中国血液净化

中国血液净化 ›› 2026, Vol. 25 ›› Issue (01): 5-10.doi: 10.3969/j.issn.1671-4091.2026.01.002

• 临床研究 • 上一篇    下一篇

恩那度司他在非透析依赖性慢性肾脏病合并肾性贫血患者中的有效性和安全性

卢海静   刘泊吟   董凤鸣    曹熙名    帅 林    王 垚    王 彬    曹婧媛   

  1. 225300 泰州，1南京医科大学附属泰州人民医院肾内科
    226000 南通，2南通大学医学院
    225001 扬州，3扬州大学附属医院肾内科
    210009 南京，4东南大学附属中大医院肾内科

  • 收稿日期:2025-06-05 修回日期:2025-08-19 出版日期:2026-01-12 发布日期:2025-12-31
  • 通讯作者: 曹婧媛 E-mail:caojingyuan1989@163.com
  • 基金资助:
    国家自然科学基金(82100721)；江苏省卫生健康委员会医学科研项目(M2021048)；南京医科大学泰州临床医学院基础研究项目(TZKY20230101)

The efficacy and safety of enarodustat in patients with non-dialysis-dependent chronic kidney disease combined with renal anemia

LU Hai-jing, LIU Bo-yin, DONG Feng-ming, CAO Xi-ming, SHUAI Lin, WANG Yao, WANG Bin, CAO Jing-yuan   

  1. Department of Nephrology, The Affiliated Taizhou People's Hospital of Nanjing Medical University, Taizhou 225300, China; 2Medical School of Nantong University, Nantong 226000, China; 3Department of Nephrology, Affiliated Hospital of Yangzhou University, Yangzhou 225001,  China; 4Institute of Nephrology, Zhongda Hospital Affiliated to Southeast University, Nanjing 210009, China
  • Received:2025-06-05 Revised:2025-08-19 Online:2026-01-12 Published:2025-12-31
  • Contact: 225300 泰州，1南京医科大学附属泰州人民医院肾内科 E-mail:caojingyuan1989@163.com

摘要： 目的   评价恩那度司他在非透析依赖性慢性肾脏病(non-dialysis dependent chronic kidney disease，NDD-CKD)G3～5合并肾性贫血患者中的有效性和安全性。 方法  回顾性收集2024年6月1日—2025年2月1日在南京医科大学附属泰州人民医院接受恩那度司他治疗的NDD-CKD G3～5合并肾性贫血患者的临床资料，比较治疗前后实验室指标的变化，并统计不良反应发生情况。 结果  共纳入89例NDD-CKD G3～5合并肾性贫血的患者，年龄(69±10)岁，其中男性39例(43.8%)，随访时间4～16周(中位随访时间8周)。治疗后血红蛋白(hemoglobin，Hb)[(100.83±16.28)g/L]较治疗前[(87.70±13.65)g/L]升高(t=-5.403，P＜0.001)。21例患者复查造血原料相关指标，其中铁蛋白由197.12(73.89,272.93)μg/L下降至116.74(51.78,242.35)μg/L(Z=-2.374，P=0.018)，可溶性转铁蛋白受体由1.29(0.89,2.12)μg/L升高至1.78(1.01,2.38)μg/L(Z=-2.052，P=0.040)。9例合并恶性肿瘤的患者治疗后Hb由(80.89±14.19)g/L上升至(96.67±18.24)g/L(t=-3.784，P=0.005)。甲状旁腺激素(parathyroid hormone,PTH)＞300 pg/ml的患者(n=73)中，Hb由(82.50±18.20)g/L升高至(95.50±12.52)g/L(t=-3.227，P=0.006)。在治疗及随访过程中，10例患者出现降压药物加量，8例患者出现高钾血症，1例患者发生动静脉内瘘血栓栓塞，未发现因不良反应停药。 结论  恩那度司他可安全、有效提升NDD-CKD合并肾性贫血患者的Hb水平。对于合并恶性肿瘤、继发性甲状旁腺功能亢进者仍然有效，为存在并发症和/或合并症的NDD-CKD患者贫血治疗提供了新选择。

关键词: 恩那度司他, 肾性贫血, 非透析依赖性慢性肾脏病, 恶性肿瘤, 继发性甲状旁腺功能亢进

Abstract: Objective  To evaluate the efficacy and safety of enarodustat in patients with stage 3-5 non-dialysis dependent chronic kidney disease (NDD-CKD) with concurrent renal anemia.  Methods  This retrospective study analyzed clinical data from NDD-CKD stage 3～5 patients with renal anemia treated at the Department of Nephrology, The Affiliated Taizhou People's Hospital of Nanjing Medical University between June 1, 2024 and February 1 2025. Serial laboratory parameters were compared before and after treatment, and adverse events were systematically documented.  Results  The study included 89 patients (69±10 years old, 39 males) with NDD-CKD stage 3～5 combined with renal anemia. After 4～16 weeks of observation (median follow-up was 8 weeks), hemoglobin (Hb) significantly increased from (87.70±13.65) g/L to (100.83±16.28) g/L (t= -5.403, P＜0.001). Date from 21 patients who underwent reassessment of hematopoietic parameters showed that ferritin decreased from 197.12 (73.89, 272.93) μg/L to 116.74 (51.78, 242.35) μg/L (Z=         -2.374, P=0.018), while soluble transferrin receptor levels increased from 1.29 (0.89, 2.12) μg/L to 1.78 (1.01, 2.38)μg/L (Z=-2.052, P=0.040). Notably, in patients with malignancies (n=9), Hb increased from (80.89±14.19)g/L to （96.67±18.24）g/L (t=-3.784, P=0.005). Among patients with parathyroid hormone (PTH) ＞300 pg/mL, Hb increased from (82.50±18.20)g/L to (95.50±12.50)g/L (t=-3.227, P=0.006). During treatment and follow-up, 10 patients required intensification of antihypertensive medication, 8 developed hyperkalemia, and 1 experienced arteriovenous fistula thrombotic embolism; no treatment discontinuations due to adverse reactions occurred. No additional clinically significant adverse events were observed.  Conclusion  Enarodustat safely and effectively increases Hb levels in NDD-CKD patients with renal anemia, with consistent efficacy in subgroups with malignancies or secondary hyperparathyroidism. These findings support its potential as a therapeutic option for anemia management in complex clinical settings.

Key words: Enarodustat, Renal anemia, Non-dialysis-dependent chronic kidney disease, Malignant tumor, Secondary hyperparathyroidism

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