Department of Pediatric Nephrology, School of Medicine, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.
Clin Exp Nephrol. 2013 Aug;17(4):582-8. doi: 10.1007/s10157-012-0714-3. Epub 2012 Oct 23.
Darbepoetin alfa (DA) is an attractive alternative to recombinant human erythropoietin (rHuEPO) in managing renal anemia. Since DA has not been approved by the appropriate Japanese drug regulatory agencies for the indication of renal anemia in children in Japan, we have conducted a multicenter prospective study to determine the efficacy and safety of DA in Japanese children undergoing peritoneal dialysis (PD).
Pediatric patients subcutaneously receiving rHuEPO were switched to DA treatment for a period of 28 weeks. The conversion to the initial dose of DA was calculated as 1 μg DA for 200 IU rHuEPO, and DA was administered intravenously once every 2 weeks. The target hemoglobin (Hb) concentration was defined as 11.0 to ≤13.0 g/dL. In some patients, the dose of DA was adjusted appropriately to achieve this target level, and/or the dosing frequency changed to once every 4 weeks.
In the 25 patients switched from rHuEPO to DA the mean Hb concentration increased from 9.9 ± 1.0 to 11.1 ± 1.0 g/dL at 8 weeks following commencement of the DA treatment. The target Hb concentration was achieved in 88 % of these patients, and 60 % maintained this target value on completion of the study. The dosing frequency was extended to once every 4 weeks in 60 % of patients. Twenty-four adverse events were noted in 11 of 25 patients (44 %); however, there was no causality between DA and adverse events.
The results of this study suggest that intravenous administration of DA once every 2 or 4 weeks is an effective and safe treatment for renal anemia in Japanese children undergoing PD.
达贝泊汀 α（DA）是一种有吸引力的替代物，可用于治疗肾性贫血的重组人红细胞生成素（rHuEPO）。由于 DA 尚未获得日本适当的药品监管机构批准用于日本儿童的肾性贫血适应症，我们进行了一项多中心前瞻性研究，以确定 DA 在日本接受腹膜透析（PD）的儿童中的疗效和安全性。
接受 rHuEPO 皮下治疗的儿科患者转换为 DA 治疗 28 周。DA 的初始剂量转换计算为 200IU rHuEPO 对应 1μg DA，每 2 周静脉注射一次。目标血红蛋白（Hb）浓度定义为 11.0 至≤13.0g/dL。在一些患者中，适当调整 DA 剂量以达到该目标水平，并/或改变给药频率为每 4 周一次。
在 25 例从 rHuEPO 转换为 DA 的患者中，DA 治疗开始后 8 周，平均 Hb 浓度从 9.9±1.0g/dL 增加至 11.1±1.0g/dL。这些患者中有 88%达到了目标 Hb 浓度，60%在研究结束时维持了该目标值。60%的患者给药频率延长至每 4 周一次。在 25 例患者中的 11 例（44%）中观察到 24 例不良事件；然而，DA 与不良事件之间无因果关系。
本研究结果表明，静脉注射 DA 每 2 或 4 周一次是治疗日本 PD 儿童肾性贫血的一种有效且安全的治疗方法。
