中国血液净化

中国血液净化 ›› 2024, Vol. 23 ›› Issue (10): 741-746.doi: 10.3969/j.issn.1671-4091.2024.10.003

• 临床研究 • 上一篇    下一篇

安立生坦治疗IgA肾病的疗效及安全性分析

李秉哲    师素芳    朱 厉    周绪杰    刘立军    吕继成    张 宏   

  1. 100034 北京，1北京大学第一医院肾内科 北京大学肾脏疾病研究所 卫生部肾脏疾病重点实验室教育部慢性肾脏病防治重点实验室
  • 收稿日期:2024-04-24 修回日期:2024-06-28 出版日期:2024-10-12 发布日期:2024-10-12
  • 通讯作者: 刘立军 E-mail:lijun.liu@aliyun.com

Efficacy and safety analysis of ambrisentan treatment for IgA nephropathy

LI Bing-zhe, SHI Su-fang, ZHU  Li, ZHOU Xu-jie, LIU Li-jun, LYU Ji-cheng, ZHANG Hong   

  1. Renal Division, Peking University First Hospital; Peking University Institute of Nephrology; Key Laboratory of Nephrology, Ministry of Health; Key Laboratory of Chronic Kidney Disease Prevention and Treatment, Ministry of Education, Beijing 100034, China
  • Received:2024-04-24 Revised:2024-06-28 Online:2024-10-12 Published:2024-10-12
  • Contact: 100034 北京，1北京大学第一医院肾内科 北京大学肾脏疾病研究所 卫生部肾脏疾病重点实验室教育部慢性肾脏病防治重点实验室 E-mail:lijun.liu@aliyun.com

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摘要： 目的 探讨安立生坦作为选择性内皮素受体拮抗剂(endothelin receptor antagonist，ERA)在IgA肾病(IgA nephropathy, IgAN)患者中的疗效和安全性。 方法 收集北京大学第一医院肾内科2022年11月─2023年12月接受安立生坦治疗的IgA肾病患者的病历资料和随访数据，并在第4、8和12w时进行随访评估。研究的主要结果是随时间变化的24h尿蛋白、24h尿蛋白变化率、估算肾小球滤过率(estimate glomerular filtration rate，eGFR)，同时监测药物的安全性。 结果  共纳入了147例IgA肾病患者。基线24h尿蛋白水平为1.16(0.74,1.99)g/d，安立生坦治疗后第4、第8、第12w的尿蛋白水平分别低于基线水平(Z=-8.157、-5.866、-5.238,均P＜0.001)。在不同性别、eGFR分组、合并用药包括激素、免疫抑制剂、肾素-血管紧张素-醛固酮系统抑制剂(renin-angiotensin-aldosterone system inhibitor，RAASi)等亚组中，24h尿蛋白下降率无统计学差异(均P＞0.05)。在12w随访期间，eGFR保持稳定。安立生坦在随访患者中耐受性良好，2例患者因水肿或肝功能损害停药。 结论 安立生坦可以降低IgA肾病患者尿蛋白且安全性良好。

关键词: 内皮素受体拮抗剂, IgA肾病, 尿蛋白, 安立生坦

Abstract: Background  The efficacy of endothelin receptor antagonists (ERA) in reducing proteinuria in patients with IgA nephropathy (IgAN) has been validated in phase III clinical trials. Ambrisentan, as a selective ERA receptor antagonist, protects the kidneys by antagonizing endothelin. Our study aimed to investigate the efficacy and safety of ambrisentan in patients with IgAN.  Methods  Medical records and follow-up data of IgAN patients treated with ambrisentan in our hospital from November 2022 to December 2023 were collected. Follow-up assessments were conducted at weeks 4, 8, and 12. The primary outcomes were 24-hour urinary protein, 24-hour urinary protein change rate estimated glomerular filtration rate (eGFR), and drug safety monitoring.  Results  A total of 147 IgAN patients were included in the study. The baseline 24h urinary protein level was 1.16 [0.74,1.99] g/day. Compared to baseline, the urinary protein level was 0.7 (0.38 to 1.32) g/day at week 4, with a reduction of 40.5%, Z=-8.157,P＜0.001. At week 8, the urinary protein level was 0.60 (0.43 to 1.44) g/day, with a reduction of 40.25%, Z=-5.866, P＜0.001. At week 12, the urinary protein level was 0.66 (0.43 to 1.43) g/day, with a reduction of 38.9%, Z=-5.238, P＜0.001.There was no significant difference in the rate of 24h UP reduction among subgroups stratified by gender, eGFR, or concomitant medication including steroids, immunosuppressants, and Renin-Angiotensin-Aldosterone System inhibitor (RAASi). eGFR remained stable during the 12-week follow-up period. Ambrisentan was well tolerated in the follow-up patients, with two patients discontinuing treatment due to edema or impaired liver function. Conclusion Ambrisentan can reduce proteinuria in patients with IgAN and is well tolerated.

Key words: Endothelin receptor antagonists; , IgA nephropathy, Proteinuria, Ambrisentan

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