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2023年7月 第38卷 第7期11
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羧基麦芽糖铁注射液用于非透析慢性肾脏病贫血患者的有效性和安全性:一项真实世界研究

Efficacy and safety of ferric carboxymaltose injection in the treatment of anemia in patients with non-dialysis chronic kidney disease: a real-world study

来源期刊: 广州医药 | - 发布时间: 收稿时间:2026/6/1 20:47:07 阅读量:13
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羧基麦芽糖铁;慢性肾脏病;真实世界研究
ferric carboxymaltose;chronic kidney disease;real-world study
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目的:初步探索羧基麦芽糖铁(FCM)治疗非透析慢性肾脏病(ND-CKD)贫血患者的有效性与安全性,为FCM在我国ND-CKD贫血患者中的临床应用提供参考。方法:本研究为单中心、前瞻性、单臂研究,纳入25例ND-CKD贫血患者,给予FCM 500 mg或1000 mg单次静脉输注,分别于基线和 FCM治疗的1周后、1月后采集患者外周血,检测血红蛋白、血清铁蛋白、转铁蛋白饱和度,同时观察、记录不良事件发生情况。结果:(1)患者经FCM单次输注后,1周后及1月后的血红蛋白、血清铁蛋白、转铁蛋白饱和度均显著升高(P<0.05)。与FCM治疗1周后相比,1月后的血红蛋白显著升高(P<0.05),血清铁蛋白、转铁蛋白饱和度均显著降低(P<0.05)。(2)2例患者发生低磷血症,1例患者出现过敏性皮疹,1例患者出现输注侧上肢酸胀不适。结论:FCM作为新型快速补铁制剂,可有效改善ND-CKD患者的贫血及铁代谢,短期安全性整体可控。
Objective: To preliminarily explore the efficacy and safety of ferric carboxymaltose (FCM) in the treatment of anemia in patients with non-dialysis chronic kidney disease (ND-CKD), and to provide a reference for the clinical application of FCM in Chinese ND-CKD patients with anemia. Methods: This was a single-center, prospective, single-arm study. A total of 25 ND-CKD patients with anemia were enrolled and received a single intravenous infusion of FCM at a dose of 500 mg or 1000 mg. Peripheral blood samples were collected from the patients at baseline, 1 week, and 1 month after FCM treatment to measure hemoglobin, serum ferritin, and transferrin saturation. Meanwhile, adverse events were observed and recorded. Results: (1) After a single infusion of FCM, the levels of hemoglobin, serum ferritin, and transferrin saturation were significantly increased at one week and one month post-treatment (P<0.05). Compared with the values at one week after FCM treatment, hemoglobin levels at one month were significantly higher (P<0.05), while serum ferritin and transferrin saturation levels were significantly lower (P<0.05). (2) Two patients developed hypophosphatemia, one patient experienced an allergic rash, and one patient reported soreness and discomfort in the upper limb on the infusion side. Conclusion: As a novel and rapid iron supplement preparation, FCM can effectively improve anemia and iron metabolism in patients with ND-CKD, with overall manageable short-term safety.
1、四川省医学会肾病(上药国风)专项科研项目(/upload/408084/20260601/20260601204631_0947.pdf)
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