基于真实世界数据评价恩那度司他治疗肾性贫血的有效性与安全性
来源期刊：
广州医药
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收稿时间：2026/6/16 17:03:21
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- 恩那度司他；罗沙司他；肾性贫血；有效性；安全性；JADER数据库
- Enarodustat；Roxadustat；Renal anemia；Efficacy；Safety；JADER database
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比较恩那度司他片与罗沙司他胶囊治疗肾性贫血的临床疗效与安全性。 方法 采用前瞻性队列研究设计，选取2025年1月-2025年12月就诊于我院肾内科使用恩那度司他片与罗沙司他胶囊的非透析肾性贫血患者，比较两者治疗4周后红细胞计数（RBC）、血红蛋白（Hb）、红细胞压积（HCT）水平。通过JADER数据库调取与恩那度司他和罗沙司他相关的药物不良事件（ADE）报告，采用报告比值比法（ROR）和比例报告比值法（PRR）进行信号挖掘，对比分析两者的不良事件信号。 结果 共纳入恩那度司他组18例、罗沙司他组27例。治疗4周后，恩那度司他组Hb、RBC、HCT水平均较治疗前显著升高（P＜0.05），两组间治疗后Hb、RBC、HCT水平比较差异无统计学意义（P＞0.05）。JADER数据库共提取恩那度司他相关ADE报告65例，挖掘得到13个阳性信号；罗沙司他相关ADE报告3542例，挖掘得到135个阳性信号。两组重叠信号11个，主要为血栓栓塞事件（深静脉血栓形成、肺栓塞、分流道阻塞等）和代谢异常（高钾血症）。恩那度司他组检出的高血压（5例，ROR=8.63）未在罗沙司他组中出现。 结论 恩那度司他治疗肾性贫血疗效确切，与罗沙司他疗效相当。安全性方面，恩那度司他相关的血栓事件、高钾血症等信号需引起关注，同时需动态监测血压水平。
To compare the clinical efficacy and safety of Enarodustat Tablets and Roxadustat Capsules in the treatment of renal anemia. METHODS A prospective cohort study design was used to select patients with non-dialysis renal anemia who were treated with Enarodustat Tablets and Roxadustat Capsules in the Department of Nephrology of our hospital from January 2025 to December 2025. The levels of Red Blood Cell count ( RBC ), Hemoglobin ( Hb ) and Hematocrit ( HCT ) were compared between the two groups after 4 weeks of treatment. The adverse drug events ( ADE ) reports related to Enarodustat and Roxadustat were retrieved from the JADER database. The report odds ratio method ( ROR ) and the proportional report ratio method ( PRR ) were used for signal mining, and the adverse event signals of the two were compared and analyzed.RESULTS A total of 18 cases in the Enarodustat group and 27 cases in the Roxadustat group were included. After 4 weeks of treatment, the levels of Hb, RBC and HCT in the Enarodustat group were significantly higher than those before treatment ( P < 0.05 ),and there was no significant difference in Hb, RBC and HCT levels between the two groups after treatment ( P > 0.05 ). A total of 65 ADE reports related to Enarodustat were extracted from JADER database, and 13 positive signals were mined. A total of 3542 cases of Roxadustat-related ADE were reported, and 135 positive signals were mined. There were 11 overlapping signals in the two groups, mainly thromboembolic events ( deep vein thrombosis, pulmonary embolism, shunt obstruction, etc. ) and metabolic abnormalities ( hyperkalemia ). Hypertension ( 5 cases, ROR = 8.63 ) was not detected in the Roxadustat group.CONCLUSION Enarodustat is effective in the treatment of renal anemia, which is equivalent to Roxadustat. In terms of safety, signals such as thrombotic events and hyperkalemia related to Enarodustat need to be paid attention to, and blood pressure levels need to be dynamically monitored.
