Otsuka Tomoyuki, Sakai Yukinao, Yui Shizuka, Sukegawa Masami, Suzuki Anna, Mugishima Koji, Sumi Yuichiro, Otsuka Yusuke, Tsuruoka Shuichi
Department of Nephrology, Nippon Medical School Musashi Kosugi Hospital.
J Nippon Med Sch. 2015;82(1):21-6. doi: 10.1272/jnms.82.21.
BACKGROUND: Sustained erythropoiesis-stimulating agents (ESAs) have recently been identified as the standard therapeutic agent for anemia in patients undergoing peritoneal dialysis (PD). However, few reports have compared pain between various types of sustained ESAs or between administration routes. Furthermore, the change ratio of the dose of sustained ESAs reportedly ranges from 0.8 to 1.3. In the present study, to compare darbepoetin alfa and epoetin beta pegol (a continuous erythropoietin receptor activator [CERA]), we examined the dolorific differences between administration routes and the effect on anemia by using a chjange ratio of 0.8 with darbepoetin alfa in patients with renal anemia undergoing PD. SUBJECTS AND METHOD: We randomly assigned 20 patients with stable hemoglobin levels undergoing PD to either a darbepoetin alfa therapy group or a CERA therapy group. Based on a previous report, the change ratio of the CERA group from CERA to darbepoetin alfa therapy was assumed to be 0.8, and therapy was crossed-over to darbepoetin alfa again 2 months later. The dolorific evaluation (pain measurement) used both a face scale and a visual analogue scale. We compared the agents as well as administration routes with respect to pain. We also measured variables related to anemia and iron metabolism. RESULTS: The change ratio of the CERA group at the start of the study was 0.821. On resumption of darbepoetin alfa therapy 2 months later, the doses of darbepoetin alfa increased. The darbepoetin alfa group showed a stronger tendency for pain, although the difference was not significant. In contrast, subcutaneous administration in the CERA group showed significant pain just after injection. The CERA group, however, showed a significant decrease in hemoglobin levels after 2 months of treatment (p=0.0489). No significant change was found in the hematocrit or the reticulocyte count. There were no significant differences in iron metabolism, as shown by serum iron levels and total iron-binding capacity, in either group. However, serum ferritin levels showed a tendency to decrease in the darbepoetin alfa group. CONCLUSION: No significant difference in pain was found between darbepoetin alfa and CERA therapies, but a significant difference in pain was noted between administration routes, just after injection, in the CERA group. The results also suggest that a change ratio of 0.8 from darbepoetin alfa to CERA is low for managing anemia.
背景：促红细胞生成素刺激剂（ESAs）已被确定为腹膜透析（PD）患者贫血的标准治疗药物。然而，很少有报告比较不同类型的长效ESAs之间或给药途径之间的疼痛情况。此外，据报道长效ESAs剂量的变化率在0.8至1.3之间。在本研究中，为了比较聚乙二醇化促红细胞生成素β（一种持续促红细胞生成素受体激活剂 [CERA]）和阿法达贝泊汀，我们通过使用阿法达贝泊汀0.8的变化率，研究了PD肾性贫血患者给药途径之间的疼痛差异以及对贫血的影响。 对象与方法：我们将20例血红蛋白水平稳定的PD患者随机分为阿法达贝泊汀治疗组或CERA治疗组。根据之前的一份报告，CERA组从CERA转换为阿法达贝泊汀治疗的变化率假定为0.8，2个月后再次交叉至阿法达贝泊汀治疗。疼痛评估（疼痛测量）使用面部量表和视觉模拟量表。我们比较了药物以及给药途径的疼痛情况。我们还测量了与贫血和铁代谢相关的变量。 结果：研究开始时CERA组的变化率为0.821。2个月后恢复阿法达贝泊汀治疗时，阿法达贝泊汀的剂量增加。阿法达贝泊汀组疼痛倾向更强，尽管差异不显著。相比之下，CERA组皮下注射后立即出现明显疼痛。然而，CERA组治疗2个月后血红蛋白水平显著下降（p = 0.0489）。血细胞比容或网织红细胞计数无显著变化。两组的铁代谢指标，如血清铁水平和总铁结合力，均无显著差异。然而，阿法达贝泊汀组血清铁蛋白水平有下降趋势。 结论：阿法达贝泊汀和CERA治疗之间在疼痛方面未发现显著差异，但CERA组在注射后给药途径之间的疼痛存在显著差异。结果还表明，从阿法达贝泊汀转换为CERA时0.8的变化率对管理贫血来说较低。
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