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Role of SGLT-2 Inhibitors in Ultrafiltration Failure in Peritoneal Dialysis: A Narrative Review. SGLT-2 抑制剂在腹膜透析超滤失败中的作用:叙述性综述。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-11-05 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241293500
Magdalena Riedl Khursigara, Ping Liu, Reetinder Kaur, Thomas A Mavrakanas

Purpose of review: Sodium-glucose co-transporter-2 (SGLT-2) inhibitors are glucose lowering agents with protective effects on cardiovascular health and the ability to slow chronic kidney disease (CKD) progression. The benefits of SGLT-2 inhibitors have not been studied in patients with advanced CKD or on maintenance dialysis. Ultrafiltration failure is a common reason for failure of peritoneal dialysis (PD). Glucose transporters, such as SGLT-2, are involved in the progression to ultrafiltration failure, and hence, SGLT-2 inhibitors might be beneficial in patients on PD to prevent ultrafiltration failure.

Source of information: Here, we review data from animal models and ongoing clinical trials of SGLT-2 inhibitors in advanced CKD, as well as considerations for a phase III trial in patients on PD.

Methods: A literature search was conducted and information on clinical trials was obtained from clinicaltrials.gov.

Key findings: Animal models of PD have shown upregulation of glucose transporters in the peritoneal membrane and a potential effect of SGLT-2 inhibitors on glucose absorption and ultrafiltration. Several clinical trials are currently ongoing with SGLT-2 inhibitors in patients on PD. We discuss their study designs and propose a mixed-methods, patient-centered approach to studying SGLT-2 inhibitors in PD patients. We also discuss the potential implications of SGLT-2 inhibitors on people living with kidney failure, especially in remote communities.

综述目的:钠-葡萄糖共转运体-2(SGLT-2)抑制剂是一种降糖药物,对心血管健康具有保护作用,并能延缓慢性肾病(CKD)的进展。目前尚未研究 SGLT-2 抑制剂对晚期 CKD 患者或维持性透析患者的益处。超滤失败是腹膜透析(PD)失败的常见原因。SGLT-2等葡萄糖转运体参与了超滤衰竭的进展,因此,SGLT-2抑制剂可能有利于腹膜透析患者预防超滤衰竭:在此,我们回顾了SGLT-2抑制剂在晚期CKD中的动物模型和正在进行的临床试验数据,以及在PD患者中进行III期试验的考虑因素:方法:进行文献检索,并从 clinicaltrials.gov.cn 获取临床试验信息:主要发现:腹膜透析动物模型显示腹膜葡萄糖转运体上调,SGLT-2抑制剂对葡萄糖吸收和超滤有潜在影响。目前正在进行几项针对腹膜透析患者的 SGLT-2 抑制剂临床试验。我们讨论了它们的研究设计,并提出了一种以患者为中心的混合方法来研究 SGLT-2 抑制剂在帕金森病患者中的应用。我们还讨论了 SGLT-2 抑制剂对肾衰竭患者,尤其是偏远社区患者的潜在影响。
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引用次数: 0
GLP-1 Agonism for Kidney Transplant Recipients: A Narrative Review of Current Evidence and Future Directions Across the Research Spectrum. 肾移植受者的 GLP-1 激动剂:当前证据和未来研究方向综述》。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-31 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241290317
Victoria J Riehl-Tonn, Kyle D Medak, Christie Rampersad, Anne MacPhee, Tyrone G Harrison

Purpose of review: Diabetes is the most common cause of kidney disease in individuals that receive a kidney transplant, and those without pre-existing diabetes are at greater risk of developing diabetes following kidney transplant. A class of diabetes treatment medications called glucagon-like peptide-1 receptor agonists (GLP-1RA) has seen recent widespread use for people with diabetes or obesity, with efficacy for improved glycemic control, weight loss, and reduced risk of cardiovascular events. Given these benefits, and indications for use that often co-occur in kidney transplant recipients, use of GLP-1RAs warrants consideration in this population. Therefore, we sought to review the current literature to better understand the mechanisms of action, clinical application, and person-centred considerations of GLP-1RAs in kidney transplant recipients.

Sources of information: Original articles were identified between December 2023 and July 2024 from electronic databases including the Ovid MEDLINE database, PubMed, and Google Scholar using terms "kidney transplant," "GLP-1," "glucagon-like peptide-1 receptor agonist," and "diabetes."

Methods: A comprehensive review of the literature was conducted to explore the relationship between GLP-1RAs and kidney transplant recipients. We reviewed the current state of evidence across the research disciplines of basic or fundamental science, clinical and health services research, and person-centred equity science, and highlighted important knowledge gaps that offer opportunities for future research.

Key findings: Numerous clinical studies have demonstrated the benefit of GLP-1RAs in people with and without diabetic kidney disease, including decreased risk of cardiovascular events. However, there is a paucity of high-quality randomized controlled trials and observational studies analyzing use of GLP-1RAs in kidney transplant recipients. Evidence of benefit in this population is therefore limited to small studies or inferred from research conducted in nontransplant populations. Growing evidence from preclinical and clinical studies may elucidate renoprotective mechanisms of GLP-1RAs and remove barriers to application of these drugs in the transplant recipient population. Individuals who are female, non-white, have lower socioeconomic status, and live in rural communities are at greater risk of diabetes and have lower uptake of GLP-1RAs. There is a need for clinical trials across diverse kidney transplant populations to estimate the efficacy of GLP-1RAs on important health outcomes.

Limitations: The search strategy for this narrative review may not have been sensitive to identify all relevant articles. Our search was limited to English language articles.

审查目的:在接受肾移植的患者中,糖尿病是导致肾脏疾病的最常见原因,而没有糖尿病的患者在接受肾移植后患糖尿病的风险更大。最近,一类名为胰高血糖素样肽-1受体激动剂(GLP-1RA)的糖尿病治疗药物被广泛用于糖尿病或肥胖症患者,其疗效包括改善血糖控制、减轻体重和降低心血管事件风险。鉴于这些益处以及肾移植受者中经常出现的适应症,在这一人群中使用 GLP-1RAs 值得考虑。因此,我们试图回顾目前的文献,以更好地了解 GLP-1RA 在肾移植受者中的作用机制、临床应用以及以人为本的考虑因素:采用 "肾移植"、"GLP-1"、"胰高血糖素样肽-1 受体激动剂 "和 "糖尿病 "等术语,从 Ovid MEDLINE 数据库、PubMed 和 Google Scholar 等电子数据库中查找 2023 年 12 月至 2024 年 7 月间的原创文章:我们对文献进行了全面回顾,以探讨 GLP-1RA 与肾移植受者之间的关系。我们回顾了基础或基本科学、临床和健康服务研究以及以人为本的公平科学等研究学科的证据现状,并强调了为未来研究提供机会的重要知识缺口:大量临床研究表明,GLP-1RAs 可为糖尿病肾病患者或非糖尿病肾病患者带来益处,包括降低心血管事件风险。然而,对肾移植受者使用 GLP-1RA 进行分析的高质量随机对照试验和观察性研究却很少。因此,在这一人群中获益的证据仅限于小型研究,或根据在非移植人群中进行的研究推断。临床前研究和临床研究中越来越多的证据可能会阐明 GLP-1RAs 的肾脏保护机制,并消除这些药物在移植受者人群中应用的障碍。女性、非白人、社会经济地位较低、生活在农村社区的人患糖尿病的风险更大,对 GLP-1RAs 的吸收率也更低。需要对不同的肾移植人群进行临床试验,以评估 GLP-1RA 对重要健康结果的疗效:本综述的搜索策略可能无法识别所有相关文章。我们的搜索仅限于英语文章。
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引用次数: 0
Patient Perspectives of Telemedicine in Outpatient Nephrology Clinics During COVID-19: A Qualitative Study. COVID-19 期间患者对肾脏病门诊远程医疗的看法:定性研究。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-28 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241293192
Abdelhady Osman, Seung Heyck Lee, Mateen Noori, Melissa Al-Jaishi, Kerri Gallo, Lori Harwood, Louise Moist

Background: The COVID-19 pandemic notably disrupted care for patients with chronic kidney disease (CKD) care, necessitating a rapid shift to telemedicine. Despite the growing use of telemedicine, the impact of this transition on patients' experiences, particularly in Canada and considering sociocultural factors, remains underexplored. This study aims to investigate patients with CKD perspectives on telemedicine versus in-person care and to offer recommendations for enhancing telemedicine services.

Objective: The objective was to understand patients with CKD views on telemedicine clinics during the pandemic compared to traditional in-person clinics.

Design: This was a qualitative descriptive study employing semi-structured interviews.

Setting: This study was conducted in general nephrology and multidisciplinary kidney care clinics in London, Canada.

Population: The study population was English-speaking patients with CKD with at least one in-person nephrology visit before March 15, 2020, and one telemedicine appointment after March 30, 2020.

Methods: Interviews were conducted using a structured guide, with transcripts analyzed line-by-line by 3 independent reviewers through directed content analysis. Themes were identified and agreed upon through group consensus.

Results: Interviews with 12 participants revealed 5 key themes: (1) convenience; (2) building connection and trust; (3) necessity of in-person care; (4) role of family or caregivers; and (5) preferences for clinic types. Most participants (11/12) valued the convenience of telemedicine, noting similar levels of care compared to in-person visits. However, they found it easier to establish personal connections in face-to-face appointments. Most (8/12) preferred in-person visits if their condition worsened. Overall, a combination of in-person and telemedicine was favored, with a preference for video over telephone.

Limitations: The study's focus on one academic nephrology center in Ontario and predominantly white participants limits broader applicability. Additionally, recall bias may affect the findings due to the interview-based design.

Conclusions: Telemedicine will remain integral to CKD care, with a hybrid model combining in-person and telemedicine preferred. Integrating patient feedback into future telemedicine practices is essential to enhance flexibility, access, and patient satisfaction.

背景:COVID-19 大流行明显扰乱了对慢性肾脏病 (CKD) 患者的护理,因此有必要迅速转向远程医疗。尽管远程医疗的使用越来越多,但这一转变对患者体验的影响,尤其是在加拿大并考虑到社会文化因素,仍未得到充分探讨。本研究旨在调查慢性肾脏病患者对远程医疗与面对面医疗的看法,并为加强远程医疗服务提供建议:目的:了解慢性肾脏病患者对大流行期间远程医疗诊所与传统面对面诊所的看法:这是一项采用半结构化访谈的定性描述性研究:研究在加拿大伦敦的普通肾脏病学和多学科肾脏护理诊所进行:研究对象:2020 年 3 月 15 日之前接受过至少一次肾内科面诊、2020 年 3 月 30 日之后接受过一次远程医疗预约的讲英语的慢性肾脏病患者:采用结构化指南进行访谈,由 3 位独立审稿人通过定向内容分析对访谈记录进行逐行分析。结果:对 12 名参与者的访谈揭示了 5 个主题:对 12 名参与者的访谈揭示了 5 个关键主题:(1) 便捷性;(2) 建立联系和信任;(3) 亲自护理的必要性;(4) 家庭或护理人员的作用;(5) 对诊所类型的偏好。大多数参与者(11/12)重视远程医疗的便利性,并指出远程医疗的护理水平与面对面就诊的护理水平相似。不过,他们认为面对面的预约更容易建立个人联系。如果病情恶化,大多数人(8/12)倾向于亲自到医院就诊。总的来说,他们更倾向于将面诊和远程医疗结合起来,视频比电话更受欢迎:局限性:这项研究的重点是安大略省的一家肾脏病学术中心,参与者主要是白人,这限制了研究的广泛适用性。此外,基于访谈的设计可能会影响研究结果的回忆偏差:结论:远程医疗仍将是慢性肾脏病治疗不可或缺的一部分,最好采用现场和远程医疗相结合的混合模式。将患者的反馈融入未来的远程医疗实践对提高灵活性、可及性和患者满意度至关重要。
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引用次数: 0
Increasing Accessibility to Intradialytic Cycling in Rural and Remote Settings: Program Report. 提高农村和偏远地区椎管内循环的可及性:计划报告。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-21 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241287591
Sherry Erian, Rachelle Davies, Kylie Morrison, Christina West, Maria Ruiz, Iwona Zubik, Julie Nhan, Stephanie Thompson
<p><strong>Purpose of program: </strong>Access to exercise and rehabilitation is often lower in rural or remote areas and hemodialysis (HD) dependence imposes additional barriers. Intradialytic cycling (IDC) can improve HD-related symptoms, such as leg cramping, restless legs, and symptoms of depression, as well as physical function and fitness, but access to exercise professionals with this expertise is limited. To promote access to IDC in rural and remote HD units, we describe the implementation and initial evaluation of a novel IDC program using virtual assessment to safely prescribe and individualize IDC.</p><p><strong>Sources of information: </strong>We developed and piloted a protocol for virtual IDC assessment and prospectively collected metrics informed by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to support future quality improvement activities.</p><p><strong>Methods: </strong>Rural HD units were defined as per Alberta Kidney Care North (AKC-N)'s operations. The virtual IDC program components were: HD unit education sessions, support and interest from local unit staff and those receiving HD, a bike, a supervising kinesiologist, a stable Internet connection, a nurse present during the 25-minute initial virtual assessment, and virtual follow-up every 3 to 4 weeks with the kinesiologist. The initial assessment consists of a virtual bike test where the participant performs a graded, symptom-limited cycling trial with documentation of vital signs and rating of self-perceived exertion (relative intensity). The data are used to prescribe IDC (frequency, intensity, time). The HD unit staff learn participant and bike set-up, confirm safe exercise parameters for that day, adjust the bike intensity, and take vital signs. Outcomes for evaluating the impact of the IDC program using the RE-AIM health framework were selected.</p><p><strong>Key findings: </strong>Out of the 24 HD units in AKC-N, 18 units were defined as either remote or rural (75%). Four of the units (22%) adopted the program, which was less than our target of 30% of units. Individual-level participation (Reach) within those units ranged widely (1-67%) with only one unit reaching the target of at least 30% individual-level participation. Reasons for starting IDC were intradialytic cramping, restless legs, deconditioning, and boredom during HD. Reasons for non-participation were lack of interest and a desire to sleep. Routine exercise program questionnaires on health-related quality of life for program effectiveness were not consistently completed by participants. All virtual assessments were completed as per protocol with a nurse (100% fidelity); however, tests often needed to be re-scheduled due to technical issues with Wi-Fi, limited unit staffing, operational demands, and/or safety concerns. At 1 year, all 4 units continued to participate with 2 additional HD units starting the following year.</p><p><strong>Limitations: </strong>Reach coul
计划的目的:在农村或偏远地区,获得锻炼和康复的机会通常较少,而血液透析(HD)依赖性又增加了障碍。椎管内循环(IDC)可以改善血液透析相关症状,如腿部抽筋、腿部不宁、抑郁症状以及身体功能和体能,但具备这方面专业知识的运动专业人员却非常有限。为了促进农村和偏远地区的 HD 单位获得 IDC,我们介绍了一项新型 IDC 计划的实施和初步评估,该计划利用虚拟评估安全地开具 IDC 处方并使其个性化:我们制定并试行了虚拟 IDC 评估协议,并根据 "覆盖面、有效性、采用、实施和维护"(RE-AIM)框架对指标进行了前瞻性收集,以支持未来的质量改进活动:方法:根据阿尔伯塔省肾脏护理北部公司(AKC-N)的运营情况,对农村高清单位进行定义。虚拟 IDC 计划的组成部分包括HD 单位教育课程、当地单位员工和接受 HD 治疗者的支持和兴趣、一辆自行车、一名指导运动师、稳定的互联网连接、一名护士在 25 分钟的初始虚拟评估期间在场,以及运动师每 3 到 4 周的虚拟跟踪。初始评估包括虚拟自行车测试,参与者进行分级的、症状有限的自行车测试,并记录生命体征和自我感觉用力程度(相对强度)。这些数据将用于制定 IDC(频率、强度和时间)处方。血液透析室的工作人员会了解参与者和自行车的设置,确认当天的安全运动参数,调整自行车强度,并测量生命体征。利用 RE-AIM 健康框架评估 IDC 计划的影响:在 AKC-N 的 24 个高清单位中,18 个单位被定义为偏远地区或农村地区(75%)。其中 4 个单位(22%)采用了该计划,低于我们设定的 30% 单位采用的目标。这些单位的个人参与率(Reach)差别很大(1-67%),只有一个单位达到了至少 30% 的个人参与率目标。开始 IDC 的原因是肾内抽筋、腿部不宁、体能下降以及对 HD 厌烦。不参加的原因是缺乏兴趣和想睡觉。参与者没有坚持完成常规运动项目的健康相关生活质量调查问卷,以了解项目的有效性。所有虚拟评估均按照协议由一名护士完成(100% 忠实度);但是,由于 Wi-Fi 技术问题、病房人员有限、运行需求和/或安全问题,测试经常需要重新安排时间。一年后,所有 4 个单位都继续参与,次年又有 2 个高清单位开始参与:局限性:在转入当地卫星 HD 单位之前,可通过在 HD 启动时向个人介绍椎管内锻炼来提高覆盖率。现有的计划有效性衡量标准可能与计划参与者不相关,或者在没有现场专业锻炼人员的情况下无法实施。技术问题和单位员工繁忙的日程安排限制了测试的如期完成:在没有专业运动人员的情况下,通过虚拟支持实施规范化方法,可以提高血液透析病房对循证治疗的可及性。对于需要进行血液透析的人来说,在血液透析开始时进行早期教育和接触,并为工作人员提供指导课程,可以提高他们的可及性。为工作人员增加一个虚拟 IDC 评估日,作为他们每月例行任务安排的一部分,可以促进制度化。为运动师和护士举办正式的跟进会议,讨论项目关注的问题,将有利于项目的未来发展。通过选择更加个性化的方案,例如,与个人转介原因相关的个人报告方案,可能会改善计划有效性测量的完成情况。
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引用次数: 0
An Exercise and Wellness Behavior Change Program for Solid Organ Transplant: A Clinical Research Protocol for the Transplant Wellness Program. 针对实体器官移植的运动和健康行为改变计划:移植健康计划的临床研究方案。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-21 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241289196
Jenna A P Sim, Maneka A Perinpanayagam, Vanessa Bahry, Kathryn Wytsma-Fisher, Kelly W Burak, Debra L Isaac, Stefan Mustata, S Nicole Culos-Reed

Background: Exercise prehabilitation is an evidence-based, safe, and effective method to increase quality of life, physical fitness and function, and post-surgical outcomes in solid organ transplant (SOT) patients. However, few prehabilitation programs for SOT patients exist in practice. Furthermore, there is a lack of multimodal prehabilitation programs that include behavior change support. To address this need, the Transplant Wellness Program (TWP) was designed.

Objectives: The objective of the TWP is to assess both the effectiveness and implementation of a comprehensive and multimodal exercise and wellness behavior change intervention for patients undergoing kidney or liver transplant.

Design: The TWP is a hybrid effectiveness-implementation trial consisting of exercise and wellness behavior change support.

Patients: Individuals who are in evaluation or listed for kidney or liver transplant in Southern Alberta, Canada.

Measurements: The primary outcomes of self-reported exercise and quality of life are assessed at intake, post-exercise intervention, 6 months post-intake, 12 weeks post-transplant, and annually for 5 years after program completion. Functional fitness measures will be assessed at intake, post-exercise intervention, 12 weeks post-transplant, 6 months post-intake, and 1-year post-intake. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework is used to determine the impact of TWP at the individual and health care system level.

Methods: Recruitment began in November 2023 and will continue until November 2028. Participants take part in a 12-week exercise intervention and are offered individualized and group behavior change support. Continued exercise support is offered through maintenance classes after the completion of the 12-week intervention.

Limitations: The design of the hybrid effectiveness-implementation trial with a single experimental group will not allow for comparisons to a control or usual care group, potentially impacting internal validity. Differences in number of participants between organ groups (kidney vs liver) and cohorts (pre-transplant vs post-transplant) will likely be uneven, requiring consideration when running and interpreting analyses.

Conclusions: The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program. Results from this study will determine the effectiveness of the program and inform future scale-up and sustainability.

Trial registry number: NCT06367244.

背景:运动前康复是一种循证、安全且有效的方法,可提高实体器官移植(SOT)患者的生活质量、体能和功能,并改善手术后的预后。然而,在实践中针对 SOT 患者的预康复计划却寥寥无几。此外,还缺乏包括行为改变支持在内的多模式康复计划。为了满足这一需求,我们设计了移植健康计划(TWP):TWP 的目标是评估针对接受肾脏或肝脏移植患者的综合、多模式运动和健康行为改变干预措施的有效性和实施情况:TWP是一项由运动和健康行为改变支持组成的混合有效性-实施性试验:患者:加拿大阿尔伯塔省南部正在接受肾脏或肝脏移植评估或列入名单的患者:主要结果为自我报告的运动量和生活质量,分别在入组时、运动干预后、入组后 6 个月、移植后 12 周以及计划完成后 5 年内每年进行一次评估。功能性体能测量将在入组时、运动干预后、移植后 12 周、入组后 6 个月和入组后 1 年进行评估。采用覆盖、有效性、采用、实施和维持(RE-AIM)框架来确定 TWP 在个人和医疗保健系统层面的影响:招募从 2023 年 11 月开始,将持续到 2028 年 11 月。参与者参加为期 12 周的运动干预,并获得个性化和小组行为改变支持。在完成为期 12 周的干预后,还将通过维持课程继续提供运动支持:局限性:有效性-实施性混合试验的设计只有一个实验组,无法与对照组或常规护理组进行比较,可能会影响内部有效性。器官组(肾脏组与肝脏组)和队列(移植前与移植后)之间的参与者人数差异可能会不均衡,在进行分析和解释时需要加以考虑:TWP旨在通过多模式的综合运动和健康行为改变计划,在整个移植过程中为患者提供支持。这项研究的结果将确定该计划的有效性,并为未来的推广和可持续性提供依据:NCT06367244.
{"title":"An Exercise and Wellness Behavior Change Program for Solid Organ Transplant: A Clinical Research Protocol for the Transplant Wellness Program.","authors":"Jenna A P Sim, Maneka A Perinpanayagam, Vanessa Bahry, Kathryn Wytsma-Fisher, Kelly W Burak, Debra L Isaac, Stefan Mustata, S Nicole Culos-Reed","doi":"10.1177/20543581241289196","DOIUrl":"https://doi.org/10.1177/20543581241289196","url":null,"abstract":"<p><strong>Background: </strong>Exercise prehabilitation is an evidence-based, safe, and effective method to increase quality of life, physical fitness and function, and post-surgical outcomes in solid organ transplant (SOT) patients. However, few prehabilitation programs for SOT patients exist in practice. Furthermore, there is a lack of multimodal prehabilitation programs that include behavior change support. To address this need, the Transplant Wellness Program (TWP) was designed.</p><p><strong>Objectives: </strong>The objective of the TWP is to assess both the effectiveness and implementation of a comprehensive and multimodal exercise and wellness behavior change intervention for patients undergoing kidney or liver transplant.</p><p><strong>Design: </strong>The TWP is a hybrid effectiveness-implementation trial consisting of exercise and wellness behavior change support.</p><p><strong>Patients: </strong>Individuals who are in evaluation or listed for kidney or liver transplant in Southern Alberta, Canada.</p><p><strong>Measurements: </strong>The primary outcomes of self-reported exercise and quality of life are assessed at intake, post-exercise intervention, 6 months post-intake, 12 weeks post-transplant, and annually for 5 years after program completion. Functional fitness measures will be assessed at intake, post-exercise intervention, 12 weeks post-transplant, 6 months post-intake, and 1-year post-intake. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework is used to determine the impact of TWP at the individual and health care system level.</p><p><strong>Methods: </strong>Recruitment began in November 2023 and will continue until November 2028. Participants take part in a 12-week exercise intervention and are offered individualized and group behavior change support. Continued exercise support is offered through maintenance classes after the completion of the 12-week intervention.</p><p><strong>Limitations: </strong>The design of the hybrid effectiveness-implementation trial with a single experimental group will not allow for comparisons to a control or usual care group, potentially impacting internal validity. Differences in number of participants between organ groups (kidney vs liver) and cohorts (pre-transplant vs post-transplant) will likely be uneven, requiring consideration when running and interpreting analyses.</p><p><strong>Conclusions: </strong>The TWP aims to support patients throughout the transplant journey through a multimodal and comprehensive exercise and wellness behavior change program. Results from this study will determine the effectiveness of the program and inform future scale-up and sustainability.</p><p><strong>Trial registry number: </strong>NCT06367244.</p>","PeriodicalId":9426,"journal":{"name":"Canadian Journal of Kidney Health and Disease","volume":"11 ","pages":"20543581241289196"},"PeriodicalIF":1.6,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11500225/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acute Allograft Rejection in Kidney Transplant Recipients Treated With Immune Checkpoint Inhibitors: An Educational Case Report. 接受免疫检查点抑制剂治疗的肾移植受者出现急性移植物排斥反应:教育性病例报告。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-21 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241289191
Steven A Morrison, Amanda J Vinson

Rationale: Kidney transplant (KT) recipients have an increased risk of malignancy due to chronic immunosuppression. The emerging use of immune checkpoint inhibitors (ICIs) has been a promising development for the treatment of malignancy, but their use adds to the complexity of immunosuppression management for KT recipients. This case report describes 2 cases of acute rejection in KT recipients following ICI initiation and discusses the balance of malignancy treatment with adequate immunosuppression.

Presenting concerns of patients: The first patient is a 44-year-old male KT recipient with a diagnosis of metastatic renal cell carcinoma presenting with acute kidney injury 6 days following initiation of an ICI. The second patient is a 73-year-old male KT recipient with a diagnosis of squamous cell carcinoma presenting with acute kidney injury 2 weeks following initiation of an ICI.

Diagnoses: Both patients were diagnosed with acute rejection in the setting of reduced immunosuppression and initiation of an ICI.

Interventions: Both cases received an increased dose of steroid without improvement of graft function. The first patient subsequently underwent a delayed graft nephrectomy due to complications of acute rejection, whereas the second patient did not undergo nephrectomy.

Outcomes: The first patient experienced complications including perioperative bleeding requiring multiple operations, but ultimately stabilized on hemodialysis and showed a durable response to ICI. The second patient remained dialysis-dependent post-ICI treatment and was readmitted with allograft complications leading to his eventual death.

Teaching points: This study underscores the complexity of managing KT recipients diagnosed with malignancy and receiving ICIs. The balance between immunosuppression reduction to treat malignancy and preventing allograft rejection presents a significant challenge. Key considerations include the risk of acute allograft rejection and patient-centered decision-making. These cases highlight the need for further research to develop evidence-based guidelines for managing this patient population. In addition, the patient perspective in this study highlights the importance of careful risk-benefit analysis and the impact of treatment decisions on patient-focused outcomes.

理由:肾移植(KT)受者因长期免疫抑制而增加了罹患恶性肿瘤的风险。新出现的免疫检查点抑制剂(ICIs)在治疗恶性肿瘤方面前景广阔,但其使用增加了肾移植受者免疫抑制管理的复杂性。本病例报告描述了两例 KT 受者在使用 ICI 后出现急性排斥反应的病例,并讨论了恶性肿瘤治疗与适当免疫抑制之间的平衡问题:第一例患者是一名 44 岁的男性 KT 受体,诊断为转移性肾细胞癌,在使用 ICI 6 天后出现急性肾损伤。第二名患者是一名 73 岁的男性 KT 受体,诊断为鳞状细胞癌,在开始 ICI 2 周后出现急性肾损伤:两名患者均被诊断为在免疫抑制减少和开始使用 ICI 的情况下出现急性排斥反应:干预措施: 两例患者均接受了加大剂量的类固醇治疗,但移植功能均未得到改善。第一例患者随后因急性排斥反应并发症接受了延迟移植肾切除术,而第二例患者没有接受肾切除术:第一例患者出现了包括围手术期出血在内的并发症,需要进行多次手术,但最终通过血液透析稳定了病情,并对 ICI 表现出了持久的反应。第二名患者在接受 ICI 治疗后仍需依赖透析,并因异体移植并发症再次入院,最终导致死亡:本研究强调了管理确诊为恶性肿瘤并接受 ICI 的 KT 受体的复杂性。如何在减少免疫抑制以治疗恶性肿瘤和防止异体移植排斥反应之间取得平衡是一项重大挑战。主要考虑因素包括急性异体移植排斥反应的风险和以患者为中心的决策。这些病例凸显了进一步研究的必要性,以便为管理这一患者群体制定循证指南。此外,本研究从患者的角度强调了谨慎进行风险效益分析的重要性,以及治疗决策对以患者为中心的治疗效果的影响。
{"title":"Acute Allograft Rejection in Kidney Transplant Recipients Treated With Immune Checkpoint Inhibitors: An Educational Case Report.","authors":"Steven A Morrison, Amanda J Vinson","doi":"10.1177/20543581241289191","DOIUrl":"https://doi.org/10.1177/20543581241289191","url":null,"abstract":"<p><strong>Rationale: </strong>Kidney transplant (KT) recipients have an increased risk of malignancy due to chronic immunosuppression. The emerging use of immune checkpoint inhibitors (ICIs) has been a promising development for the treatment of malignancy, but their use adds to the complexity of immunosuppression management for KT recipients. This case report describes 2 cases of acute rejection in KT recipients following ICI initiation and discusses the balance of malignancy treatment with adequate immunosuppression.</p><p><strong>Presenting concerns of patients: </strong>The first patient is a 44-year-old male KT recipient with a diagnosis of metastatic renal cell carcinoma presenting with acute kidney injury 6 days following initiation of an ICI. The second patient is a 73-year-old male KT recipient with a diagnosis of squamous cell carcinoma presenting with acute kidney injury 2 weeks following initiation of an ICI.</p><p><strong>Diagnoses: </strong>Both patients were diagnosed with acute rejection in the setting of reduced immunosuppression and initiation of an ICI.</p><p><strong>Interventions: </strong>Both cases received an increased dose of steroid without improvement of graft function. The first patient subsequently underwent a delayed graft nephrectomy due to complications of acute rejection, whereas the second patient did not undergo nephrectomy.</p><p><strong>Outcomes: </strong>The first patient experienced complications including perioperative bleeding requiring multiple operations, but ultimately stabilized on hemodialysis and showed a durable response to ICI. The second patient remained dialysis-dependent post-ICI treatment and was readmitted with allograft complications leading to his eventual death.</p><p><strong>Teaching points: </strong>This study underscores the complexity of managing KT recipients diagnosed with malignancy and receiving ICIs. The balance between immunosuppression reduction to treat malignancy and preventing allograft rejection presents a significant challenge. Key considerations include the risk of acute allograft rejection and patient-centered decision-making. These cases highlight the need for further research to develop evidence-based guidelines for managing this patient population. In addition, the patient perspective in this study highlights the importance of careful risk-benefit analysis and the impact of treatment decisions on patient-focused outcomes.</p>","PeriodicalId":9426,"journal":{"name":"Canadian Journal of Kidney Health and Disease","volume":"11 ","pages":"20543581241289191"},"PeriodicalIF":1.6,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11497508/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142495648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Program Report: Expanding the Deceased Donor Pool in Manitoba With an Age-Targeted Kidney Transplant Program. 计划报告:通过年龄目标肾移植计划扩大马尼托巴省的死亡捐献者库。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-13 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241287288
Aaron Trachtenberg, Vaishali Shenoy, Nancy Dodd, Drew Hager, Martin Karpinski, Joshua Koulack, Krista Maxwell, Andrea Mazurat, Denise Pochinco, Christie Sathianathan, James Shaw, Chris Wiebe, Peter Nickerson, Julie Ho
<p><strong>Purpose of program: </strong>The ongoing shortage of organs for transplant combined with the highest prevalence of end-stage kidney disease (ESKD) in Canada has resulted in long wait times for a deceased donor transplant in Manitoba. Therefore, the Transplant Manitoba Adult Kidney Program has ongoing quality improvement initiatives to expand the deceased donor pool. This clinical transplant protocol describes an age-targeted program intended to increase the use of transplants with a kidney donor profile index (KDPI) >85 by allocating them to suitable pre-consented recipients age ≥65 with low wait times. The goal is to improve survival and quality of life for older recipients by maximizing a previously under-utilized donor pool.</p><p><strong>Sources of information: </strong>Scoping literature review; Transplant Manitoba deceased donor audit; and key stakeholder engagement with patient partners, inter-disciplinary health care providers, and health system leaders.</p><p><strong>Methods: </strong>The alternative donor pool criteria include deceased donor kidneys with KDPI 86-100 or another concern for graft longevity but are otherwise suitable for transplantation. Patients with no living donor, age ≥65, low wait times and otherwise eligible for transplant listing will be educated, and if suitable, pre-consented for the age-targeted program. All patients remain eligible for a standard criteria donor according to the local allocation criteria. The age-targeted program waitlist follows the same provincial allocation rules using wait time, panel reactive antibody (PRA), and human leukocyte antigen (HLA) match points for determining rank order. If an age-targeted recipient experiences early graft loss from a KDPI 86-100 kidney within 12 months from transplant, their cumulative wait time, including time with the transplant, will be reinstated upon relisting.</p><p><strong>Key findings: </strong>Transplant Manitoba's provincial allocation rules do not permit bypassing top of the list recipients for kidney offers; therefore, transplant providers were previously reluctant to utilize KDPI 86-100 donor kidneys to top of the list recipients eligible for higher quality kidneys. This age-targeted program facilitates allocation of KDPI 86-100 kidneys to suitable older pre-consented recipients with low wait times, who may obtain a survival and quality of life benefit from these transplants. This approach expands the utilized deceased donor pool to benefit all Manitobans awaiting a deceased donor kidney transplant.</p><p><strong>Limitations: </strong>This program was launched in January 2023, and there are no data reported on outcomes given the small numbers and abbreviated follow-up.</p><p><strong>Implications: </strong>The goal of this quality improvement project is to improve access to deceased donor kidney transplantation for Manitobans with ESKD. This program was developed with patient and provider feedback, including multimedia patient education mat
计划目的:用于移植的器官持续短缺,加之加拿大终末期肾病(ESKD)发病率最高,导致马尼托巴省等待死亡供体移植的时间很长。因此,马尼托巴省成人肾脏移植项目(Transplant Manitoba Adult Kidney Program)不断采取质量改进措施,以扩大死亡供体库。本临床移植方案介绍了一项以年龄为目标的计划,旨在通过将肾脏捐献者档案指数(KDPI)>85 的移植患者分配给年龄≥65 岁、等待时间较短的合适预同意受者,从而提高移植患者的使用率。其目的是通过最大限度地利用以前未得到充分利用的捐赠者库,提高老年受者的存活率和生活质量:资料来源:范围界定文献综述;马尼托巴移植组织已故捐献者审计;主要利益相关者与患者合作伙伴、跨学科医疗服务提供者和医疗系统领导者的接触:替代捐献者库标准包括KDPI为86-100的已故捐献者肾脏,或存在其他移植寿命问题但适合移植的已故捐献者肾脏。将对没有活体捐献者、年龄≥65 岁、等待时间较短、符合移植条件的患者进行教育,如果合适,将预先征得他们对年龄目标计划的同意。根据当地的分配标准,所有患者仍符合标准供体的资格。年龄定向计划候选名单遵循相同的省级分配规则,使用等待时间、面板反应性抗体(PRA)和人类白细胞抗原(HLA)匹配点数来决定排名顺序。如果年龄目标受者在移植后 12 个月内出现 KDPI 86-100 肾脏早期移植物丢失的情况,其累计等待时间(包括移植时间)将在重新列表时恢复:马尼托巴省移植机构的省级分配规则不允许绕过名单前列的受者提供肾脏;因此,移植机构以前不愿意将 KDPI 86-100 捐赠者的肾脏提供给名单前列的、有资格获得更高质量肾脏的受者。这项以年龄为目标的计划有助于将 KDPI 86-100 肾脏分配给合适的、等待时间较短的老年预同意受者,这些受者可能会从这些移植中获得生存和生活质量方面的益处。这种方法扩大了已利用的已故捐赠者库,使所有等待已故捐赠者肾移植的马尼托巴人受益:该计划于 2023 年 1 月启动,由于人数较少且随访时间较短,因此没有关于结果的数据报告:本质量改进项目的目标是改善患有 ESKD 的马尼托巴人获得先体肾移植的机会。该计划是根据患者和医疗服务提供者的反馈意见制定的,其中包括多媒体患者教育材料,这些材料可能对其他计划有所帮助。我们预计,该计划是一种安全有效的方法,可利用以前未得到充分利用的捐赠者库,扩大接受已故捐赠者肾移植的机会。
{"title":"Program Report: Expanding the Deceased Donor Pool in Manitoba With an Age-Targeted Kidney Transplant Program.","authors":"Aaron Trachtenberg, Vaishali Shenoy, Nancy Dodd, Drew Hager, Martin Karpinski, Joshua Koulack, Krista Maxwell, Andrea Mazurat, Denise Pochinco, Christie Sathianathan, James Shaw, Chris Wiebe, Peter Nickerson, Julie Ho","doi":"10.1177/20543581241287288","DOIUrl":"https://doi.org/10.1177/20543581241287288","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Purpose of program: &lt;/strong&gt;The ongoing shortage of organs for transplant combined with the highest prevalence of end-stage kidney disease (ESKD) in Canada has resulted in long wait times for a deceased donor transplant in Manitoba. Therefore, the Transplant Manitoba Adult Kidney Program has ongoing quality improvement initiatives to expand the deceased donor pool. This clinical transplant protocol describes an age-targeted program intended to increase the use of transplants with a kidney donor profile index (KDPI) &gt;85 by allocating them to suitable pre-consented recipients age ≥65 with low wait times. The goal is to improve survival and quality of life for older recipients by maximizing a previously under-utilized donor pool.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Sources of information: &lt;/strong&gt;Scoping literature review; Transplant Manitoba deceased donor audit; and key stakeholder engagement with patient partners, inter-disciplinary health care providers, and health system leaders.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;The alternative donor pool criteria include deceased donor kidneys with KDPI 86-100 or another concern for graft longevity but are otherwise suitable for transplantation. Patients with no living donor, age ≥65, low wait times and otherwise eligible for transplant listing will be educated, and if suitable, pre-consented for the age-targeted program. All patients remain eligible for a standard criteria donor according to the local allocation criteria. The age-targeted program waitlist follows the same provincial allocation rules using wait time, panel reactive antibody (PRA), and human leukocyte antigen (HLA) match points for determining rank order. If an age-targeted recipient experiences early graft loss from a KDPI 86-100 kidney within 12 months from transplant, their cumulative wait time, including time with the transplant, will be reinstated upon relisting.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Key findings: &lt;/strong&gt;Transplant Manitoba's provincial allocation rules do not permit bypassing top of the list recipients for kidney offers; therefore, transplant providers were previously reluctant to utilize KDPI 86-100 donor kidneys to top of the list recipients eligible for higher quality kidneys. This age-targeted program facilitates allocation of KDPI 86-100 kidneys to suitable older pre-consented recipients with low wait times, who may obtain a survival and quality of life benefit from these transplants. This approach expands the utilized deceased donor pool to benefit all Manitobans awaiting a deceased donor kidney transplant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Limitations: &lt;/strong&gt;This program was launched in January 2023, and there are no data reported on outcomes given the small numbers and abbreviated follow-up.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Implications: &lt;/strong&gt;The goal of this quality improvement project is to improve access to deceased donor kidney transplantation for Manitobans with ESKD. This program was developed with patient and provider feedback, including multimedia patient education mat","PeriodicalId":9426,"journal":{"name":"Canadian Journal of Kidney Health and Disease","volume":"11 ","pages":"20543581241287288"},"PeriodicalIF":1.6,"publicationDate":"2024-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472366/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142458603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Climate Change and Environmentally Sustainable Kidney Care in Canada: A Knowledge, Attitudes, and Practices Survey of Kidney Care Providers. 加拿大气候变化与环境可持续肾脏护理:对肾脏护理提供者的知识、态度和实践调查》(Knowledge, Attitudes, and Practices Survey of Kidney Care Providers)。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-08 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241287286
Isabelle Ethier, Shaifali Sandal, Ahmad Raed Tarakji, S Neil Finkle, Bhavneet Kahlon, Kristen Pederson, Ratna Samanta, Caroline Stigant

Background: Climate change impacts health and threatens the stability of care delivery systems, while healthcare is mobilizing to reduce its significant environmental impact.

Objective: This study aimed to assess knowledge, attitudes, and practices (KAP) about climate change among Canadian kidney care providers.

Design setting participants measurements and methods: An electronic KAP survey, created by the Canadian Society of Nephrology-Sustainable Nephrology Action Planning committee, was distributed to kidney care providers across Canada, from March to April 2023.

Results: A total of 516 people responded to the survey. Most respondents (79%) identified as women; 83% were aged 30 to 59 years. Nurses and nephrologists made up 44% and 23% of respondents, respectively. About half of the participants felt informed about climate change to an average degree. Most respondents (71%; 349/495 and 62%; 300/489) were either extremely or very concerned about climate change and waste generated in their kidney care program, respectively. The vast majority of respondents (89%; 441/495) reported taking steps to lower their personal carbon footprint. People who felt more informed about climate change presented higher degrees of concern. Similarly, both those who felt more informed and those who reported higher degrees of concern about climate change were more likely to take steps to reduce their carbon footprint. Over 80% of respondents (314/386) were at least moderately interested in learning sessions about environmentally sustainable initiatives in care.

Limitations: This survey is at risk of social acceptability, representative, and subjective bias. Overrepresentation from Quebec and British Columbia, as well as the majority of respondents identifying as women and working in academic centers, may affect generalizability of the findings.

Conclusions: Most kidney care providers who responded to this survey are informed and concerned about climate change, and their knowledge is directly associated with attitude and practices. This indicates that educational initiatives to increase awareness and knowledge on climate change will likely lead to practice changes.

背景:气候变化影响健康并威胁着医疗服务系统的稳定性,而医疗保健机构正在努力减少气候变化对环境的重大影响:本研究旨在评估加拿大肾脏病医疗服务提供者对气候变化的认识、态度和做法(KAP):由加拿大肾脏病学会--可持续肾脏病行动规划委员会制作的电子 KAP 调查表于 2023 年 3 月至 4 月间分发给加拿大各地的肾脏病医疗机构:共有 516 人对调查做出了回复。大多数受访者(79%)认为自己是女性;83%的受访者年龄在 30 至 59 岁之间。护士和肾病专家分别占受访者的 44% 和 23%。大约一半的参与者认为自己对气候变化的了解程度一般。大多数受访者(71%;349/495 和 62%;300/489)分别对气候变化和肾脏护理项目中产生的废物表示极为或非常关注。绝大多数受访者(89%;441/495)表示已采取措施降低个人碳足迹。对气候变化了解较多的受访者对气候变化的关注程度较高。同样,对气候变化了解较多的人和关注度较高的人都更有可能采取措施减少碳足迹。超过 80% 的受访者(314/386)至少对了解护理领域的环境可持续倡议有一定兴趣:该调查存在社会接受度、代表性和主观偏差的风险。来自魁北克省和不列颠哥伦比亚省的受访者人数过多,以及大多数受访者为女性和在学术中心工作,可能会影响调查结果的普遍性:大多数肾脏保健提供者都对气候变化有所了解和关注,他们的知识与态度和做法直接相关。这表明,提高对气候变化的认识和知识的教育活动很可能会带来实践上的改变。
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引用次数: 0
The Efficacy and Safety of Bisphosphonate Therapy for Osteopenia/Osteoporosis in Patients With Chronic Kidney Disease: A Systematic Review and Individual Patient-Level Meta-Analysis of Placebo-Controlled Randomized Trials. 双膦酸盐疗法治疗慢性肾病患者骨质疏松/骨质疏松症的有效性和安全性:安慰剂对照随机试验的系统回顾与个体患者层面的 Meta 分析》。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-08 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241283523
Reid Whitlock, Kerry MacDonald, Navdeep Tangri, Michael Walsh, David Collister

Background: The efficacy and safety of bisphosphonate therapy for the treatment of osteoporosis and osteopenia in the setting of chronic kidney disease (CKD) is unclear.

Objective: To determine the effect of bisphosphonate therapy on fractures, bone mineral density (BMD), and adverse events in adults across the spectrum of CKD and dialysis.

Design: Systematic review and individual patient-level meta-analysis.

Setting: Searches of Ageline, CINAHL, the Cochrane Library, EMBASE, and Medline from inception to August 25, 2016, supplemented with manual screening and clinicalstudydatarequest.com. Authors were contacted for individual patient-level data.

Patients: Randomized, placebo-controlled trials with 100 or more participants that evaluated the treatment of primary osteoporosis/osteopenia in adult men and women with bisphosphonate therapy.

Measurements: Study characteristics, quality, and data were assessed independently by 2 reviewers. Outcome measures were fractures, BMD, and adverse events including decline in estimated glomerular filtration rate (eGFR) and hypocalcemia (calcium <2.00 mmol/L).

Methods: Single-stage individual patient-level meta-analysis.

Results: Of 39 eligible studies, individual patient-level data was available for 7 studies, all of which were studies of ibandronate. Of 7428 participants (5010 ibandronate, 2418 placebo), 100% were female, 98.6% were white, the mean body mass index was 25.7 kg/m2 (SD 3.9), 18.9% were smokers and there were 740 fracture events. The mean eGFR was 69.1 mL/min/1.73 m2 (SD 15.9) including 14.5%, 54.9%, 27.5%, 3.0%, and 0.2% stages G1, G2, G3A, G3B, and G4 CKD. Ibandronate increased hip and lumbar spine BMD and decreased the risk of fracture in the overall population (hazard ratio (HR) 0.871, 95% confidence interval (CI) 0.746, 1.018) but in patients with stage G3B CKD, it increased the risk of fracture (HR 3.862, 95% CI 1.156, 12.903). Ibandronate did not impact eGFR over 12 months but increased the risk of hypocalcemia (HR 1.324, 95% CI 1.056, 1.660) with no evidence of any effect modification by CKD stage (all tests of interaction p > 0.05).

Limitations: Clinically significant heterogeneity among studies, lack of long-term follow-up and bone biopsy results, limited representation of stage G4 and G5 CKD patients.

Conclusions: Chronic kidney disease potentially modifies the efficacy but not the safety of bisphosphonate therapy in osteopenia and osteoporosis.

Registration: PROSPERO CRD42020145613.

背景:双膦酸盐疗法治疗慢性肾脏病(CKD)患者骨质疏松症和骨质疏松症的疗效和安全性尚不明确:目的:确定双膦酸盐疗法对各种慢性肾脏病和透析成人的骨折、骨矿物质密度(BMD)和不良事件的影响:设计:系统综述和单个患者水平的荟萃分析:检索从开始到 2016 年 8 月 25 日的 Ageline、CINAHL、Cochrane Library、EMBASE 和 Medline,并辅以人工筛选和 clinicalstudydatarequest.com。我们联系了作者以获取患者的个人数据:参试人数在 100 人以上的随机安慰剂对照试验,这些试验评估了使用双膦酸盐疗法治疗成年男性和女性原发性骨质疏松症/骨质疏松症的效果:研究特点、质量和数据由两名评审员独立评估。结果指标为骨折、BMD和不良事件,包括估计肾小球滤过率(eGFR)下降和低钙血症(钙方法):单阶段单个患者水平荟萃分析:在 39 项符合条件的研究中,有 7 项研究提供了患者个体水平的数据,所有这些研究都是关于伊班膦酸钠的研究。在7 428名参与者(5010名伊班膦酸盐患者,2 418名安慰剂患者)中,100%为女性,98.6%为白人,平均体重指数为25.7 kg/m2(SD 3.9),18.9%为吸烟者,共发生了740起骨折事件。平均 eGFR 为 69.1 mL/min/1.73 m2(SD 15.9),包括 14.5%、54.9%、27.5%、3.0% 和 0.2% 的 G1、G2、G3A、G3B 和 G4 期慢性肾脏病患者。伊班膦酸钠能增加髋部和腰椎 BMD,降低总体人群的骨折风险(危险比 (HR) 0.871,95% 置信区间 (CI) 0.746-1.018 ),但在 G3B 期 CKD 患者中,它增加了骨折风险(HR 3.862,95% CI 1.156-12.903)。伊班膦酸钠对12个月内的eGFR没有影响,但会增加低钙血症的风险(HR 1.324,95% CI 1.056,1.660),没有证据表明CKD分期会改变影响(所有交互检验P>0.05):局限性:各研究之间存在明显的临床异质性,缺乏长期随访和骨活检结果,G4和G5期慢性肾脏病患者的代表性有限:慢性肾病可能会改变双膦酸盐治疗骨质疏松症和骨质疏松症的疗效,但不会改变其安全性:PROPRONO CRD42020145613.
{"title":"The Efficacy and Safety of Bisphosphonate Therapy for Osteopenia/Osteoporosis in Patients With Chronic Kidney Disease: A Systematic Review and Individual Patient-Level Meta-Analysis of Placebo-Controlled Randomized Trials.","authors":"Reid Whitlock, Kerry MacDonald, Navdeep Tangri, Michael Walsh, David Collister","doi":"10.1177/20543581241283523","DOIUrl":"https://doi.org/10.1177/20543581241283523","url":null,"abstract":"<p><strong>Background: </strong>The efficacy and safety of bisphosphonate therapy for the treatment of osteoporosis and osteopenia in the setting of chronic kidney disease (CKD) is unclear.</p><p><strong>Objective: </strong>To determine the effect of bisphosphonate therapy on fractures, bone mineral density (BMD), and adverse events in adults across the spectrum of CKD and dialysis.</p><p><strong>Design: </strong>Systematic review and individual patient-level meta-analysis.</p><p><strong>Setting: </strong>Searches of Ageline, CINAHL, the Cochrane Library, EMBASE, and Medline from inception to August 25, 2016, supplemented with manual screening and clinicalstudydatarequest.com. Authors were contacted for individual patient-level data.</p><p><strong>Patients: </strong>Randomized, placebo-controlled trials with 100 or more participants that evaluated the treatment of primary osteoporosis/osteopenia in adult men and women with bisphosphonate therapy.</p><p><strong>Measurements: </strong>Study characteristics, quality, and data were assessed independently by 2 reviewers. Outcome measures were fractures, BMD, and adverse events including decline in estimated glomerular filtration rate (eGFR) and hypocalcemia (calcium <2.00 mmol/L).</p><p><strong>Methods: </strong>Single-stage individual patient-level meta-analysis.</p><p><strong>Results: </strong>Of 39 eligible studies, individual patient-level data was available for 7 studies, all of which were studies of ibandronate. Of 7428 participants (5010 ibandronate, 2418 placebo), 100% were female, 98.6% were white, the mean body mass index was 25.7 kg/m<sup>2</sup> (SD 3.9), 18.9% were smokers and there were 740 fracture events. The mean eGFR was 69.1 mL/min/1.73 m<sup>2</sup> (SD 15.9) including 14.5%, 54.9%, 27.5%, 3.0%, and 0.2% stages G1, G2, G3A, G3B, and G4 CKD. Ibandronate increased hip and lumbar spine BMD and decreased the risk of fracture in the overall population (hazard ratio (HR) 0.871, 95% confidence interval (CI) 0.746, 1.018) but in patients with stage G3B CKD, it increased the risk of fracture (HR 3.862, 95% CI 1.156, 12.903). Ibandronate did not impact eGFR over 12 months but increased the risk of hypocalcemia (HR 1.324, 95% CI 1.056, 1.660) with no evidence of any effect modification by CKD stage (all tests of interaction <i>p</i> > 0.05).</p><p><strong>Limitations: </strong>Clinically significant heterogeneity among studies, lack of long-term follow-up and bone biopsy results, limited representation of stage G4 and G5 CKD patients.</p><p><strong>Conclusions: </strong>Chronic kidney disease potentially modifies the efficacy but not the safety of bisphosphonate therapy in osteopenia and osteoporosis.</p><p><strong>Registration: </strong>PROSPERO CRD42020145613.</p>","PeriodicalId":9426,"journal":{"name":"Canadian Journal of Kidney Health and Disease","volume":"11 ","pages":"20543581241283523"},"PeriodicalIF":1.6,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11459530/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142388283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Pregnancy Outcomes in Living Kidney Donors: Protocol of a Population-Based Cohort Study in Three Canadian Provinces. 活体肾脏捐赠者的妊娠结局:加拿大三省基于人口的队列研究协议》。
IF 1.6 Q3 UROLOGY & NEPHROLOGY Pub Date : 2024-10-06 eCollection Date: 2024-01-01 DOI: 10.1177/20543581241284030
Carol Wang, Kyla L Naylor, Eric McArthur, Jessica M Sontrop, Pavel Roshanov, Ngan N Lam, Sarah D McDonald, Krista L Lentine, James King, Erik Youngson, Joseph Beyene, Elizabeth Hendren, Amit X Garg
<p><strong>Background: </strong>A substantial proportion of living kidney donors are women of childbearing age. Some prior studies report a higher risk of gestational hypertension and pre-eclampsia in living kidney donors compared with nondonors. Further research is needed to better quantify the risk of adverse maternal, fetal/infant, and neonatal outcomes attributable to living kidney donation.</p><p><strong>Objective: </strong>To determine the risk of hypertensive disorders of pregnancy, including gestational hypertension, pre-eclampsia, and eclampsia, and other maternal and fetal/infant outcomes in living kidney donors compared with a matched group of nondonors of similar baseline health.</p><p><strong>Design and setting: </strong>Protocol for a population-based, matched cohort study using Canadian administrative health care databases. The protocol will be run separately in 3 provinces, Ontario, Alberta, and British Columbia, and results will be combined statistically using meta-analysis.</p><p><strong>Participants: </strong>The cohort will include women aged 18 to 48 years who donated a kidney between July 1992 and March 2022 and had at least one postdonation singleton pregnancy of ≥20 weeks gestation between January 1993 and February 2023. We expect to include at least 150 living kidney donors with over 200 postdonation pregnancies from Ontario and a similar number of donors and pregnancies across Alberta and British Columbia combined. Nondonors will include women from the general population with at least one pregnancy of ≥20 weeks gestation between January 1993 and February 2023. Nondonors will be randomly assigned cohort entry dates based on the distribution of nephrectomy dates in donors. The sample of nondonors will be restricted to those aged 18 to 48 years on their cohort entry dates with delivery dates at least 6 months after their assigned entry dates. A concern with donor and nondonor comparisons is that donors are healthier than the general population. To reduce this concern, we will also apply 30+ exclusion criteria to further restrict the nondonor group so that they have similar health measures at cohort entry as the donors. Donor and nondonor pregnancies will then be matched (1:4) on 5 potential confounders: delivery date, maternal age at delivery date, time between cohort entry and delivery date, neighborhood income quintile, and parity at delivery date.</p><p><strong>Measurements: </strong>The primary outcome will be a composite of maternal gestational hypertension, preeclampsia, or eclampsia. Secondary maternal outcomes will include components of the primary outcome, early pre-eclampsia, severe maternal morbidity, cesarean section, postpartum hemorrhage, and gestational diabetes. Fetal/infant/neonatal outcomes will include premature birth/low birth weight, small for gestational age, neonatal intensive care unit admission, stillbirth, and neonatal death.</p><p><strong>Methods: </strong>The primary unit of analysis will be the
背景:活体肾脏捐献者中有很大一部分是育龄妇女。之前的一些研究报告显示,与非活体捐肾者相比,活体捐肾者患妊娠高血压和先兆子痫的风险较高。为了更好地量化活体肾脏捐献对产妇、胎儿/婴儿和新生儿造成不良后果的风险,还需要进一步的研究:目的:确定活体肾脏捐献者与基线健康状况相似的匹配非活体肾脏捐献者相比,妊娠期高血压、先兆子痫和子痫等妊娠期高血压疾病的风险,以及其他孕产妇和胎儿/婴幼儿结局的风险:设计与环境:利用加拿大行政医疗保健数据库开展基于人群的配对队列研究。该方案将在安大略省、阿尔伯塔省和不列颠哥伦比亚省三个省分别进行,研究结果将采用荟萃分析法进行统计合并:队列将包括在 1992 年 7 月至 2022 年 3 月期间捐献肾脏的 18 至 48 岁女性,以及在 1993 年 1 月至 2023 年 2 月期间至少有一次妊娠≥20 周的捐肾后单胎妊娠。我们预计安大略省至少有 150 名活体肾脏捐献者和 200 多名捐献后怀孕者,阿尔伯塔省和不列颠哥伦比亚省也有类似数量的捐献者和怀孕者。非捐献者将包括在 1993 年 1 月至 2023 年 2 月期间至少有一次妊娠≥20 周的普通人群中的女性。将根据捐献者肾切除术日期的分布情况,随机分配非妊娠期妇女的入组日期。新生儿样本将仅限于在其队列进入日期时年龄在 18 至 48 岁之间、分娩日期至少在其指定进入日期之后 6 个月的新生儿。对捐献者和非捐献者进行比较的一个顾虑是,捐献者比一般人群更健康。为了减少这种顾虑,我们还将采用 30 岁以上的排除标准来进一步限制非孤儿群体,使他们在队列进入时拥有与捐献者相似的健康指标。然后,捐献者孕妇和非捐献者孕妇将就以下 5 个潜在的混杂因素进行匹配(1:4):分娩日期、分娩日期时的产妇年龄、队列进入与分娩日期之间的时间、社区收入五分位数以及分娩日期时的胎次:主要结果是产妇妊娠高血压、子痫前期或子痫的综合结果。次要产妇结局将包括主要结局的组成部分、早期子痫前期、严重产妇发病率、剖宫产、产后出血和妊娠糖尿病。胎儿/婴儿/新生儿结局将包括早产/出生体重不足、胎龄小、新生儿重症监护室入院、死胎和新生儿死亡:分析的主要单位是妊娠。我们将使用随机效应对数二项式混合回归模型计算供体与非供体的主要综合结果风险比,以考虑多胎妊娠妇女之间以及供体与非供体配对组之间的相关性。我们将在每个省内进行统计分析,然后使用元分析技术合并汇总结果,得出研究结果的总体估计值:限制因素:由于相关法规禁止将个人层面的记录发送到其他省份,因此我们无法汇集所有 3 个省份的个人层面数据:与之前的研究相比,本研究能更好地估算出孕产妇、胎儿/婴儿和新生儿不良结局的捐赠可归因风险。移植中心可以利用研究结果为育龄女性活体捐献者提供咨询,并为怀孕的活体肾脏捐献者的随访和护理提供建议。
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引用次数: 0
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Canadian Journal of Kidney Health and Disease
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