重组人促红细胞生成素（血宝素）用于泰国腹膜透析患者贫血治疗的疗效及安全性
Efficacy and safety of recombinant human erythropoietin (Hema-Plus) for management of anemia in Thai patients on peritoneal dialysis.
作者信息
Chuengsaman Piyatida, Narenpitak Surapong, Sritippayawan Suchai
机构信息
Banphaeo Dialysis Group, Banphaeo Hospital (Public Organization), Banphaeo 74120, Samutsakhon, Thailand.
Department of Medicine, Udon Thani Hospital, Udon Thani 41000, Thailand.
出版信息
World J Nephrol. 2021 Nov 25;10(6):109-121. doi: 10.5527/wjn.v10.i6.109.
BACKGROUND
Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach.
AIM
To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD).
METHODS
This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36.
RESULTS
All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired -test, value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators' assessment. At week 12, the QoL scores in all domains were significantly increased from baseline.
CONCLUSION
Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.
背景
Hema-Plus，一种重组人促红细胞生成素（rHuEPO）或阿法依泊汀，在临床实践中已显示出对泰国人群贫血的纠正效果。本研究旨在基于循证医学方法证明其有效性和安全性。
目的
评估rHuEPO（Hema-Plus）对接受腹膜透析（PD）的V期慢性肾脏病（CKD）泰国患者治疗12周以上贫血的有效性和安全性。
方法
本研究是一项开放标签、多中心研究，纳入30例开始PD且血红蛋白（Hb）低于9.5g/dL、血清铁蛋白高于100ng/mL、血清转铁蛋白饱和度大于或等于20%且既往未接受过依泊汀治疗的CKD患者。排除有可能增加研究参与不良反应风险或干扰研究结果的情况、正在使用雄激素或患有继发性甲状旁腺功能亢进的患者。所有符合条件的患者在第0周开始通过皮下注射Hema-Plus，4000IU，每周一次或两次，并在第2、4、8和12周进行随访。可进行剂量调整以达到Hb水平为11 - 12g/dL。主要终点是从基线到治疗结束（第12周）Hb水平的平均变化。在整个研究过程中评估安全性。使用KDQOL-36评估生活质量（QoL）。
结果
所有30例纳入患者均完成研究。从基线（第0周）到12周结束时，平均（标准差）Hb从7.39（1.29）g/dL显著增加至11.15（1.73）g/dL（配对t检验，P值<0.001）。在其他4次访视中，Hb均值相对于基线的总体变化在统计学上显著增加（重复测量方差分析，P值<0.001）。39例不良事件（AE）中有10例为严重不良事件。根据研究者评估，2例严重不良事件可能与研究用药有关。在第12周时，所有领域的QoL评分均较基线显著增加。
结论
对接受PD的患者使用Hema-Plus治疗12周以纠正贫血可有效提高Hb水平，且安全性可接受。
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