Medication Systems

药物治疗系统
  • 文章类型: Journal Article
    许多因素会影响住院患者的血糖(BG),使BG难以预测和管理。除了已经建立的改变BG的药物之外,如β受体阻滞剂,可能有许多药物对BG变异性有未发现的影响.识别这些药物以及这些关系的强度和时机有可能改善血糖管理和患者安全性。
    来自超过8年的103,871名住院患者的EHR数据,城市卫生系统被用来提取500多种药物,实验室测量,和BG的临床预测因子。使用优化的Lasso模型对80%的训练集进行重复的5倍交叉验证,进行特征选择,然后是线性混合回归模型来评估统计显著性。然后针对全面的药物不良事件数据库评估了重要的药物预测因子的新颖性。
    我们发现29个与BG相关的统计学显著特征;24个是药物,包括10个以前没有记录的改变BG的药物。其余五个因素是黑人/非裔美国人种族,2型糖尿病病史,先前的BG(平均和最后)和肌酐。
    意外的药物,包括几种参与胃肠蠕动的药物,发现影响BG得到了现有研究的支持。这项研究可能会使轻度药物在高血糖或低血糖患者中谨慎使用。需要进一步研究这些潜在的候选者以增强这些发现的临床效用。
    这项研究独特地确定了参与胃肠道转运的药物是BG的预测因子,这在临床实践中可能没有很好地确定和认可。
    UNASSIGNED: A multitude of factors affect a hospitalized individual\'s blood glucose (BG), making BG difficult to predict and manage. Beyond medications well established to alter BG, such as beta-blockers, there are likely many medications with undiscovered effects on BG variability. Identification of these medications and the strength and timing of these relationships has potential to improve glycemic management and patient safety.
    UNASSIGNED: EHR data from 103,871 inpatient encounters over 8 years within a large, urban health system was used to extract over 500 medications, laboratory measurements, and clinical predictors of BG. Feature selection was performed using an optimized Lasso model with repeated 5-fold cross-validation on the 80% training set, followed by a linear mixed regression model to evaluate statistical significance. Significant medication predictors were then evaluated for novelty against a comprehensive adverse drug event database.
    UNASSIGNED: We found 29 statistically significant features associated with BG; 24 were medications including 10 medications not previously documented to alter BG. The remaining five factors were Black/African American race, history of type 2 diabetes mellitus, prior BG (mean and last) and creatinine.
    UNASSIGNED: The unexpected medications, including several agents involved in gastrointestinal motility, found to affect BG were supported by available studies. This study may bring to light medications to use with caution in individuals with hyper- or hypoglycemia. Further investigation of these potential candidates is needed to enhance clinical utility of these findings.
    UNASSIGNED: This study uniquely identifies medications involved in gastrointestinal transit to be predictors of BG that may not well established and recognized in clinical practice.
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  • 文章类型: Journal Article
    背景:在人口老龄化和熟练工人日益短缺的背景下,越来越多地讨论无人机在医疗保健部门的使用。特别是,在农村地区使用无人机提供药物可以为需要和不需要照顾的人带来好处。然而,几乎没有任何数据关注人类和无人机之间的相互作用。
    目的:本研究旨在揭示和分析与用户接受基于无人机的药物交付相关的因素,以得出与实践相关的指导点,用于参与式技术开发(针对应用程序和无人机)。
    方法:进行了一项对照混合方法研究,该研究支持基于参与性研究设计的无人机辅助药物输送应用程序设计的技术开发过程。为了定量分析,建立和标准化的调查仪器,以获取技术验收,例如系统可用性量表;技术使用清单(TUI);和动机,订婚,并在用户体验模型中蓬勃发展,被使用。为了避免来自连续用户开发的可能的偏置效应(例如,反应转变和学习效果),在3个迭代开发步骤中的每一个步骤中都成立了一个特设小组,随后与组成的核心小组进行了比较,它经历了所有3次迭代。
    结果:研究发现药房无人机应用程序的可用性与参与者使用意愿之间存在正相关关系(r=0.833)。参与者对有用性的感知对他们使用应用程序的意愿有积极影响(r=0.487;TUI)。怀疑主义对感知的可用性和使用意愿有负面影响(r=-0.542;系统可用性量表和r=-0.446;TUI)。研究发现,有用性,怀疑论,好奇心和好奇心解释了使用该应用程序的大部分意图(F3,17=21.12;P<.001;R2=0.788;调整后的R2=0.751)。核心小组对使用药房无人机应用程序的意图的评价高于特设小组。双尾t测试的结果显示,与第一次迭代相比,核心组第三次迭代的可用性评分更高。
    结论:在参与式设计的帮助下,有关无人机辅助药物输送的人员可以揭示接受的重要方面。例如,使用该技术的时间长短是使用该应用程序的重要因素。用户友好性或好奇心等特定技术因素与无人机应用程序的使用接受度直接相关。这项研究的结果表明,越多的参与者感知到自己处理应用程序的能力,他们越愿意使用该技术,他们就越认为该应用程序可用。
    BACKGROUND: The use of drones in the health care sector is increasingly being discussed against the background of the aging population and the growing shortage of skilled workers. In particular, the use of drones to provide medication in rural areas could bring advantages for the care of people with and without a need for care. However, there are hardly any data available that focus on the interaction between humans and drones.
    OBJECTIVE: This study aims to disclose and analyze factors associated with user acceptance of drone-based medication delivery to derive practice-relevant guidance points for participatory technology development (for apps and drones).
    METHODS: A controlled mixed methods study was conducted that supports the technical development process of an app design for drone-assisted drug delivery based on a participatory research design. For the quantitative analysis, established and standardized survey instruments to capture technology acceptance, such as the System Usability Scale; Technology Usage Inventory (TUI); and the Motivation, Engagement, and Thriving in User Experience model, were used. To avoid possible biasing effects from a continuous user development (eg, response shifts and learning effects), an ad hoc group was formed at each of the 3 iterative development steps and was subsequently compared with the consisting core group, which went through all 3 iterations.
    RESULTS: The study found a positive correlation between the usability of a pharmacy drone app and participants\' willingness to use it (r=0.833). Participants\' perception of usefulness positively influenced their willingness to use the app (r=0.487; TUI). Skepticism had a negative impact on perceived usability and willingness to use it (r=-0.542; System Usability Scale and r=-0.446; TUI). The study found that usefulness, skepticism, and curiosity explained most of the intention to use the app (F3,17=21.12; P<.001; R2=0.788; adjusted R2=0.751). The core group showed higher ratings on the intention to use the pharmacy drone app than the ad hoc groups. Results of the 2-tailed t tests showed a higher rating on usability for the third iteration of the core group compared with the first iteration.
    CONCLUSIONS: With the help of the participatory design, important aspects of acceptance could be revealed by the people involved in relation to drone-assisted drug delivery. For example, the length of time spent using the technology is an important factor for the intention to use the app. Technology-specific factors such as user-friendliness or curiosity are directly related to the use acceptance of the drone app. Results of this study showed that the more participants perceived their own competence in handling the app, the more they were willing to use the technology and the more they rated the app as usable.
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  • 文章类型: Journal Article
    电子药物系统(EMS)提高了医院的用药安全性;但是,需要进行修改以优化其性能。根据一项为期五年的研究计划,我们开发了健康创新系列,向广大观众传播我们研究中提出的建议。每个问题都包含EMS优化提示,可由EMS经理和系统供应商执行。以及包括护士在内的卫生专业人员的用户提示,医生和药剂师。到2022年11月30日,通过两次电子邮件活动发布了五期,计划进一步的问题。到2023年3月,这五个问题的下载量为2,035。最近的电子邮件活动打开和点击率表明非常好的受众参与。
    Electronic medication systems (EMS) improve medication safety in hospitals; however require modifications to optimize their performance. Drawing on a five-year program of research, we developed the Health Innovation Series to disseminate recommendations arising from our research to a wide audience. Each issue contains EMS optimization tips that can be actioned by EMS managers and system vendors, as well as user tips for health professionals including nurses, doctors and pharmacists. Five issues were released by 30 Nov 2022, via two email campaigns, with further issues planned. The five issues had 2,035 downloads by March 2023. The most recent email campaign open and click rates indicate very good audience engagement.
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  • 文章类型: Randomized Controlled Trial
    用药错误是医院可预防伤害的主要原因。电子药物系统(EMS)在降低处方错误的风险方面取得了成功,但是关于这些系统是否支持减少儿科用药错误的证据却很少。使用阶梯式楔形集群随机对照试验,我们调查了在悉尼一家儿科转诊医院引入EMS后药物管理错误率的变化。澳大利亚。对284名护士在准备和施用4555剂药物时进行了直接观察,并将观察数据与患者记录进行比较,以确定给药错误。我们发现EMS后给药错误没有显着变化(调整后赔率比[aOR]1.09;95%CI0.89-1.32),潜在严重给药错误的发生率也没有变化(aOR1.18;95CI0.9-1.56),或导致实际伤害的人(aOR0.92;95CI0.34-2.46)。EMS后,某些途径给药的错误增加了。在EMS使用的前70天,药物管理错误率基本没有变化。
    Medication errors are a leading cause of preventable harm in hospitals. Electronic medication systems (EMS) have shown success in reducing the risk of prescribing errors, but considerable less evidence is available about whether these systems support a reduction in medication administration errors in paediatrics. Using a stepped wedge cluster randomized controlled trial we investigated changes in medication administration error rates following the introduction of an EMS in a paediatric referral hospital in Sydney, Australia. Direct observations of 284 nurses as they prepared and administered 4555 medication doses was undertaken and observational data compared against patient records to identify administration errors. We found no significant change in administration errors post EMS (adjusted Odds Ratio [aOR] 1.09; 95% CI 0.89-1.32) and no change in rates of potentially serious administration errors (aOR 1.18; 95%CI 0.9-1.56), or those resulting in actual harm (aOR 0.92; 95%CI 0.34-2.46). Errors in administration of medications by some routes increased post EMS. In the first 70 days of EMS use medication administration error rates were largely unchanged.
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  • 文章类型: Journal Article
    儿科的药物处方很复杂,需要提供与年龄和体重相关的剂量,错误仍然是有问题的。电子药物系统(EMS)可以通过剂量计算器和计算机化决策支持来减少错误。然而,关于这些系统的成本和收益的证据有限,特别是在儿科医院。本文介绍了成本效益分析(CBA)框架的开发,以评估儿科三级医院实施EMS的影响。该框架的一个创新组成部分是纳入EMS对卫生系统以及患者及其更广泛的家庭网络的影响,允许净社会效益评估。我们描述了非临床自付费用的影响,并使用离散选择实验来衡量与药物相关的危害以及药物安全对家庭和社区成员的重要性。
    Medication prescribing in paediatrics is complex and compounded by the need to provide age and weight related doses, and errors continue to be problematic. Electronic medication systems (EMS) can reduce errors through dosing calculators and computerised decision support. However, evidence on costs and benefits of these systems is limited, particularly in paediatric hospitals. This paper presents the development of a cost-benefit analysis (CBA) framework to assess the impact of an EMS implementation in a paediatric tertiary hospital. An innovative component of the framework is the incorporation of the impact of the effects of the EMS for both the health system as well as for patients and their wider family networks, allowing a net social benefit assessment. We describe the impact of non-clinical out-of-pocket costs of admission and use discrete choice experiments to measure both medication related harm and the importance of medication safety to families and members of the community.
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  • 文章类型: Journal Article
    目的:联合委员会滴定输液的标准要求规定最大输液速率。这种做法导致了可以由提供者命令(“软最大值”)覆盖的原型化最大剂量的发展,以及不能被取代的剂量上限(“硬最大值”)。这项研究的目的是确定去甲肾上腺素剂量上限的患病率和态度。方法:一项20项横断面调查,评估去甲肾上腺素剂量封顶实践,对去甲肾上腺素方案的认知,受访者和执业地点的人口统计信息以电子方式分发到国际医疗播客的邮件列表中。根据去甲肾上腺素的基于体重的给药(WBD)或非WBD的使用对反应进行分层。主要目的是表征去甲肾上腺素给药实践,包括原生质化的最大剂量和/或剂量封顶。使用卡方检验和Mann-WhitneyU检验比较分类变量和连续变量,分别,P<0.05表示有统计学意义。结果:586名医生完成了调查,护士,药剂师,和先进的实践提供者。WBD使用率为51%,非WBD使用率为47%。标准化滴定方案报告65%,剂量封顶报告19%。使用非WBD的受访者的原型最大剂量范围为20-400mcg/min(中位数[四分位数范围]30[30-50]),使用WBD的受访者的最大剂量范围为2-10mcg/kg/min(1[.5-3])。非WBD的剂量上限为50(40-123)mcg/min,WBD的剂量上限为2(1-3)mcg/kg/min。结论:国际,对重症监护和急诊医学临床医生的多专业调查显示,去甲肾上腺素给药方式差异很大,包括允许的最大剂量.
    Purpose: The Joint Commission standards for titrated infusions require specification of maximum rates of infusion. This practice has led to the development of protocolized maximum doses that can be overridden by provider order (\"soft maximums\") and to dose caps that cannot be superseded (\"hard maximums\"). The purpose of this study was to determine the prevalence of and attitudes towards dose capping of norepinephrine. Methods: A 20-item cross-sectional survey assessing norepinephrine dose capping practices, perceptions of norepinephrine protocols, and respondent and practice site demographics was distributed electronically to the mailing list of an international medical podcast. Responses were stratified according to use of weight-based dosing (WBD) or non-WBD of norepinephrine. The primary objective was to characterize norepinephrine dosing practices including protocolized maximum doses and/or dose capping. Categorical and continuous variables were compared using the Chi-square test and Mann-Whitney U test, respectively, with P < .05 indicating statistical significance. Results: The survey was completed by 586 physicians, nurses, pharmacists, and advanced practice providers. WBD was used by 51% and non-WBD by 47%. A standardized titration protocol was reported by 65% and dose capping was reported by 19%. The protocolized maximum dose ranged from 20-400 mcg/min for respondents using non-WBD (median [interquartile range] 30 [30-50]) and ranged from .2-10 mcg/kg/min for respondents using WBD (1 [.5-3]). The dose cap was 50 (40-123) mcg/min with non-WBD and 2 (1-3) mcg/kg/min with WBD. Conclusions: An international, multi-professional survey of critical care and emergency medicine clinicians revealed wide variability in norepinephrine dosing practices including maximum doses allowed.
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  • 文章类型: Journal Article
    背景:急诊科(ED)准备的药物清单是住院期间诊断和治疗患者的基础。由于不完整的用药信息可能会导致患者的伤害,在入院时获得正确和完整的药物清单至关重要。在这项横断面回顾性研究中,我们希望探索挪威ED入院记录中的药物信息完整性,并调查哪些因素与完整性水平相关。
    方法:通过应用五个评估标准来评估药物信息的完整性;通用名称,配方,剂量,频率,和使用指示。计算每种药物的药物完整性评分,以百分比为单位,根据录取通知书和标准。分位数回归分析用于调查哪些变量与药物信息完整性相关。
    结果:纳入了2018年10月至2019年9月收治并使用至少一种药物的患者的入院记录。共有1,080份录取通知书,包含8,604份药物订单,被评估。单个药物的平均药物完整性评分为88.1%(SD16.4),而入院记录的平均用药完整性评分为86.3%(SD16.2)。超过90%的个体药物都有关于通用名称的信息,配方,剂量和频率,而使用指征仅存在于60%。使用电子工具准备药物信息与完整性有很强的正相关。过去30天内的医院就诊,病人的生活状况,使用的药物数量,病人住在哪家医院,也与信息完整性有关。
    结论:入院记录中的药物信息完整性很高,但关于使用适应症的文件方面的改进潜力被确定。在ED中准备录取通知书时应用电子工具对于确保药物信息的完整性至关重要。
    BACKGROUND: Medication lists prepared in the emergency department (ED) form the basis for diagnosing and treating patients during hospitalization. Since incomplete medication information may lead to patient harm, it is crucial to obtain a correct and complete medication list at hospital admission. In this cross-sectional retrospective study we wanted to explore medication information completeness in admission notes from Norwegian EDs and investigate which factors were associated with level of completeness.
    METHODS: Medication information was assessed for completeness by applying five evaluation criteria; generic name, formulation, dose, frequency, and indication for use. A medication completeness score in percent was calculated per medication, per admission note and per criterion. Quantile regression analysis was applied to investigate which variables were associated with medication information completeness.
    RESULTS: Admission notes for patients admitted between October 2018 and September 2019 and using at least one medication were included. A total of 1,080 admission notes, containing 8,604 medication orders, were assessed. The individual medications had a mean medication completeness score of 88.1% (SD 16.4), while admission notes had a mean medication completeness score of 86.3% (SD 16.2). Over 90% of all individual medications had information about generic name, formulation, dose and frequency stated, while indication for use was only present in 60%. The use of an electronic tool to prepare medication information had a significantly strong positive association with completeness. Hospital visit within the last 30 days, the patient\'s living situation, number of medications in use, and which hospital the patient was admitted to, were also associated with information completeness.
    CONCLUSIONS: Medication information completeness in admission notes was high, but potential for improvement regarding documentation of indication for use was identified. Applying an electronic tool when preparing admission notes in EDs seems crucial to safeguard completeness of medication information.
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  • 文章类型: Multicenter Study
    目的:评估西班牙医院实施预防用药差错的程度。
    方法:对医院药物使用系统安全自我评估中包含的安全实践实施程度的描述性多中心研究。版本。II\"。在2021年10月至2022年9月之间完成问卷的西班牙医院参加了调查。调查包含265个评估项目,分为10个关键要素。基于总体调查的最大可能值的平均得分和平均百分比,对于关键要素和每个单独的评价项目进行了计算。将结果与先前2011年研究的结果进行了比较。
    结果:共有来自15个自治区的131家医院参与了这项研究。所有医院的总体问卷的平均得分为898.2(最大可能得分的57.4%)。根据依赖性没有发现差异,医院的大小或类型,无论是在总体问卷中还是在关键要素中。关于卫生专业人员在安全实践方面的能力和培训的关键要素8、1和6的最低值(45.1%),患者基本信息的可用性和可及性(48%),和给药装置(52.3%)。关于2011年,发现总体问卷和关键要素都有显著增加,除了5和7,指的是标准化,药物的储存和分配,环境因素和人力资源。关于高危药品安全管理的几个评价项目,药物和解,将临床药剂师纳入医疗团队,并实施允许整个药物系统完全可追溯的技术,显示低百分比结论:西班牙医院的一些药物错误预防实践的实施程度取得了明显进展,但是世界卫生组织和安全组织推荐的许多经过验证的疗效实践仍然执行不力。获得的信息可用于确定要处理的做法的优先次序,并作为监测进展的新基线。
    To assess the degree of implementation of medication error prevention practices in Spanish hospitals.
    Descriptive multicenter study of the degree of implementation of the safety practices included in the \"Medication use-system safety self-assessment for hospitals. Version. II\". Spanish hospitals that completed the questionnaire between October/2021 and September/2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study.
    A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements 8, 1 and 6, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except 5 and 7, referring to standardization, storage and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams and implementation of technologies that allow full traceability throughout the medication system, showed low percentages CONCLUSIONS: There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress.
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  • 文章类型: Multicenter Study
    目的:评估西班牙医院实施预防用药差错的程度。
    方法:对医院药物使用系统安全自我评估中包含的安全实践实施程度的描述性多中心研究。版本。II\"。西班牙医院在10月之间完成了问卷,2021年9月,2022年参与。调查包含265个评估项目,分为10个关键要素。基于总体调查的最大可能值的平均得分和平均百分比,对于关键要素,并对每个单独的评价项目进行了计算。将结果与先前2011年研究的结果进行了比较。
    结果:共有来自15个自治区的131家医院参与了这项研究。所有医院的总体问卷的平均得分为898.2(最大可能得分的57.4%)。根据依赖性没有发现差异,尺寸,或者医院的类型,无论是在总体问卷中还是在关键要素中。发现关键要素VIII的最低值,I和VI,关于卫生专业人员在安全实践方面的能力和培训(45.1%),患者基本信息的可用性和可及性(48%),和给药装置(52.3%)。关于2011年,发现总体问卷和关键要素都有显著增加,除了V和VII,提到标准化,storage,以及药物的分配,环境因素和人力资源。关于高危药品安全管理的几个评价项目,药物和解,将临床药师纳入医疗团队,以及实施允许整个药物系统完全可追溯的技术,显示低百分比。
    结论:西班牙医院在实施一些预防用药错误的做法方面取得了明显进展,但是世界卫生组织和安全组织推荐的许多经过验证的疗效实践仍然执行不力。获得的信息可用于确定要处理的做法的优先次序,并作为监测进展的新基线。
    To assess the degree of implementation of medication error prevention practices in Spanish hospitals.
    Descriptive multicenter study of the degree of implementation of the safety practices included in the \"Medication use-system safety self-assessment for hospitals. Version. II\". Spanish hospitals that completed the questionnaire between October, 2021 and September, 2022 participated. The survey contains 265 items for evaluation grouped into 10 key elements. Mean score and mean percentages based on the maximum possible values for the overall survey, for the key elements, and for each individual item of evaluation were calculated. The results were compared with those of the previous 2011 study.
    A total of 131 hospitals from 15 autonomous regions participated in the study. The mean score of the overall questionnaire in all hospitals was 898.2 (57.4% of the maximum possible score). No differences were found according to dependency, size, or type of hospital, either in the overall questionnaire or in the key elements. The lowest values were found for key elements VIII, I and VI, on competence and training of health professionals in safety practices (45.1%), availability and accessibility of essential information on patients (48%), and devices for administering drugs (52.3%). With respect to 2011, significant increases were found both in the overall questionnaire and in the key elements, except V and VII, referring to standardization, storage, and distribution of medications, and environmental factors and human resources. Several evaluation items on the safe management of high-risk drugs, medication reconciliation, incorporation of clinical pharmacists into the healthcare teams, and implementation of technologies that allow full traceability throughout the medication system, showed low percentages.
    There has been appreciable progress in the degree of implementation of some medication error prevention practices in Spanish hospitals, but many proven efficacy practices recommended by the World Health Organization and safety organizations are still poorly implemented. The information obtained can be useful for prioritizing the practices to be addressed and as a new baseline for monitoring progress.
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  • 文章类型: Journal Article
    背景:美国食品和药物管理局和欧洲药品管理局对心房颤动患者根据肾功能给药阿哌沙班的建议不一致。阿哌沙班在慢性肾脏病中的最佳给药仍未知。
    方法:通过使用Optum实验室数据仓库中的去识别电子健康记录数据,我们确定了2013年至2021年期间接受阿哌沙班治疗的房颤和慢性肾病4/5期患者.通过阿哌沙班剂量(5对2.5mg)比较出血和中风/全身性栓塞的风险,通过治疗加权的逆概率调整基线特征。使用Fine-Gray子分布风险模型来解释竞争的死亡风险。Cox回归用于检查阿哌沙班剂量的死亡风险。
    结果:在4313个apixaban新用户中,1705(40%)接受5mg,2608(60%)接受2.5mg。用5mg阿哌沙班治疗的患者年龄较小(平均年龄,72岁对80岁),体重较大(95对80kg)和血清肌酐较高(2.7对2.5mg/dL)。两组之间的平均估计肾小球滤过率没有差异(24对24mL·min-1·1.73m-2)。在治疗权重分析的逆概率中,阿哌沙班5mg与更高的出血风险相关(每100人年的发生率为4.9和2.9;发生率差异,每100人年2.0[95%CI,0.6-3.4]事件;子分布危险比,1.63[95%CI,1.04-2.54])。阿哌沙班5mg组和2.5mg组之间的卒中/全身性栓塞风险没有差异(每100人年发生3.3和3.0事件;发生率差异,每100人年0.2[95%CI,-1.0至1.4]事件;子分布危险比,1.01[95%CI,0.59-1.73]),或死亡(每100人年9.9例和9.4例;发病率差异,每100人年0.5[95%CI,-1.6至2.6]个事件;危险比,1.03[95%CI,0.77-1.38])。
    结论:与2.5mg相比,使用5毫克阿哌沙班与房颤和严重慢性肾病患者出血风险较高相关,卒中/全身性栓塞或死亡的风险没有差异,支持欧洲药品管理局基于肾功能的阿哌沙班剂量建议,这与美国食品和药物管理局发布的不同。
    Recommendations for apixaban dosing on the basis of kidney function are inconsistent between the US Food and Drug Administration and European Medicines Agency for patients with atrial fibrillation. Optimal apixaban dosing in chronic kidney disease remains unknown.
    With the use of deidentified electronic health record data from the Optum Labs Data Warehouse, patients with atrial fibrillation and chronic kidney disease stage 4/5 initiating apixaban between 2013 and 2021 were identified. Risks of bleeding and stroke/systemic embolism were compared by apixaban dose (5 versus 2.5 mg), adjusted for baseline characteristics by the inverse probability of treatment weighting. The Fine-Gray subdistribution hazard model was used to account for the competing risk of death. Cox regression was used to examine risk of death by apixaban dose.
    Among 4313 apixaban new users, 1705 (40%) received 5 mg and 2608 (60%) received 2.5 mg. Patients treated with 5 mg apixaban were younger (mean age, 72 versus 80 years), with greater weight (95 versus 80 kg) and higher serum creatinine (2.7 versus 2.5 mg/dL). Mean estimated glomerular filtration rate was not different between the groups (24 versus 24 mL·min-1·1.73 m-2). In inverse probability of treatment weighting analysis, apixaban 5 mg was associated with a higher risk of bleeding (incidence rate 4.9 versus 2.9 events per 100 person-years; incidence rate difference, 2.0 [95% CI, 0.6-3.4] events per 100 person-years; subdistribution hazard ratio, 1.63 [95% CI, 1.04-2.54]). There was no difference between apixaban 5 mg and 2.5 mg groups in the risk of stroke/systemic embolism (3.3 versus 3.0 events per 100 person-years; incidence rate difference, 0.2 [95% CI, -1.0 to 1.4] events per 100 person-years; subdistribution hazard ratio, 1.01 [95% CI, 0.59-1.73]), or death (9.9 versus 9.4 events per 100 person-years; incidence rate difference, 0.5 [95% CI, -1.6 to 2.6] events per 100 person-years; hazard ratio, 1.03 [95% CI, 0.77-1.38]).
    Compared with 2.5 mg, use of 5 mg apixaban was associated with a higher risk of bleeding in patients with atrial fibrillation and severe chronic kidney disease, with no difference in the risk of stroke/systemic embolism or death, supporting the apixaban dosing recommendations on the basis of kidney function by the European Medicines Agency, which differ from those issued by the US Food and Drug Administration.
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