ISSN 1006-298X      CN 32-1425/R

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肾脏病与透析肾移植杂志 ›› 2021, Vol. 30 ›› Issue (3): 222-227.DOI: 10.3969/j.issn.1006298X.2021.03.006

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罗沙司他治疗腹膜透析肾性贫血的有效性及安全性分析

  

  • 出版日期:2021-06-28 发布日期:2021-06-22

Efficacy and safety of Roxadustat for renal anemia in patients undergoing peritoneal dialysis

  • Online:2021-06-28 Published:2021-06-22

摘要: 目的:观察罗沙司他治疗腹膜透析(PD)肾性贫血患者的有效性及安全性。
方法:回顾性分析2019年6月至2020年2月国家肾脏疾病临床医学研究中心口服罗沙司他的PD患者为罗沙司他组,按照1∶1比例随机选取皮下注射重组人促红细胞生成素(rHuEPO)的PD患者为对照组,分析两组患者的一般资料、血红蛋白(Hb)、铁代谢指标、炎症指标、脂代谢指标、不良反应等,所有患者至少完成随访时间1年。
结果:共收集罗沙司他组34例,对照组34例,两组患者基线临床资料及实验室指标无统计学差异,罗沙司他组基线平均Hb(853±114) g/L。两组患者经治疗后使Hb维持在110~120 g/L,1年后 Hb较基线值均显著升高,两组患者Hb无明显差异(P=0081),但与对照组相比,罗沙司他组患者的铁代谢指标、脂代谢指标、炎症指标、平均动脉压(MAP)、空腹血糖优于对照组(P<005)。与基线相比,罗沙司他治疗1年后血清铁、转铁蛋白饱和度(TSAT)和铁蛋白降低,总铁结合力升高(P<005)。罗沙司他组患者不同炎症状态下Hb无明显变化,而对照组炎症指标高的患者Hb更低(P<005)。罗沙司他组血压升高发生率低于对照组(0 vs 235%,P=0005)。
结论:罗沙司他治疗PD肾性贫血疗效不低于rHuEPO,其疗效不受炎症状态影响,且可改善脂代谢、糖代谢和炎症指标,对血压影响较小,故具有较好的疗效及安全性。


关键词: 罗沙司他,腹膜透析,肾性贫血,铁代谢,炎症指标

Abstract: Objective:To observe the efficacy and safety of Roxadustat in treatment of renal anemia in peritoneal dialysis(PD) patients.
Methodology:PD patients with renal anemia who were treated with Roxadustat(Roxadustat group) recruited from June 2019 to February 2020 were retrospectively analyzed. PD patients who were treated with recombinant human erythropoietin(rHuEPO) by subcutaneous injection therapy were randomly enrolled in a 1∶1 ratio as control group. Clinical characteristics, hemoglobin(Hb), iron metabolism index, inflammatory index, lipid metabolism index and adverse events in the two groups were analyzed. All patients were completely followed up for at least 1 year.
Results:A total of 34 PD patients in roxadustat group and 34 PD patients in rHuEPO group were collected. There were no significant differences in baseline clinical data and laboratory values between the two groups. The baseline Hb in Roxadustat group was 853±114 g/L.Drug doses were adjusted to reach a Hb level of 110 to 120 g per liter in both groups. After 1 year of treatment, Hb in both groups was significantly higher than the baseline value.There was no significant difference in Hb levels between the two groups after 1year treatment(P=0081). However, compared with control group, Roxadustat group had improved iron metabolism, lipid metabolism and inflammation indexes, better MAP and fasting blood glucose.Compared with the baseline, serum iron, transferrin safuration (TSAT) and ferritin decreased, total ironbinding capacity increased after 1year of Roxadustat treatment (P<005). There was no significance in Hb between different inflammatory indexes based on CRP levels in Roxadustat group, but it had a less increase of Hb among patients with elevated CRP levels in control group (P<005). The incidence of elevated blood pressure in Roxadustat group was lower than that in control group (0 vs 235%, P=0005).
Conclusion:Roxadustat effectively corrected anemia not less than rHuEPO in PD patients, and improved iron metabolism, lipid metabolism,glycometabolism and inflammatory indexes. Inflammation state did not affect the efficacy of Roxadustat. Therefore, Roxadustat has good efficacy and safety in PD patients.


Key words: Roxadustat, peritoneal dialysis, renal anemia, iron metabolism, inflammatory index