基于促红细胞生成素、白细胞介素-6水平及血红蛋白治疗前后最大差值变化评价罗沙司他在血液透析肾性贫血患者的应用疗效与安全性

    Efficacy and safety of roxadustat in hemodialysis patients with renal anemia based upon the changes of erythropoietin, interleukin-6 and △Hbmax

    • 摘要:
      目的  基于促红细胞生成素(erythropoietin,EPO)、白介细胞素-6(interleukin 6,IL-6)水平及血红蛋白治疗后实测值与基线值的最大差(△Hbmax)值变化评价罗沙司他在血液透析(hemodialysis,HD)肾性贫血患者的应用疗效与安全性。
      方法  选取2020年1月至2021年12月在张家口市第一医院进行诊治的HD肾性贫血患者共计80例为研究对象,依据简单数字表法将其分为对照组(n = 40)和观察组(n = 40)。给予对照组重组人促红素注射液治疗,给予观察组罗沙司他胶囊治疗,两组均治疗8周。对比两组治疗前后贫血指标、炎症因子指标、△Hbmax值变化以及治疗期间不良反应发生情况。
      结果  治疗后两组红细胞计数(red blood cell count,RBC)、血红蛋白(hemoglobin,Hb)、红细胞压积(hematocrit,Hct)、EPO均高于治疗前,并且观察组高于对照组(P<0.05)。治疗后两组C反应蛋白(c-reactive protein,CRP)、IL-6、肿瘤坏死因子-α(tumor necrosis factor-α,TNF-α)均低于治疗前,并且观察组低于对照组(P<0.05)。观察组中0 g/L<△Hbmax≤10 g/L的占比低于对照组,△Hbmax值>30 g/L的占比高于对照组(P<0.05)。治疗期间观察组不良反应总发生率为7.50%,低于对照组的22.50%,但组间差异无统计学意义(P>0.05)。
      结论  HD肾性贫血患者应用罗沙司他治疗可有效改善机体贫血症状,同时抑制机体炎症反应,且安全性良好。

       

      Abstract:
      Objective  To evaluate the efficacy and safety of roxadustat in hemodialysis (HD) patients with renal anemia based upon the changes of erythropoietin (EPO), interleukin-6 (IL-6) and △Hbmax.
      Methods  A total of 80 HD patients with renal anemia diagnosed and treated from January 2020 to December 2021 were selected as research subjects. They were assigned into two groups of observation and control group (n=40 each) according to the simple number table method. Control group received an injection of recombinant human erythropoietin while observation group had roxadustat capsules. Both groups were treated for 8 weeks. The parametric changes of anemia, inflammation and occurrence of adverse reactions during treatment were compared between two groups.
      Results  After treatment, red blood cell count (RBC), hemoglobin (Hb), hematocrit (Hct) and EPO in two groups were higher than those before treatment. And observation group was higher than control group (P<0.05). After treatment, C-reactive protein (CRP), IL-6 and tumor necrosis factor-α (TNF-α) in two groups were lower than those before treatment. And observation group was lower than control group (P<0.05). The proportion of 0 g/L<△Hbmax≤10 g/L was lower in observation group than that in control group; the proportion of △HbmaX >30 g/L was higher than that in control group (P<0.05). During treatment, overall incidence of adverse reactions was lower in observation group than that in control group (7.50% vs 22.50%). However, there was no significant inter-group difference (P>0.05).
      Conclusions  Dosing of roxadustat in HD patients with renal anemia can effectively improve the symptoms of anemia and suppress the inflammatory response of body. And safety profile is excellent.

       

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