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Associations of Skeletal Muscle Mass and Body Mass Index With Clinical Outcomes in Autosomal Dominant Polycystic Kidney Disease: An Observational Study. 常染色体显性多囊肾病骨骼肌质量和体重指数与临床预后的关系:一项观察性研究
IF 13.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-14 DOI: 10.1053/j.ajkd.2025.09.004
Dha Woon Im,Jiyun Jung,Miso Ha,Yon Su Kim,Kwon Wook Joo,Kook-Hwan Oh,Dong Ki Kim,Hajeong Lee,Seung Seok Han,Eunjeong Kang,Sehoon Park,Sung Joon Shin,Jangwook Lee,Jeongin Song,Yun Kyu Oh,Hayne Cho Park,Curie Ahn,Kyu-Beck Lee,Yeong Hoon Kim,Seungyeup Han,Yaerim Kim,Eun Hui Bae,Jae Yoon Park,Yong Chul Kim
RATIONALE & OBJECTIVELow muscle mass is a risk factor for chronic kidney disease. In this study, we examined the relationship between muscle mass and mortality, as well as end-stage kidney disease (ESKD), in patients with autosomal dominant polycystic kidney disease (ADPKD).STUDY DESIGNRetrospective cohort study.SETTING & PARTICIPANTS1,443 patients with ADPKD from eight tertiary-care hospitals in Korea between 2006 and 2020.EXPOSURESComputed tomography images were obtained at the third lumbar vertebra to measure the skeletal muscle area (SMA) using an artificial intelligence system. SMA indexed for w a height2 s classified as low-attenuation muscle area (LAMA) or normal-attenuation muscle area (NAMA) based on muscle quality.OUTCOMESAll-cause mortality and ESKD.ANALYTICAL APPROACHCox proportional hazards regression, adjusted for sex, age, creatinine, glucose, and height-adjusted total kidney volume, was used to investigate the associations of muscle indices with all-cause mortality and ESKD. Subgroup analyses were conducted based on body mass index categories: low or normal (<25 kg/m2) and overweight or obese (≥25 kg/m2).RESULTSThe study population included more than half female patients, and the mean estimated glomerular filtration rate was 68.4 ml/min/1.73m2. Mean follow-up was 5.14 years. Greater SMA/height2 and NAMA/height2 were associated with a lower risk of mortality (HRs 0.58 (95% CI 0.39-0.88) and 0.55 (95% CI, 0.39-0.79), respectively). Greater NAMA/height2 was associated with a 26% lower ESKD incidence (0.74 (0.59,0.92), but a greater LAMA/height2 was associated with a lower ESKD incidence (HR 1.18, 95% CI 1.01-1.37). A higher NAMA/LAMA ratio was associated with a lower ESKD incidence (HR 0.74, 95% CI 0.60-0.92). Greater muscle mass was associated with a lower risk of mortality among overweight individuals and a lower risk of ESKD in underweight individuals.LIMITATIONSLack of details about muscle strength and performance.CONCLUSIONSAmong individuals with ADPKD, greater and higher-quality muscle mass were associated with lower risk of mortality and progression of CKD to ESKD.
理由与目的低肌肉质量是慢性肾脏疾病的危险因素。在这项研究中,我们研究了常染色体显性多囊肾病(ADPKD)患者的肌肉质量与死亡率以及终末期肾病(ESKD)之间的关系。研究设计回顾性队列研究。环境与参与者:2006年至2020年间,韩国8家三级医院的1443例ADPKD患者。在第三腰椎处获取计算机断层图像,使用人工智能系统测量骨骼肌面积(SMA)。SMA根据肌肉质量分为低衰减肌区(LAMA)和正常衰减肌区(NAMA)。结果:全因死亡率和ESKD。分析方法:采用cox比例风险回归,校正性别、年龄、肌酐、血糖和身高调整后的总肾体积,研究肌肉指标与全因死亡率和ESKD的关系。根据体重指数分类进行亚组分析:低或正常(<25 kg/m2)和超重或肥胖(≥25 kg/m2)。结果研究人群中女性患者占一半以上,肾小球滤过率平均估计为68.4 ml/min/1.73m2。平均随访5.14年。较高的SMA/height2和NAMA/height2与较低的死亡风险相关(hr分别为0.58 (95% CI 0.39-0.88)和0.55 (95% CI, 0.39-0.79))。较高的NAMA/height2与ESKD发生率降低26%相关(0.74(0.59,0.92),但较高的LAMA/height2与较低的ESKD发生率相关(HR 1.18, 95% CI 1.01-1.37)。较高的NAMA/LAMA比值与较低的ESKD发生率相关(HR 0.74, 95% CI 0.60-0.92)。在超重人群中,更大的肌肉质量与更低的死亡风险相关,在体重不足人群中,更低的ESKD风险相关。限制:缺乏肌肉力量和表现的细节。结论:在ADPKD患者中,更大和更高质量的肌肉质量与较低的死亡率和CKD向ESKD进展的风险相关。
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引用次数: 0
In Reply to “Clarifying Dialysis Modality Classification in Algorithm-Based ESKD Identification” 答复“基于算法的ESKD识别中透析方式分类的澄清”。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-13 DOI: 10.1053/j.ajkd.2025.08.009
Chenxi Gao MBBS, MS, MHS , Jung-Im Shin MD, PhD
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引用次数: 0
Clarifying Dialysis Modality Classification in Algorithm-Based ESKD Identification 在基于算法的ESKD识别中澄清透析模式分类。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-13 DOI: 10.1053/j.ajkd.2025.06.023
Dharmenaan Palamuthusingam PhD
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引用次数: 0
Management of Chronic Hyponatremia in the Outpatient Setting 慢性低钠血症在门诊的处理。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-13 DOI: 10.1053/j.ajkd.2025.06.024
Angelique B.M.C. Savelberg , Ewout J. Hoorn , Julie C. Refardt
The diagnostic evaluation and management of chronic hyponatremia in outpatients can be challenging for several reasons. First, chronic hyponatremia is often mild, leading to uncertainty about whether it is clinically significant and warrants further diagnostic evaluation and treatment. Second, if the initial diagnostic workup does not identify a clear cause, it becomes uncertain how much further investigation is required. Third, when no clear cause is found or the underlying condition cannot be treated, physicians may struggle to choose the most appropriate treatment approach. This review offers practical guidance to navigate these challenges in managing chronic hyponatremia in the outpatient setting.
慢性低钠血症在门诊患者的诊断评估和管理可能是具有挑战性的几个原因。首先,慢性低钠血症通常是轻微的,导致不确定是否具有临床意义,是否需要进一步的诊断评估和治疗。其次,如果最初的诊断检查没有确定明确的原因,就不确定需要进行多少进一步的调查。第三,当找不到明确的病因或根本的疾病无法治疗时,医生可能难以选择最合适的治疗方法。本综述为在门诊治疗慢性低钠血症中应对这些挑战提供了实用的指导。
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引用次数: 0
Revisiting New Data on the Mortality Benefit of Rapid Correction of Hyponatremia: Déjà Vu All Over Again 重新审视快速纠正低钠血症的死亡率益处的新数据:重新开始。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-13 DOI: 10.1053/j.ajkd.2025.07.015
Richard H. Sterns , Helbert Rondon-Berrios
Studies in the 1980s linking rapid correction of severe, chronic hyponatremia to the osmotic demyelination syndrome (ODS) led to a major controversy that eventually gave way to consensus guidelines. Efforts to limit correction to ≤8 mmol/L per day in patients at high risk of developing ODS became common practice. Recent studies have questioned these guidelines, suggesting that ODS is rare and that slow correction may increase mortality. In this review, we revisit the history of the controversy and find that these claims have persisted for 4 decades. Older studies supporting faster correction are flawed by referral bias while newer studies are limited by confounding as comorbidities influence rates of both mortality and hyponatremia correction. Although both old and new studies emphasize the rarity of magnetic resonance imaging–documented ODS after rapid correction, they were not conducted in hyponatremic patients who were at risk for ODS. Old studies reporting hyponatremic deaths due to cerebral edema overestimate its true incidence, and new studies reporting an association of mortality and slow rates of sodium correction do not document cerebral edema as a common contributor to death. Further research is required to better define the incidence of both ODS and cerebral edema in patients at risk for these complications. Until then, we conclude that the risks of rapid correction—including irreversible neurological damage—necessitate caution. Clinicians should continue to prioritize slow, controlled sodium correction to protect high-risk patients from harm.
20世纪80年代的研究将严重慢性低钠血症与渗透性脱髓鞘综合征(ODS)的快速纠正联系起来,导致了一场重大的争议,最终让位于共识指南。在发生ODS的高危患者中,将纠正量限制在每天≤8mmol /L已成为普遍做法。最近的研究对这些指南提出了质疑,认为消耗臭氧层物质是罕见的,缓慢的纠正可能会增加死亡率。在这篇综述中,我们重新审视了争议的历史,并发现这些说法已经持续了四十年。支持更快矫正的较早研究因转诊偏倚而存在缺陷,而较新的研究因混淆而受到限制,因为合并症影响死亡率和低钠血症矫正率。虽然旧的和新的研究都强调快速纠正后mri记录的ODS的罕见性,但它们并没有在有ODS风险的低钠血症患者中进行。报道脑水肿导致低钠血症死亡的旧研究高估了其真实发生率,而报道死亡率与钠校正速度缓慢相关的新研究并未将脑水肿作为导致死亡的常见因素。需要进一步的研究来更好地确定有这些并发症风险的患者中ODS和脑水肿的发生率。在此之前,我们得出结论,快速矫正的风险——包括不可逆转的神经损伤——需要谨慎。临床医生应继续优先考虑缓慢、有控制的钠纠正,以保护高危患者免受伤害。
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引用次数: 0
Environmental Impacts of Kidney Replacement Therapies: A Comparative Lifecycle Assessment 肾脏替代疗法对环境的影响:一项比较生命周期评估。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-10 DOI: 10.1053/j.ajkd.2025.08.010
Saba Saleem , Caroline Stigant , Tasleem Rajan , Kasun Hewage , Rehan Sadiq , Andrea J. MacNeill , Christopher Nguan
<div><h3>Rationale & Objective</h3><div>Health care delivery is associated with considerable emissions of greenhouse gases and other pollutants. Although the relative health and economic impacts of kidney replacement therapies (KRTs) have been examined, their comparative environmental impacts have been poorly described. This study sought to characterize these impacts, comparing them across types of KRT.</div></div><div><h3>Study Design</h3><div>A comparative lifecycle assessment (LCA).</div></div><div><h3>Setting & Participants</h3><div>Data collection implemented at Vancouver General Hospital in Vancouver, British Columbia, Canada.</div></div><div><h3>Exposure</h3><div>Three KRTs: deceased-donor kidney transplant (KT), automated/cycler peritoneal dialysis (PD), or in-center hemodialysis (HD).</div></div><div><h3>Outcome</h3><div>Environmental impacts of KRTs over 1 year were evaluated using the World ReCiPe (H) 2016 method.</div></div><div><h3>Analytical Approach</h3><div>Lifecycle inventory results were transformed into 3 end-point and 18 midpoint environmental impact categories including climate change, air pollution, human toxicity, and water depletion.</div></div><div><h3>Results</h3><div>Across the majority of environmental impact categories, including climate change, air pollution, human toxicity, and water depletion, HD had the highest environmental impact and KT the lowest. The climate impact from a patient receiving HD was 74% and 46% more than from patients receiving KT and PD, respectively. Similarly, HD accounted for 65% of total air pollution impacts, 54% of human toxicity, and 44% of water depletion. The highest impact of PD was on water depletion (41%) and metal depletion (81%). KT demonstrated the lowest impact across all categories except terrestrial ecotoxicity. Within each therapy, patient and staff travel and consumables were the largest contributors to greenhouse gas emissions.</div></div><div><h3>Limitations</h3><div>Pharmaceuticals were excluded from this study because of a lack of publicly available data.</div></div><div><h3>Conclusions</h3><div>KT is the most environmentally preferred KRT. PD had fewer environmental impacts than HD. Understanding the relative environmental impacts of KRTs can help inform clinical decision-making in the management of kidney failure.</div></div><div><h3>Plain-Language Summary</h3><div>The environmental impacts of health care are gaining attention, yet kidney care, and especially kidney replacement therapies (KRTs), have been underexamined. This study was inspired by growing concerns about the environmental consequences of KRTs like hemodialysis, peritoneal dialysis, and transplantation. We used environmental assessment tools to measure emissions and resource use across different KRTs in a clinical setting in Vancouver, Canada. We found that these therapies vary widely in their environmental impacts, with in-center hemodialysis having the greatest negative impact and kidney transpla
理由与目的医疗服务的提供与大量温室气体(GHG)和其他污染物的排放有关。虽然肾脏替代疗法(KRTs)的相对健康和经济影响已经被研究过,但它们对环境的相对影响却没有得到很好的描述。本研究试图通过比较不同类型的KRT来描述这些影响。研究设计:比较生命周期评估(LCA)。地点和参与者数据收集在不列颠哥伦比亚省温哥华的温哥华总医院实施。三种KRTs:已故供体肾移植(KT)、自动/循环腹膜透析(PD)或中心血液透析(HD)。结果:使用世界配方(H) 2016方法评估KRTs一年以上的环境影响。分析方法生命周期清单结果被转化为3个端点和18个中间点的环境影响类别,包括气候变化、空气污染、人类毒性和水资源枯竭。结果:在大多数环境影响类别中,包括气候变化、空气污染、人类毒性和水资源枯竭,HD的环境影响最大,KT的环境影响最小。接受HD的患者对气候的影响分别比接受KT和PD的患者高74%和46%。同样,HD占总空气污染影响的65%,人类毒性的54%,水资源消耗的44%。PD对水分消耗(41%)和金属消耗(81%)的影响最大。除陆地生态毒性外,KT的影响在所有类别中均最低。在每项治疗中,患者和工作人员的旅行和消耗品是温室气体排放的最大贡献者。由于缺乏公开数据,制药被排除在本研究之外。结论kt是最环保的KRT。PD对环境的影响小于HD。了解KRTs的相对环境影响有助于为肾衰竭管理的临床决策提供信息。
{"title":"Environmental Impacts of Kidney Replacement Therapies: A Comparative Lifecycle Assessment","authors":"Saba Saleem ,&nbsp;Caroline Stigant ,&nbsp;Tasleem Rajan ,&nbsp;Kasun Hewage ,&nbsp;Rehan Sadiq ,&nbsp;Andrea J. MacNeill ,&nbsp;Christopher Nguan","doi":"10.1053/j.ajkd.2025.08.010","DOIUrl":"10.1053/j.ajkd.2025.08.010","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Rationale &amp; Objective&lt;/h3&gt;&lt;div&gt;Health care delivery is associated with considerable emissions of greenhouse gases and other pollutants. Although the relative health and economic impacts of kidney replacement therapies (KRTs) have been examined, their comparative environmental impacts have been poorly described. This study sought to characterize these impacts, comparing them across types of KRT.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Study Design&lt;/h3&gt;&lt;div&gt;A comparative lifecycle assessment (LCA).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Setting &amp; Participants&lt;/h3&gt;&lt;div&gt;Data collection implemented at Vancouver General Hospital in Vancouver, British Columbia, Canada.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Exposure&lt;/h3&gt;&lt;div&gt;Three KRTs: deceased-donor kidney transplant (KT), automated/cycler peritoneal dialysis (PD), or in-center hemodialysis (HD).&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Outcome&lt;/h3&gt;&lt;div&gt;Environmental impacts of KRTs over 1 year were evaluated using the World ReCiPe (H) 2016 method.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Analytical Approach&lt;/h3&gt;&lt;div&gt;Lifecycle inventory results were transformed into 3 end-point and 18 midpoint environmental impact categories including climate change, air pollution, human toxicity, and water depletion.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;Across the majority of environmental impact categories, including climate change, air pollution, human toxicity, and water depletion, HD had the highest environmental impact and KT the lowest. The climate impact from a patient receiving HD was 74% and 46% more than from patients receiving KT and PD, respectively. Similarly, HD accounted for 65% of total air pollution impacts, 54% of human toxicity, and 44% of water depletion. The highest impact of PD was on water depletion (41%) and metal depletion (81%). KT demonstrated the lowest impact across all categories except terrestrial ecotoxicity. Within each therapy, patient and staff travel and consumables were the largest contributors to greenhouse gas emissions.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Limitations&lt;/h3&gt;&lt;div&gt;Pharmaceuticals were excluded from this study because of a lack of publicly available data.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Conclusions&lt;/h3&gt;&lt;div&gt;KT is the most environmentally preferred KRT. PD had fewer environmental impacts than HD. Understanding the relative environmental impacts of KRTs can help inform clinical decision-making in the management of kidney failure.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Plain-Language Summary&lt;/h3&gt;&lt;div&gt;The environmental impacts of health care are gaining attention, yet kidney care, and especially kidney replacement therapies (KRTs), have been underexamined. This study was inspired by growing concerns about the environmental consequences of KRTs like hemodialysis, peritoneal dialysis, and transplantation. We used environmental assessment tools to measure emissions and resource use across different KRTs in a clinical setting in Vancouver, Canada. We found that these therapies vary widely in their environmental impacts, with in-center hemodialysis having the greatest negative impact and kidney transpla","PeriodicalId":7419,"journal":{"name":"American Journal of Kidney Diseases","volume":"87 1","pages":"Pages 65-74.e1"},"PeriodicalIF":8.2,"publicationDate":"2025-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145261606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Identifying Adaptation Needs of a Decision Aid for Older Latino Adults With Advanced CKD: A Qualitative Study 一项定性研究:确定拉丁裔老年晚期CKD患者决策辅助的适应需求。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-10-08 DOI: 10.1053/j.ajkd.2025.07.014
Thalia Porteny , Kristen Kennefick , Hillary Matos , Kelli Collins Damron , Daniel E. Weiner , Sean Kalloo , Keren Ladin

Rationale & Objective

Latino adults aged 65 years and older comprise the fastest growing minoritized group in the United States and experience a disproportionate burden of kidney failure. Decision aids improve decisional quality and goal-concordant care among older patients with chronic kidney disease (CKD). However, decision aids for kidney replacement therapy have yet to be adapted for the older Latino adult population with advanced CKD. This study assessed the acceptability, accessibility and adaptions needed to facilitate use of a Spanish version of the Decision-Aid for Renal Therapy (DART-S) for older Latino adults with advanced CKD.

Study Design

Qualitative study applying the Cultural Targeting and Tailoring of Shared Decision-Making Technology Framework in focus groups and structured interviews. Suggested adaptations were grouped into recommendations and analyzed qualitatively.

Setting & Participants

Five focus groups (N = 17) and interviews (N = 15) with Spanish-speaking patients and care partners were conducted.

Analytical Approach

Thematic analysis.

Results

Among patient participants, 55% were male, and the mean age was 68 ± 9 years. Overall, the participants found DART-S to be acceptable and accessible. Thematic analysis revealed the importance of incorporating lived experiences, including patient and family testimonials, to illustrate the mental health impact of CKD, self-care strategies, and home dialysis adaptations. Some found the delivery of prognostic information distressing, highlighting the need for more sensitive communication. The tailoring recommendations included information about financial barriers, nutrition, and lifestyle. Participants preferred that DART-S be disseminated via kidney clinicians upon CKD diagnosis and recommended leveraging social media for broader reach.

Limitations

Findings are not generalizable beyond the Latino subgroups in this study. Legal status was not ascertained.

Conclusions

Targeting and tailoring decision aids is a necessary step in providing goal-concordant and person-centered care for older Latino adults with advanced CKD. Future research should examine the comparative efficacy of DART-S in increasing knowledge and decisional quality among Latino patients.
理由与目的65岁及以上的非裔成年人构成了美国增长最快的少数群体,他们承受着不成比例的肾衰竭负担。决策辅助提高老年慢性肾病患者的决策质量和目标一致性护理。然而,肾脏替代疗法的辅助决策尚未适用于老年拉丁裔成年晚期CKD患者。本研究的目的是评估西班牙语版本的Decision-Aid for Renal Therapy (DART-S)对老年拉丁裔晚期CKD患者的可接受性、可及性和适应性。研究设计:在焦点小组和结构化访谈中应用共享决策技术框架的文化目标和裁剪的定性研究。建议的适应被归类为建议并进行定性分析。环境和参与者进行了5个焦点小组(N=17)和对讲西班牙语的患者和护理伙伴的访谈(N=15)。分析方法:主题分析。结果患者中55%为男性,平均年龄为68±9岁。总体而言,参与者认为DART-S是可接受和可访问的。专题分析揭示了纳入生活经验的重要性,包括患者和家属的证词,以说明慢性肾病的心理健康影响,自我护理策略和家庭透析适应。一些人发现传递预后信息令人苦恼,强调需要更敏感的沟通。量身定制的建议包括有关经济障碍、营养和生活方式的信息。参与者更倾向于在CKD诊断时通过肾脏临床医生传播DART-S,并建议利用社交媒体进行更广泛的传播。局限性:本研究的发现不能推广到拉丁裔亚组之外。法律地位尚未确定。结论有针对性和量身定制的决策辅助是为拉丁裔老年晚期CKD患者提供目标一致和以人为本的护理的必要步骤。未来的研究应该检验DART-S在增加拉丁裔患者的知识和决策质量方面的比较功效。
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引用次数: 0
Urine Oxalate Excretion and CKD Stage in Patients With Primary Hyperoxaluria Type 1 原发性高草酸尿1型患者尿草酸排泄与CKD分期。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-09-20 DOI: 10.1053/j.ajkd.2025.07.013
Lisa E. Vaughan , Phillip J. Schulte , Felix Knauf , David J. Sas , Dawn S. Milliner , John C. Lieske
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引用次数: 0
Pharmaceutical Practice Considerations Regarding Adoption of the Race-Free Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 Equations 关于采用无种族慢性肾脏疾病流行病学合作(CKD-EPI) 2021方程的制药实践考虑。
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-09-19 DOI: 10.1053/j.ajkd.2025.06.022
Ruth Tarzi , Jennifer McKenzie , Michel Reid , Sophia Goodison , James Oyee , Thomas F. Hiemstra , Maciej J. Zamek-Gliszczynski , Mary Muoneke , Leslie A. Obert , Nneka Nwokolo , Benjamin Young , Anna Richards
The race-free Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 estimated glomerular filtration rate–creatinine (eGFRcr) equation is being adopted in the United States. Elsewhere there is debate regarding its validation and adoption. Absence of a perfect solution and a lack of alignment present challenges when considering global clinical trials. While acknowledging these challenges, GSK decided to adopt the CKD-EPI 2021 eGFRcr equation for new adult trials to support health equity and delivery benefits from standardized data management. The eGFRcr obtained using the CKD-EPI 2021 equation versus CKD-EPI 2009 equation is moderately lower in US Black individuals and moderately higher in non-Black individuals. Analyses before adoption suggested no major impact for study safety or efficacy evaluations although racial/ethnic representation may need to be examined in trials with an eGFR ≥ 60 mL/min/1.73 m2 inclusion criterion because enrollment of eligible Black participants could be reduced. Sensitivity analyses using 2009 and 2021 equations may be necessary to understand any effect size with population change, especially where there are kidney end points or relevant safety concerns. GSK plans to monitor the impact of adopting the CKD-EPI 2021 eGFRcr equation on adverse event reporting across studies and pharmacovigilance outcomes and to monitor the evolution of regulatory guidance for eGFR equation implementation.
无种族慢性肾脏疾病流行病学合作(CKD-EPI) 2021年估算肾小球滤过率-肌酐(eGFRcr)方程正在美国采用。在其他地方,关于它的有效性和采用存在争议。在考虑全球临床试验时,缺乏完美的解决方案和缺乏一致性是目前的挑战。在认识到这些挑战的同时,GSK决定在新的成人试验中采用CKD-EPI 2021 eGFRcr公式,以支持健康公平,并从标准化数据管理中获益。与CKD-EPI 2009方程相比,使用CKD-EPI 2021方程获得的eGFRcr在美国黑人中略低,在非黑人中略高。采用前的分析表明,虽然在eGFR≥60 mL/min/1.73m2纳入标准的试验中可能需要检查种族/民族代表性,但对研究的安全性或有效性评估没有重大影响,因为符合条件的黑人参与者的入组可能会减少。使用2009年和2021年方程进行敏感性分析可能是必要的,以了解人口变化的任何效应大小,特别是在存在肾脏终点或相关安全问题的情况下。GSK计划监测采用CKD-EPI 2021 eGFRcr方程对研究不良事件报告和药物警戒结果的影响,并监测eGFR方程实施的监管指南的演变。
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引用次数: 0
A 16-Year-Old With a Hypertension Emergency: A Quiz 一个16岁的高血压急症:一个小测验
IF 8.2 1区 医学 Q1 UROLOGY & NEPHROLOGY Pub Date : 2025-09-19 DOI: 10.1053/j.ajkd.2025.05.007
Travis Churilla , Joe B. Baker , Anthony Chang , Gal Finer
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引用次数: 0
期刊
American Journal of Kidney Diseases
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