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铁储备充足的血液透析患者从皮下给药转换为静脉给药时不需要更高剂量的促红细胞生成素:意大利促红细胞生成素转换研究(ISEC)的结果。

Iron-replete hemodialysis patients do not require higher EPO dosages when converting from subcutaneous to intravenous administration: results of the Italian Study on Erythropoietin Converting (ISEC).

作者信息

Pizzarelli Francesco, David Salvatore, Sala Patrizio, Icardi Andrea, Casani Aldo

机构信息

Nephrology Unit, SM Annunziata Hospital, Florence, Italy.

出版信息

Am J Kidney Dis. 2006 Jun;47(6):1027-35. doi: 10.1053/j.ajkd.2006.02.176.

Abstract

BACKGROUND

Previous studies reported significant increases in epoetin dosages when converting hemodialysis patients from subcutaneous (SC) to intravenous (IV) administration. More recent studies that corrected for iron deficiency found a much lower, if any, increase in epoetin dosage and/or decrease in hemoglobin (Hb) level after conversion from SC to IV epoetin administration. Therefore, the matter is still open for debate.

METHODS

This multicenter observational study evaluated stable hemodialysis patients without iron deficiency who had a stable SC epoetin dosage and Hb level of 10 g/dL or greater (> or =100 g/L) at the time of study enrollment. Data for epoetin dosage, anemia, and inflammatory markers were collected retrospectively during the last 6 months of SC epoetin treatment and prospectively for 6 months after conversion to IV administration. The primary efficacy assessment was difference in Hb levels and epoetin dosages between patients administered epoetin SC and IV. Changes in values for iron stores, C-reactive protein, intact parathyroid hormone, and albumin were monitored as control parameters.

RESULTS

Data were analyzed for 262 hemodialysis patients from 6 Italian centers. Overall, mean Hb levels were similar with SC and IV epoetin administration (11.49 g/dL [114.9 g/L] and 11.44 g/dL [114.4 g/L]). Mean epoetin dosages also were similar with SC and IV administration (7,185 and 7,270 IU/wk). In patients requiring epoetin dosages of 12,000 IU/wk or greater at study entry, mean dosages tended to decrease after conversion to IV administration. There were no significant changes in control parameters.

CONCLUSION

Conversion from SC to IV epoetin administration did not result in changes in Hb levels or epoetin dosage requirements in iron-replete hemodialysis patients.

摘要

背景

既往研究报道,血液透析患者从皮下(SC)给药转换为静脉(IV)给药时,促红细胞生成素剂量显著增加。最近针对缺铁进行校正的研究发现,从SC促红细胞生成素给药转换为IV给药后,促红细胞生成素剂量增加幅度小得多(若有增加的话),和/或血红蛋白(Hb)水平降低。因此,这一问题仍有待辩论。

方法

这项多中心观察性研究评估了无缺铁的稳定血液透析患者,这些患者在研究入组时SC促红细胞生成素剂量稳定,Hb水平为10 g/dL或更高(≥100 g/L)。在SC促红细胞生成素治疗的最后6个月回顾性收集促红细胞生成素剂量、贫血和炎症标志物数据,并在转换为IV给药后前瞻性收集6个月的数据。主要疗效评估是接受SC和IV促红细胞生成素治疗患者之间Hb水平和促红细胞生成素剂量的差异。监测铁储备、C反应蛋白、全段甲状旁腺激素和白蛋白值的变化作为对照参数。

结果

对来自6个意大利中心的262例血液透析患者的数据进行了分析。总体而言,SC和IV促红细胞生成素给药时的平均Hb水平相似(分别为11.49 g/dL [114.9 g/L]和11.44 g/dL [114.4 g/L])。SC和IV给药时的平均促红细胞生成素剂量也相似(分别为7,185和7,270 IU/周)。在研究入组时需要12,000 IU/周或更高促红细胞生成素剂量的患者中,转换为IV给药后平均剂量有降低趋势。对照参数无显著变化。

结论

在铁储备充足的血液透析患者中,从SC促红细胞生成素给药转换为IV给药不会导致Hb水平或促红细胞生成素剂量需求的变化。

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