Lonnemann G, Wrenger E
Private Outpatient Clinic and Dialysis Centre, Langenhagen, Germany.
Clin Nephrol. 2011 Jan;75(1):59-62.
An observational clinical study was performed to test the efficiency of the biosimilar product epoetin zeta to maintain stable hemoglobin levels in end-stage renal disease (ESRD) patients on intermittent high-flux hemodialysis.
Before the start of the study, 17 out of 18 patients were on various erythropoiesis-stimulating agents (ESA). After a run-in period of 2 months, all patients switched to epoetin zeta and were followed for 6 months. The initial weekly doses as well as the frequency of application per week were kept constant. To convert patients on darbepoetin (n = 12) to epoetin zeta, a factor of 1 : 200 was used. During the follow-up, hemoglobin levels, iron status, dialysis efficiency, body weight, and adverse events were monitored at least once a month.
Comparing time 0 (before the start of epoetin zeta) with the end of the study (6 months of epoetin zeta), no significant changes were observed: Hemoglobin 11.72 ± 0.64 g/dl versus 11.62 ± 0.70 g/dl (p = 0.64); weekly dose of ESA: 79.4 ± 57.7 IU/kg/week at start versus 91.8 ± 65.4 IU/kg/week at the end (p = 0.55). It is noteworthy that the frequency of application could be reduced to once a week or less with epoetin zeta in 66% of the 18 patients. After 6 months of epoetin zeta, 10 patients received 1 dose/week, and 2 patients received only 1 dose every 2 weeks. There were no significant changes in mean blood pressure, body weight and hemodialysis efficiency comparing the end with the start of the observation. No side effects attributable to the ESA-therapy have been observed.
The biosimilar product epoetin zeta is safe in clinical practice and is effective and stable in the weekly dose as well as in the frequency of application. Biosimilars offer a welcome opportunity to reduce treatment costs of renal anemia.
进行一项观察性临床研究，以测试生物类似药促红细胞生成素ζ在接受间歇性高通量血液透析的终末期肾病（ESRD）患者中维持稳定血红蛋白水平的有效性。
在研究开始前，18名患者中有17名正在使用各种促红细胞生成素（ESA）。经过2个月的导入期后，所有患者改用促红细胞生成素ζ，并随访6个月。初始每周剂量以及每周的应用频率保持不变。将使用达贝泊汀（n = 12）的患者转换为促红细胞生成素ζ时，使用的转换系数为1:200。在随访期间，每月至少监测一次血红蛋白水平、铁状态、透析效率、体重和不良事件。
将时间0（促红细胞生成素ζ开始使用前）与研究结束时（促红细胞生成素ζ使用6个月后）进行比较，未观察到显著变化：血红蛋白水平分别为11.72±0.64 g/dl和11.62±0.70 g/dl（p = 0.64）；ESA的每周剂量：开始时为79.4±57.7 IU/kg/周，结束时为91.8±65.4 IU/kg/周（p = 0.55）。值得注意的是，在18名患者中的66%中，使用促红细胞生成素ζ后应用频率可降至每周一次或更低。使用促红细胞生成素ζ 6个月后，10名患者每周接受1次剂量，2名患者每2周仅接受1次剂量。观察结束时与开始时相比，平均血压、体重和血液透析效率无显著变化。未观察到归因于ESA治疗的副作用。
生物类似药促红细胞生成素ζ在临床实践中是安全的，在每周剂量和应用频率方面均有效且稳定。生物类似药为降低肾性贫血的治疗成本提供了一个受欢迎的机会。
