Abstract：
Acute gastrointestinal bleeding (AGIB) is common in older patients but the use of iron in this context remains understudied.
This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB.
This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180.
From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups.
Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).
This study aimed to evaluate prospectively the efficacy of ferric carboxymaltose to treat anaemia in older patients after AGIB.
This randomised double-blinded placebo-controlled clinical trial was conducted in 10 French centres. Eligible patients were 65 years or more, had controlled upper or lower gastrointestinal bleeding and a haemoglobin level of 9-11 g/dl. Patients were randomly assigned, in a 1:1 ratio, to receive either one intravenous iron injection of ferric carboxymaltose or one injection of saline solution. The primary endpoint was the difference in haemoglobin level between day 0 and day 42. Secondary endpoints were treatment-emergent adverse events, serious adverse events, rehospitalisation and improvement of quality of life (QOL) at day 180.
From January 2013 to January 2017, 59 patients were included. The median age of patients was 81.9 [75.8, 87.3] years. At day 42, a significant difference in haemoglobin level increase was observed (2.49 g/dl in the ferric carboxymaltose group vs. 1.56 g/dl in the placebo group, P = 0.02). At day 180, QOL, measured on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, improved by 10.5 points in the ferric carboxymaltose group and by 8.2 points in the placebo group (P = 0.56). Rates of adverse events and rehospitalisation were similar in the two groups.
Intravenous iron seems safe and effective to treat anaemia in older patients after AGIB and should be considered as a standard-of-care treatment. ClinicalTrials.gov (NCT01690585).
摘要：
背景：急性消化道出血（AGIB）在老年患者中很常见，但在这种情况下使用铁仍未得到充分研究。
目的：本研究旨在前瞻性评估羧基麦芽糖铁治疗老年AGIB术后贫血的疗效。
方法：这项随机双盲安慰剂对照临床试验在10个法国中心进行。符合条件的患者为65岁或以上，控制了上或下消化道出血，血红蛋白水平为9-11g/dl。患者被随机分配，以1:1的比例，接受一次静脉注射铁的羧基麦芽糖铁或一次注射盐水溶液。主要终点是第0天和第42天之间血红蛋白水平的差异。次要终点是治疗引起的不良事件，严重不良事件,第180天再次住院和生活质量（QOL）的改善。
结果：从2013年1月至2017年1月，共纳入59例患者。患者的中位年龄为81.9[75.8,87.3]岁。在第42天，观察到血红蛋白水平增加的显着差异（羧基麦芽糖铁组的2.49g/dl与安慰剂组1.56g/dl，P=0.02)。在第180天，QOL，在欧洲癌症研究和治疗组织的生活质量问卷核心30中测量，羧基麦芽糖铁组提高了10.5分，安慰剂组提高了8.2分（P=0.56）。两组的不良事件和再住院率相似。
结论：静脉补铁治疗老年患者AGIB术后贫血似乎安全有效，应被视为一种标准的治疗方法。ClinicalTrials.gov（NCT01690585）。
目的：本研究旨在前瞻性评估羧基麦芽糖铁治疗老年AGIB术后贫血的疗效。
方法：这项随机双盲安慰剂对照临床试验在10个法国中心进行。符合条件的患者为65岁或以上，控制了上或下消化道出血，血红蛋白水平为9-11g/dl。患者被随机分配，以1:1的比例，接受一次静脉注射铁的羧基麦芽糖铁或一次注射盐水溶液。主要终点是第0天和第42天之间血红蛋白水平的差异。次要终点是治疗引起的不良事件，严重不良事件,第180天再次住院和生活质量（QOL）的改善。
结果：从2013年1月至2017年1月，共纳入59例患者。患者的中位年龄为81.9[75.8,87.3]岁。在第42天，观察到血红蛋白水平增加的显着差异（羧基麦芽糖铁组的2.49g/dl与安慰剂组1.56g/dl，P=0.02)。在第180天，QOL，在欧洲癌症研究和治疗组织的生活质量问卷核心30中测量，羧基麦芽糖铁组提高了10.5分，安慰剂组提高了8.2分（P=0.56）。两组的不良事件和再住院率相似。
结论：静脉补铁治疗老年患者AGIB术后贫血似乎安全有效，应被视为一种标准的治疗方法。ClinicalTrials.gov（NCT01690585）。
