| Objective: To assess the clinical observation on the therapeutic efficacy of roxadustat in remedying patients with peritoneal dialysis(PD)complicated with renal anemia and its effect on the quality of life in this population.Method: In this study,a total of 80 patients with peritoneal dialysis complicated by renal anemia who attended the First Hospital of Hebei North College from January 2022 to March 2022 were selected,and all patients were on continuous ambulatory peritoneal dialysis and treated with Recombinant Human Erythropoietin Injection(CHO cell)(hereinafter referred to as EPO)for not less than 6 weeks.General clinical data such as age,sex,dialysis age and type of primary disease were recorded,and the observation period was 48 weeks.The 80 patients were randomly assigned1:1 to the experimental group and the control group,with the experimental group receiving oral roxadustat capsules and the control group continued the original regimen of subcutaneous injection of EPO.The initial dose of roxadustat was determined according to the patients’ body weight and hemoglobin level,and the dose of both drugs was adjusted according to the patients’ hemoglobin level and its changes and the clinical judgment of the investigator during the treatment and follow-up period until the patients’ hemoglobin level was maintained at 110 g/L-130 g/L.The changes of anemia,microinflammation and lipid metabolism-related indexes before and at 12 and 48 weeks of administration were compared between the two groups;the hemoglobin compliance rates at 12 and 24 weeks of administration were compared between the two groups.The number of cardiovascular events at12 and 48 weeks of treatment were compared between the two groups;the quality of life scores before and at 12 and 48 weeks of treatment were compared between the two groups.Results: 1.General clinical data: There was no statistically significant difference between the test group and the control group in terms of general clinical data such as age,dialysis age,past medical history and primary disease(P>0.05).2.Laboratory indexes: In intra-group comparison,the hemoglobin and erythrocyte specific volume of the test and control groups were higher than those before drug administration at 12 weeks and 48 weeks,and the differences were statistically significant(P<0.05).There were no significant differences between the groups in terms of anemia,microinflammation and lipid metabolism-related indicators between the two groups before the administration of the drug(P>0.05).The hemoglobin concentration,erythrocyte specific volume,serum iron and transferrin saturation were higher in the test group than in the control group at 12 weeks of dosing,and the differences were statistically significant(P<0.05).Ferritin,C-reactive protein,interleukin 6,total serum cholesterol,total serum triglycerides,and LDL-cholesterol esters were lower in the test group than in the control group,and the differences were statistically significant(P<0.05).No statistical difference in HDL-cholesterol ester comparison between the two groups(P>0.05).The hemoglobin concentration and erythrocyte volume of the test group and the control group in 48 weeks of drug administration indicators were not significantly different(P>0.05).Serum iron and transferrin saturation were higher in the test group than in the control group and the difference was statistically significant(P<0.05).Ferritin,C-reactive protein,interleukin 6,total serum cholesterol,total serum triglycerides,and LDLcholesterol esters were lower in the test group than in the control group,and the differences were statistically significant(P<0.05).There was no statistical difference in HDL-cholesterol esters between the two groups at 48 weeks of dosing(P>0.05),In terms of hemoglobin attainment rate,the test group was higher than the control group at 12 and 24 weeks of drug administration,and the difference was statistically significant.3.The occurrence of cardiovascular events at the follow-up: there were 4cases of cardiovascular events at 12 weeks,including 1 case(heart failure)in the test group and the remaining 3 cases(1 case of arrhythmia and 2 cases of heart failure)in the control group;there were 17 cases of cardiovascular events at 48 weeks,including 4 cases(1 case of arrhythmia and 3 cases of heart failure)in the test group and 13 cases(3 cases of arrhythmia,9 cases of heart failure and 1 case of myocardial infarction)in the control group.There was no cardiovascular death during the follow-up period in both groups,and there was no significant difference in the risk of cardiovascular events between the two groups at 12 weeks(P>0.05);whereas the incidence of cardiovascular events was higher in the control group compared with the test group at 48 weeks(P<0.05).4.Quality of life scores: the SF-36 scores of all dimensions were higher in both groups at 12 weeks and 48 weeks of dosing than before dosing,and the differences were statistically significant(P<0.05);the SF-36 scores of all dimensions were higher in patients in the test group at 12 weeks and 48 weeks of dosing than in the control group,and the differences were statistically significant(P<0.05).Conclusion: Compared with recombinant human erythropoietin,roxadustat can improve the anemia status of peritoneal dialysis patients faster,reduce the microinflammation status of patients,improve the body lipid metabolism,and have a low risk of cardiovascular events,which can improve the quality of life of peritoneal dialysis patients. |
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