The Research Of The Efficacy And Safety Of Roxadustat On VEGF In Renal Anemia Patients With MHD

Objective: To compare the variations of hemoglobin(Hb),vascular endothelial growth factor(VEGF),iron changes in metabolic levels,hepcidin,C reactive protein(CRP)and clinical indicators on maintenance hemodialysis(MHD)renal anemia patients with hypoxia-inducible factor prolyl hydroxylase inhibitor(HIF-PHI)and with roxadustat and erythropoiesis-stimulating agents(ESAs).To analyze the safety and efficacy of roxadustat.Methods: Selected 60 patients with MHD in the department of nephrology from Nov,2019 to Jan,2020 in Hebei Provincial People’s Hospital and divided them into roxadustat group and ESAs group,30 cases in each group.The initial does of roxadustat was taken by 100mg(45-60Kg)or120mg(≥60Kg).In the first 8 weeks,the data of the level of the hemoglobin(Hb)were monitored.After the first 8 weeks,the data would be monitored every 4 weeks.According to the results of the Hb level,adjusted the dosage to keep the Hb level reaching and maintaining at 100-120g/L.The patients in ESA group continued to be given a therapeutic dose of 100IU/Kg based on their body weight and the dosage would be adjusted in the basis of the growth rate of Hb.Both two groups received iron supplementation by taking: ferrous succinate 0.2g 3/day.Except for rescue therapy,intravenous iron supplementation is prohibited.Collected the data of the patients of Hb,VEGF,serum iron,ferritin,total iron-binding capacity,transferrin saturation,hepcidin,blood pressure,total cholesterol,triacylglycerol,changes in levels of high-density lipoprotein,low-density lipoprotein,blood calcium,blood phosphorus,blood potassium,alanine transferase,aspartate transferase,CRP,and parathyroid hormone(PTH)from the 12 weeks to 24 weeks before the treatment and after the treatment.Observed the adverse reactions of the patients in two groups.The laboratory data of patients were blood samples collected at the puncture needle of internal fistula at the venous before dialysis in limosis condition at 7 o’clock in the morning.VEGF was determined by enzyme linked immunosorbent assay(ELISA,Chinese proteintech),and serum hepcidin was determined by enzyme-linked immunosorbent method(kit purchased from German DRG).Results:1.There were no significant differences in baseline indexes between 2groups(P>0.05).2.The level of Hb increased in roxadustat group after 12 weeks and 24 weeks of treatment.After 24 weeks of treatment,the level of Hb in roxadustat group was significantly higher than that of ESAs group,the difference was statistically significant(P<0.05).According to the increase rate of Hb in 24 weeks is divided into effective group(Hb increase ≥10g/L),and invalid group(Hb increase<10g/L).The effective rate of roxadustat group was higher than that of ESAS group(66.7% vs 22.2%,P < 0.01).There were no significant differences in gender,body weight,blood lipid,serum potassium,CRP,PTH and ferritin between effective group and ineffective group(P>0.05).There were significant differences in age and BMI(P<0.05).3.There was no significant difference in VEGF level within the respective groups(P>0.05).At the 12 weeks and 24 weeks of treatment,there was no significant increase in VEGF level between the two groups(P>0.05).VEGF level was not affected by diabetes,CRP level and dialysis age.4.The level of transferrin and total iron binding capacity of the rosadustat group were significantly increased after treatment compared with the baseline(P<0.05),and the level of hepcidin was significantly decreased(P<0.05).There was no significant change in the above indicators in the ESAs group before and after treatment(P>0.05).The transferrin level,total iron binding force and serum iron content in roxadustat group were higher than those in ESAs group on average(P<0.05),and there was no significant difference in ferritin level between the two groups(P>0.05).The level of hepcidin in roxadustat group was significantly lower than that in ESAS group(P<0.05).5.There was no significant difference in blood pressure level within the respective groups(P>0.05).At the 12 weeks and 24 weeks of treatment,there was no significant increase in blood pressure level between the two groups(P>0.05).6.Compared with before treatment,the levels of total cholesterol and low density lipoprotein decreased in roxadustat group at 24 weeks after treatment(P < 0.05).Compared with before treatment,serum potassium increased slightly in roxadustat group at 24 weeks after treatment(P<0.05),but there was no statistical significance in serum potassium between the two groups(P>0.05),and there was no statistical significance in serum calcium,serum phosphorus,liver function,CRP,PTH and other indexes between the two groups(P>0.05).Conclusions:1.Roxadustat and erythropoiesis-stimulating agents have no significant effect on the level of the VEGF and the level was not affected by diabetes,CRP levels and dialysis age.2.Roxadustat is better than erythropoiesis-stimulating agents in the aspect of treating renal anemia.Roxadustat can improve the serum iron metabolism indicators,improve iron utilization,and decrease total cholesterol and low-density lipoprotein levels.There was no serious adverse events such as hyperkalemia or infection during the whole experiment.