罗沙司他与促红细胞生成素（EPO）治疗糖尿病肾病患者贫血的疗效比较：一项回顾性队列研究
Effect of Roxadustat versus erythropoietin (EPO) for treating anemia in patients with diabetic kidney disease: a retrospective cohort study.
作者信息
Zhang Lei, Liu Yulu, Huang Ying, Zhao Yuee, Wei Cong, Yang Kexin, Li Xiaohui, Zhang Shumin, Wang Wenpeng, Liu Yu, Liu Fuyou, Sun Lin, Xiao Li
机构信息
Department of Nephrology, Hunan Key Laboratory of Kidney Disease and Blood Purification, The Second Xiangya Hospital, Central South University, Changsha, China.
Department of Nephrology, The First Affiliated Hospital of Zhejiang University, Zhejiang University, Hangzhou, China.
出版信息
Ann Transl Med. 2022 Nov;10(22):1224. doi: 10.21037/atm-22-4344.
BACKGROUND
Renal anemia of diabetic kidney disease (DKD) shows higher incidence rate, earlier onset and higher severity than other chronic kidney disease (CKD). Roxadustat, an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor, improves CKD anemia. This retrospective cohort study evaluates if Roxadustat could effectively treat DKD anemia.
METHODS
DKD anemia patients treated with either Roxadustat or erythropoietin (EPO) for 3 months in two hospitals were enrolled. EPO group were matched 1:1 to Roxadustat group based on age, gender and baseline Hb. Baseline data include age, sex, dialysis, height, weight, hemoglobin (Hb), hematocrit (Hct), serum albumin (ALB), serum creatinine (Scr), eGFR, C-reactive protein (CRP), and intact parathyroid hormone (iPTH). Primary and secondary outcomes were change of Hb (ΔHb) and Hct (ΔHct), Hb response rate and Hb qualified rate. Sensitivity analyses were performed and the effect size were calculated.
RESULTS
No significant differences were observed in body mass index (BMI), Scr, eGFR, Hct, CRP, and dialysis between the 2 groups (61 subjects each). ALB, iPTH, and DKD stage differed between the 2 groups. After 3-month treatment, Roxadustat significantly increased patients' Hb and Hct. Although ΔHb and ΔHct of the Roxadustat group was higher than those of EPO group, difference in the least-square mean changes (95% CI) were 4.9 (-2.4, 12.1) and 1.2 (-1.1, 3.4), while Cohen's d were 0.18 and 0.14, suggesting that Roxadustat's ability to increase Hb within 3-month was similar to EPO. 78.7% and 54.1% of the patients responded to anti-anemia therapy in the Roxadustat and EPO group, respectively. Logistic regression analysis showed the Hb response rate of Roxadustat was 3.30 (1.20, 9.94) times higher than that of EPO. Subgroup analysis suggested that Roxadustat might have better efficacy in treating patients in the advanced stage, with high CRP and iPTH, and low ALB levels.
CONCLUSIONS
In DKD patients, Roxadustat improves renal anemia. Effect of Roxadustat is similar to that of EPO.
背景
糖尿病肾病（DKD）所致肾性贫血的发病率、发病时间及严重程度均高于其他慢性肾脏病（CKD）。罗沙司他是一种口服低氧诱导因子脯氨酰羟化酶抑制剂，可改善CKD贫血。这项回顾性队列研究评估罗沙司他是否能有效治疗DKD贫血。
方法
选取两家医院中接受罗沙司他或促红细胞生成素（EPO）治疗3个月的DKD贫血患者。根据年龄、性别和基线血红蛋白将EPO组与罗沙司他组按1:1匹配。基线数据包括年龄、性别、透析情况、身高、体重、血红蛋白（Hb）、血细胞比容（Hct）、血清白蛋白（ALB）、血清肌酐（Scr）、估算肾小球滤过率（eGFR）、C反应蛋白（CRP）和全段甲状旁腺激素（iPTH）。主要和次要结局指标分别为Hb变化量（ΔHb）和Hct变化量（ΔHct）、Hb反应率和Hb达标率。进行敏感性分析并计算效应量。
结果
两组（每组61例受试者）的体重指数（BMI）、Scr、eGFR、Hct、CRP和透析情况无显著差异。两组的ALB、iPTH和DKD分期有所不同。治疗3个月后，罗沙司他显著提高了患者的Hb和Hct。虽然罗沙司他组的ΔHb和ΔHct高于EPO组，但最小二乘均值变化的差异（95%CI）分别为4.9（-2.4，12.1）和1.2（-1.1，3.4），而Cohen's d分别为0.18和0.14，表明罗沙司他在3个月内升高Hb的能力与EPO相似。罗沙司他组和EPO组分别有78.7%和54.1%的患者对抗贫血治疗有反应。Logistic回归分析显示，罗沙司他的Hb反应率比EPO高3.30（1.20，9.94）倍。亚组分析表明，罗沙司他在治疗晚期、CRP和iPTH水平高以及ALB水平低的患者时可能具有更好的疗效。
结论
在DKD患者中，罗沙司他可改善肾性贫血。罗沙司他的疗效与EPO相似。
Zotero 插件