机构地区:[1]Department of Nephrology,Zhongda Hospital Southeast University,Nanjing,Jiangsu 210009,China [2]Department of Nephrology,Ruijin Hospital Shanghai Jiaotong University School of Medicine,Shanghai 200025,China [3]Department of Nephrology,Xinqiao Hospital of Army Medical University,Chongqing 400037,China [4]Department of Nephrology,First Affiliated Hospital of Xi'an liaotong University,Xi'an,Shaanxi 710061,China [5]Department of Nephrology,Southwest Hospital of Army Medical University,Chongqing 400039,China [6]Department of Nephrology,Jiangsu Provincial Hospital,Nanjing,Jiangsu 210036,China [7]Department of Nephrology,Xinhua Hospital Affiliated to Shanghai丨iao Tong University School of Medicine,Shanghai 200092,China [8]Department of Nephrology,Guangzhou First People's Hospital,Ciuaiigzhou,Guangdong 510180,China [9]Department of Nephrology,Peking University People's Hospital,Beijing 100044,China [10]Department of Nephrology,Shandong Provincial Hospital,linan,Shandong 250021,China [11]Department of Nephrology,Shanghai Fifth People's Hospital,Fudan University,Shanghai 200240,China [12]Department of Nephrology,West China Hospital,Sichuan University,Chengdu,Sichuan 610041,China [13]Department of Nephrology,Henji Hospital Shanghai Jiaotong University School of Medicine,Shanghai 200001,China [14]Department of Nephrology,Nanfang Hospital Southern Medical University,Guangzhou,Guangdong 510510,China [15]Department of Nephrology,The Second Hospital of Dalian Medical University,Dalian,Liaoning 116023,China [16]Department of Nephrology,Huashan Hospital,Fudan University,Shanghai 200040,China [17]Department of Nephrology,Peking University First Hospital,Beijing 100034,China [18]Department of Nephrology,Guangdong Provincial People's Hospital,Guangzhou,Guangdong 510080,China [19]Department of Nephrology,The First Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou,Zhejiang 310003,China [20]Department of Nephrology,China-Japan Friendship Hospital,Beijing 100029,China [21]Department of Nephrology,Tongji Hospital Ton
出 处:《Chronic Diseases and Translational Medicine》2022年第2期134-144,共11页慢性疾病与转化医学(英文版)
摘 要:Background:This study was to explore the clinical efficacy and safety of darbepoetin alfa injection replacing epoetin alfa injection(recombinant human erythropoietin injection,rHuEPO)for the treatment of anemia associated with chronic kidney failure in Chinese patients undergoing hemodialysis.Method:This study was a multicenter,randomized,open-label,intergroup parallel control phase III noninferiority trial from April 19,2013 to September 9,2014 at 25 sites.In this study,the members of the darbepoetin alfa group underwent intravenous administration once per week or once every two weeks.The members of the control drug epoetin alfa group underwent intravenous administration two or three times per week.All subjects underwent epoetin alfa administration during the 8-week baseline period.After that,subjects were randomly assigned to the darbepoetin alfa group or epoetin alfa group.The noninferiority in the changes of the average Hb concentrations from the baseline to the end of the evaluation period(noninferiority threshold:-1.0 g/dl)was tested between the two treatments.The time-dependent hemoglobin(Hb)concentration and the maintenance rate of the target Hb concentration(the proportion of subjects with Hb concentrations between 10.0 and 12.0 g/dl)were also evaluated.Iron metabolism,including changes in the serum iron,total iron-binding capacity,ferritin,transferrin saturation,and comparisons of the dose adjustments between the two groups during the treatment period were analyzed further.Adverse events(AEs)were also observed and compared,and the safety was analyzed between the two treatment groups.The conversion rate switching from epoetin alfa to darbepoetin alfa was also discussed.SAS?software version 9.2 was used to perform all statistical analyses.Descriptive statistics were used for all efficacy,safety,and demographic variable analyses,including for the primary efficacy indicators.Results:Four hundred and sixty-six patients were enrolled in this study,and ultimately 384 cases were analyzed for safety,including 26
关 键 词:ANEMIA conversion ratio darbepoetin alfa epoetin alfa HEMODIALYSIS
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