Bajo M A, Pérez Fontán M, Remón C, Sánchez-Tomero J A, Lladós F, Selgas R
Servicio de Nefrología, Hospital La Paz, Madrid, Spain.
Nefrologia. 2009;29(2):136-42. doi: 10.3265/Nefrologia.2009.29.2.4869.en.full.
Less frequent dosing regimens during anemia treatment could benefit Peritoneal Dialysis (PD) patients. We investigated the effectiveness of darbepoetin alfa dosed every-other-week (Q2W) for maintaining hemoglobin (Hb) levels (11-13 g/dL).
One hundred and nine PD patients from 14 centers participated in an 8-month observational, prospective study. Patients (Hb 11-13 g/dL) receiving weekly (QW) darbepoetin alfa switched to Q2W dosing at the investigator's discretion. Doses were adjusted according to published guidelines.
Sixty-nine percent (75 out of 109) of patients switched to Q2W dosing. Thirty-three percent maintained the g/week, equivalent to twice the previous mean weekly dose (26.1-25.8 g/week, QW dose). Forty-seven percent received a dose reduction (35.8-20.2 equivalent to the previous QW dose). More patients in the maintenance dose group 11 g/dL than those receiving a reduced weekly dose (80% vs. had Hb levels 51.4%, respectively, p = 0.0236). During the Q2W phase, the mean Hb level ranged from 12.0-12.5 g/dL for the maintenance dose group and 11.5-12.0 g/dL for the reduced dose group. From the switch to the end of the study, the mean (SD) change in Hb was -0.7 g/dL (0.98 g/dL, p = 0.0557) and -0.6 g/dL (1.6 g/dL, p = 0.1296) for the maintenance and reduced dose groups, respectively. The Q2W darbepoetin alfa was well tolerated. Only a single treatment-related adverse event (polycythemia) occurred.
The majority of PD patients receiving QW darbepoetin alfa can be effectively switched to Q2W and still maintain their Hb level.
摘要 背景:在贫血治疗期间采用较低频率的给药方案可能会使腹膜透析(PD)患者受益。我们研究了每两周(Q2W)给药一次的阿法达贝泊汀维持血红蛋白(Hb)水平(11 - 13 g/dL)的有效性。
来自14个中心的109例PD患者参与了一项为期8个月的观察性前瞻性研究。接受每周(QW)阿法达贝泊汀治疗的患者(Hb 11 - 13 g/dL)由研究者酌情决定改为Q2W给药。剂量根据已发表的指南进行调整。
69%(109例中的75例)的患者改为Q2W给药。33%的患者维持每周剂量,相当于之前平均每周剂量的两倍(26.1 - 25.8 μg/周,QW剂量)。47%的患者接受了剂量减少(35.8 - 20.2 μg,相当于之前的QW剂量)。维持剂量组中Hb水平≥11 g/dL的患者比接受每周剂量减少的患者更多(分别为80%和51.4%,p = 0.0236)。在Q2W阶段,维持剂量组的平均Hb水平在12.0 - 12.5 g/dL之间,减少剂量组在11.5 - 12.0 g/dL之间。从换药至研究结束,维持剂量组和减少剂量组Hb的平均(标准差)变化分别为 - 0.7 g/dL(0.98 g/dL,p = 0.0557)和 - 0.6 g/dL(1.6 g/dL,p = 0.1296)。Q2W阿法达贝泊汀耐受性良好。仅发生了1例与治疗相关的不良事件(红细胞增多症)。
大多数接受QW阿法达贝泊汀治疗的PD患者可以有效地改为Q2W给药,并且仍能维持其Hb水平。