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Objective:To investigate the effect of roxadustat combined with levocarnitine in the treatment of renal anemia in hemodialysis patients with diabetic kidney disease (DKD), and its effects on iron metabolism, microinflammation status and microvascular complications.Methods:The clinical data of 89 hemodialysis renal anemia patients with DKD from January 2020 to October 2021 in Beijing Geriatric Hospital were retrospectively analyzed. Among them, 44 patients (control group)were treated with recombinant human erythropoietin and levocarnitine for renal anemia, and 45 patients (study group) were treated with recombinant human erythropoietin, levocarnitine and roxadustat for renal anemia. Both groups were treated for 3 months. The efficacy was compared between two groups. The laboratory indexes were measured before treatment and after 1, 3 months of treatment, including anemia related indexes such as hemoglobin, red blood cell count and mean corpuscular volume (MCV); iron metabolism indexes such as serum iron, ferritin and transferrin saturation (TSAT); inflammatory indexes such as interleukin-8 (IL-8), C-reactive protein (CRP) and tumor necrosis factor-α (TNF-α). The adverse reactions were recorded. The patients were followed up for 1 year after treatment, the incidence of diabetic microvascular complications, including diabetic peripheral neuropathy (DPN) and diabetic retinopathy (DR), was recorded.Results:The total effective rate in study group was significantly higher than that in control group: 93.33% (42/45) vs. 77.27% (34/44), and there was statistical difference ( χ2 = 4.60, P<0.05). There were no statistical differences in the laboratory indexes before treatment between two groups ( P<0.05); the hemoglobin, red blood cell count, MCV, serum iron, ferritin and TSAT after 1 and 3 months of treatment in study group were significantly higher than those in control group, the IL-8, CRP and TNF-α were significantly lower than those in control group, and there were statistical differences ( P<0.01 or <0.05). There was no significant difference in the incidence of adverse reactions between two groups ( P>0.05). After 1 year follow-up, 2 cases were lost in study group and 3 cases in the control group. The incidence of DR and DPN in study group were significantly lower than those in control group: 0 vs. 14.63% (6/41) and 2.33% (1/43) vs. 19.51% (8/41), and there were statistical differences ( χ2 = 4.75 and 4.81, P<0.05). Conclusions:Roxadustat combined with levocarnitine in the treatment of renal anemia in hemodialysis patients with DKD is reliable and safe, and can effectively relieve anemia symptoms, improve iron metabolism, reduce inflammatory response, and reduce the risk of diabetic microvascular complications.
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Objective To establish the drug use evaluation(DUE)standards of roxadustat,and to evaluate its clinical application to promote its rational use.Methods Based on the drug labels,referring to relevant guidelines and expert consensus,the DUE criteria for roxadustat were established through the Delphi method,including items such as drug indications,drug use process and the results of medication.A retrospective study was conducted to evaluate the rationality of cases which included inpatients who used roxadustat for the first time from January 1,2020 to December 31,2022,with a medication period of more than one month in Fujian Provincial Hospital.Results A total of 175 medical records were included,of which 14 records were fully met the clinical application evaluation criteria,and the medication reasonable rate was 8.0％.The unreasonable situation were mainly manifested in the inappropriate clinical outcomes(92.0％),the inappropriate use dosages(52.6％),inappropriate monitoring of adverse reactions(34.9％),inappropriate timing of administration(13.1％),drug interactions(8.7％),inappropriate drug conversion(5.7％),inappropriate efficacy monitoring(4.0％).Conclusion The established DUE standards for roxadustat are scientific,practical and feasible,and the evaluation results show a rate of irrationality in the use of roxadustat in the hospital,and it is necessary to standardize the use of roxadustat in terms of dosage,adverse reaction monitoring,and timing of administration.
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OBJECTIVE To compare the effects of roxadustat and recombination human erythropoietin （rHuEPO） on coronary artery calcification in maintenance hemodialysis （MHD） patients. METHODS In retrospective analysis， MHD patients prescribed roxadustat in the Blood Purification Center of the First Affiliated Hospital of Chongqing Medical University from April 2019 to June 2021 were selected as the ROX group （56 patients）， and MHD patients prescribed rHuEPO during the same period were selected as the EPO group （60 patients）， and follow-up observation was conducted for 12 months. The differences in laboratory index， coronary artery calcification score （CACS）， and cardiac ultrasound parameters before and after treatment as well as the occurrence of cardiac and cerebrovascular adverse events during follow-up period were compared between the two groups. RESULTS There was no statistical difference in CACS between the two groups before and after treatment （P＞0.05）； but the difference of CACS in the ROX group was significantly lower than the EPO group （P＜0.05）. There was no statistically significant difference in cardiac ultrasound parameters and laboratory indexes between the two groups before and after treatment （P＜0.05）. The incidence of apoplexy and myocardial infarction in the ROX group was lower than that in the EPO group （P＜0.05）， and there was no statistically significant difference in the incidence of hospitalization due to heart failure between the two groups （P＞0.05）. CONCLUSIONS Compared with rHuEPO， roxadustat may have a positive effect on delaying coronary artery calcification in MHD patients and may be beneficial in reducing the incidence of myocardial infarction and apoplexy in MHD patients.
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Objective:To compare the clinical curative effect of roxadustat and recombinant human erythropoietin (rhEPO) on non-dialysis stage 3 to 5 chronic kidney disease (CKD) combined with renal anemia (RA).Methods:A total of 108 patients with non-dialysis stage 3 to 5 CKD and RA admitted to Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University were prospectively enrolled between January 2020 and October 2022. According to random number table method, they were divided into group A and group B, 54 cases in each group. The group A was treated with roxadustat and polysaccharide-iron complex (PIC) for 3 months, while group B was treated with rhEPO and PIC for 3 months. The clinical curative effect, levels of hemoglobin (Hb), red blood cell count (RBC), hematocrit (Hct), serum ferritin (SF), transferrin saturation (TSAT), transferrin (TRF), blood urea nitrogen (BUN), serum creatinine (Scr) and β2-microglobulin (β2-MG) before and after treatment, and the incidence of adverse reactions during treatment in the two groups were compared.Results:The total response rate of treatment in group A was significantly higher than that in group B: 87.04% (47/54) vs. 70.37% (38/54), and the difference was statistically significant ( P<0.05). After treatment, levels of RBC, Hb and Hct in group A were significantly higher than those in group B: (3.47 ± 0.59) × 10 12/L vs. (2.60 ± 0.51) × 10 12/L, (110.45 ± 12.97) g/L vs. (93.64 ± 10.58) g/L, 0.358 ± 0.054 vs. 0.303 ± 0.043, and the difference was statistically significant ( P<0.05). The levels of TSAT, SF and TRF in group A were significantly higher than those in group B: (35.17 ± 3.65)% vs. (29.82 ± 3.10)%, (286.74 ± 17.23) μg/L vs. (243.16 ± 15.49) μg/L, (2.76 ± 0.45) g/L vs. (2.40 ± 0.32) g/L, and the difference was statistically significant ( P<0.05). The levels of BUN, Scr and β2-MG in group A were significantly lower than those in group B: (3.98 ± 0.41) mmol/L vs. (4.36 ± 0.54) mmol/L, (62.57 ± 7.89) μmol/L vs. (80.34 ± 9.65) μmol/L, (1.50 ± 0.42) μg/L vs. (1.99 ± 0.58) μg/L, and the difference was statistically significant ( P<0.05). During treatment, incidence of adverse reactions in group A was significantly lower than that in group B: 11.11% (6/54) vs. 25.93% (14/54), and the difference was statistically significant ( P<0.05). Conclusions:Compared with rhEPO, roxadustat has better curative effect, which can effectively relieve anemia and improve iron metabolism in patients with non-dialysis stage 3 to 5 CKD and RA, with good safety.
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Objective To observe the regulatory effect of roxadustat on lipid metabolism while correcting anemia in hemodialysis patients.Methods Sixty patients with chronic kidney disease(CKD)receiving hemodialysis treatment at Nanjing Drum Tower Hospital and combined with concurrent renal anemia were selected.These included 30 patients receiving erythropoietin(EPO)therapy at a dose of 10 000 U per week,and 30 patients receiving roxadustat treatment at a dose based on body weight.The patients'hemoglobin levels were measured,and data on lipid and iron metabolism-related indicators were collected for statistical analysis.Results After 6 months of treatment,the mean hemoglobin levels of both groups of patients were significantly higher than the baseline levels.The mean hemoglobin level in the roxadustat group was higher than that in the EPO group(114.1±7.88 vs.122.23±10.33,P<0.05),but there was no significant difference in the achievement rate between the two groups(77%vs.93%,P>0.05).The total cholesterol(TC),low-density lipoprotein cholesterol(LDL-C),and triglycerides(TG)in the roxadustat group decreased significantly(P<0.05),while there was no significant change in the EPO group.Compared with the EPO group,roxadustat showed an improvement in iron metabolism indicators.Conclusion Roxadustat has been shown to improve lipid metabolism while correcting anemia.
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Objective:To observe the efficacy and safety of roxadustat in the treatment of renal anemia in calciphylaxis dialysis patients who had poor response to recombinant human erythropoietin (rHuEPO).Methods:This study was a prospective cohort study. The dialysis patients who were diagnosed with calciphylaxis and had previous regular use of rHuEPO≥3 months with hemoglobin (Hb) levels<110 g/L in the Department of Nephrology of Zhong Da Hospital affiliated to Southeast University from January 1, 2019 to March 28, 2021 were recruited. The effect of oral roxadustat in calciphylaxis dialysis patients with renal anemia was analyzed by self-comparison method.Results:There were totally 18 calciphylaxis dialysis patients with renal anemia enrolled in the study and the age was (49.7±16.2) years old, including 11 males and 7 females, and 14 cases on hemodialysis and 4 cases on peritoneal dialysis. The high-sensitivity C-reactive protein level was 27.3(15.6, 48.5) mg/L(reference value 0-3 mg/L) at baseline. The baseline Hb level was (85.4±11.6) g/L, and after 3 months of oral roxadustat, the Hb level was (105.8±15.2) g/L ( t=-9.282, P<0.001). The Hb compliance rate was 44.4%(8/18). Ferritin decreased significantly at 3 months compared with the baseline level [208.0(59.0, 306.3) μg/L vs 229.0(127.3, 385.2) μg/L, Z=-3.637, P<0.001]. The total iron binding capacity level increased significantly compared with the baseline level [127.0(65.0, 211.5) μmol/L vs 105.5(43.8, 153.7) μmol/L, Z=-2.156, P=0.031]. Transferrin saturation level at 3 months was lower than that at baseline, but there was no significant difference [20.2%(14.2%, 27.7%) vs 20.5%(18.7%, 34.9%), Z=-1.546, P=0.122]. No adverse reactions occurred during the observation period. Conclusion:The application of roxadustat can effectively correct Hb level and improve iron metabolism with high safety in calciphylaxis dialysis patients with renal anemia under inflammatory status.
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OBJECTIVE：To observe the efficacy and safet y of roxadustat in the treatment of chronic kidney disease （CKD） combined with renal anemia. METHODS ：The data of 80 inpatients with CKD combined with renal anemia treated in the nephrology department of the First Affiliated Hospital of Anhui University of Science and Technology during Nov. 2019 to Dec. 2020 were analyzed retrospectively. They were divided into observation group （40 case）and control group （40 case）according to different treatment methods. Control group was given Human erythropoieti n for injection subcutaneously ，100-150 IU/kg every week，3 times a week. Observation group were given Roxadu- stat capsules orally ，100 mg each time for dialysis patients with a bodyweight of 45-＜60 kg，70 mg each time for non- 717060193@qq.com dialysis patients ，3 times a week ；120 mg each time for dialysis patients with bodyweight ≥60 kg and 100 mg each time for non-dialysis patients ，3 times a week. After 4 weeks of treatment ，the dosage of the two groups w as adjusted according to the level of hemoglobin （Hb）. Treatment course of 2 groups were 12 weeks. The levels of anemia indexes （Hb，red blood cell count （RBC），hematocrit（Hct）），iron metabolism indexes （serum iron （Fe），ferritin（Fer），total iron-binding capacity （TIBC），tranfeerrin saturation （TSAT）），lipid metabolism indexes （total cholesterol （TC），triglycerides（TG），high-density lipoprotein （HDL），low-density lipoprotein （LDL））and inflammation index（C-reactive protein （CRP））were detected in 2 groups before treatment and after 12 weeks of treatment. The levels of Hb were observed in high-level CRP subgroup and low-level CRP subgroup ；the occurrence of ADR was recorded in 2 groups during treatment. RESULTS ：Before treatment ，there was no statistical significance in the anemia indexes ，iron metabolism indexes ，lipid metabolism indexes or inflammation index between 2 groups（P＞0.05）. After treatment ，the levels of Hb ，RBC and Hct in 2 groups and the levels of TIBC and HDL in observation group were significantly higher than before treatment. The levels of Fe ，Fer and TSAT in 2 groups and the levels of TC and LDL in observation group were significantly lower than before treatment ；the levels of Hb ，RBC，Hct，TIBC and HDL in observation group were significantly higher than before control group ，while the level of TC was significantly lower than control group （P＜0.05）. The incidence of high reactivity in observation group was significantly higher than control group ，while the incidence of low reactivity was significantly lower than control group （P＜0.05）. There was no statistical significance in the levels of CRP between 2 groups before and after treatment （P＞0.05）. Subgroup comparison results showed that there was no statistical significance in the level of Hb between high-level CRP subgroup and low-level CRP subgroup of 2 groups before treatment （P＞0.05）. After treatment ，the level of Hb in high-level CRP subgroup of observation group was significantly higher than that of high-level CRP subgroup of control group （P＜0.05）. The total incidence of ADR in observation group was significantly lower than control group （P＜0.05），and no severe ADR was observed in 2 groups. CONCLUSIONS ： Roxadustat can effectively improve anemia in CKD patients with renal anemia ，and curative effect is less affected by inflammatory state，and it has good short-term safety.