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促红细胞生成素刺激剂用于规律血液透析的终末期肾病患者贫血管理:卡塔尔的一项前瞻性随机对照研究

Erythropoietin-stimulating agents in the management of anemia of end-stage renal disease patients on regular hemodialysis: a prospective randomized comparative study from Qatar.

作者信息

Al-Ali Fadwa Saqr, El-Sayed Abdelfattah Mohamed, Fawzy Ashraf Ahmed, Hamdy Ahmed Farouk, Abdulla Aisha Elsayed

机构信息

Nephrology Division, Hamad General Hospital, Doha, Qatar.

出版信息

Hemodial Int. 2015 Jan;19(1):33-43. doi: 10.1111/hdi.12181. Epub 2014 Jun 3.

DOI:10.1111/hdi.12181
PMID:24894344
Abstract

Despite extensive use, to the best of our knowledge, no trial has simultaneously compared the three currently used erythropoietin-stimulating agents (ESAs) in a prospective manner in the treatment of anemia of end-stage renal disease patients. All hemodialysis patients in Qatar who were treated with short-acting epoetin alfa or beta have been screened. Eligible patients had been prospectively randomized, either to continue on the previous regimen of epoetin or to receive darbepoetin alfa or continuous erythropoietin receptor activator (CERA) for a total period of 40 weeks. All groups were assessed at the end of the study for safety and efficacy parameters. A total of 327 eligible patients were randomized. Mean hemoglobin concentration remained constant within the recommended target range (11-12 g/dL) throughout the study in the three studied groups. The percentage of patients who reached the target range was constantly above 50% in the second half of the study among CERA group patients who also had significantly lower mean number of dose adjustments as compared with the other two groups (P = 0.001). Similarly, the number of discontinuations of ESA among epoetin, darbepoetin, and CERA groups was 17, 19, and 9, respectively (P = 0.042). The frequencies of adverse events were similar in all groups. This study has specifically compared the effect of ESA type on the variability of serum hemoglobin levels in hemodialysis patients. Furthermore, it confirmed the efficacy and safety of once monthly CERA for maintaining tight hemoglobin control within recommended target ranges.

摘要

尽管促红细胞生成素刺激剂(ESAs)已被广泛使用,但据我们所知,尚无试验以前瞻性方式同时比较目前使用的三种促红细胞生成素刺激剂在治疗终末期肾病患者贫血方面的效果。卡塔尔所有接受短效促红细胞生成素α或β治疗的血液透析患者均已接受筛查。符合条件的患者被前瞻性随机分组,要么继续使用之前的促红细胞生成素治疗方案,要么接受达贝泊汀α或持续促红细胞生成素受体激活剂(CERA)治疗,为期40周。在研究结束时对所有组的安全性和有效性参数进行评估。共有327名符合条件的患者被随机分组。在整个研究过程中,三个研究组的平均血红蛋白浓度在推荐的目标范围内(11 - 12 g/dL)保持恒定。在研究后半期,CERA组中达到目标范围的患者百分比始终高于50%,该组患者的平均剂量调整次数也明显低于其他两组(P = 0.001)。同样,促红细胞生成素组、达贝泊汀组和CERA组中促红细胞生成素刺激剂停药的患者人数分别为17、19和9人(P = 0.042)。所有组中不良事件的发生率相似。本研究特别比较了促红细胞生成素刺激剂类型对血液透析患者血清血红蛋白水平变异性的影响。此外,它证实了每月一次使用CERA在将血红蛋白严格控制在推荐目标范围内的有效性和安全性。

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