从阿法达贝泊汀转换为聚乙二醇化β-促红细胞生成素的血液透析患者的剂量转换率：确认研究。

Dose conversion ratio in hemodialysis patients switched from darbepoetin alfa to PEG-epoetin beta: AFFIRM study.

作者信息

Choi Peter, Farouk Mourad, Manamley Nick, Addison Janet

机构信息

Department of Nephrology, John Hunter Hospital, Lookout Road, New Lambton Heights, NSW, 2305, Australia,

出版信息

Adv Ther. 2013 Nov;30(11):1007-17. doi: 10.1007/s12325-013-0063-y. Epub 2013 Oct 31.

DOI:10.1007/s12325-013-0063-y

PMID:24173670

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3898130/

Abstract

INTRODUCTION

There is limited information published on switching erythropoiesis-stimulating agent (ESA) treatment for anemia associated with chronic kidney disease (CKD) from darbepoetin alfa (DA) to methoxy polyethylene glycol-epoetin beta (PEG-Epo) outside the protocol of interventional clinical studies. AFFIRM (Aranesp Efficiency Relative to Mircera) was a retrospective, multi-site, observational study designed to estimate the population mean maintenance dose conversion ratio [DCR; dose ratio achieving comparable hemoglobin level (Hb) between two evaluation periods] in European hemodialysis patients whose treatment was switched from DA to PEG-Epo.

METHODS

Eligible patients had received hemodialysis for ≥ 12 months and DA for ≥ 7 months. Data were collected from 7 months before until 7 months after switching treatment. DCR was calculated for patients with Hb and ESA data available in both evaluation periods (EP; Months 1 and 2 were defined as the pre-switch EP, and Months 6 and 7 as the post-switch EP). Red blood cell transfusions pre- and post-switch were quantified.

RESULTS

Of 302 patients enrolled, 206 had data available for DCR analysis. The geometric mean DCR was 1.17 (95% CI 1.05, 1.29). Regression analysis indicated a non-linear relationship between pre- and post-switch ESA doses; DCR decreased with increasing pre-switch DA dose. The geometric mean weekly ESA doses were 24.1 μg DA in the pre-switch EP and 28.6 μg PEG-Epo in the post-switch EP. Mean Hb was 11.5 g/dL in the pre-switch EP and 11.4 g/dL in the post-switch EP. There were 16 transfusions and 34 units transfused in the pre-switch period, versus 48 transfusions and 95 units transfused post-switch. Excluding patients receiving a transfusion within 90 days of or during either EP, the DCR was 1.21 (95% CI 1.09, 1.35).

CONCLUSION

In these hemodialysis patients switched from DA to PEG-Epo the DCR was 1.17 and 1.21 after accounting for the effect of transfusions. The number of transfusions and units transfused increased approximately threefold from the pre-switch to the post-switch period.

摘要

引言

在干预性临床研究方案之外，关于将促红细胞生成素刺激剂（ESA）治疗从达比加群酯（DA）转换为甲氧基聚乙二醇促红细胞生成素β（PEG-Epo）用于治疗慢性肾脏病（CKD）相关贫血的信息有限。AFFIRM（阿法达贝泊汀相对于米内网的疗效）是一项回顾性、多中心观察性研究，旨在估计欧洲血液透析患者从DA转换为PEG-Epo治疗时的总体平均维持剂量转换率[DCR；两个评估期内达到可比血红蛋白水平（Hb）的剂量比]。

方法

符合条件的患者接受血液透析≥12个月且接受DA治疗≥7个月。收集从转换治疗前7个月到转换治疗后7个月的数据。对两个评估期（EP；第1个月和第2个月定义为转换前EP，第6个月和第7个月定义为转换后EP）均有Hb和ESA数据的患者计算DCR。对转换前后的红细胞输注量进行量化。

结果

在纳入的302例患者中，206例有可用数据进行DCR分析。几何平均DCR为1.17（95%CI 1.05，1.29）。回归分析表明转换前后ESA剂量之间存在非线性关系；DCR随转换前DA剂量增加而降低。转换前EP中每周ESA平均剂量为24.1μg DA，转换后EP中为28.6μg PEG-Epo。转换前EP中平均Hb为11.5g/dL，转换后EP中为11.4g/dL。转换前有16次输血，输注34单位，转换后有48次输血，输注95单位。排除在任何一个EP期间或转换前90天内接受输血的患者后，DCR为1.21（95%CI 1.09，1.35）。