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羧基麦芽糖铁(FCM)用于治疗慢性肾脏病患者和肾移植受者缺铁性贫血的安全性和耐受性

Safety and tolerability of ferric carboxymaltose (FCM) for treatment of iron deficiency in patients with chronic kidney disease and in kidney transplant recipients.

作者信息

Grimmelt A-C, Cohen C D, Fehr T, Serra A L, Wuethrich R P

机构信息

Clinic for Nephrology, University Hospital, Zürich, Switzerland.

出版信息

Clin Nephrol. 2009 Feb;71(2):125-9. doi: 10.5414/cnp71125.

DOI:10.5414/cnp71125
PMID:19203504
Abstract

BACKGROUND

Iron deficiency is common in patients with chronic kidney disease and in kidney transplant recipients.

PATIENTS AND METHODS

We analyzed the safety and tolerability of the new intravenous iron preparation ferric carboxymaltose (FCM) in these two patient groups. Adverse events after administration of the drug were assessed by using a questionnaire. Vital signs and laboratory data were collected before and after the application of FCM. A total of 46 FCM doses were applied to 44 patients (17 with chronic kidney disease and 27 kidney transplant recipients) either as single injection of 100 or 200 mg (n = 42) or as short infusion with up to 500 mg (n = 4).

RESULTS

Mild and transient adverse events (metallic taste, headache, dizziness) occurred in six patients. The estimated glomerular filtration rate remained unchanged by the FCM administration.

CONCLUSION

We conclude that safety and tolerability of FCM were excellent. Compared with other intravenous iron preparations the considerably shorter administration time of FCM allows to save time and to reduce costs.

摘要

背景

缺铁在慢性肾脏病患者和肾移植受者中很常见。

患者和方法

我们分析了新型静脉铁制剂羧基麦芽糖铁(FCM)在这两组患者中的安全性和耐受性。通过问卷调查评估给药后的不良事件。在应用FCM之前和之后收集生命体征和实验室数据。共对44例患者(17例慢性肾脏病患者和27例肾移植受者)应用了46剂FCM,给药方式为单次注射100或200mg(n = 42)或短时间输注高达500mg(n = 4)。

结果

6例患者出现轻度短暂不良事件(金属味、头痛、头晕)。应用FCM后估计肾小球滤过率保持不变。

结论

我们得出结论,FCM的安全性和耐受性极佳。与其他静脉铁制剂相比,FCM给药时间显著缩短,可节省时间并降低成本。

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