The Efficacy Of Different Initial Doses Of Roxadustat In The Treatment Of Renal Anemia In Maintenance Hemodialysis Patients

Background: One of the common complications of chronic kidney disease(CKD)is renal anemia,with a higher incidence of anemia in dialysis patients compared to no dialysis-Chronic kidney disease patients.Anemia seriously affects patients’ physical health and quality of life.At present,the main treatment drugs for renal anemia are erythropoiesis-stimulating agents(ESAs)and iron.Roxadustat,as the first hypoxiainducible factor prolyl hydroxylase inhibitor(HIF-PHI)used for the treatment of renal anemia.Multiple studies have shown that Roxadustat can increase patients’ hemoglobin levels,improve anemia and improve their quality of life with high safety.Its main mechanism is to stabilize the hypoxia-inducible factor(HIF),stimulate the synthesis of endogenous erythropoietin(EPO)and reduce hepcidin levels,promoting iron absorption.Studies have shown that the recommended initial dose of Roxadustat can quickly achieve hemoglobin standards,and the dosage needs to be gradually reduced during subsequent treatment.However,the rapid increase of hemoglobin can cause thrombosis and cardiovascular and cerebrovascular disease,so the starting dose of Roxadustat may be have room for downward adjustment.There are relatively few studies on the use of lower initial doses for the treatment of renal anemia in the hemodialysis population.This experiment aims to study the efficacy and safety of Roxadustat at low initial dose in patients with renal anemia,providing a more reliable basis for clinical practice.Objective: To explore the efficacy of Roxadustat at low initial doses compared with standard initial doses in the treatment of renal anemia in maintenance hemodialysis patients.Method: This study is a nonrandomized controlled trial,a total of 54 patients with chronic kidney disease and renal anemia undergoing maintenance hemodialysis were screened from the Department of Renal Medicine and the Hemodialysis Room of the First Affiliated Hospital of Henan University from October2021 to November 2022.The patients were divided into a standard-dose group and a low-dose group in a 1:1ratio,with 27 patients in each group.Collect information such as gender,age,weight,and body mass index of patients before medication.During the treatment process,dosage adjustments were made according to this study protocol,and the treatment time was 12 weeks.Observe the total effective rate of the two groups of patients achieving clinical efficacy within 12 weeks.Observe the changes of anemia indicators [hemoglobin(Hb)、red blood cell count(RBC)、hematocrit(Hct)],iron metabolism indicators [transferrin(TRF)、ferritin(Fer)、total iron binding capacity(TIBC)、transferrin saturation(TSAT))],blood lipids [total cholesterol(TC)、triglycerides(TG)]in both groups before and after treatment.Adverse reactions occurred during medication were recorded in both groups of patients.Results: 1.A total of 54 patients were included in this study,4 of whom were lost to follow-up,with 25 in the standard-dose group and 25 in the low-dose group.There were 17 males and 8 females in the low-dose group,and 12 males and 13 females in the standard-dose group.There were 5 and 3 cases of primary glomerular disease,6 and 7 cases of hypertensive renal injury,8 and 10 cases of diabetes nephropathy,2 and1 cases of polycystic kidney,and 4 cases of other diseases in the low-dose group and the standard-dose group,respectively.There was no significant difference in general data such as gender,age,weight,body mass index,anemia index,iron metabolism index,and blood lipid level between the two groups(P>0.05).2.The total effective rates of the low-dose group and the standard-dose group at 12 weeks were 60% and 72%,and the clinical efficacy was comparable between the two groups(P>0.05).After treatment,the Hb levels in the low-dose group and the standard-dose group were 99.16 ± 9.03 g/L and 103.76 ± 7.82 g/L,respectively,with a significant increase in Hb levels compared to baseline in both groups(P<0.05).There was no significant difference in anemia indicators between the two groups at week 12(P>0.05),indicating that the low-dose group was not inferior to the standard-dose group in terms of increasing anemia ability.During the treatment process,the adjusted dosage of the standard-dose group was significantly higher than that of the low-dose group,and there was a significant difference in the total number of adjusted dosages between the two groups(P<0.05).3.The levels of TRF and TIBC in both groups of patients were significantly higher than before treatment(P<0.05);There was no significant change in Fer and TSAT between the two groups of patients compared to before treatment,and the difference was not statistically significant(P>0.05).4.The TC levels of the two groups significantly decreased compared to before treatment(P<0.05);The TG levels of the two groups showed no significant change compared to before treatment,and the difference was not statistically significant(P>0.05).There was no significant difference in TC and TG levels between the two groups after treatment(P>0.05).5.There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Neither group of patients had liver dysfunction or severe cardiovascular or cerebrovascular events.Conclusion: This study shows that low initial doses of Roxadustat can effectively improve anemia,with efficacy comparable to standard initial doses.Low initial dose can improve the level of anemia indicators such as hemoglobin,improve iron metabolism,and blood lipid levels in patients,and have good tolerance.