罗沙司他治疗维持性血液透析肾性贫血患者的临床研究  

Clinical trial of roxadustat in the treatment of maintenance hemodialysis patients with renal anemia

作　　者：王金宝 黄琳 张卫东 WANG Jin-bao;HUANG Lin;ZHANG Wei-dong(Blood Purification Center,The First Affiliated Hospital of Wannan Medical College,Wuhu 241000,Anhui Province,China)

机构地区：[1]皖南医学院第一附属医院血液净化中心,安徽芜湖241000

出　　处：《中国临床药理学杂志》2024年第2期180-184,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探讨罗沙司他与重组人红细胞生成素(rHuEPO)治疗维持性血液透析(MHD)肾性贫血(RA)患者临床疗效及微炎症反应。方法回顾性分析尿毒症MHD RA患者。对照组给予rHuEPO 120 U·kg^(-1)的剂量皮下注射,蔗糖铁注射液100 mg,血液透析2 h后由透析器静脉端缓慢滴入大于30 min,每周1次;试验组在对照组的基础上给予罗沙司他胶囊治疗,起始剂量100 mg,每周3次均持续治疗3个月。比较2组患者的临床疗效和治疗前后血红蛋白(Hb)、血细胞比容(Hct)、尿素氮(BUN)、血清肌酸酐(SCr)、铁蛋白(SF)、转铁蛋白饱和度(TSAT)、转铁蛋白(TRF)、中性粒细胞绝对值/淋巴细胞绝对值(NLR)、血小板绝对值/淋巴细胞绝对值(PLR)和超敏C反应蛋白(hs-CRP)水平,以及药物不良反应的发生情况。结果试验组和对照组分别纳入32例和28例。治疗后试验组和对照组的总有效率分别为93.75%(30例/32例)和75.00%(21例/28例),在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的Hb分别为(113.64±12.58)和(104.39±11.67)g·L^(-1),Hct分别为(31.51±4.33)%和(28.72±5.47)%,TSAT分别为(21.11±1.26)%和(19.57±1.29)%,SF分别为161.25±7.91)和(210.68±9.02)ng·mL^(-1),TRF分别为(13.06±1.29)和(16.57±1.45)g·L^(-1),BUN分别为(21.90±4.41)和(24.37±3.51)mmol·L^(-1),Scr分别(862.56±97.81)和(980.30±99.67)μmol·L^(-1),NLR分别为(1.30±0.29)%和(2.01±0.41)%,PLR分别为(86.57±16.55)%和(104.82±26.31)%,hs-CRP水平分别为(4.82±0.36)和(6.57±0.55)mg·L^(-1)。试验组的上述指标除BUN和Scr外与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有消化道反应、肝功能损伤,对照组的药物不良反应主要有血钾升高、消化道反应、肝功能损伤;试验组和对照组的总药物不良反应发生率分别12.50%和21.43%,在统计学上差异无统计学意义(P>0.05)。结论罗沙司他可有效提高尿毒症MHD RA患者的疗效Objective To investigate the clinical efficacy and microinflammatory response of roxadustat and recombinant human erythropoietin(rHuEPO)in the treatment of renal anemia(RA)in maintenance hemodialysis(MHD).Methods MHD RA patients with uremia were analyzed retrospectively.The control group was given subcutaneous injection of 120 U·kg^(-1)rHuEPO and iron sucrose inje ct ion 100 mg.After 2 h of hemodialysis,rHuEPO was slowly dropped into the intravenous end of the dialyser for more than 30 min,once a week.The treatment group was additionally treated with roxadustat capsule,starting at 100 mg,3 times a week for 3 months.The clinical efficacy and serum creatinine(Scr),hemoglobin(Hb),hematocrit(Hct),urea nitrogen(BUN),serum creatinine(SCR),ferritin(SF),transferrin saturation(TSAT),transferrin(TRF),centriocyte absolute value/lymphocyte absolute value(NLR)and absolute value of neutrophils/absolute value of lymphocytes(NLR),absolute value of platelets/absolute value of lymphocytes(PLR),and high-sensitivity C-reactive protein(hs-CRP)levels,as well as the occurrence of adverse drug reactions were compared.Results Thirty-two cases were included in the treatment group and twenty-eight cases in the control group.After treatment,the total effective rate of the treatment group and the control group were 93.75%(30 cases/32 cases)and 75.00%(21 cases/28 cases),respectively,and the difference was statistically significant(P<0.05).Hb in treatment group and control group were(113.64±12.58)and(104.39±11.67)g·L^(-1);Hct were(31.51±4.33)%and(28.72±5.47)%;TSAT were(21.11±1.26)%and(19.57±1.29)%,respectively;SF were(161.25±7.91)and(210.68±9.02)ng·mL^(-1);TRF were(13.06±1.29)and(16.57±1.45)g·L^(-1),respectively;BUN were(21.90±4.41)and(24.37±3.51)mmol·L^(-1);Scr were(862.56±97.81)and(980.30±99.67)μmol·L^(-1);NLR were(1.30±0.29)%and(2.01±0.41)%,respectively;PLR levels were(86.57±16.55)%and(104.82±26.31)%,and hs-CRP levels were(4.82±0.36)and(6.57±0.55)mg·L^(-1),respectively.Compared with control group,the above indexe

关 键 词：罗沙司他 重组人红细胞生成素 尿毒症 维持性血液透析 肾性贫血 微炎症反应 

分 类 号：R973[医药卫生—药品]