Kwong Winghan J, Numan Syed, Hunter Tina D, Alves Dalila, Patel Anish, Shanbhag Satish
Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.
American Regent, Norristown, PA, USA.
Int J Gen Med. 2023 Aug 2;16:3291-3300. doi: 10.2147/IJGM.S413105. eCollection 2023.
Iron deficiency anemia (IDA) is a common cause of fatigue and impaired quality of life. The present study aimed to evaluate the impact of intravenous iron supplementation with ferric carboxymaltose (FCM) on fatigue, physical function, and general health among patients with IDA attending routine clinical care.
This was a prospective, single arm, observational study of adult patients prescribed with intravenous FCM for the treatment of IDA during routine clinical care. We used Patient-Reported Outcomes Measurement Information System (PROMIS) instruments to evaluate fatigue (PROMIS Short Form v1.0 13a [FACIT-Fatigue]), general health status (PROMIS Scale v1.2), and physical function (PROMIS Short Form v2.0 4a) before and at 3 and 6 months after FCM treatment.
A total of 152 patients were enrolled. Mean age was 47.4 ± 16.0 years and 82.2% were female. Mean serum hemoglobin was 10.2 ± 1.4 g/dL at baseline. All patients were treated with at least one FCM dose at baseline, with 77.6% receiving a two-dose treatment course. The mean baseline FACIT-Fatigue score was 61.0 ± 9.0, improving significantly to 50.2 ± 9.5 at 3 months after FCM treatment. A minimum 5-point improvement, pre-defined as clinically meaningful, was seen in the FACIT-Fatigue, PROMIS Global Physical Health, Global Mental Health and PROMIS Physical Function scores for 72.7%, 52.8%, 41.7% and 39.8% of patients at 3 months (p < 0.0001 for each change from baseline), with statistically significant improvement continuing at 6 months. Mean serum hemoglobin was significantly increased at both 3 and 6 months (12.8 g/dL [N = 44] and 12.4 g/dL [N = 54], respectively).
IDA patients attending routine clinical practice reported substantial levels of fatigue and impairments in physical function and global health prior to intravenous iron treatment. Patients experienced significant improvements in fatigue symptoms, physical function, and global health at 3 months after treatment with FCM, which were sustained at 6 months.
缺铁性贫血（IDA）是导致疲劳和生活质量受损的常见原因。本研究旨在评估在常规临床护理中，静脉注射羧麦芽糖铁（FCM）补充铁剂对IDA患者的疲劳、身体功能和总体健康状况的影响。
这是一项前瞻性、单臂观察性研究，研究对象为在常规临床护理中接受静脉注射FCM治疗IDA的成年患者。我们使用患者报告结局测量信息系统（PROMIS）工具，在FCM治疗前、治疗后3个月和6个月评估疲劳（PROMIS简表v1.0 13a[FACIT-疲劳量表]）、总体健康状况（PROMIS量表v1.2）和身体功能（PROMIS简表v2.0 4a）。
共纳入152例患者。平均年龄为47.4±16.0岁，82.2%为女性。基线时平均血清血红蛋白为10.2±1.4 g/dL。所有患者在基线时均接受了至少一剂FCM治疗，77.6%的患者接受了两剂治疗疗程。基线时FACIT-疲劳量表的平均评分为61.0±9.0，在FCM治疗后3个月显著改善至50.2±9.5。在治疗3个月时，72.7%、52.8%、41.7%和39.8%的患者在FACIT-疲劳量表、PROMIS总体身体健康、总体心理健康和PROMIS身体功能评分上出现了至少5分的改善（预先定义为具有临床意义）（每次与基线相比的变化p<0.0001），在6个月时仍有统计学意义的持续改善。在3个月和6个月时，平均血清血红蛋白均显著升高（分别为12.8 g/dL[N = 44]和12.4 g/dL[N = 54]）。
在接受静脉补铁治疗前，参与常规临床实践的IDA患者报告了较高水平的疲劳以及身体功能和总体健康方面的损害。在接受FCM治疗3个月后，患者的疲劳症状、身体功能和总体健康状况有显著改善，并在6个月时得以维持。
