Department of Gastroenterology and Human Nutrition Unit, All India Institute of Medical Sciences, New Delhi, India.
Am J Gastroenterol. 2024 Oct 1;119(10):2061-2069. doi: 10.14309/ajg.0000000000002775. Epub 2024 Mar 22.
Limited evidence exists on the optimal strategy to correct iron deficiency anemia after variceal bleeding (VB) in cirrhosis. This trial compared the efficacy and safety of intravenous ferric carboxymaltose (IV-FCM) with those of oral iron therapy in this cohort.
In this open-label, single-center, randomized controlled trial, eligible patients with hemoglobin <10 g/dL and iron deficiency (ferritin <100 ng/mL) after VB received either IV-FCM (1,500-2,000 mg) divided into 2 doses (n = 48) or oral carbonyl iron (100 mg elemental iron/day) (n = 44) for 3 months. The primary outcome was change in hemoglobin at 3 months. Secondary outcomes included improvement in anemia (last hemoglobin >12 g/dL), normalization of iron stores (ferritin >100 ng/mL), liver-related adverse events, adverse drug reactions, and changes in quality of life (CLDQOL questionnaire).
Baseline characteristics, including median Child-Turcotte-Pugh score 7 (interquartile range [IQR] 6-9), Model for End-Stage Liver Disease score 12 (IQR 10-17), blood hemoglobin (8.25 ± 1.06 g/dL), and ferritin (30.00 ng/mL [15.00-66.50]), were comparable in both arms. The median increase in hemoglobin at 3 months in the IV and oral arms was 3.65 g/dL (IQR 2.55-5.25) and 1.10 g/dL (IQR 0.05-2.90 g/dL) ( P < 0.001), respectively. Iron stores normalized in 84.6% and 21% of the IV and oral arms, respectively ( P < 0.001). Anemia improved in 50% and 21.9% in the IV and oral arms, respectively ( P < 0.009). Patients in the IV arm showed a significant improvement in all domains of CLDQOL. Liver-related adverse events were comparable in both arms. Transient mild/moderate hypophosphatemia developed in 43% of patients receiving IV-FCM.
Intravenous iron replacement is efficacious and safe to treat iron deficiency anemia after VB in patients with cirrhosis.
肝硬化患者静脉曲张出血（VB）后纠正缺铁性贫血的最佳策略证据有限。本试验比较了静脉注射羧基麦芽糖铁（IV-FCM）与口服铁剂治疗该队列的疗效和安全性。
在这项开放标签、单中心、随机对照试验中，血红蛋白<10 g/dL 且 VB 后缺铁（铁蛋白<100 ng/mL）的合格患者分别接受 IV-FCM（1500-2000 mg）分为 2 剂（n=48）或口服羰基铁（100 mg 元素铁/天）（n=44）治疗 3 个月。主要结局是 3 个月时血红蛋白的变化。次要结局包括贫血改善（末次血红蛋白>12 g/dL）、铁储存正常（铁蛋白>100 ng/mL）、肝脏相关不良事件、药物不良反应和生活质量变化（CLDQOL 问卷）。
两组的基线特征，包括中位 Child-Turcotte-Pugh 评分 7（四分位距 [IQR] 6-9）、终末期肝病模型评分 12（IQR 10-17）、血血红蛋白（8.25±1.06 g/dL）和铁蛋白（30.00 ng/mL [15.00-66.50]），均相似。IV 组和口服组 3 个月时血红蛋白的中位数增加分别为 3.65 g/dL（IQR 2.55-5.25）和 1.10 g/dL（IQR 0.05-2.90 g/dL）（P<0.001）。IV 组和口服组的铁储存分别有 84.6%和 21%正常化（P<0.001）。IV 组和口服组的贫血分别有 50%和 21.9%改善（P<0.009）。IV 组患者在 CLDQOL 的所有领域均表现出显著改善。两组肝脏相关不良事件相当。接受 IV-FCM 的患者中有 43%出现短暂的轻度/中度低磷血症。
静脉铁替代治疗对肝硬化患者 VB 后缺铁性贫血有效且安全。
