罗沙司他在治疗红细胞生成刺激剂(ESAs)低反应性的维持性血液净化(MBP)患者的初步研究

A preliminary study on roxadustat capsules treating patients received maintenance blood purification (MBP) those present low reaction to erythropoietin-stimulating agents(ESAs)

目的 探讨罗沙司他胶囊在治疗红细胞生成刺激剂(ESAs)低反应性(即促红细胞生成素(EPO)抵抗)的维持性血液净化(MBP)患者的疗效。方法 选择2019年1月—2021年3月本院收治的符合诊断为红细胞生成刺激剂(ESAs)低反应性的MBP合并肾性贫血的患者61例作为研究对象,根据患者意愿选择治疗方案,将使用促红细胞生成素(EPO)治疗的31例患者作为对照组,使用罗沙司他治疗的30例患者作为观察组。对照组每周予EPO 300 IU/kg(最大剂量为20000 IU/周),口服多糖铁,增加透析剂量,并将输血作为挽救治疗;观察组则使用罗沙司他胶囊进行治疗,两组均随访治疗3个月。比较两组治疗前及治疗3个月后贫血指标[(血红蛋白浓度(Hb)、红细胞计数(RBC)、红细胞压积(Hct)]、血液生化指标[胱抑素(Cysc)、血清肌酐(Cr)、尿素氮(BUN)、C反应蛋白(CRP)]、铁代谢指标[血清铁(Fe)、铁蛋白(SF)、转铁蛋白饱和度(TSAT)]及各种并发症等数据。结果 两组治疗前Hb、RBC、Hct、Cysc、Cr、BUN、CRP水平比较,差异无统计学意义(P>0.05);治疗3个月后Hb、RBC、Hct水平均高于治疗前,且观察组高于对照组,差异均有统计学意义(均P<0.05)。两组治疗3个月后Cysc、Cr、BUN、CRP水平比较无明显变化,差异无统计学意义(P>0.05)。两组治疗前Fe、SF、TSAT水平比较,差异无统计学意义(P>0.05);治疗3个月后,两组Fe、TSAT水平均高于治疗前,观察组Fe、TSAT水平高于对照组,差异有统计学意义(P<0.05)。两组治疗前后SF无明显差异。观察组不良反应率未高于使用促红细胞生成素(EPO)组,差异无统计学意义(P>0.05)。结论 罗沙司他胶囊在红细胞生成刺激剂(ESAs)低反应性(即促红细胞生成素(EPO)抵抗)的维持性血液净化患者中可显著提高血红蛋白浓度,纠正贫血症状,改善铁代谢,安全性较高,有较高的临床应用价值。

Objective To investigate the therapeutic effect of roxadustat capsules in treating maintenance blood purification(MBP) patients present low reaction to erythropoietin-stimulating agents(ESAs)(i.e. Erythropoietin(EPO) resistance).Methods A total of 61 patients suffered with MBP renal anemia those present low reaction to erythropoietin-stimulating agents(ESAs) in the hospital of traditional Chinese medicine of Meizhou city from January 2019 to march 2021 were enrolled as study subjects. According to the patients’ decision, the patients were divided into erythropoietin group and Roxadustat group. 31 patients in control group were treated with erythropoietin(EPO) at the dose of 300 IU/kg(maximum dose of 20 000 IU/week), oral administrated with polysaccharide iron, increase dialysis dose and blood transfusions was used as salvage treatment. While 30 patients in the observation group were treated with Roxadustat capsules. They were treated for 3 months. Anemia indicators [hemoglobin(Hb),red blood cell count(RBC), hematocrit(Hct)], blood biochemical indicators [serum cystatin C(Cysc), serum creatinine(Cr), blood urea nitrogen(BUN), C-reactive protein(CRP), iron metabolism indicators [serum iron(Fe), serum ferritin(SF), transferrin saturation(TSAT)] and various complications were compared between two groups before and after 3 months of treatment.Results There was no significant difference in the levels of Hb, RBC, Hct, Cysc, Cr, BUN and CRP between the two groups before treatment(P>0.05). After 3 months of treatment, the levels of Hb, RBC and Hct in both two groups were significantly higher than those before treatment, and the those of Roxadustat group were higher than the erythropoietin group, and the differences were statistically significant(all P<0.05). There were no significant differences in the levels of Cysc, Cr, BUN and CRP between the two groups after 3 months treatment(P>0.05). There were no significant differences in the levels of Fe, SF and TSAT between the two groups before treatment(P>0.05). After 3 months of treatment, the levels of Fe and TSAT in both groups were higher than those before treatment, and those in the Roxadustat group were higher than those in the erythropoietin group, withstatistical significance(allP<0.05). There was no significant difference in SF between the two groups before andafter treatment. The adverse reaction rate in the Roxadustat group was no higher than that in the erythropoietingroup, and the difference was not statistically significant(P> 0.05).Conclusions Roxadustat capsules couldsignificantly increase hemoglobin concentration, correct anemia symptoms and improve iron metabolism inmaintenance blood purification patients those present low reaction to erythropoietin-stimulating agents(ESAs),which has high safety and high clinical application value.