Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Department of Clinical Pharmacy, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China; Zhejiang Provincial Key Laboratory for Drug Evaluation and Clinical Research, Hangzhou, China.
Ann Palliat Med. 2021 Nov;10(11):11859-11867. doi: 10.21037/apm-21-2916.
To observe the efficacy and safety of roxadustat, an inhibitor of proline hydroxylase, in renal allograft anemia patients.
This prospective study collected the clinical data of renal transplant patients treated with roxadustat for anemia at the Kidney Disease Center of the First Affiliated Hospital of Zhejiang University from April to August 2020. The patients were followed up every 2 weeks, and the changes in their hemoglobin index and any adverse reactions were recorded during 10 weeks of treatment. The efficacy of roxadustat for treatment of anemia after kidney transplantation was analyzed by comparing the change and increase in average hemoglobin levels before and after treatment. Rates of treatment response and achievement of the standard hemoglobin level were statistically analyzed. In addition, any potential adverse events and the glomerular filtration rate were recorded for 10 weeks to assess the safety of roxadustat in renal allograft anemia patients.
After 10 weeks of roxadustat treatment, the mean hemoglobin level was 10.4±3.9 g/dL, which was significantly higher than at baseline. Over the entire period, treatment was observed to have a therapeutic effect at weeks 2-4, with mean hemoglobin levels increasing as treatment time increased. At the 10-week endpoint, the percentage of patients reaching the standard hemoglobin level and exhibiting a response to treatment was 52.4% and 71.4%, respectively. During the treatment, there was no rejection, and the glomerular filtration rate was stable. Only one person showed symptoms of fatigue, and there were no other obvious adverse reactions reported.
Roxadustat significantly improves hemoglobin levels and can be safely used in renal transplant anemia patients.
观察脯氨酰羟化酶抑制剂罗沙司他治疗肾移植后贫血患者的疗效和安全性。
本前瞻性研究收集了 2020 年 4 月至 8 月期间在浙江大学第一附属医院肾脏病中心接受罗沙司他治疗贫血的肾移植患者的临床数据。患者每 2 周随访一次,记录 10 周治疗期间血红蛋白指数的变化和任何不良反应。通过比较治疗前后平均血红蛋白水平的变化和增加,分析罗沙司他治疗肾移植后贫血的疗效。统计分析治疗反应率和达到标准血红蛋白水平的比例。此外,记录 10 周内任何潜在的不良反应和肾小球滤过率,以评估罗沙司他在肾移植后贫血患者中的安全性。
罗沙司他治疗 10 周后,平均血红蛋白水平为 10.4±3.9 g/dL,明显高于基线水平。在整个治疗期间,第 2-4 周观察到治疗有疗效,随着治疗时间的增加,平均血红蛋白水平逐渐升高。在 10 周终点时,达到标准血红蛋白水平和治疗反应的患者比例分别为 52.4%和 71.4%。在治疗期间,没有发生排斥反应,肾小球滤过率稳定。只有 1 人出现疲劳症状,没有报告其他明显的不良反应。
罗沙司他显著提高血红蛋白水平,可安全用于肾移植后贫血患者。