应用罗沙司他与重组人促红素治疗的初始血液透析肾性贫血患者的临床疗效及安全性分析

Clinical efficacy and safety analysis in initial hemodialysis patient with renal anemia treated by roxadustat or recombinant human erythropoietin

目的比较罗沙司他与重组人促红素(recombinant human erythropoietin,rhEPO)在治疗初始血液透析患者肾性贫血的临床疗效及安全性。方法回顾性分析陕西省人民医院肾病血透中心2020年1月至2021年6月收治的初始进入血液透析的肾性贫血患者107例,其中使用罗沙司他治疗57例(罗沙司他组),使用rhEPO治疗50例(促红素组),两组患者均予以铁剂、甲钴胺及叶酸治疗。比较两组患者临床疗效及安全性,分别在治疗后1、3、6个月观察红细胞(red blood cell,RBC)、血红蛋白(hemoglobin,Hb)、红细胞压积(hematocrit,Hct)、促红细胞生成素(erythropoietin,EPO)、血清铁蛋白(serum ferrin,SF)、转铁蛋白(transferrin,TRF)、转铁蛋白饱和度(transferrin saturation,TSAT)、铁调素(hepcidin,HePc)、白细胞(white blood cell,WBC)及C反应蛋白(C-reactive protein,CRP)、白介素6(interleukin-6,IL-6)的变化。并观察6个月期间两组患者不良反应的发生情况。结果治疗前两组间RBC、Hb、Hct、EPO、SF、TRF、TSAT、HePc、WBC、CRP、IL-6比较,差异无统计学意义(P>0.05)。治疗1个月后,两组患者组内比较RBC、Hb、Hct、EPO、SF、TRF、TSAT较治疗前上升,HePc较治疗前下降(P<0.05)。治疗3、6个月两组内比较RBC、Hb、Hct、EPO、SF、TRF、TSAT较治疗前进一步升高(P<0.05);组间比较,罗沙司他组RBC、Hb、Hct、SF、TRF高于促红素组(P<0.05),EPO低于促红素组(P<0.05),TSAT两组间比较差异无统计学意义(P>0.05)。治疗3、6个月HePc在两组进一步下降(P<0.05),组间比较罗沙司他组比促红素组下降更加明显(P<0.05)。治疗1个月后CRP和IL-6在罗沙司他组开始下降,与治疗前比较差异有统计学意义(P<0.05),治疗3、6个月与治疗1个月变化不大(P>0.05),而促红素组CRP和IL-6治疗1、3、6个月无明显变化(P>0.05)。WBC在治疗1、3、6个月与治疗前变化不大(P>0.05)。两组患者不良反应发生率的差异无统计学意义(P>0.05)。结论与rhEPO比较,罗沙司他治疗初始血液透析肾性贫血的患者临床疗效良好,可更有效改善患者贫血、调节体内铁代谢、降低炎症因子水平且安全性好。

Objective To compare the clinical efficacy and safety of roxadustat versus recombinant human erythropoietin(rhEPO)for renal anemia in initial hemodialysis patients.Methods From January 2020 to June 2021,retrospective analysis was performed for 107 patients with renal anemia on hemodialysis.They were assigned to two groups of roxadustat(n=57)and rhEPO(n=50).Both groups received polyferose,methycobal and folic acid.For comparing the clinical efficacy and safety of two groups,the changes of red blood cell(RBC),hemoglobin(Hb),hematocrit(Hct),erythropoietin(EPO),serum ferrin(SF),transferrin(TRF),transferrin saturation(TSAT),hepcidin(HePc),white blood cell(WBC),inflammatory factor including C-reactive protein(CRP)and interleukin-6(IL-6)were recorded at Month 1/3/6 post-treatment.The incidences of side effects within 6 months were analyzed.Results At the beginning,no significant inter-group differences existed in RBC,Hb,HCT,EPO,SF,TRF,TSAT,HEPC,WBC,CRP or IL-6(P>0.05).After 1-month treatment,RBC,Hb,HCT,EPO,SF,TRF and TSAT spiked while HePc declined in two groups(P<0.05).After 3/6-month treatment,RBC,Hb,HCT,EPO,SF,TRF and TSAT in two groups were higher than those at the beginning and there were significant inter-group differences(P<0.05);RBC,Hb,Hct,SF and TRF were higher in roxadustat group than in erythropoietin group(P<0.05).However,EPO was lower and TSAT showed no significant inter-group difference(P>0.05).HePc dropped further in both groups and decrease of HePc was more marked in roxadustat group than that in rythropoietin group(P<0.05).After 1-month treatment,CRP and IL-6 declined in roxadustat group and the values varied markedly from previously(P<0.05).The changes were slight at Month 3/6(P>0.05)while CRP and IL-6had no significant change in erythropoietin group at Month 1/3/6(P>0.05)and there were significant inter-group differences(P<0.05).WBC had no obvious changes at Month 6(P>0.05)and there was no significant inter-group difference(P>0.05).The incidence of adverse reactions showed no significant inter-group difference(P>0.05).Conclusion As compared with rhEPO,roxadustat offers a better clinical efficacy for patients with renal anemia on initial hemodialysis.It can more effectively and safely improve renal anemia,modulate iron metabolism and lower the level of inflammatory factors.