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罗沙司他治疗慢性肾脏病合并心力衰竭患者贫血的疗效和安全性:一项回顾性队列研究

Efficacy and safety of roxadustat for treating anaemia in patients with chronic kidney disease and heart failure: a retrospective cohort study.

作者信息

Liu Jiang, Meng Zhen, Feng Lina, Zhuo Li, Liang Yan, Yang Mengxi, Su Lina, Zheng Zhaoqi, Liu Bowei, Ren Jingyi

机构信息

Heart Failure Center of Department of Cardiology, China-Japan Friendship Hospital, Beijing, China.

Peking University China-Japan Friendship School of Clinical Medicine, Beijing, China.

出版信息

Clin Kidney J. 2025 Feb 24;18(4):sfaf061. doi: 10.1093/ckj/sfaf061. eCollection 2025 Apr.

Abstract

BACKGROUND

Anaemia is a common comorbidity in patients with chronic kidney disease (CKD) and heart failure (HF). Roxadustat has been approved for the treatment of anaemia in patients with CKD. However, its efficacy and safety in treating anaemia in patients with both CKD and HF remain unclear. We conducted a retrospective study with propensity score matching (PSM) to evaluate the efficacy and safety of roxadustat in this population.

METHODS

This retrospective study enrolled patients diagnosed with HF comorbid with CKD and anaemia. The patients were divided into two groups: a roxadustat group and a control group. One-to-one PSM was used to balance baseline characteristics between the groups. The primary endpoint was the change in haemoglobin (Hb) at week 8. Secondary endpoints included Hb response, changes in haematocrit, iron parameters, echocardiographic parameters, B-type natriuretic peptides and lipid levels. Exploratory endpoints were mortality and rehospitalization rates over 30 days-2 years. Safety endpoints included the incidence of hyperkalaemia, liver damage and thrombotic events.

RESULTS

A total of 1055 patients were screened. After PSM, 206 patients were included. Baseline characteristics were comparable between the matched cohorts. At week 8, the roxadustat group experienced a greater increase in Hb than the control group, with a difference of 0.8 g/dl (95% confidence interval 0.3-1.3;  = .003). The roxadustat group also demonstrated a higher Hb response (60.2% versus 28.2%;  < .001) and a greater increase in haematocrit (4.7 ± 0.9% versus 2.8 ± 0.6%;  = .008) than the control group. No significant differences were observed for other secondary endpoints. Thrombotic events were similar between the two groups and there were no differences in the risks of mortality or rehospitalization.

CONCLUSIONS

Roxadustat was effective in correcting and maintaining Hb levels in patients with anaemia, HF and CKD. It did not increase thrombotic and other adverse events, mortality or rehospitalization risks, making it a promising treatment option for anaemia in this population.

摘要

背景

贫血是慢性肾脏病(CKD)和心力衰竭(HF)患者常见的合并症。罗沙司他已被批准用于治疗CKD患者的贫血。然而,其在治疗CKD合并HF患者贫血方面的疗效和安全性仍不清楚。我们进行了一项倾向评分匹配(PSM)的回顾性研究,以评估罗沙司他在该人群中的疗效和安全性。

方法

这项回顾性研究纳入了诊断为HF合并CKD和贫血的患者。患者分为两组:罗沙司他组和对照组。采用一对一PSM来平衡两组之间的基线特征。主要终点是第8周时血红蛋白(Hb)的变化。次要终点包括Hb反应、血细胞比容、铁参数、超声心动图参数、B型利钠肽和血脂水平的变化。探索性终点是30天至2年期间的死亡率和再住院率。安全终点包括高钾血症、肝损伤和血栓形成事件的发生率。

结果

共筛选出1055例患者。PSM后,纳入206例患者。匹配队列之间的基线特征具有可比性。在第8周时,罗沙司他组的Hb升高幅度大于对照组,差异为0.8 g/dl(95%置信区间0.3 - 1.3;P = 0.003)。罗沙司他组的Hb反应也高于对照组(60.2%对28.2%;P < 0.001),血细胞比容升高幅度更大(4.7 ± 0.9%对2.8 ± 0.6%;P = 0.008)。其他次要终点未观察到显著差异。两组之间的血栓形成事件相似,死亡率或再住院风险无差异。

结论

罗沙司他在纠正和维持贫血、HF和CKD患者的Hb水平方面有效。它不会增加血栓形成及其他不良事件、死亡率或再住院风险,使其成为该人群贫血治疗的一个有前景的选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2ce8/11992559/27a82206ffdf/sfaf061fig1g.jpg

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