中国现代医学杂志2025,Vol.35Issue(15):23-30,8.DOI:10.3969/j.issn.1005-8982.2025.15.004
不同起始剂量罗沙司他在糖尿病肾病合并肾性贫血患者中的疗效
Efficacy of different starting doses of Roxadustat in patients with diabetic nephropathy complicated by renal anemia
摘要
Abstract
Objective To compare the efficacy and safety of three different starting doses of Roxadustat for treating renal anemia in diabetic nephropathy(DN)patients undergoing maintenance hemodialysis(MHD).Methods One hundred and four MHD patients with DN complicated by renal anemia were enrolled between January 2023 and November 2024.Using envelope randomization,patients were assigned to a low-dose group(n=35),medium-dose group(n=35),or standard-dose group(n=34).Doses were adjusted based on hemoglobin(Hb)levels over 12 weeks.Clinical efficacy,anemia indicators(Hb,red blood cell count[RBC],hematocrit[Hct]),renal function(Scr,estimated glomerular filtration rate[eGFR]),iron metabolism(serum iron[SI],ferritin[Fer],total iron binding capacity[TIBC],transferrin saturation[TSAT]),lipid metabolism(TC,TG),dose adjustments,and adverse events were recorded.Results No significant differences in total treatment efficacy rates were observed among the groups(P>0.05).Baseline and post-treatment levels of Hb,RBC,Hct,SI,Fer,TIBC,TSAT,Scr,eGFR,TC,and TG showed no significant differences between groups(P>0.05).After 12 weeks,Hb,RBC,Hct,SI,TIBC,and TSAT significantly increased from baseline in all groups(P<0.05),while Fer,TC,and TG significantly decreased(P<0.05).Dose reductions occurred in 8(23.53%)standard-dose patients and 1(2.86%)medium-dose patient;4(11.43%)low-dose patients required dose increases.Total dose adjustment rates,adjustment amounts,and final total doses differed significantly among groups(P<0.05).No significant difference was found in the total incidence of adverse events(P>0.05).Conclusion Low and medium starting doses of Roxadustat are as effective as the standard dose in treating renal anemia in MHD patients with DN.They positively influence iron and lipid metabolism,demonstrate comparable efficacy and safety,exhibit good tolerance,and require minimal dose adjustments.关键词
糖尿病肾病/肾性贫血/罗沙司他/维持性血液透析/起始剂量Key words
diabetic nephropathy/renal anemia/Roxadustat/maintenance hemodialysis/initial dose分类
医药卫生引用本文复制引用
张颖,徐燕,胡淑阳,燕雪..不同起始剂量罗沙司他在糖尿病肾病合并肾性贫血患者中的疗效[J].中国现代医学杂志,2025,35(15):23-30,8.基金项目
江苏省科技计划专项资金社会发展面上项目(No:BE2022825) (No:BE2022825)