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Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
Song J, Wang Y, Xu F, Sun H, Zhang X, Xia L, Zhang S, Li K, Peng X, Li B, et al
CNS drugs. 2021
Abstract
BACKGROUND Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury. OBJECTIVE The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH. METHODS This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age. RESULTS A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026. CONCLUSIONS Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH. TRIAL REGISTRATION The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).
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Efficacy and Safety of Daprodustat for Anemia Therapy in Chronic Kidney Disease Patients: A Systematic Review and Meta-Analysis
Zheng Q, Wang Y, Yang H, Sun L, Fu X, Wei R, Liu YN, Liu WJ
Frontiers in pharmacology. 2020;11:573645
Abstract
Objective: Daprodustat is a novel oral agent in treating anemia of chronic kidney disease (CKD), and several clinical trials have been conducted to compare daprodustat with recombinant human erythropoietin (rhEPO) or placebo. Our systematic review aimed to investigate the efficacy and safety of daprodustat for anemia treatment in both dialysis-dependent (DD) and non-dialysis-dependent (NDD) patients. Methods: Six databases were searched for randomized controlled trials (RCTs) reporting daprodustat vs. rhEPO or placebo for anemia patients in CKD. The outcome indicators were focused on hemoglobin (Hb), ferritin, transferrin saturation (TSAT), total iron-binding capacity (TIBC), vascular endothelial growth factor (VEGF), and serious adverse events (SAEs). Results: Eight eligible studies with 1,516 participants were included. For both NDD and DD patients, changes in Hb levels from baseline were significantly higher in daprodustat group than that in the placebo (mean difference (MD) = 1.73, [95% confidence interval (CI), 0.34 to 3.12], p = 0.01; MD = 1.88, [95% CI, 0.68 to 3.09], p = 0.002; respectively), and there was no significant difference between daprodustat and rhEPO group (MD = 0.05, [95% CI, -0.49 to 0.59], p = 0.86; MD = 0.12, [95% CI, -0.28 to 0.52], p = 0.55; respectively). The indexes of iron metabolism were improved significantly in the daprodustat group compared to placebo- or rhEPO-treated patients, while there was no similar change in terms of TSAT for DD patients. Furthermore, no trend of increasing plasma VEGF was observed in daprodustat-treated subjects. As for safety, there was no significant difference in the incidence of SAEs between daprodustat and placebo treatment, while the incidence of SAEs in the daprodustat group was significantly lower than that in the rhEPO group. Conclusion: Daprodustat was efficacious and well tolerated for anemia in both NDD and DD patients in the short term based on current RCTs. And daprodustat may become an effective alternative for treatment of anemia with CKD. Since the application of daprodustat is still under exploration, future researches should consider the limitations of our study to evaluate the value of daprodustat.
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Efficacy and safety of HIF prolyl-hydroxylase inhibitor vs epoetin and darbepoetin for anemia in chronic kidney disease patients not undergoing dialysis: a network meta-analysis
Zheng Q, Yang H, Sun L, Wei R, Fu X, Wang Y, Huang Y, Liu YN, Liu WJ
Pharmacol Res. 2020;:105020
Abstract
Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) are a new class of oral medicines being developed for the treatment of anemia in chronic kidney disease (CKD) patients. This study aimed to compare the efficacy and safety of HIF-PHI vs epoetin and darbepoetin in CKD patients with anemia not undergoing dialysis. The PubMed, Embase, Cochrane Library, Web of Science, and http://clinicaltrials.gov/ clinicaltrials.gov databases were searched from inception to October 2019 for randomized controlled trials investigating different agents (six HIF-PHIs, epoetin, darbepoetin, and placebo) for treating CKD patients with anemia that did not undergo dialysis. The outcomes included a change in hemoglobin (Hb) levels and all-cause mortality. A total of 19 studies were included. Compared with the placebo, except for vadadustat (mean differences: 1.12, 95% confidence interval [CI]: 0.11-2.35), the other drugs significantly increased Hb levels, with mean differences of 2.46 (95% CI: 0.933.99) for desidustat, 1.81 (0.872.75) for enarodustat, 1.68 (0.642.72) for molidustat, 1.66 (0.892.44) for epoetin, 1.63 (0.692.56) for darbepoetin, 1.61 (0.992.22) for roxadustat, and 1.55 (0.742.36) for daprodustat. No differences were found in the Hb level elevations among these eight drugs. Compared with the placebo, there also was no significant association between the drugs and all-cause mortality (molidustat of RR, 0.39 [95% CI, 0.062.59]; roxadustat, 0.40 (0.062.84); enarodustat, 0.33 (0.0116.25); desidustat, 0.34 (0.0117.00); epoetin, 0.50 (0.181.42); daprodustat, 0.54 (0.093.31); darbepoetin, 1.03 (0.651.65); and vadadustat, 1.43 (0.1513.27)). No differences were observed in the all-cause mortality among the drugs. In conclusion, these HIF-PHIs are effective and relatively tolerant for treating anemia patients with CKD not undergoing dialysis. Further research should consider the limitations of our study to evaluate the value of these HIF-PHIs in clinical settings.
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Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial
Wang Y, Song J, Sun H, Xu F, Li K, Nie C, Zhang X, Peng X, Xia L, Shen Z, et al
Journal of translational medicine. 2020;18(1):308
Abstract
BACKGROUND Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants. METHODS The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age. RESULTS A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028). CONCLUSION Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.
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Erythropoietin for cancer-associated malignant anemia: A meta-analysis
Zhao F, Wang Y, Liu L, Bian M
Molecular and Clinical Oncology. 2017;6((6)):925-930.
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Abstract
The present study aimed to evaluate the effectiveness of erythropoietin (EPO) for improving cancer-associated malignant anemia. A search was performed for randomized clinical trials, conducted according to the Cochrane manual, using electronic databases including PubMed, EMBASE, the Cochrane Library and ClinicalTrails.gov up to 15 August 2015. A total of 6 eligible studies from 5 articles enrolling a total of 453 patients were entered into the current meta-analysis. Upon EPO treatment, there were significant differences in the change in hemoglobin (HB) levels compared with the placebo at short-term follow-up [mean difference (MD)=0.66; 95% confidence interval (CI), 0.14-1.18; I2=Not applicable; P=0.01) and long-term follow-up (MD=0.10; 95% CI, 0.02-0.18; I2=Not applicable; P=0.01) under the random effects model. For changes in hematocrit (HCT) compared with the placebo, the results revealed there were significant differences at short-term follow-up (MD=2.47; 95% CI, 0.75-4.19; I2=Not applicable; P=0.005) and long-term follow-up (MD=7.60; 95% CI, 6.15-9.05; I2=Not applicable; P<0.00001) under the random effects model. Compared with the placebo in short-term follow-up under the fixed effects model with homogeneity, the result was a significant difference for the transfusion ratio [relative risk (RR)=0.81; 95% CI, 0.67- 0.97; I2=34%; P=0.02) and the transfusion requirements (MD=-0.45; 95% CI, -0.92, 0.03; I2=6%; P=0.07). Funnel plots did not detect any publication bias. These results suggest that EPO was beneficial to alleviate cancer-associated anemia and improve survival outcomes for patients with cancer.
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Effects of erythropoiesis-stimulating agents on heart failure patients with anemia: a meta-analysis
Zhang H, Zhang P, Zhang Y, Yan J, Dong P, Wang Y, Niu X
Postepy W Kardiologii Interwencyjnej = Advances in Interventional Cardiology. 2016;12((3)):247-53.
Abstract
INTRODUCTION Heart failure (HF) is always complicated with anemia and is associated with bad prognosis in this patient population. Several studies have assessed the potential role of erythropoietin-stimulating agent (ESA) in improving cardiac function and reducing the number of hospitalizations in anemic patients with HF. AIM: We performed a meta-analysis to assess the potential role of ESA in the treatment of anemic patients with HF. MATERIAL AND METHODS A literature and Medline search was performed to identify studies with control groups that examined the efficacy of ESA therapy in patients with HF and anemia. RESULTS A total of 11 studies were included (n = 3044 subjects) in the final analysis. Compared to placebo, ESA therapy was associated with increased hemoglobin levels (1.89 g/dl; 95% CI: 1.64-2.14, p < 0.00001), increased left ventricular ejection fraction (LVEF) to 6.88 (95% CI: 0.49-13.28, p = 0.03), decreased B-type natriuretic protein (-272.20; 95% CI: (-444.52)-(-99.89), p = 0.002), improvement in New York Heart Association functional class to -0.33 mean difference (95% CI: (-0.44)-(-0.23), p < 0.00001), and decreased hospitalization (OR = 0.61, 95% CI: 0.39-0.94, p = 0.02). There was no significant between-group difference in all-cause mortality (OR = 0.78, 95% CI: 0.51-1.21, p = 0.27). CONCLUSIONS The treatment of anemia with ESA therapy did not reduce the rate of all-cause mortality among patients with heart failure, but ESA therapy made a potential important contribution to patients' symptomatic improvement.
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Efficacy and safety of iron supplementation for the elderly patients undergoing hip or knee surgery: a meta-analysis of randomized controlled trials
Yang Y, Li H, Li B, Wang Y, Jiang S, Jiang L
Journal of Surgical Research. 2011;171((2):):e201-7.
Abstract
BACKGROUND Anemia is a frequent co-morbidity in the elderly patients undergoing hip or knee surgery and is often associated with poor clinical outcomes. Mild to moderate anemia is often treated with intravenous or oral iron supplementation. However, the efficacy and safety of iron supplementation in treating anemia for the elderly patients undergoing hip or knee surgery remains controversial. METHODS Only prospective, randomized studies that compared iron supplementation with no iron supplementation in the elderly patients undergoing hip or knee surgery were included. Six studies met the inclusion criteria: the target population consisted of patients undergoing hip or knee surgery treated with iron supplementation; the study was a published randomized trial. Each outcome measure tested was assessed for heterogeneity. If significant heterogeneity was present for more than 75%, data from the studies were not combined. If there was no significant heterogeneity (less than 40%), a weighted mean difference (WMD) or combined relative risk was calculated using a fixed effects model, while a random effects model was applied when heterogeneity was within 40% to 75%. RESULTS Our meta-analysis demonstrated the increase of hemoglobin level in patients undergoing hip or knee surgery with iron supplementation. However, no significant difference on the length of hospital stay, morbidity, 1-mo mortality, the infection rate, the rate and volume of allogeneic blood transfusions, and the adverse drug effects was found between the patients with iron treatment and those without. CONCLUSION Our meta-analysis suggested that iron supplementation was safe and effective in treating anemia for the elderly patients undergoing hip or knee surgery. Copyright Copyright 2011 Elsevier Inc. All rights reserved.