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

作　　者：Piyatida Chuengsaman Surapong Narenpitak Suchai Sritippayawan 

机构地区：[1]Banphaeo Dialysis Group,Banphaeo Hospital(Public Organization),Banphaeo 74120,Samutsakhon,Thailand [2]Department of Medicine,Udon Thani Hospital,Udon Thani 41000,Thailand [3]Department of Medicine,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok 10700,Thailand

出　　处：《World Journal of Nephrology》2021年第6期109-121,共13页世界肾病学杂志（英文版）

基　　金：the Ethics Committee,Institute for the Development of Human Research Protections(IHRP),No.IHRP 2365/2556;The Ethics Committee of Udon Thani Hospital,No.8/2559;and Siriraj Institutional Review Board Faculty of Medicine Siriraj Hospital,Mahidol University,No.Si 588/2016.

摘　　要：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 evidencebased 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.

关 键 词：Recombinant human erythropoietin ANEMIA Peritoneal dialysis Chronic kidney disease Epoetin alfa 

分 类 号：R69[医药卫生—泌尿科学]