Charmila Ayyavoo, Natarajan Suma, Chitra Thevoor Venkatesan, Pawar Nivedita, Kinjawadekar Sucheta, Firke Yogini, Murugesan Umaiyal, Yadav Poonam, Ohri Neelam, Modgil Vidhu, Rodge Ajinkya, Swami Onkar C
Obstetrics and Gynecology, Aditi Hospital, Tiruchirappalli, Tamil Nadu, India.
Obstetrics and Gynecology, Ganga Medical Centre & Hospitals, Coimbatore, Tamil Nadu, India.
J Blood Med. 2022 Jun 8;13:303-313. doi: 10.2147/JBM.S361210. eCollection 2022.
Parenteral iron preparations, like ferric carboxymaltose (FCM), are commonly used to manage moderate-to-severe iron deficiency anemia (IDA). Real-world data on efficacy and safety of FCM is limited in India.
A retrospective, observational and real-world study was conducted to assess the efficacy and safety of FCM in adolescents and adults with IDA across 269 centers in India. Data was retrieved from medical records of patients who received FCM for management of IDA. Physicians' clinical assessment of efficacy and safety of FCM was also assessed. Data were analyzed for hematological parameters at baseline and at 4 ± 1 week for study population, and for severity of anemia.
In 1800 patients with IDA, intravenous FCM resulted in a significant increase in hemoglobin (Hb) of 2.76 g/dL, serum ferritin of 35.85 µg/L, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (P < 0.001 for all) at 4 ± 1 week as compared to baseline. In subjects with severe IDA, an increase in Hb was of 3.31 g/dL, serum ferritin increased of 35.84 µg/L, RBC count, hematocrit and MCH improved significantly (P < 0.001 for all). In subjects with moderate IDA, Hb (increase of 2.63 g/dL), serum ferritin (increase of 35.92 µg/L), RBC count, hematocrit, MCV, and MCH improved significantly (P < 0.001 for all). In subjects with mild IDA, only the mean Hb values at 4 weeks were significantly higher (P < 0.001; increased by 1.89 g/dL). Physicians rated efficacy of FCM as very good to good in 97.5% of patients. Similarly, safety of FCM was rated very good to good in 97.2% subjects.
FCM efficiently, safely and quickly corrects moderate-to-severe anemia in Indian patients in a short span of 4 weeks. Physicians' positive clinical impression of efficacy and safety supports clinical usage of FCM in real-world scenario.
肠外铁剂，如羧基麦芽糖铁（FCM），常用于治疗中重度缺铁性贫血（IDA）。在印度，关于FCM疗效和安全性的真实世界数据有限。
开展了一项回顾性、观察性的真实世界研究，以评估FCM在印度269个中心的青少年和成人IDA患者中的疗效和安全性。数据取自接受FCM治疗IDA患者的病历。还评估了医生对FCM疗效和安全性的临床评估。分析了研究人群基线时和4±1周时的血液学参数以及贫血严重程度的数据。
在1800例IDA患者中，与基线相比，静脉注射FCM在4±1周时使血红蛋白（Hb）显著增加2.76 g/dL，血清铁蛋白增加35.85 μg/L，红细胞（RBC）计数、血细胞比容、平均红细胞体积（MCV）和平均红细胞血红蛋白含量（MCH）均显著增加（所有P<0.001）。在重度IDA患者中，Hb增加3.31 g/dL，血清铁蛋白增加35.84 μg/L，RBC计数、血细胞比容和MCH显著改善（所有P<0.001）。在中度IDA患者中，Hb（增加2.63 g/dL）、血清铁蛋白（增加35.92 μg/L）、RBC计数、血细胞比容、MCV和MCH显著改善（所有P<0.001）。在轻度IDA患者中，仅4周时的平均Hb值显著更高（P<0.001；增加1.89 g/dL）。97.5%的患者中医生将FCM的疗效评为非常好至良好。同样，97.2%的受试者将FCM的安全性评为非常好至良好。
FCM在短短4周内有效、安全且迅速地纠正了印度患者的中重度贫血。医生对疗效和安全性的积极临床印象支持FCM在真实临床场景中的应用。
