恩那度司他治疗维持性血液透析合并肾性贫血患者的临床研究OA

Objective To observe the clinical efficacy and safety of enarodustat tablets in the treatment of renal anemia(RA)in patients on maintenance hemodialysis(MHD).Methods An openlabel,randomized,positive drug parallelcontrolled design was adopted.MHDRA patients treated in our hospital were randomly assigned to control group and treatment group.The control group received intravenous recombinant human erythropoietin(rHuEPO)injection after dialysis,at a weekly intravenous bolus dose of(1.0-2.5)×104U,given in 1-3 divided doses.The treatment group received oral enarodustat tablets once daily before bedtime,with a starting dose of 2 mg and an adjustment range of 1-8 mg·d-1.Both groups received routine basic symptomatic treatment,including intravenous iron and calcium supplements.The treatment duration was 24 weeks for both groups.Anemia parameters and iron metabolism indices were compared between the two groups,and clinical efficacy and safety were evaluated.Results A total of 96 patients were enrolled in this study,including 47 patients in the treatment group and 49 patients in the control group.After treatment,the overall clinical effective rates of treatment group and control group were 78.72％(37 cases/47 cases)and 83.67％(41 cases/49 cases),respectively,with no statistically significant difference(P＞0.05).After treatment,the hemoglobin levels of treatment group and control group were(116.00±13.53)and(117.34±11.45)g·L1,respectively,with no statistically significant difference(P＞0.05).After adjustment for baseline covariates,the leastsquares mean(LSM)difference was-1.37 g·L-1[95％confidence interval(CI),-6.33 to 3.58].The lower bound of the 95％CI was greater than the prespecified noninferiority margin of-10 g·L-1,indicating that enarodustat was noninferior to erythropoietin with respect to efficacy.After treatment,the serum iron(SI)levels of treatment group and control group were(14.93±5.09)and(11.41±3.53)μmol·L-1,respectively;the total iron binding capacity(TIBC)levels were(47.37±8.33)and(39.48±7.20)μmol·L-1,respectively;there were statistically significant differences in all the above indicators between treatment group and control group(all P＜0.05).The total incidence of adverse drug reactions in treatment and control group were 61.70％(29 cases/47 cases)and 57.14％(28 cases/49 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Enarodustat tablets can effectively improve iron metabolism and increase hemoglobin levels in patients on maintenance hemodialysis.Its efficacy in correcting renal anemia is noninferior to that of traditional erythropoietin,with a favorable safety profile.However,the current confidence intervals are relatively wide,indicating limited precision of effect estimation;therefore,largesample studies are warranted for further validation.