Hospital General Universitario de Valencia, Servicio de Patología Digestiva, Valencia, Spain.
Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) y Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
Aliment Pharmacol Ther. 2019 Aug;50(3):258-268. doi: 10.1111/apt.15327. Epub 2019 Jun 14.
Acute gastrointestinal bleeding is prevalent condition and iron deficiency anaemia is a common comorbidity, yet anaemia treatment guidelines for affected patients are lacking.
To compare efficacy and safety of intravenous ferric carboxymaltose (FCM) and oral ferrous sulphate (FeSulf) in patients with anaemia secondary to non-variceal gastrointestinal bleeding METHODS: A prospective 42-day study randomised 61 patients with haemoglobin <10 g/dL upon discharge (Day 0) to receive FCM (n = 29; Day 0: 1000 mg, Day 7: 500 or 1000 mg; per label) or FeSulf (n = 32; 325 mg/12 hours for 6 weeks). Outcome measures were assessed on Days 0 (baseline), 7, 21 and 42. The primary outcome was complete response (haemoglobin ≥12 g/dL [women], ≥13 g/dL [men]) after 6 weeks.
A higher proportion of complete response was observed in the FCM vs the FeSulf group at Days 21 (85.7% vs 45.2%; P = 0.001) and 42 (100% vs 61.3%; P < 0.001). Additionally, the percentage of patients with partial response (haemoglobin increment ≥2 g/dL from baseline) was significantly higher in the FCM vs the FeSulf group (Day 21:100% vs 67.7%; P = 0.001, Day 42:100% vs 74.2%; P = 0.003). At Day 42, normalisation of transferrin saturation to 25% or greater was observed in 76.9% of FCM vs 24.1% of FeSulf-treated patients (P < 0.001). No patient in the FCM group reported any adverse event vs 10 patients in the FeSulf group.
FCM provided greater and faster Hb increase and iron repletion, and was better tolerated than FeSulf in patients with iron deficiency anaemia secondary to non-variceal acute gastrointestinal bleeding.
急性胃肠道出血是一种常见病症，缺铁性贫血是其常见合并症，但目前缺乏针对此类患者的贫血治疗指南。
比较静脉注射羧基麦芽糖铁（FCM）和口服硫酸亚铁（FeSulf）治疗非静脉曲张性胃肠道出血继发贫血患者的疗效和安全性。
一项前瞻性 42 天研究，将血红蛋白<10 g/dL 的 61 例出院患者（第 0 天）随机分为 FCM 组（n=29；第 0 天：1000 mg，第 7 天：500 或 1000 mg；按标签）或 FeSulf 组（n=32；12 小时 325 mg，共 6 周）。在第 0 天（基线）、第 7 天、第 21 天和第 42 天评估结局指标。主要结局是 6 周后完全缓解（血红蛋白≥12 g/dL[女性]，≥13 g/dL[男性]）。
在第 21 天（85.7% vs 45.2%；P=0.001）和第 42 天（100% vs 61.3%；P<0.001），FCM 组完全缓解的比例明显高于 FeSulf 组。此外，FCM 组的部分缓解（血红蛋白从基线增加≥2 g/dL）患者比例显著高于 FeSulf 组（第 21 天：100% vs 67.7%；P=0.001，第 42 天：100% vs 74.2%；P=0.003）。第 42 天，FCM 组转铁蛋白饱和度正常化至 25%或以上的比例为 76.9%，而 FeSulf 组为 24.1%（P<0.001）。FCM 组无患者报告任何不良事件，而 FeSulf 组有 10 例。
FCM 可更快速、更显著地增加血红蛋白和铁的补充，在非静脉曲张性急性胃肠道出血继发缺铁性贫血患者中耐受性优于 FeSulf。
