罗沙司他联合重组人促红细胞生成素在肾性贫血血液透析患者中的临床研究OA

Objective To evaluate the application effect of roxadustat capsules combined with recombinant human erythropoietin(rHuEPO)for injection in hemodialysis patients with renal anemia.Methods Patients with renal anemia undergoing hemodialysis were randomly divided into control group and treatment group using a random number table method.The control group received treatment with rHuEPO injection,intravenous injection of 120-150 IU·kg-1,2-3 times a week;the treatment group was administered roxadustat capsules orally after meals(100 mg for patients weighing＜60 kg,120 mg for patients weighing ≥60 kg)on the basis of the control group,3 times per week.Both groups were treated continuously for 3 months.Iron metabolism indicators,anemia indicators and inflammatory factors were compared between the two groups.Clinical efficacy and adverse drug reactions were also assessed.Results A total of 148 patients were enrolled in this study,including 70 cases in treatment group and 68 cases in control group.After treatment,the overall clinical effective rates of treatment group and control group were 95.71％(67 cases/70 cases)and 83.82％(57 cases/68 cases),respectively,with a statistically significant difference(P＜0.05).After treatment,the serum iron(SI)levels of treatment group and control group were(15.98±4.04)and(13.41±3.72)μmol·L-1,respectively;the transferrin saturation(TSAT)levels were(35.23±5.03)％and(29.38±4.94)％,respectively;the serum ferritin(SF)levels were(284.69±31.41)and(219.57±28.47)μg·L-1,respectively;the hemoglobin(Hb)levels were(97.57±11.16)and(91.09±9.84)g·L-1,respectively;the hematocrit(Hct)levels were(34.62±4.09)％and(28.34±3.47)％,respectively;the red blood cell(RBC)counts were(3.41±0.74)and(2.77±0.61)× 1012·L-1,respectively;the interleukin-6(IL-6)levels were(58.02±6.19)and(64.23±7.63)ng·L-1,respectively;and the tumor necrosis factor-α(TNF-α)levels were(111.02±12.54)and(120.63±15.29)ng·L-1,respectively.There were statistically significant differences in all the above indicators between treatment group and control group(all P＜0.05).Adverse drug reactions in treatment group included dizziness,fever,elevated blood pressure,nausea and vomiting,diarrhea and abnormal liver function,while those in control group included dizziness,fever,elevated blood pressure,nausea and vomiting,diarrhea and abnormal liver function.The total incidence of adverse drug reactions in treatment and control groups were 17.14％(12 cases/70 cases)and 19.12％(13 cases/68 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Roxadustat capsules combined with rHuEPO solution for injection can improve iron metabolism and anemia status,reduce inflammatory factor levels,and do not increase the risk of adverse drug reactions in hemodialysis patients with renal anemia.