To assess the efficacy and the optimum dose of recombinant human erythropoietin (rhEpo) on the anemia of premature, 45 preterm infants with a gestational age of less than 35 weeks and birth weight of less 1 800 g were...To assess the efficacy and the optimum dose of recombinant human erythropoietin (rhEpo) on the anemia of premature, 45 preterm infants with a gestational age of less than 35 weeks and birth weight of less 1 800 g were randomly assigned to treatment group 1 (n = 15, receiving subcutaneous rhEpo 150 U/kg·time), treatment group 2 (n = 15, receiving 250 U/kg·time), three times a week for 6 weeks, and control group (n = 15, no treatment was given). All preterm infants received supplements of vitamin E (20 IU) and iron (20 mg) each day. Our results showed that postnatal decline of hemoglobin (Hb) and hematocrit (Hct) were lessened in the treatment groups, particularly in the group 2 and the differences were very significant (P<0. 0001 for all). Treated infants had significantly higher reticulocyte counts (Ret) (P<0. 000] for all), but there was no significant difference between the two treatment groups (P>0. 05). Serum iron dropped significantly in the treatment groups as compared with control group (P<0. 01 for all), but no dose-dependent relationship was observed in treated infants (P>0. 05). After treatment, serum levels of erythropoietin was higher in group 2 than those in group 1 and control group (P<0. 0001, P<0. 01 and P<0. 05, respectively). There was no significant difference between group 1 and control group (P>0. 05). No side effects related to rhEpo therapy were observed. Our study suggested that rhEpo therapy stimulates endogenous erythro-poiesis and enhances Ret, Hct and level of Hb in a dose-dependent manner in premature infants. The therapy is more efficient when given in higher dosages.展开更多
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 s...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.展开更多
AIM:Anaemia caused by acute upper gastrointestinal bleeding is treated with blood transfusion or iron,but patients usually face a two-month recovery period from post- haemorrhage anaemia.This prospective,randomised,op...AIM:Anaemia caused by acute upper gastrointestinal bleeding is treated with blood transfusion or iron,but patients usually face a two-month recovery period from post- haemorrhage anaemia.This prospective,randomised,open, pilot study was designed to investigate whether recombinant human erythropoietin(Epoetin)therapy accelerate haematocrit increase in the post-bleeding recovery period. METHODS:We studied hospitalised patients admitted because of acute ulcer bleeding or haemorrhagic gastritis, who had a haematocrit of 27-33% and did not receive blood transfusions.One day after the endoscopic confirmation of cessation of bleeding,they were randomised either to erythropoietin(20 000 IU Epoetin alfa subcutaneously,on days 0,4 and 6)plus iron(100 mg im,on days 1-6,(G_1)or iron only(G_2).Haematocdt was measured on days 0,6,14, 30,45,and 60,respectively. RESULTS:One patient from G_1 and two from G_2 were lost to follow-up.Therefore,14 and 13 patients from G_1 and G_2 respectively were analysed.Demographic characteristics,serum iron,ferritin,total iron binding capacity,reticulocytes,and haernatoait were not significantly different at entry to the study. Median reticulocyte counts were significantly different between groups on day six(G_1:4.0,3.0-6.4 vs G_2:3.5,2.1-4.4%, P=0.03)and median haematocrit on day fourteen [G_1:35.9, 30.7-41.0 vs G_2:32.5,29.5-37.0%(median,range),P=0.04]. CONCLUSION:Erythropoietin administration significantly accelerates correction of anemia after acute ulcer bleeding. The haematocrit gain is equivalent to one unit of transfused blood two weeks after the bleeding episode.展开更多
Objective:To explore the efficacy and mechanism of Yixuesheng capsule(益血生胶囊,YXS) combined with recombination human erythropoietin(RHE) in treating male neoplastic anemia(NA).Methods: Sixty-five patients were rand...Objective:To explore the efficacy and mechanism of Yixuesheng capsule(益血生胶囊,YXS) combined with recombination human erythropoietin(RHE) in treating male neoplastic anemia(NA).Methods: Sixty-five patients were randomized into two groups,the 33 patients in the treated group treated with a combined therapy of YXS and RHE,and the 32 in the control group treated with RHE alone,all for 12 weeks.Related clinical indexes,including hemoglobin(Hgb),red blood cell(RBC),hematocrit(HMC),testosterone(T),estradiol (E_2) an...展开更多
文摘To assess the efficacy and the optimum dose of recombinant human erythropoietin (rhEpo) on the anemia of premature, 45 preterm infants with a gestational age of less than 35 weeks and birth weight of less 1 800 g were randomly assigned to treatment group 1 (n = 15, receiving subcutaneous rhEpo 150 U/kg·time), treatment group 2 (n = 15, receiving 250 U/kg·time), three times a week for 6 weeks, and control group (n = 15, no treatment was given). All preterm infants received supplements of vitamin E (20 IU) and iron (20 mg) each day. Our results showed that postnatal decline of hemoglobin (Hb) and hematocrit (Hct) were lessened in the treatment groups, particularly in the group 2 and the differences were very significant (P<0. 0001 for all). Treated infants had significantly higher reticulocyte counts (Ret) (P<0. 000] for all), but there was no significant difference between the two treatment groups (P>0. 05). Serum iron dropped significantly in the treatment groups as compared with control group (P<0. 01 for all), but no dose-dependent relationship was observed in treated infants (P>0. 05). After treatment, serum levels of erythropoietin was higher in group 2 than those in group 1 and control group (P<0. 0001, P<0. 01 and P<0. 05, respectively). There was no significant difference between group 1 and control group (P>0. 05). No side effects related to rhEpo therapy were observed. Our study suggested that rhEpo therapy stimulates endogenous erythro-poiesis and enhances Ret, Hct and level of Hb in a dose-dependent manner in premature infants. The therapy is more efficient when given in higher dosages.
基金the Ethics Committee,Institute for the Development of Human Research Protections(IHRP),No.IHRP 2365/2556The Ethics Committee of Udon Thani Hospital,No.8/2559and Siriraj Institutional Review Board Faculty of Medicine Siriraj Hospital,Mahidol University,No.Si 588/2016.
文摘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.
文摘AIM:Anaemia caused by acute upper gastrointestinal bleeding is treated with blood transfusion or iron,but patients usually face a two-month recovery period from post- haemorrhage anaemia.This prospective,randomised,open, pilot study was designed to investigate whether recombinant human erythropoietin(Epoetin)therapy accelerate haematocrit increase in the post-bleeding recovery period. METHODS:We studied hospitalised patients admitted because of acute ulcer bleeding or haemorrhagic gastritis, who had a haematocrit of 27-33% and did not receive blood transfusions.One day after the endoscopic confirmation of cessation of bleeding,they were randomised either to erythropoietin(20 000 IU Epoetin alfa subcutaneously,on days 0,4 and 6)plus iron(100 mg im,on days 1-6,(G_1)or iron only(G_2).Haematocdt was measured on days 0,6,14, 30,45,and 60,respectively. RESULTS:One patient from G_1 and two from G_2 were lost to follow-up.Therefore,14 and 13 patients from G_1 and G_2 respectively were analysed.Demographic characteristics,serum iron,ferritin,total iron binding capacity,reticulocytes,and haernatoait were not significantly different at entry to the study. Median reticulocyte counts were significantly different between groups on day six(G_1:4.0,3.0-6.4 vs G_2:3.5,2.1-4.4%, P=0.03)and median haematocrit on day fourteen [G_1:35.9, 30.7-41.0 vs G_2:32.5,29.5-37.0%(median,range),P=0.04]. CONCLUSION:Erythropoietin administration significantly accelerates correction of anemia after acute ulcer bleeding. The haematocrit gain is equivalent to one unit of transfused blood two weeks after the bleeding episode.
文摘Objective:To explore the efficacy and mechanism of Yixuesheng capsule(益血生胶囊,YXS) combined with recombination human erythropoietin(RHE) in treating male neoplastic anemia(NA).Methods: Sixty-five patients were randomized into two groups,the 33 patients in the treated group treated with a combined therapy of YXS and RHE,and the 32 in the control group treated with RHE alone,all for 12 weeks.Related clinical indexes,including hemoglobin(Hgb),red blood cell(RBC),hematocrit(HMC),testosterone(T),estradiol (E_2) an...
