重组人促红细胞生成素(Hema-Plus®)治疗泰国腹膜透析患者贫血的疗效和安全性

Piyatida Chuengsaman, Surapong Narenpitak, Suchai Sritippayawan
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引用次数: 6

摘要

背景:Hema-Plus是一种重组人促红细胞生成素(rHuEPO)或促红细胞生成素α (epoetin alfa),在泰国人群的临床实践中显示出纠正贫血的有效性。本研究旨在证明循证方法下的有效性和安全性。目的:评价rHuEPO (Hema-Plus)治疗泰国V期慢性肾病(CKD)腹膜透析(PD)患者12周以上贫血的疗效和安全性。方法:本研究是一项开放标签、多中心的研究,纳入30例CKD患者,确定为开始PD时血红蛋白(Hb)小于9.5 g/dL,血清铁蛋白大于100 ng/mL,血清转铁蛋白饱和度大于或等于20%,之前未接受过生成素治疗。排除了可能增加研究参与不良反应风险或干扰研究结果的患者,同时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通过每周一次或两次4000 IU的SC注射Hema-Plus(第0周),并在第2、4、8和12周进行随访。调整剂量可使血红蛋白水平达到11-12 g/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。在整个研究过程中对安全性进行了评估。生活质量(QoL)采用KDQOL-36进行评估。结果:所有30例入组患者均完成了研究。基线(第0周)至12周结束时的平均(标准差)Hb从7.39 (1.29)g/dL显著增加到11.15 (1.73)g/dL(配对t检验,P值< 0.001)。在其他4次就诊中,Hb平均值从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例不良事件中有10例为严重不良事件。据研究者评估,两例严重ae可能与研究用药有关。在第12周,各领域的生活质量评分较基线显著提高。结论:Hema-Plus治疗PD患者贫血12周,有效提高血红蛋白水平,安全性可接受。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Efficacy and safety of recombinant human erythropoietin (Hema-Plus<sup>®</sup>) for management of anemia in Thai patients on peritoneal dialysis.

Efficacy and safety of recombinant human erythropoietin (Hema-Plus<sup>®</sup>) for management of anemia in Thai patients on peritoneal dialysis.

Efficacy and safety of recombinant human erythropoietin (Hema-Plus<sup>®</sup>) for management of anemia in Thai patients on peritoneal dialysis.

Efficacy and safety of recombinant human erythropoietin (Hema-Plus®) for management of anemia in Thai patients on peritoneal dialysis.

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 t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P 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.

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