Sánchez-Fructuoso A, Guirado L, Ruiz J C, Torregrosa V, González E, Suárez M L, Gallego R
Department of Nephrology, Hospital Clínico San Carlos, Madrid, Spain.
Transplant Proc. 2010 Oct;42(8):2931-4. doi: 10.1016/j.transproceed.2010.09.012.
Kidney transplant, the gold standard treatment for chronic kidney disease (CKD), is increasingly complicated by anemia. Once-monthly dosing of methoxy polyethylene glycol-epoetin beta provides stable, sustained hemoglobin levels in CKD patients. The present study evaluated anemia control in recipients treated with methoxy polyethylene glycol-epoetin beta to correct or as conversion treatment from other erythropoiesis-stimulating agents (ESAs).
This observational, retrospective study included kidney transplant patients treated with methoxy polyethylene glycol-epoetin beta according to investigators' clinical practice. Information about demographics, CKD, anemia, blood analyses, treatment, and adverse events were collected from patients' medical charts at baseline as well as months 1, 3, and 6.
From October 2009 to March 2010, the 285 patients in the study included: an overall mean age of 52.8±13.9 years with 146 females (51.2%) and 152 patients (55.1%) in stage 3 CKD. Forty-five patients (15.8%) were in the immediate posttransplant period; 51, naïve- treatment (17.9%) and 189, converted subjects (66.3%). Eighty-two of the converted patients (48.0%) had previously received darbepoietin; 81 (47.4%), epoetin beta; and 8 (4.7%), epoetin alfa. The mean doses of methoxy polyethylene glycol-epoetin beta at baseline were 75.0±22.4 μg per month, 95.8±45.5 μg per month, and 118.9±58.9 μg per month among naïve, converted, and immediate posttransplant patients, respectively. Mean hemoglobin content varied from baseline to month 6, namely 10.2±0.7 versus 11.8±0.9 g/dL in naïve (P<.001) and 11.4±1.3 versus 12.0±1.2 g/dL in converted patients (P=.001). Patients in the immediate posttransplant period showed mean hemoglobin values maintained between 10.4±1.7 g/dL at baseline and 11.5±1.2 g/dL at month 3. The only study-drug-related adverse event was hypertension. No patient died during the study.
These preliminary results suggested that hemoglobin stability can be achieved and maintained after correction or conversion to once-monthly methoxy polyethylene glycol-epoetin beta in kidney recipients. It was well tolerated; the safety profile was that expected and comparable with shorter acting ESAs.
肾移植作为慢性肾脏病（CKD）的金标准治疗方法，越来越多地受到贫血问题的困扰。每月一次注射甲氧基聚乙二醇 - 促红细胞生成素β可为CKD患者提供稳定、持续的血红蛋白水平。本研究评估了接受甲氧基聚乙二醇 - 促红细胞生成素β治疗以纠正贫血或从其他促红细胞生成剂（ESA）转换治疗的肾移植受者的贫血控制情况。
这项观察性、回顾性研究纳入了根据研究者临床实践接受甲氧基聚乙二醇 - 促红细胞生成素β治疗的肾移植患者。在基线以及第1、3和6个月时，从患者病历中收集了有关人口统计学、CKD、贫血、血液分析、治疗及不良事件的信息。
2009年10月至2010年3月，研究中的285例患者包括：总体平均年龄为52.8±13.9岁，其中146例为女性（51.2%），152例患者（55.1%）处于CKD 3期。45例患者（15.8%）处于移植后即刻阶段；51例为初治患者（17.9%），189例为转换治疗患者（66.3%）。转换治疗的患者中，82例（48.0%）之前接受过达贝泊汀；81例（47.4%）接受过促红细胞生成素β；8例（4.7%）接受过促红细胞生成素α。初治患者、转换治疗患者及移植后即刻患者在基线时甲氧基聚乙二醇 - 促红细胞生成素β的平均剂量分别为每月75.0±22.4μg、95.8±45.5μg和118.9±58.9μg。从基线到第6个月，平均血红蛋白含量有所变化，初治患者中为10.2±0.7与11.8±0.9g/dL（P<0.001），转换治疗患者中为11.4±1.3与12.0±1.2g/dL（P = 0.001）。移植后即刻阶段的患者，其血红蛋白平均值在基线时为10.4±1.7g/dL，在第3个月时为11.5±1.2g/dL。唯一与研究药物相关的不良事件是高血压。研究期间无患者死亡。
这些初步结果表明，肾移植受者在纠正贫血或转换为每月一次的甲氧基聚乙二醇 - 促红细胞生成素β治疗后，血红蛋白稳定性可以实现并维持。该药物耐受性良好；安全性符合预期，与短效ESA相当。
