard care\'s 256.67%. Fatigue scale scores reduced by 47.51%, and all presenting health complaints resolved completely. Gastrointestinal symptoms observed were similar in both the groups. Both groups exhibited moderate treatment adherence. Quality of life improved in pain and general health domains, exhibiting a good tolerability. Adverse events were unrelated to the investigational products. Feroglobin serves as an efficacious therapeutic alternative for improving hemoglobin, ferritin, and reducing fatigue with low doses compared to standard of care. However, longer-term effects of low-dose require further investigations in different target groups.
摘要：
我们的研究旨在验证在诊断为非贫血至轻度贫血缺铁和疲劳的成年受试者中，与不同补铁相比，血红蛋白胶囊的安全性和有效性。招募了302名被诊断为非贫血至轻度贫血缺铁和疲劳的参与者。A组（n=147）接受血红蛋白，B组（n=146）接受标准护理[HaemUpGems胶囊（富马酸亚铁）或Fericip片剂（抗坏血酸亚铁）]。293名受试者在第30、60和90天完成随访研究。血红蛋白治疗在90天内将血红蛋白水平从平均12.43g/dl显着增加到13.24g/dl。与标准护理的256.67%相比，铁蛋白水平显著提高了442.87%。疲劳量表得分降低47.51%,所有提出的健康投诉都得到了完全解决。两组观察到的胃肠道症状相似。两组均表现出中等的治疗依从性。疼痛和一般健康领域的生活质量得到改善，表现出良好的耐受性。不良事件与研究产品无关。血红蛋白作为一个有效的治疗替代改善血红蛋白，铁蛋白,与标准护理相比，低剂量减少疲劳。然而,低剂量的长期影响需要在不同的目标人群中进一步研究.
