| Part One:Short-term effects of multicenter Roxadustat on anemia and iron metabolism in maintenance hemodialysis patients with iron overloadObjective:To observe the correction of anemia and the changes of iron metabolism in maintenance hemodialysis(MHD)patients with iron overload after Roxadustat treatment.Methods:96 MHD patients with anemia in 10 dialysis centers from August 2019 to September 2020 were enrolled,and the average baseline age was 54±15 years old,weight was 57(49,66)kg,including 52 males(54.2%).According to the level of serum ferritin(SF)before treatment,the patients were divided into two groups:iron overload group(SF>500ng/L,n=42)and normal SF group(SF<500ng/L,n=54).And the patients were treated with Roxadustat for 12 weeks according to their body weight.The changes of hemoglobin(Hb)and iron metabolism index[serum ferritin(SF),transferrin saturation(TSAT),total iron binding capacity(TIBC)]were observed between the two groups before and after treatment with Roxadustat.The information of combined drug use and adverse events were collected,and the drug usage,dosage in patients and the reasons for drug adjustment were recorded.The above indicators were observed to evaluate the clinical efficacy and safety of Roxadustat in MHD patients with iron overload and anemia.Result:1.Baseline characteristics:After comparing the baseline indexes of the two groups,it was found that the patients with hypertensive nephropathy in the iron overload group were more than those in the SF normal group,meanwhile,the body weight of the patients in the iron overload group was bigger,the differences were statistically significant.While,there was no significant difference in age and gender between the two groups.2.The Hb level of the patients in the group increased 13g/L compared with the baseline(95%CI 10～16g/L;P<0.05).Multivariate repeated-measure analysis of variance(ANOVA)showed that there was no statistical difference between two groups of patients treated with Roxadustat,and the effect was approximate(F=1.168,P=0.283).The Hb transform was no statistical difference in two groups(F=0.17,P=0.897).3.After treatment,SF decreased and TIBC increased in patients in the iron overload group and SF normal group,and the differences were statistically significant;while TSAT remained stable.4.During the 12-week follow-up,there were 2 cases had gastrointestinal adverse reactions and 1 case had hyperkalemia in the iron overload group,and 1 case had gastrointestinal adverse reactions in the SF normal group.There were no liver dysfunction,cardiovascular and cerebrovascular events,thromboembolism,death and other serious adverse reactions in both the two groups.Conclusion:In MHD patients with iron overload,Roxadustat can also effectively correct anemia,reduce iron load in the body,and has no obvious hepatotoxicity and nephrotoxicity,which is worthy of clinical application.Part Two:Effect of monocentric Roxadustat on oxidative stress in maintenance hemodialysis patients with anemiaObjective:To explore the effects of Roxadustat on oxidative stress in maintenance hemodialysis patients with anemia through a prospective clinical studyMethods:Oxidative stress indexes[malondialdehyde(MDA),superoxide dismutase(SOD)],iron metabolism indexes[serum iron,hepcidin(Hepc)]and total cholesterol(TC)were detected in 38 MHD patients with anemia included in the first part of the study in our center.Through the comparative analysis of the above indexes before and after treatment,the effects of Roxadustat on oxidative stress,iron metabolism and total cholesterol in MHD patients with anemia were explored.In addition,in this study,there were 6 MHD patients with anemia who failed to be treated with rHuEPO.The changes of hemoglobin response rate and iron metabolism indexes[serum ferritin(SF),transferrin saturation(TSAT),hepcidin(Hepc)]were observed to evaluate the curative effect of Roxadustat on MHD patients with rHuEPO-resistant anemia.Result:1.The level of MDA after treatment was lower than that before treatment,and the difference was statistically significant.SOD was higher than that before treatment,but there was no significant difference.2.The serum iron of 38 patients was higher than that before treatment(P<0.05).The Hepc was lower than that before treatment,and the difference was statistically significant.3.The total cholesterol decreased from 3.71(3.14,4.44)mmol/L to 3.69(2.39,4.02)mmol/L,and the difference was statistically significant.4.6 MHD patients with rHuEPO-resistant anemia were treated with Roxadustat for 12 weeks.The response rate of Hb was 83.3%(5/6),the average level of Hb increased from(87±11)g/L to(105±9)g/L,and the difference was statistically significant.Conclusion:Roxadustat can effectively reduce oxidative stress,improve iron metabolism,and improve lipid metabolism in MHD patients with anemia.It also has a good curative effect on anemia in MHD patients with erythropoietin resistance. |
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