基于罗沙司他改善腹膜透析患者肾性贫血的真实世界研究  

Real world study based upon Roxadustat for improving renal anemia in peritoneal dialysis patients

作　　者：罗雨轻 许清玉[1] 姬利珂 朱琼杰 师晶晶 郭明好[1] Luo Yu-qing;Xu Qing-yu;Ji Li-ke;Zhu Qiong-jie;Shi Jing-jing;Guo Ming-hao(Department of Nephrology,The First Affiliated Hospital of Xinxiang Medical University,Weihui 453100,China)

机构地区：[1]新乡医学院第一附属医院肾内科,卫辉453100

出　　处：《临床肾脏病杂志》2023年第4期313-319,共7页Journal Of Clinical Nephrology

基　　金：河南省医学科技攻关计划联合共建项目(LHGJ20200494)。

摘　　要：目的观察真实世界中罗沙司他相较于重组人促红细胞生成素在治疗腹膜透析伴有肾性贫血患者的临床疗效。方法选取2020年10月至2021年10月规律就诊于新乡医学院第一附属医院肾内科的腹膜透析患者83例,按照治疗方式不同分为对照组(重组人促红细胞生成素组39例)和实验组(罗沙司他组44例)。对照组患者予以皮下注射重组人促红细胞生成素每周100~150 IU/kg,分3次注射。实验组患者予以口服罗沙司他胶囊,具体服药剂量按体重服用,体重<60 kg的患者100 mg/次;体重≥60 kg的患者120 mg/次,每周3次。开始随访时,患者每4周复查1次血常规,在随访的第12周及第24周复查铁代谢及生化等相关实验室指标,总治疗周期为24周。观察两组患者开始治疗后贫血、铁代谢及生化等指标的变化。结果经过为期24周的随访,实验组44例及对照组39例完成了本研究。第24周时,实验组患者的血红蛋白水平[(120.02±17.79)g/L比(113.13±9.40)g/L]高于对照组,差异有统计学意义(P=0.028)。随访结束时,实验组患者转铁蛋白[(2.86±0.57)g/L比(2.17±0.37)g/L,P<0.001]、血清铁[(19.94±5.11)μmol/L比(15.52±7.46)μmol/L,P=0.002]、总铁结合力[(61.29±16.77)μmol/L比(54.68±12.50)μmol/L,P=0.047]高于对照组,而转铁蛋白饱和度[(12.67±4.30)%比(20.64±6.56)%,P<0.001]明显低于对照组,两组铁蛋白水平比较差异无统计学意义(P=0.743)。实验组患者总胆固醇[(3.45±0.90)mmol/L比(4.42±0.99)mmol/L,P<0.001]、三酰甘油[(0.95±0.30)mmol/L比(1.24±0.59)mmol/L,P=0.007]显著低于对照组。实验组患者的C反应蛋白[0.51(0.23,2.34)mg/L比2.42(0.59,9.89)mg/L,P=0.001]较治疗前明显降低,而对照组较治疗前差异无统计学意义(P=0.968)。在随访的24周内,两组患者的总蛋白、白蛋白、血肌酐、血钾、血磷、血钙相比较,均差异无统计学意义。结论罗沙司他在改善腹膜透析伴有肾性贫血患者的贫血状态、铁代谢�Objective To explore the clinical efficacy of Roxadustat versus recombinant human erythropoietin in peritoneal dialysis(PD)patients with renal anemia in the real world.Methods A total of 90 PD patients regularly visiting from October 2020 to October 2021 were selected.According to different treatment options,they were divided into two groups of control(recombinant human erythropoietin,n=39)and experiment(Roxadustat group,n=44).Control group received a subcutaneous injection of rHuEPO 100-150 IU/kg thrice a week.Experiment group received Roxadustat capsule orally at 100 mg for body weight<60 kg and 120 mg thrice a week for body weight≥60 kg.At the beginning of follow-ups,blood routine was examined every 4 weeks and iron metabolism,biochemical and other laboratory parameters were measured at Week 12/24.The total treatment course was 24 weeks.The improvements of anemia,iron metabolism and biochemical parameters in two groups were recorded.Results After 24-week fol-low-ups,44 cases in experiment group and 39 cases in control group completed this study.At Week 24,hemoglobin(Hb)level of experimental group was significantly higher than that of control group[(120.02±17.79)g/L vs(113.13±9.40)g/L,P=0.028].At the end of follow-ups,the levels of transferrin[(2.86±0.57)g/L vs(2.17±0.37)g/L,P<0.001],serum iron[(19.94±5.11)μmol/L vs(15.52±7.46)μmol/L,P=0.002]and total iron binding capacity[(61.29±16.77)μmol/L vs(54.68±12.50)μmol/L,P=0.047]were higher in experimental group than those in control group while transferrin saturation was significant-ly lower than that in control group[(12.67±4.30)%vs(20.64±6.56)%,P<0.001].No significant inter-group difference existed in ferritin(P=0.743).Total cholesterol[(3.45±0.90)mmol/L vs(4.42±0.99)mmol/L,P<0.001]and triglycerides[(0.95±0.30)mmol/L vs(1.24±0.59)mmol/L,P=0.007]were sig-nificantly lower in experimental group than those in control group.C-reactive protein(CRP)level was sig-nificantly lower in experimental group than that pre-treatment[0.51(0.23,2.34)mg/L vs 2.42(

关 键 词：罗沙司他 促红细胞生成素 腹膜透析 贫血 

分 类 号：R692.5[医药卫生—泌尿科学]