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Letter to Effect of Hemodialysis Treatment on Sarcopenia in Patients Newly Starting Hemodialysis. 血液透析治疗对新开始血液透析患者肌肉减少症的影响。
IF 1.2 Pub Date : 2026-01-14 DOI: 10.1111/hdi.70054
Huiling Su
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引用次数: 0
Volume Overload Assessed by Vector Impedance Analysis and Physical Function in Hemodialysis Patients. 用向量阻抗分析和身体功能评估血液透析患者的容量过载。
IF 1.2 Pub Date : 2026-01-14 DOI: 10.1111/hdi.70052
Geovana Martin-Alemañy, Monserrat Pérez-Navarro, Paola Miranda-Alatriste, Eloísa Colin-Ramirez, Milad Hasankhani, Samuel Ramos-Acevedo, Rafael Valdez-Ortiz, Ángeles Espinosa-Cuevas, Kenneth R Wilund

Introduction: Loss of skeletal muscle mass in chronic kidney disease is strongly associated with reduced physical function and increased mortality. Although well recognized, the impact of volume overload, on physical function and muscle strength, remains understudied. This study aimed to assess the association between volume overload, physical function, and muscle strength in individuals on hemodialysis.

Methods: Fifty-two individuals on hemodialysis were included. Muscle strength was assessed using hand dynamometry, defining dynapenia as muscle strength < 20 kg in women and < 30 kg in men. Physical function was measured using the short physical performance battery, with "low physical function" defined as a score ≤ 8.0. Bioelectrical impedance vector analysis z-score graph was plotted according to physical function and muscle strength classification as normal or reduced. Resistance and reactance data, normalized to height, were converted into z-scores and plotted on a z-score graph. The comparison of bioelectrical impedance vector analysis between groups was performed using Hotelling's T2 test. In addition, multivariate logistic regression was used to explore the association between volume overload with muscle strength and physical function.

Findings: Bioelectrical impedance vector analysis z-score graphs showed that individuals with reduced physical function were outside the 95th percentile of the major axis, indicating volume overload, while those with normal physical function had adequate hydration status (p < 0.0001). In Model 1 of the multivariate logistic regression, volume overload was associated with low physical function. In Model 2, none of the independent variables were associated with muscle strength.

Discussion: Individuals on hemodialysis with reduced physical function exhibited higher volume overload. Although volume overload is associated with worse physical function, no association was observed with muscle strength.

慢性肾脏疾病骨骼肌质量的丧失与身体功能下降和死亡率增加密切相关。虽然大家都认识到,但容量过载对身体功能和肌肉力量的影响仍未得到充分研究。本研究旨在评估血液透析个体的容量过载、身体功能和肌肉力量之间的关系。方法:纳入52例血液透析患者。用手测力法评估肌力,将动力不足定义为肌力2测试。此外,采用多元逻辑回归探讨容量过载与肌肉力量和身体功能之间的关系。结果:生物电阻抗矢量分析z得分图显示,身体机能下降的个体在长轴的第95百分位之外,表明体积过载,而身体机能正常的个体有足够的水合状态(p)。讨论:身体机能下降的血液透析个体表现出更高的体积过载。虽然容量过载与身体功能恶化有关,但与肌肉力量没有关系。
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引用次数: 0
Petting Zoo Perils: Escherichia coli O157:h7 Associated Hemolytic Uremic Syndrome Secondary to Animal Exposure. 宠物动物园危险:大肠杆菌O157:h7继发于动物暴露的相关溶血性尿毒症综合征。
IF 1.2 Pub Date : 2026-01-07 DOI: 10.1111/hdi.70043
Bailey Mims, Eric Stickles, Mihail M Subtirelu, Sai Sudha Mannemuddhu

Animal exhibits can be a source of E. coli O157:h7 transmission and may lead to hemolytic uremic syndrome. The E. coli O157:h7 outbreak in Tennessee affected over 64 children. Five children, 15 months to 7 years of age, developed acute renal failure due to HUS, requiring renal replacement therapy. They were admitted to the hospital with acute renal failure between 7 and 12 days after exposure to animals. All children presented with vomiting, diarrhea, abdominal pain, and oligo-anuria and had laboratory confirmation of E. coli O157:h7 in the stool sample. They all required renal replacement therapy, and one child required therapeutic plasma exchange due to thrombotic microangiopathy vasculitis-associated encephalopathy. These children experienced dialysis catheter malfunction (n = 1), encephalopathy (n = 1), and thrombosis of the right jugular vein (n = 1). All children developed hypertension, and three out of five required anti-hypertensives at discharge. At the 1-year follow-up, the GFR ranged from 54 to 92 mL/min. Hypertension was noted in two. Hemolytic uremic syndrome can cause long-term sequelae like cerebral atrophy, hypertension, and chronic kidney disease. Hygiene measures can potentially prevent hemolytic uremic syndrome.

动物展品可能是大肠杆菌O157:h7传播的一个来源,并可能导致溶血性尿毒症综合征。田纳西州爆发的O157:h7大肠杆菌感染了64名儿童。5名15个月至7岁的儿童因溶血性尿毒综合征发生急性肾功能衰竭,需要肾脏替代治疗。他们在接触动物后7至12天因急性肾衰竭入院。所有儿童均出现呕吐、腹泻、腹痛和少尿,并在粪便样本中经实验室确认为大肠杆菌O157:h7。他们都需要肾脏替代治疗,一名儿童由于血栓性微血管病变血管炎相关脑病需要治疗性血浆置换。这些患儿出现透析导管失灵(n = 1)、脑病(n = 1)和右颈静脉血栓形成(n = 1)。所有儿童都患上了高血压,其中五分之三的儿童在出院时需要服用抗高血压药物。在1年的随访中,GFR从54到92 mL/min不等。高血压有2例。溶血性尿毒症综合征可引起脑萎缩、高血压和慢性肾病等长期后遗症。卫生措施可以潜在地预防溶血性尿毒症综合征。
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引用次数: 0
Meropenem-Heparin Lock Therapy for Ochrobactrum intermedium Catheter-Related Bloodstream Infection in a Pediatric Hemodialysis Patient: A Case Report and Literature Review. 美罗培尼-肝素锁栓治疗小儿血液透析患者中嗜铬杆菌导管相关血流感染1例报告及文献复习。
IF 1.2 Pub Date : 2026-01-06 DOI: 10.1111/hdi.70050
Mônica Cristina Dutra Rodrigues, Fernanda Teixeira Sillva, Anderson Pereira de Oliveira, Yeo Jim Kinoshita Moon, Jhohann Richard de Lima Benzi

Background: In pediatric hemodialysis patients with exhausted vascular access, managing rare pathogens like Ochrobactrum intermedium is challenging, often posing a dilemma between catheter removal and salvage attempts. There are few reports on the supported viability of meropenem-heparin lock therapy for this purpose in pediatric patients.

Case presentation: We present the case of a 12-year-old male with chronic kidney disease on hemodialysis who was admitted with sepsis attributed to her long-term hemodialysis catheter. Ochrobactrum intermedium was isolated from all catheter lumens and blood cultures. Due to a documented history of vascular access failure, catheter salvage was the primary goal. A combined systemic antibiotic and lock therapy with meropenem and unfractionated heparin was initiated. Critically, bacteremia relapsed promptly after a planned temporary suspension of the lock therapy, while systemic antibiotics were continued. Definitive microbiological eradication was only achieved after the re-initiation and completion of a 14-day course of the lock therapy, resulting in full clinical recovery and long-term catheter preservation. This case report suggests the potential efficacy of meropenem lock therapy as a salvage strategy for O. intermedium CRBSI when catheter removal is not a viable option. The relapse upon its suspension highlights that the lock therapy itself was the critical component for eradicating the O. intermedium biofilm, a feat the systemic antibiotic alone could not achieve. This approach is a viable alternative when catheter removal is not feasible.

背景:在血管通路衰竭的儿童血液透析患者中,处理像中间嗜铬杆菌这样的罕见病原体是具有挑战性的,通常导致导管拔除和抢救尝试之间的两难境地。很少有报道支持美罗培尼-肝素锁定治疗在儿科患者中的可行性。病例介绍:我们提出的情况下,12岁的男性慢性肾脏疾病的血液透析谁是入院败血症归因于长期血液透析导管。从所有导管管腔和血液培养中分离出中间嗜铬杆菌。由于有记录的血管通路失败的历史,导管抢救是主要目标。开始了联合全身抗生素和锁治疗美罗培南和未分离肝素。关键的是,在计划暂时停止lock治疗后,菌血症迅速复发,而全身抗生素继续使用。只有在重新开始并完成14天的锁定治疗后,才实现了明确的微生物根除,从而实现了完全的临床恢复和长期的导管保存。本病例报告表明,当导管切除不可行时,美罗培南锁定治疗作为O. intermedium CRBSI的挽救策略的潜在疗效。停药后的复发突出表明,锁定疗法本身是根除O. intermedimedium生物膜的关键组成部分,这是单独的全身抗生素无法实现的壮举。当不能取出导管时,这种方法是一种可行的替代方法。
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引用次数: 0
The Effectiveness of Peer Support on Self-Management and Psychosocial Outcomes in Maintenance Hemodialysis Patients: A Systematic Review and Meta-Analysis. 同伴支持对维持性血液透析患者自我管理和心理社会结局的有效性:系统回顾和荟萃分析。
IF 1.2 Pub Date : 2026-01-06 DOI: 10.1111/hdi.70044
Tiqiong Gong, Hong Wang, Qingshu Zhang, Yansheng Ye

Introduction: Patients undergoing maintenance hemodialysis frequently encounter a substantial psychosocial burden, yet conventional care frequently lacks the capacity to deliver comprehensive, sustained psychosocial support due to limitations in resources. Nurse-led peer support, which integrates professional expertise with the lived experience of peers, presents a promising complementary model; however, its consolidated efficacy in this population lacks rigorous synthesis.

Objective: This systematic review and meta-analysis aimed to evaluate the effects of nurse-led peer support on self-management, psychological status, and quality of life in patients receiving maintenance hemodialysis.

Methods: This review systematically searched ten databases (PubMed, Web of Science, Embase, CINAHL, Cochrane Library, Scopus, CNKI, WanFang, VIP, and SinoMed) from their inception to 20 January 2025 for randomized controlled trials and quasi-experimental studies. A meta-analysis was performed using random-effects models to pool standardized mean difference (SMD). The quality assessment and meta-analysis were conducted utilizing the Cochrane RevMan 5.4 software, with the evidence quality being evaluated employing the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) system. The present study is registered in PROSPERO with the registration number CRD42025639997.

Results: A total of 292 literature records were retrieved, among which 27 studies met the inclusion criteria, and 11 provided data suitable for analysis (n = 1074). The overall risk of bias was thus determined to be low to moderate. Peer support demonstrated significant benefits for self-management (SMD = 0.77, 95% CI: 0.60-0.94; I2 = 35%), quality of life (SMD = 0.91, 95% CI: 0.50-1.32; I2 = 77%), and depression (SMD = -0.87, 95% CI: -1.39-0.36; I2 = 70%). Evidence from two studies suggests that anxiety may be alleviated. The certainty of evidence was moderate for most outcomes.

Conclusions: This systematic review and meta-analysis indicates that nurse-guided peer support improves self-management capabilities and quality of life among maintenance hemodialysis patients while alleviating depressive and anxiety symptoms. Due to the limited number of included studies and heterogeneity in intervention protocols, implementation formats, and supporter criteria, the certainty of evidence is mostly moderate. However, consistent results support the positive clinical benefits of this intervention. Therefore, integrating structured peer support into routine care systems represents an effective complementary strategy. Future research should focus on identifying key factors influencing its efficacy, developing standardized intervention protocols, and validating the effectiveness and sustainability of blended online-offline delivery models.

导言:接受维持性血液透析的患者经常会遇到严重的社会心理负担,然而由于资源的限制,传统护理往往缺乏提供全面、持续的社会心理支持的能力。护士主导的同伴支持,将专业知识与同伴的生活经验相结合,提出了一种有希望的互补模式;然而,其在这一人群中的综合疗效缺乏严格的综合。目的:本系统回顾和荟萃分析旨在评估护士主导的同伴支持对维持性血液透析患者自我管理、心理状态和生活质量的影响。方法:系统检索PubMed、Web of Science、Embase、CINAHL、Cochrane Library、Scopus、CNKI、WanFang、VIP、SinoMed等10个数据库,检索自该数据库成立至2025年1月20日的随机对照试验和准实验研究。采用随机效应模型对标准化平均差(SMD)进行meta分析。采用Cochrane RevMan 5.4软件进行质量评价和meta分析,采用GRADE (Grading of Recommendations, assessment, Development and Evaluation)系统评价证据质量。本研究已在PROSPERO注册,注册号为CRD42025639997。结果:共检索文献292篇,符合纳入标准的文献27篇,提供适合分析的资料11篇(n = 1074)。因此,偏倚的总体风险被确定为低至中等。同伴支持在自我管理(SMD = 0.77, 95% CI: 0.60-0.94; I2 = 35%)、生活质量(SMD = 0.91, 95% CI: 0.50-1.32; I2 = 77%)和抑郁(SMD = -0.87, 95% CI: -1.39-0.36; I2 = 70%)方面显示出显著的益处。两项研究的证据表明,焦虑可能会得到缓解。对于大多数结果,证据的确定性是中等的。结论:本系统综述和荟萃分析表明,护士引导的同伴支持可提高维持性血液透析患者的自我管理能力和生活质量,同时减轻抑郁和焦虑症状。由于纳入的研究数量有限,干预方案、实施格式和支持者标准存在异质性,证据的确定性大多是中等的。然而,一致的结果支持这种干预的积极临床益处。因此,将有组织的同伴支持整合到日常护理系统中是一种有效的补充策略。未来的研究应侧重于确定影响其有效性的关键因素,制定标准化的干预方案,并验证在线-离线混合交付模式的有效性和可持续性。
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引用次数: 0
Letter to the Editor: Effect of Aerobic Combined Resistance Exercise in Dialysis on Restless Legs Syndrome: A Randomized Controlled Study. 致编辑的信:透析中有氧联合阻力运动对不宁腿综合征的影响:一项随机对照研究。
IF 1.2 Pub Date : 2026-01-02 DOI: 10.1111/hdi.70051
Suyin Yu
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引用次数: 0
Effects of Interactive Handgrip Game on Vascular Maturation and Grip Strength in Patients Undergoing Arteriovenous Fistula Surgery: A Feasibility Randomized Controlled Trial. 交互式握力游戏对动静脉瘘手术患者血管成熟和握力的影响:一项可行性随机对照试验。
IF 1.2 Pub Date : 2026-01-01 DOI: 10.1111/hdi.70045
Yi-Chin Luo, Ping-Hsuan Han, Ying-Ying Chen, Pei-Chen Wu, I-Wen Wu, Yen-Chun Fan, Hsiao-Yean Chiu

Objectives: This study evaluated the effects of an interactive handgrip game on vascular maturation and grip strength in patients undergoing arteriovenous fistula (AVF) surgery.

Methods: This was a preliminary randomized controlled trial. Thirty patients who underwent AVF surgery were randomly assigned to either an interactive handgrip game group or a soft ball group, with 15 participants in each. Both groups began their respective interventions on the first day after returning home; they engaged in either the interactive handgrip game or soft ball exercises for 30 min per session, twice daily (morning and afternoon) for 2 months. Data were obtained using a self-designed structured questionnaire, a Noblus ultrasound machine, and a Jamar hand dynamometer. Assessments were conducted the day before AVF surgery, at the fourth week, and at the eighth week.

Results: A total of 30 participants with mean age of 56 years adhered fully to the prescribed training sessions. Compared with the soft ball group, the interactive handgrip game group demonstrated greater improvements in blood flow rate at 8 weeks (1230 vs. 930 mL/min; p < 0.001) and in handgrip strength at both 4 weeks (14 vs. 12 kg; p < 0.001) and 8 weeks (18 vs. 14 kg; p < 0.001). No significant time-by-group interactions were observed for vein diameter or fistula depth. Participants also reported high satisfaction (scores 4.6-5) and strong agreement on the feasibility of the interactive handgrip game (mean = 5).

Conclusion: A 2-month regimen of an interactive handgrip game yielded significantly greater vascular maturation and grip strength relative to soft ball exercises. In addition, the game resulted in high patient satisfaction and was feasible to implement, supporting its potential as an effective intervention for AVF maturation.

Trial registration: ClinicalTrials.gov: NCT05493046.

目的:本研究评估交互式握力游戏对动静脉瘘(AVF)手术患者血管成熟和握力的影响。方法:采用初步随机对照试验。30名接受AVF手术的患者被随机分配到互动握握游戏组和软球组,每组15名参与者。两组在回家后的第一天开始各自的干预措施;他们进行互动握拍游戏或软球练习,每次30分钟,每天两次(上午和下午),持续2个月。使用自行设计的结构化问卷、Noblus超声仪和Jamar手测力仪获得数据。评估分别在AVF手术前一天、第4周和第8周进行。结果:共有30名参与者,平均年龄56岁,完全遵守了规定的训练课程。与软球组相比,互动手柄游戏组在8周时的血流量有更大的改善(1230 mL/min vs 930 mL/min); p结论:相对于软球运动,2个月的互动手柄游戏方案显著提高了血管成熟度和握力。此外,该游戏获得了很高的患者满意度,并且易于实施,支持其作为AVF成熟的有效干预手段的潜力。试验注册:ClinicalTrials.gov: NCT05493046。
{"title":"Effects of Interactive Handgrip Game on Vascular Maturation and Grip Strength in Patients Undergoing Arteriovenous Fistula Surgery: A Feasibility Randomized Controlled Trial.","authors":"Yi-Chin Luo, Ping-Hsuan Han, Ying-Ying Chen, Pei-Chen Wu, I-Wen Wu, Yen-Chun Fan, Hsiao-Yean Chiu","doi":"10.1111/hdi.70045","DOIUrl":"https://doi.org/10.1111/hdi.70045","url":null,"abstract":"<p><strong>Objectives: </strong>This study evaluated the effects of an interactive handgrip game on vascular maturation and grip strength in patients undergoing arteriovenous fistula (AVF) surgery.</p><p><strong>Methods: </strong>This was a preliminary randomized controlled trial. Thirty patients who underwent AVF surgery were randomly assigned to either an interactive handgrip game group or a soft ball group, with 15 participants in each. Both groups began their respective interventions on the first day after returning home; they engaged in either the interactive handgrip game or soft ball exercises for 30 min per session, twice daily (morning and afternoon) for 2 months. Data were obtained using a self-designed structured questionnaire, a Noblus ultrasound machine, and a Jamar hand dynamometer. Assessments were conducted the day before AVF surgery, at the fourth week, and at the eighth week.</p><p><strong>Results: </strong>A total of 30 participants with mean age of 56 years adhered fully to the prescribed training sessions. Compared with the soft ball group, the interactive handgrip game group demonstrated greater improvements in blood flow rate at 8 weeks (1230 vs. 930 mL/min; p < 0.001) and in handgrip strength at both 4 weeks (14 vs. 12 kg; p < 0.001) and 8 weeks (18 vs. 14 kg; p < 0.001). No significant time-by-group interactions were observed for vein diameter or fistula depth. Participants also reported high satisfaction (scores 4.6-5) and strong agreement on the feasibility of the interactive handgrip game (mean = 5).</p><p><strong>Conclusion: </strong>A 2-month regimen of an interactive handgrip game yielded significantly greater vascular maturation and grip strength relative to soft ball exercises. In addition, the game resulted in high patient satisfaction and was feasible to implement, supporting its potential as an effective intervention for AVF maturation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT05493046.</p>","PeriodicalId":94027,"journal":{"name":"Hemodialysis international. International Symposium on Home Hemodialysis","volume":" ","pages":""},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145890738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Effect of Hemodialysis Treatment on Sarcopenia in Patients Newly Starting Hemodialysis. 血液透析治疗对新开始血液透析患者肌肉减少症的影响。
IF 1.2 Pub Date : 2025-12-28 DOI: 10.1111/hdi.70040
Serap Yadigar, Kübra Aydın Bahat

Background: The research aimed to establish sarcopenia occurrence rates among patients beginning hemodialysis treatment and assess muscle mass and function changes and sarcopenia status after six months of dialysis.

Methods: The prospective observational study included 110 patients who were new to hemodialysis (maximum 1 month). Patients were grouped as sarcopenic (n = 33) and non-sarcopenic (n = 77) according to EWGSOP2 criteria. Demographic characteristics, body composition by bioelectrical impedance analysis, hand grip strength, walking speed tests, and laboratory parameters were evaluated at baseline and at 6 months.

Results: At baseline, 30% of the patients were considered sarcopenic. After six months of hemodialysis, only 2 of 33 patients (6.1%) who were sarcopenic at baseline remained sarcopenic (p = 0.76). Skeletal Muscle Index (SMI) increased from 6.4 ± 1.0 kg/m2 to 6.9 ± 0.9 kg/m2 in the sarcopenic group (p = 0.65), but this difference was not significant when compared with the non-sarcopenic group (p = 0.32). Walking speed time improved from 10.5 ± 3.8 s to 8.7 ± 3.3 s in the sarcopenic group and the difference between the groups was statistically significant (p = 0.03). Right hand grip strength increased from 20.8 ± 9.2 kg to 31.2 ± 7.8 kg (p = 0.68). In multivariate analysis, SMI (OR: 0.38, p < 0.001) was significantly associated with sarcopenia, while age (p = 0.37), gender (p = 0.15), albumin (p = 0.62), and CRP (p = 0.82) were not significantly associated.

Conclusions: Patients who start hemodialysis have high rates of sarcopenia but have significant muscle mass and functional improvements during the first six months of effective hemodialysis treatment. The removal of uremic toxins produces beneficial effects on muscle metabolism according to these results.

背景:本研究旨在建立血液透析患者肌少症的发生率,评估透析6个月后肌肉质量和功能的改变以及肌少症的状态。方法:前瞻性观察研究纳入110例血液透析新患者(最多1个月)。根据EWGSOP2标准将患者分为肌肉减少组(n = 33)和非肌肉减少组(n = 77)。在基线和6个月时评估人口统计学特征、通过生物电阻抗分析得出的身体组成、手部握力、步行速度测试和实验室参数。结果:在基线时,30%的患者被认为是肌肉减少。血液透析6个月后,33例基线时肌肉减少的患者中只有2例(6.1%)仍然肌肉减少(p = 0.76)。骨骼肌指数(SMI)在肌少症组从6.4±1.0 kg/m2增加到6.9±0.9 kg/m2 (p = 0.65),但与非肌少症组相比差异不显著(p = 0.32)。肌肉减少组步行速度时间由10.5±3.8 s改善至8.7±3.3 s,组间差异有统计学意义(p = 0.03)。右手握力由20.8±9.2 kg增加至31.2±7.8 kg (p = 0.68)。在多变量分析中,SMI (OR: 0.38, p)结论:开始血液透析的患者肌肉减少率高,但在有效血液透析治疗的前6个月有显著的肌肉质量和功能改善。根据这些结果,尿毒症毒素的清除对肌肉代谢产生有益的影响。
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引用次数: 0
Blood Volume Cannot Be Calculated From Extracellular Volume. 血容量不能从细胞外容量计算。
IF 1.2 Pub Date : 2025-12-23 DOI: 10.1111/hdi.70042
Joachim Kron, John Volkenandt, Stefanie Broszeit, Til Leimbach, Susanne Kron
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引用次数: 0
Safety and Efficacy of Vadadustat Versus Darbepoetin Alfa for Chronic Kidney Disease-Related Anemia in Patients Receiving Dialysis by Baseline Erythropoiesis-Stimulating Agent Dose. Vadadustat与Darbepoetin对基线促红细胞生成剂剂量透析患者慢性肾病相关性贫血的安全性和有效性
IF 1.2 Pub Date : 2025-12-11 DOI: 10.1111/hdi.70034
Alan Jardine, Steven K Burke, Wenli Luo, Todd Minga, Mark J Sarnak, Wolfgang C Winkelmayer, Rajiv Agarwal, Glenn M Chertow, Kai-Uwe Eckardt, Mark J Koury

Introduction: Erythropoiesis-stimulating agents (ESAs) and iron supplementation are standard treatments for chronic kidney disease (CKD)-related anemia. Targeting higher hemoglobin values in CKD increases cardiovascular risk. Whether the increased risk is from higher ESA doses or higher hemoglobin levels is uncertain, but alternative therapies are sought for patients requiring high ESA doses. Phase 3 INNO2VATE trials in patients with dialysis-dependent CKD (DD-CKD) demonstrated vadadustat's noninferiority compared with darbepoetin alfa. To determine vadadustat's potential to treat anemia, including in patients requiring high ESA doses, its safety and efficacy were compared with those of darbepoetin alfa across prespecified baseline ESA dose subgroups in the prevalent DD-CKD INNO2VATE trial.

Methods: We compared the safety and efficacy of vadadustat versus darbepoetin alfa across prespecified baseline ESA dose subgroups (low [≤ 90 U/kg/week], intermediate [> 90 and < 300 U/kg/week], or high [≥ 300 U/kg/week]) in the INNO2VATE prevalent trial. The primary safety endpoint was time to first adjudicated major adverse cardiovascular event (MACE). Primary and secondary efficacy endpoints were mean hemoglobin level change from baseline at weeks 24-36 and weeks 40-52, respectively.

Findings: Compared with darbepoetin alfa, first MACE hazard ratios for vadadustat were 0.99 (95% CI, 0.81-1.23), 0.93 (95% CI, 0.74-1.18), and 0.62 (95% CI, 0.34-1.14) for low, intermediate, and high baseline ESA dose subgroups, respectively (interaction p = 0.92). Vadadustat was noninferior to darbepoetin alfa in hemoglobin change from baseline to primary evaluation period, with mean differences (vadadustat-darbepoetin alfa) of -0.10 g/dL (95% CI, -0.19 to -0.02), -0.20 g/dL (95% CI, -0.30 to -0.09), and -0.39 g/dL (95% CI, -0.67 to -0.11) for low, intermediate, and high ESA dose subgroups, respectively.

Discussion: Comparing safety and efficacy by baseline ESA dose among patients with CKD on maintenance dialysis, vadadustat was noninferior to darbepoetin alfa for all ESA dose subgroups, including patients with high baseline ESA requirements.

促红细胞生成剂(ESAs)和铁补充剂是慢性肾脏疾病(CKD)相关贫血的标准治疗方法。针对CKD中较高的血红蛋白值会增加心血管风险。风险增加是由于较高的欧空局剂量还是较高的血红蛋白水平尚不确定,但对于需要高剂量欧空局的患者,正在寻求替代疗法。在透析依赖性CKD (DD-CKD)患者中进行的3期INNO2VATE试验表明,与达贝泊汀相比,vadadustat具有非劣效性。为了确定vadadustat治疗贫血的潜力,包括需要高ESA剂量的患者,在流行的DD-CKD INNO2VATE试验中,将其安全性和有效性与darbepoetin alfa在预先指定的基线ESA剂量亚组进行了比较。方法:在预先设定的基线ESA剂量亚组(低[≤90 U/kg/周],中[≤90 U/kg/周]和2VATE流行试验中,我们比较了vadadustat和darbepoetin alfa的安全性和有效性。主要安全终点是首次判定主要心血管不良事件(MACE)的时间。主要和次要疗效终点分别是24-36周和40-52周时平均血红蛋白水平较基线的变化。结果:与达贝泊汀相比,vadadustat在低、中、高基线ESA剂量亚组的首次MACE风险比分别为0.99 (95% CI, 0.81-1.23)、0.93 (95% CI, 0.74-1.18)和0.62 (95% CI, 0.34-1.14)(相互作用p = 0.92)。从基线到初始评估期,Vadadustat与darbepoetin α的血红蛋白变化并不逊色,低、中、高ESA剂量亚组的平均差异(Vadadustat -darbepoetin α)分别为-0.10 g/dL (95% CI, -0.19至-0.02)、-0.20 g/dL (95% CI, -0.30至-0.09)和-0.39 g/dL (95% CI, -0.67至-0.11)。讨论:比较维持透析的CKD患者基线ESA剂量的安全性和有效性,vadadustat在所有ESA剂量亚组(包括基线ESA要求高的患者)的安全性和有效性均不低于darbepoetin alfa。
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引用次数: 0
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Hemodialysis international. International Symposium on Home Hemodialysis
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