每月皮下给药甲氧基-聚乙二醇epoetin β (Mircera®)对既往接受促红细胞生成素治疗的稳定血液透析患者的疗效

María Dolores Albero Molina, Ramón López-Menchero Martínez, Carlos del Pozo Fernández, Luis Álvarez Fernández, Laura Sánchez Rodríguez
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引用次数: 2

摘要

目的分析每月皮下注射CERA (Mircera®)在维持血液透析(HD)患者血红蛋白(Hb)水平和剂量等效性方面的效果和效率,并与之前每周皮下注射促红细胞生成素治疗进行比较。方法:我们进行了一项为期6个月的前瞻性研究,纳入了30例HD患者,这些患者在前3个月接受稳定剂量的皮下促红细胞生成素治疗,根据官方数据表,每月接受等量的皮下CERA治疗。每月测量Hb、铁蛋白和转铁蛋白饱和指数(TSI),调整CERA剂量使Hb维持在11 - 13 g/dl之间。在开始研究的30名患者中,13名因死亡、移植或可能干扰Hb水平的过程而退出。在完成6个月研究的17例患者中,12例(70.6%)Hb水平稳定,变化幅度为±1 g/dl。Hb、铁蛋白和TSI的平均水平也保持稳定,基线和6个月后的水平没有差异(Hb 11.6±0.6 vs. 11.5±0.9 g/dl)。然而,CERA的平均剂量需要从基线时的160.3±40.6 mg/月增加到6个月后的200.0±95.2 mg/月(ns)。平均剂量变化为27.9±5.9%。每位患者每月平均费用从174.3±85.4欧元(促红细胞生成素)增加到290.1±69.0欧元(基线CERA),最后增加到361.6±169.3欧元(6个月CERA)。结论皮下CERA替代皮下促红细胞生成素使Hb维持在基线水平,但剂量和费用增加。然而,由于样本量小,我们的结果没有统计学意义。
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Eficiencia de la administración mensual subcutánea de metoxi-polietilenglicol epoetina β (Mircera®) en pacientes estables en hemodiálisis previamente tratados con eritropoyetinaEficiencia de la administración sc mensual de MIRCERA en pacientes en HD

Objective

To analyze the effectiveness and efficiency of monthly treatment with subcutaneous CERA (Mircera®) in terms of maintaining previous levels of hemoglobin (Hb) and dose equivalence in patients on hemodialysis (HD) compared with previous treatment with weekly subcutaneous erythropoietin.

Methodology

We conducted a 6-month prospective study that included 30 HD patients with a stable dose of subcutaneous erythropoietin for the previous 3 months, replaced by an equivalent dose of monthly subcutaneous CERA administered according to the official data sheet. Hb, ferritin and the transferrin saturation index (TSI) were measured monthly and the dose of CERA was adjusted to maintain Hb between 11 and 13 g/dl.

Results

Of the 30 patients who began the study, 13 were withdrawn because of death, transplantation or a process that might interfere with the Hb level. Of the 17 patients who completed the 6-month study, 12 (70.6%) had stable Hb levels with minor variations of ± 1 g/dl. Mean levels of Hb, ferritin and TSI also remained stable and no differences were found between levels at baseline and 6 months later (Hb 11.6 ± 0.6 vs. 11.5 ± 0.9 g/dl). However, an increase in the average dose of CERA was required from 160.3 ± 40.6 at baseline to 200.0 ± 95.2 mg/month after 6 months (ns). The mean change in dose was an increment of 27.9 ± 5.9%. The average monthly cost per patient increased from 174.3 ± 85.4 € (erythropoietin) to 290.1 ± 69.0 € (baseline CERA) and finally to 361.6 ± 169.3 € (6-month CERA).

Conclusion

Replacement of subcutaneous erythropoietin by subcutaneous CERA maintained Hb within baseline levels but with an increased dose and cost. However, because of the small sample size, our results were not statistically significant.

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