Dialysezentrum Karlstrasse, Düsseldorf, Germany.
Int J Clin Pract. 2011 Jan;65(1):64-72. doi: 10.1111/j.1742-1241.2010.02551.x. Epub 2010 Nov 22.
To analyse the impact of dosing decisions for continuous erythropoietin receptor activator (C.E.R.A.), a continuous erythropoietin receptor activator.
This was a prospective, multicentre, single-arm study in haemodialysis patients receiving epoetin alfa/beta or darbepoetin alfa. After a 2-month screening phase, patients were converted to monthly C.E.R.A. using pre-filled syringes during a 5-month titration phase and a 2-month evaluation phase.
Four hundred and twenty-four eligible patients were converted to C.E.R.A. Mean Hb were 11.7 ± 0.7, 11.7 ± 0.8 and 11.5 ± 0.8 g/dl during screening, titration and evaluation, respectively. C.E.R.A. starting dose was 125 μg (n = 311) or 200 μg (n = 106), with corresponding final doses of 129 ± 61 μg and 203 ± 58 μg. The mean number of C.E.R.A. dose decreases and increases were 0.9 ± 1.0 and 1.1 ± 1.0 per patient, respectively. Hb rarely exceeded 12.5 g/dl after a C.E.R.A. dose increase (< 8%) and remained ≥ 11 g/dl after a dose reduction on approximately three-quarters of occasions. Among the 53 occasions where Hb decreased ≥ 2 g/dl between two consecutive visits, the previous dose had been withheld (n = 9), concomitant blood loss, coagulopathy or infection was present (n = 13), or iron parameters were low (n = 17). There were 104 adverse events/month during screening, and 45/month during the titration/evaluation phases. Serious adverse events occurred in 18.0 and 21.0 patients/month during the screening and titration/evaluation phases, respectively.
Switching haemodialysis patients from shorter-acting ESA to once-monthly C.E.R.A. using pre-filled syringes is straightforward, and Hb levels remain stable. Starting dose recommendations and dose changes correlated well with the clinical setting. Collateral factors such as infection or aggravating concomitant medical conditions should be taken into account.
分析连续红细胞生成素受体激活剂（C.E.R.A.）给药决策的影响，C.E.R.A. 是一种连续红细胞生成素受体激活剂。
这是一项在接受促红细胞生成素阿尔法/贝塔或达贝泊汀阿尔法治疗的血液透析患者中进行的前瞻性、多中心、单臂研究。在为期 2 个月的筛选阶段后，患者在为期 5 个月的滴定阶段和 2 个月的评估阶段期间使用预充式注射器转换为每月一次的 C.E.R.A.。
424 名符合条件的患者转换为 C.E.R.A. 平均血红蛋白分别为筛选期 11.7 ± 0.7、11.7 ± 0.8 和 11.5 ± 0.8 g/dl。C.E.R.A. 起始剂量为 125 μg（n = 311）或 200 μg（n = 106），相应的最终剂量为 129 ± 61 μg 和 203 ± 58 μg。每位患者的 C.E.R.A. 剂量减少和增加的平均次数分别为 0.9 ± 1.0 和 1.1 ± 1.0。C.E.R.A. 剂量增加后（<8%）血红蛋白很少超过 12.5 g/dl，而大约四分之三的情况下剂量减少后血红蛋白仍保持≥11 g/dl。在两次连续就诊之间血红蛋白下降≥2 g/dl 的 53 次就诊中，前一次剂量被暂停（n = 9），同时存在失血、凝血障碍或感染（n = 13），或铁参数较低（n = 17）。筛选期每月有 104 次不良事件，滴定/评估期每月有 45 次。筛选期和滴定/评估期每月各有 18.0 和 21.0 名患者发生严重不良事件。
使用预充式注射器将血液透析患者从作用时间较短的 ESA 转换为每月一次的 C.E.R.A. 非常简单，并且血红蛋白水平保持稳定。起始剂量建议和剂量变化与临床情况密切相关。应考虑感染或加重并存疾病等相关因素。
