罗沙司他、重组人促红细胞生成素治疗非透析3~5期慢性肾脏病伴肾性贫血的临床对比研究  

Clinical comparative study of roxadustat and recombinant human erythropoietin in the treatment of non-dialysis stage 3 to 5 chronic kidney disease and renal anemia

作　　者：陈橙[1] 童天夫 徐立春 杨凯 张启杰 Chen Cheng;Tong Tianfu;Xu Lichun;Yang Kai;Zhang Qijie(Department of Nephrology,Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University,Nanjing 210000,China;Department of Laboratory Medicine,Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University,Nanjing 210000,China;Department of Pharmacy,Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University,Nanjing 210000,China;Department of Cardiology,Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University,Nanjing 210000,China)

机构地区：[1]东南大学附属中大医院江北院区肾内科,南京210000 [2]东南大学附属中大医院江北院区检验科,南京210000 [3]东南大学附属中大医院江北院区药剂科,南京210000 [4]东南大学附属中大医院江北院区心内科,南京210000

出　　处：《中国医师进修杂志》2023年第11期966-971,共6页Chinese Journal of Postgraduates of Medicine

摘　　要：目的比较研究罗沙司他、重组人促红细胞生成素(rhEPO)治疗非透析3~5期慢性肾脏病(CKD)伴肾性贫血(RA)的临床疗效。方法前瞻性选取2020年1月至2022年10月东南大学附属中大医院江北院区收治的108例非透析3~5期CKD伴RA患者,采用随机数字表法分为A组和B组各54例。A组采用罗沙司他联合多糖铁复合物(PIC)治疗,B组采用rhEPO联合PIC治疗,均持续治疗3个月。比较两组临床疗效和治疗前后血红蛋白(Hb)、红细胞计数(RBC)、红细胞压积(Hct)、铁蛋白(SF)、转铁蛋白饱和度(TSAT)、转铁蛋白(TRF)、尿素氮(BUN)、血清肌酐(Scr)、β2-微球蛋白(β2-MG)水平和治疗期间不良反应发生率。结果A组治疗总有效率显著高于B组[87.04%(47/54)比70.37%(38/54)],差异有统计学意义(P<0.05);治疗后,A组RBC、Hb、Hct水平均显著高于B组[(3.47±0.59)×10^(12)/L比(2.60±0.51)×10^(12)/L、(110.45±12.97)g/L比(93.64±10.58)g/L、(0.358±0.054)比(0.303±0.043)],差异有统计学意义(P<0.05);A组TSAT、SF、TRF水平均显著高于B组[(35.17±3.65)%比(29.82±3.10)%、(286.74±17.23)μg/L比(243.16±15.49)μg/L、(2.76±0.45)g/L比(2.40±0.32)g/L],差异有统计学意义(P<0.05);A组BUN、Scr、β2-MG水平均显著低于B组[(3.98±0.41)mmol/L比(4.36±0.54)mmol/L、(62.57±7.89)μmol/L比(80.34±9.65)μmol/L、(1.50±0.42)μg/L比(1.99±0.58)μg/L],差异有统计学意义(P<0.05);A组治疗期间不良反应发生率显著低于B组[11.11%(6/54)比25.93%(14/54)],差异有统计学意义(P<0.05)。结论罗沙司他治疗非透析3~5期CKD伴RA的疗效优于rhEPO,可有效缓解患者贫血状态,改善铁代谢状况,安全性好。Objective To compare the clinical curative effect of roxadustat and recombinant human erythropoietin(rhEPO)on non-dialysis stage 3 to 5 chronic kidney disease(CKD)combined with renal anemia(RA).Methods A total of 108 patients with non-dialysis stage 3 to 5 CKD and RA admitted to Jiangbei Branch of Zhongda Hospital Affiliated to Southeast University were prospectively enrolled between January 2020 and October 2022.According to random number table method,they were divided into group A and group B,54 cases in each group.The group A was treated with roxadustat and polysaccharide-iron complex(PIC)for 3 months,while group B was treated with rhEPO and PIC for 3 months.The clinical curative effect,levels of hemoglobin(Hb),red blood cell count(RBC),hematocrit(Hct),serum ferritin(SF),transferrin saturation(TSAT),transferrin(TRF),blood urea nitrogen(BUN),serum creatinine(Scr)andβ2-microglobulin(β2-MG)before and after treatment,and the incidence of adverse reactions during treatment in the two groups were compared.Results The total response rate of treatment in group A was significantly higher than that in group B:87.04%(47/54)vs.70.37%(38/54),and the difference was statistically significant(P<0.05).After treatment,levels of RBC,Hb and Hct in group A were significantly higher than those in group B:(3.47±0.59)×10^(12)/L vs.(2.60±0.51)×10^(12)/L,(110.45±12.97)g/L vs.(93.64±10.58)g/L,0.358±0.054 vs.0.303±0.043,and the difference was statistically significant(P<0.05).The levels of TSAT,SF and TRF in group A were significantly higher than those in group B:(35.17±3.65)%vs.(29.82±3.10)%,(286.74±17.23)μg/L vs.(243.16±15.49)μg/L,(2.76±0.45)g/L vs.(2.40±0.32)g/L,and the difference was statistically significant(P<0.05).The levels of BUN,Scr andβ2-MG in group A were significantly lower than those in group B:(3.98±0.41)mmol/L vs.(4.36±0.54)mmol/L,(62.57±7.89)μmol/L vs.(80.34±9.65)μmol/L,(1.50±0.42)μg/L vs.(1.99±0.58)μg/L,and the difference was statistically significant(P<0.05).During treatment,incidence of ad

关 键 词：慢性肾病-矿物质和骨骼疾病 罗沙司他 重组红细胞生成素 肾性贫血 疗效 

分 类 号：R692[医药卫生—泌尿科学] R556[医药卫生—外科学]