罗沙司他治疗糖尿病肾病并发肾性贫血的疗效及安全性  

Efficacy and safety of roxadustat in treatment of diabetic kidney disease complicated with renal anemia

作　　者：李敬[1] 樊星[1] 王倩 李璐[2] 杜勇 高燕[1] LI Jing;FAN Xing;WANG Qian;LI Lu;DU Yong;GAO Yan(Department of NephrologyⅡ,Affiliated Hospital of Hebei University/Key Laboratory of Bone Metabolism and Physiology in Chronic Kidney Disease of Hebei Province,Baoding HEBEI 071000,China;Department of Rheumatology and Immunology,Affiliated Hospital of Hebei University/Key Laboratory of Bone Metabolism and Physiology in Chronic Kidney Disease of Hebei Province,Baoding HEBEI 071000,China;Department of Nephrology,Baoding No.1 Hospital,Baoding HEBEI 071000,China)

机构地区：[1]河北大学附属医院,河北省慢性肾脏病骨骼代谢生理学重点实验室肾内二科,河北保定071000 [2]河北大学附属医院,河北省慢性肾脏病骨骼代谢生理学重点实验室风湿免疫科,河北保定071000 [3]保定市第一医院肾内科,河北保定071000

出　　处：《中国新药与临床杂志》2023年第5期305-310,共6页Chinese Journal of New Drugs and Clinical Remedies

基　　金：保定市科学技术局计划项目(2041ZF298)。

摘　　要：目的探讨罗沙司他在糖尿病肾病(DN)并发肾性贫血(RA)中的疗效及安全性。方法选择120例DN并发RA患者,按随机数字表法分为观察组与对照组,各60例。观察组采用罗沙司他治疗,根据体重(45~60 kg/≥60 kg)选择剂量,其中非透析者70/100 mg·次^(-1),透析者100/120 mg·次^(-1)。对照组给予人促红素注射液治疗,初始剂量每次50 U·kg^(-1)。2组均每周给药3次,每4周调整1次剂量,连续治疗24周。观察2组临床疗效及安全性。治疗前后检测2组患者贫血指标(血红蛋白、红细胞计数和血细胞比容),铁代谢指标(血清铁、铁蛋白、转铁蛋白、总铁结合力、转铁蛋白饱和度和铁调素),血清低氧诱导通路相关指标[低氧诱导因子(HIF)-1α、HIF-2α、脯氨酰羟化酶2(PHD2)]、白细胞介素(IL)-1β、超氧化物歧化酶(SOD)水平。结果治疗后,观察组总有效率明显高于对照组(95%vs.75%,P<0.05)。治疗后,观察组血红蛋白、红细胞计数、血细胞比容、血清铁、转铁蛋白、总铁结合力、转铁蛋白饱和度、SOD、HIF-1α、HIF-2α水平均显著高于对照组(P<0.05),血清铁蛋白、铁调素、IL-1β、PHD2水平均显著低于对照组(P<0.05)。观察组不良反应发生率明显低于对照组(P<0.05)。结论应用罗沙司他治疗DN并发RA能通过调控低氧诱导通路相关指标表达,较人促红素注射液更有效地改善铁代谢、炎症及氧化应激反应,以缓解患者贫血状况。AIM To explore the efficacy and safety of roxadustat in diabetic nephropathy(DN)complicated with renal anemia(RA).METHODS A total of 120 patients with DN complicated with RA were selected and divided into observation group and control group according to random number table method,with 60 cases in each group.The patients in the observation group were treated with roxadustat,weight 45-60 kg:70 mg per dose for non-dialysis and 100 mg per dose for dialysis;weight≥60 kg:100 mg per dose for non-dialysis and 120 mg per dose for dialysis.While the patients in the control group were treated with recombinant human erythropoietin at an initial dose of 50 U·kg^(-1),once every other day,3 times a week,with dose adjustment every 4 weeks to maintain the hemoglobin at 100-120 g·L^(-1).After 24 weeks of continuous treatment,the clinical efficacy and safety of the two groups were observed.Anemia index(hemoglobin,red blood cell count and red blood cell specific volume),iron metabolism index(serum iron,ferritin,transferrin,total iron binding capacity,transferrin saturation and hepcidin),serum indexes related to hypoxia-induced pathway(hypoxia-inducible factor(HIF)-1lα,HIF-2α,prolyl hydroxylase 2(PHD2)),interleukin-1β(IL-1β)and superoxide dismutase(SOD)levels were evaluated before and after treatment in the two groups.RESULTS After treatment,the total effective rate of the observation group was significantly higher than that of the control group(95%vs.75%,P<0.05).After treatment,the levels of hemoglobin,red blood cell count,red blood cell volume,serum iron,transferrin,total iron binding capacity,transferrin saturation,SOD,HIF-1αand HIF-2αin the observation group were significantly higher than those in the control group(P<0.05).The levels of serum ferritin,hepcidin,IL-1βand PHD2 were significantly lower than those of the control group(P<0.05).The incidence of adverse reactions in the observation group was significantly lower than that in the control group(P<0.05).CONCLUSION Compared with recombinant human erythropoietin,rox

关 键 词：罗沙司他 糖尿病肾病 肾性贫血 铁代谢障碍 低氧诱导通路 白细胞介素1Β 超氧化物歧化酶 

分 类 号：R692[医药卫生—泌尿科学]