基于真实世界数据评价罗沙司他治疗维持性透析肾性贫血患者的有效性和安全性  

Evaluation of the efficacy and safety of roxadustat in the treatment of patients with maintenance dialysis renal anemia based on real-world data

作　　者：龚卫卫 朱龙驯 陈向凡 陈霞[1] 丰攀峰 唐莲 Wei-Wei GONG;Long-Xun ZHU;Xiang-Fan CHEN;Xia CHEN;Pan-Feng FENG;Lian TANG(Department of Pharmacy,Nantong First People's Hospital,Nantong 226001,Jiangsu Province,China)

机构地区：[1]南通市第一人民医院药剂科,江苏南通226001

出　　处：《药物流行病学杂志》2023年第8期849-855,共7页Chinese Journal of Pharmacoepidemiology

基　　金：南通市卫生健康委员会科研项目(QA2021006);江苏省药学会-恒瑞药学服务专项科研资助项目(H202113);江苏省药学会-奥赛康医院药学科研基金项目(A202235);南通市卫生和计划生育委员会科研课题计划资助项目(QA2020006)。

摘　　要：目的比较罗沙司他与促红细胞生成素(EPO)治疗维持性透析肾性贫血患者的临床疗效与安全性。方法采用前瞻性队列研究设计,选取2020年12月—2021年12月就诊于南通市第一人民医院肾内科使用罗沙司他或EPO治疗的肾性贫血伴或不伴慢性心功能不全的维持性透析患者,比较肾性贫血患者使用罗沙司他或EPO治疗1个月、3个月及6个月后血红蛋白(Hb)、血清铁蛋白(SF)水平,及用药6个月患者心血管系统不良反应发生情况。结果共纳入142例患者,其中罗沙司他组75例,EPO组67例。两组患者基线期年龄、性别、体重、透析方式与持续时间、既往EPO用量、Hb水平、SF水平、转铁蛋白饱和度、心功能分级及血压水平差异均无统计学意义(P>0.05)。治疗1个月、3个月和6个月后,两组患者的Hb水平均较基线期升高(P<0.05);且治疗1个月后,罗沙司他组Hb水平明显高于EPO组(P<0.05),而治疗3个月、6个月后,两组的Hb水平差异无统计学意义(P>0.05)。治疗后,两组的SF水平、心脑血管系统不良反应发生率等指标差异均无统计学意义(P>0.05)。结论与EPO相比,罗沙司他在初始治疗阶段更具优势,可快速升高Hb水平。罗沙司他与EPO的心血管安全性相当。Objective To compare the clinical efficacy and safety of roxadustat and erythropoietin(EPO)in the treatment of patients with maintenance dialysis renal anemia.Methods A prospective cohort study was conducted to collect patients with maintenance dialysis renal anemia with or without chronic heart failure who were treated with roxadustat or EPO in the nephrology department of Nantong First People's Hospital from December 2020 to December 2021.The levels of hemoglobin(Hb)and serum ferritin(SF)in patients with renal anemia after 1 month,3 months and 6 months of treatment with roxadustat or EPO,and the adverse reactions of cardiovascular system in patients in 6 months of treatment were compared.Results A total of 142 patients were included,including 75 patients in the roxadustat group and 67 patients in the EPO group.There was no significant difference between two groups in age,sex,weight,dialysis mode and duration,previous EPO dosage,Hb level,SF level,transferrin saturation(TSAT),cardiac function grading and blood pressure level at baseline(P>0.05).After 1 month,3 months,and 6 months of treatment,the levels of Hb of both groups increased compared to the baseline period(P<0.05).Compared with the EPO group,the level of Hb in the roxadustat group was significantly higher after 1 month of treatment(P<0.05),and there was no significant difference between two groups after 3 or 6 months of treatment(P>0.05).There was no significant difference in SF level and the incidence of adverse reactions of cardiocerebrovascular system between two groups(P>0.05).Conclusion Roxadustat has obvious advantages in the initial treatment stage compared with EPO,which can rapidly increase the Hb level.The cardiovascular safety of roxadustat is equivalent to EPO.

关 键 词：罗沙司他 促红细胞生成素 肾性贫血 维持性透析 有效性 心血管安全性 真实世界研究 

分 类 号：R969.3[医药卫生—药理学] R692.5[医药卫生—药学]