平衡疗效、健康状况和成本-效果:去西杜司他和促红细胞生成素在慢性肾病血液透析患者中的比较研究。

Q4 Medicine
Dharanidhar Reddy Yarramachu, K Sai Sindhu Singh, Pavuluri Lakshmi Aishwarya, Kumar K Manoj, Indhumathi Elayaperumal
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引用次数: 0

摘要

背景。贫血是严重影响CKD(慢性肾脏疾病)患者生活质量和预后的常见问题。传统的治疗方法是使用ESAs(促红细胞生成剂),如促红细胞生成素;然而,最近的药物,如地西司他,一种缺氧诱导因子脯氨酰羟化酶抑制剂(HIF-PHI),在疗效和成本方面可能更有利。在这项研究中,比较了接受血液透析的CKD患者在去西杜司他和促红细胞生成素治疗之间的疗效、安全性和成本效益。方法。这项前瞻性、单中心、开放标签的平行组研究是在金奈Saveetha医学科学研究所进行的。共有60名接受维持性血液透析的CKD患者被随机分为两组,一组服用Desidustat (100mg口服,每周3次),另一组服用促红细胞生成素(皮下注射),疗程为12周。在基线、4周、8周和12周时,记录血红蛋白水平、生物标志物(TSAT、铁蛋白和hepcidin)以及身心健康状况。关键的发现是血红蛋白反应的比例(定义为从基线上升≥1g/dL)。次要结局包括血红蛋白反应、不良反应和成本-效果的预测因子。结果。Desidustat组血红蛋白应答率为83.33%,而促红细胞生成素组为73.33% (p = 0.530),两组疗效差异无统计学意义。两组血红蛋白水平在12周内逐渐升高。较高的血清白蛋白(OR = 3.32, 95% CI: 1.54-7.16, p = 0.008)和较低的iPTH水平(OR = 0.98, 95% CI: 0.97-0.99, p = 0.004)是血红蛋白反应的重要指标。与促红细胞生成素相比,Desidustat组Hepcidin水平显著降低(p = 0.038),表明Desidustat改善了铁代谢。TSAT和铁蛋白水平无显著差异。两组之间的不良反应具有可比性,住院率和感染率相似。与促红细胞生成素相比,Desidustat具有更好的成本效益,每月成本更低。结论。当CKD患者接受血液透析治疗贫血时,Desidustat是一种安全有效的促红细胞生成素替代品,具有成本效益的优势。血清白蛋白和iPTH是血红蛋白反应的重要预测因子。为了验证这些结果,需要更大规模的多中心研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Balancing Efficacy, Health Status, and Cost-Effectiveness: A Comparative Study of Desidustat and Erythropoietin in Chronic Kidney Disease Patients on Hemodialysis.

Background. Anemia is a common problem that greatly affects the quality of life and prognosis of those with CKD (chronic kidney disease). The conventional course of treatment has traditionally used ESAs (erythropoiesis-stimulating agents) such as erythropoietin; however, more recent medications, such as Desidustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), may be more advantageous in terms of both efficacy and cost. In this study, CKD patients receiving hemodialysis are compared for efficacy, safety, and cost-effectiveness between Desidustat and erythropoietin treatment. Methods. This prospective, single-center, open-label study with parallel groups was carried out at Saveetha Institute of Medical Sciences in Chennai. A total of 60 patients with CKD on maintenance hemodialysis were randomized to receive either Desidustat (100 mg orally, 3 times a week) or Erythropoietin (subcutaneous injections) for 12 weeks. At baseline, four weeks, eight weeks, and 12 weeks, hemoglobin levels, biomarkers (TSAT, ferritin, and hepcidin), and status of physical and mental health had been noted. The key finding was the proportion of hemoglobin responders (defined as a rise from baseline of ≥1g/dL). Secondary outcomes included predictors of hemoglobin response, adverse effects, and cost-effectiveness. Results. The proportion of hemoglobin responders was 83.33% in the Desidustat compared to 73.33% in the Erythropoietin group (p = 0.530), indicating no significant difference in efficacy. Hemoglobin levels increased gradually in both groups over 12 weeks. Higher serum albumin (OR = 3.32, 95% CI: 1.54-7.16, p = 0.008) and lower iPTH levels (OR = 0.98, 95% CI: 0.97-0.99, p = 0.004) have been important indicators of hemoglobin response. Hepcidin levels decreased significantly in the Desidustat group in contrast to Erythropoietin (p = 0.038), suggesting improved iron metabolism with Desidustat. No significant differences were noted in TSAT or ferritin levels. Adverse effects were comparable between the groups, with similar hospitalization and infection rates. Desidustat demonstrated better cost-effectiveness, with a lower monthly cost compared to Erythropoietin. Conclusions. When treating anemia in individuals with CKD receiving hemodialysis, Desidustat is a safe and efficient substitute for erythropoietin, with the added advantage of cost-effectiveness. Serum albumin and iPTH were significant predictors of hemoglobin response. To validate these results larger multicentric studies are necessary.

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来源期刊
CiteScore
0.70
自引率
0.00%
发文量
62
期刊介绍: Il Giornale Italiano di Nefrologia (GIN) è la rivista di educazione continua della Società Italiana di Nefrologia SIN ed è pubblicato bimestralmente. E" il più autorevole organo di informazione nefrologia disponibile a livello nazionale. Il giornale Italiano di Nefrologia offre la più aggiornata informazione medico-scientifica rivolta al nefrologo sotto forma di rassegne, casi clinici e articoli finalizzati all’Educazione Continua in Medicina, oltre ai notiziari ed agli atti dei congressi di questa prestigiosa Società Scientifica
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