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一项关于每2周为透析患者注射一次阿法达贝泊汀,持续12个月的有效性的观察性研究。

An observational study of the effectiveness of darbepoetin alpha administered in dialysis patients once every 2 weeks for 12 months.

作者信息

Rottembourg J B, Bridges I, Pronai W, Feriani M, McMahon L P, De Meester J M J, Farouk M, Molemans B

机构信息

Centre Suzanne Levy, Diaverum Group, Clinique du Mont Louis, Paris, France.

出版信息

Clin Nephrol. 2011 Mar;75(3):242-50. doi: 10.5414/cn106749.

DOI:10.5414/cn106749
PMID:21329635
Abstract

AIMS

Erythropoiesis-stimulating agents (ESAs) are recommended for managing renal anemia. ALTERNATE is an observational study in European and Australian dialysis patients evaluating darbepoetin a (DA) once every 2 weeks (Q2W) in clinical practice.

METHODS

Adult dialysis patients initiating treatment with DA Q2W were eligible regardless of previous/current ESA use. Data were collected 6 months before and 12 months after Q2W initiation. The primary endpoint was hemoglobin (Hb) concentration 12 months after initiation.

RESULTS

A total of 6,112 patients were enrolled; 6,104 were eligible (87% hemodialysis, 12% peritoneal dialysis). Before initiation, 77.3%, 8.8%, and 7.8% of patients were receiving DA, epoetin beta, and epoetin alpha, respectively; 6% were ESA naïve. Mean (95% CI) Hb (g/dl) was 11.68 (11.63-11.72) 6 months before initiation, 12.00 (11.97-12.04) at initiation, and 11.62 (11.58-11.66) 12 months after initiation. Geometric mean (95% CI) weekly ESA dose (µg/wk) was 27.27 (26.62-27.93) immediately before initiation, 23.69 (23.28 - 24.10) at initiation, and 26.80 (26.12-27.49) 12 months after initiation. At month 12, 77.3% of patients were receiving DA Q2W.

CONCLUSIONS

This large observational study demonstrates that Hb concentrations can be effectively maintained over 12 months in a general dialysis population with DA Q2W without an increase in ESA dose.

摘要

目的

促红细胞生成素(ESAs)被推荐用于治疗肾性贫血。ALTERNATE是一项在欧洲和澳大利亚透析患者中进行的观察性研究,评估临床实践中每2周一次(Q2W)使用的促红细胞生成素α(DA)。

方法

开始每2周一次使用DA治疗的成年透析患者符合条件,无论之前/当前是否使用ESAs。在开始每2周一次治疗前6个月和开始后12个月收集数据。主要终点是开始治疗12个月后的血红蛋白(Hb)浓度。

结果

共纳入6112例患者;6104例符合条件(87%为血液透析,12%为腹膜透析)。开始治疗前,分别有77.3%、8.8%和7.8%的患者接受DA、促红细胞生成素β和促红细胞生成素α治疗;6%未使用过ESAs。开始治疗前6个月,平均(95%CI)Hb(g/dl)为11.68(11.63 - 11.72),开始治疗时为12.00(11.97 - 12.04),开始治疗后第12个月为11.62(11.58 - 11.66)。开始治疗前即刻,几何平均(95%CI)每周ESA剂量(μg/wk)为27.27(26.62 - 27.93),开始治疗时为23.69(23.28 - 24.10),开始治疗后第12个月为26.80(26.12 - 27.49)。在第12个月时,77.3%的患者每2周一次接受DA治疗。

结论

这项大型观察性研究表明,在一般透析人群中,每2周一次使用DA可在12个月内有效维持Hb浓度,且ESA剂量无增加。

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引用本文的文献

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Wien Med Wochenschr. 2014 Mar;164(5-6):109-19. doi: 10.1007/s10354-013-0256-7. Epub 2014 Jan 31.
2
Differentiating factors between erythropoiesis-stimulating agents: an update to selection for anaemia of chronic kidney disease.促红细胞生成素刺激剂的区别因素:更新用于慢性肾脏病贫血的选择。
Drugs. 2013 Feb;73(2):117-30. doi: 10.1007/s40265-012-0002-2.