standardisation

标准化
  • 文章类型: Journal Article
    蜂胶的质量控制在确保活性化合物的适当浓度中起着关键作用,限制不需要的物质,验证真实性,并遵守监管标准。本研究旨在评估身份和质量标准,单独的酚类成分(LC-ESI-MS/MS),以及来自Apismellifera的商业蜂胶提取物(CPEs)的抗氧化和降血糖潜力,双斑石竹,和Meliponaquadrifasciata蜜蜂。CPE符合蜡含量和氧化活性标准,超过总酚含量(TPC)和类黄酮含量(TFC)的最低阈值,尽管无刺蜜蜂CPE对10%的醋酸铅没有检测到阳性。CPE表现出抗氧化和潜在的降血糖活性。表儿茶素在三十三个确定的酚类物质中,与TPC显著相关,DPPH,ABTS,和α-淀粉酶的EC50值。这些有希望的属性强调了来自Apismellifera和无刺蜜蜂的商业蜂胶提取物对进一步的医学和营养应用的潜在健康益处。
    Quality control of propolis plays a pivotal role in ensuring the appropriate concentrations of active compounds, limiting unwanted substances, verifying authenticity, and adhering to regulatory standards. This study aimed to assess the identity and quality standards, the individual phenolic composition (LC-ESI-MS/MS), and the antioxidant and antiglycemic potential of commercial propolis extracts (CPEs) from Apis mellifera, Scaptotrigona bipunctata, and Melipona quadrifasciata bees. CPEs met wax content and oxidation activity criteria, surpassing minimum thresholds for total phenolic content (TPC) and flavonoid content (TFC), although stingless bee CPE did not test positive for 10% lead acetate. CPEs exhibited antioxidant and potential antiglycemic activities. Epicatechin among the thirty-three identified phenolics, showed significant correlation with TPC, DPPH, ABTS, and EC50 values of α-amylase enzyme. These promising attributes underscore the potential health benefits of commercial propolis extracts from Apis mellifera and stingless bees for further medicinal and nutritional applications.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    针对护理文件标准化和质量差的调查结果,NHS威尔士于2014年通过国家电子护理文档计划开始了变革之旅。到2019年发展成为威尔士护理记录(WNCR),该计划旨在简化实践并提高准确性,合规,通过标准化的数字平台提高效率。案例研究探索了综合项目设计,强调循证实践,治理流程和国家护理信息学角色的引入。从2021年4月到2023年9月,WNCR的实施在符合条件的病房中实现了79%的推广,以战略投资为标志,健壮的训练,分阶段部署。迄今为止的评估显示对关键绩效指标的积极影响,以每位患者节省9分钟的时间为例。经验教训指出了用户参与的重要性,文化转型,以及正在进行的员工发展,为包括全国实施在内的未来战略铺平道路,利益实现,和数据可视化计划。
    In response to findings indicating poor standardisation and quality in nursing documentation, NHS Wales embarked on a transformative journey with the National Electronic Nursing Documentation Programme in 2014. Evolving into the Welsh Nursing Care Record (WNCR) by 2019, this initiative sought to streamline practices and enhance accuracy, compliance, and efficiency through a standardised digital platform. The case study explores the comprehensive project design, emphasising evidence-based practices, governance processes and the introduction of National Nursing Informatics roles. Accomplished from April 2021 to September 2023, the WNCR implementation achieved a 79% roll out across eligible wards, marked by strategic investments, robust training, and phased deployment. Evaluations to date show positive impacts on key performance indicators, exemplified by a 9-minute time saving per patient. Lessons learned noted the significance of user engagement, cultural transformation, and ongoing staff development, paving the way for future strategies including nationwide implementation, benefits realisation, and data visualisation initiatives.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    实验室生物标志物的协调对于确保跨不同临床环境的一致和可靠的诊断结果至关重要。本系统评价检查了C反应蛋白(CRP)和脑钠肽的N末端激素原(NT-proBNP)测量的协调,两者共同用于心血管疾病的诊断和管理。为了确定相关研究,我们使用特定的医学主题标题和关键字(如C-反应蛋白)搜索PubMed电子数据库,CRP,高敏C反应蛋白(hs-CRP),N末端B型利钠肽原,和NT-proBNP,专注于2021年6月1日至9月26日的出版物。该查询过滤了研究,仅包括涉及人类受试者的英语研究。从我们的搜索,97篇文章符合纳入标准,纳入进行深入分析。尽管它们广泛使用,由于缺乏标准化的预分析,CRP和NT-proBNP的测量仍然存在显著的变异性,分析,和分析后实践。这篇综述强调了这种变异性对临床决策和患者预后的影响,并强调需要国际标准和指南来实现更好的协调。我们的发现提倡建立通用协议,以增强这些生物标志物测量在不同临床环境中的可靠性。确保改善医疗保健服务。
    The harmonization of laboratory biomarkers is pivotal in ensuring consistent and reliable diagnostic outcomes across different clinical settings. This systematic review examines the harmonization of C-Reactive Protein (CRP) and N-Terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) measurements, both of which are jointly utilized in the diagnosis and management of cardiovascular diseases. To identify relevant studies, we searched the PubMed electronic database using specific medical subject headings and keywords such as C-Reactive Protein, CRP, high sensitivity C-Reactive Protein (hs-CRP), N-terminal pro B-type natriuretic peptide, and NT-proBNP, focusing on publications from June 1 to September 26, 2021. The query filtered studies to include only those in English involving human subjects. From our search, 97 articles met the inclusion criteria and were included for in-depth analysis. Despite their widespread use, significant variability remains in the measurements of CRP and NT-proBNP due to a lack of standardized pre-analytical, analytical, and post-analytical practices. This review highlights the consequences of this variability on clinical decision-making and patient outcomes and emphasizes the need for international standards and guidelines to achieve better harmonization. Our findings advocate for the establishment of universal protocols to enhance the reliability of these biomarker measurements across different clinical environments, ensuring improved healthcare delivery.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    这项研究旨在评估Hederacolchica作为Hedera螺旋物种替代治疗上呼吸道轻度炎症和慢性炎症性支气管疾病的潜力。秋葵提取物具有最高的皂苷含量(C3S;468.19±16.01mgHE/g干重)和提取物具有最高的总酚含量(C1F;108.60±5.61mgGAE/g干重)。使用LC-MS/MS技术对具有最高选择性COX-2抑制作用的提取物进行化学分析和标准化。确定C1F提取物中比例最高的物质是奎尼酸(45.909µg/g提取物)和橙皮苷(37.077µg/g提取物)。因此,次生代谢产物,除了皂苷,在Hedera物种中发现的也可能有助于提取物的有效性,与市场上可获得的总的含提取物的制剂相比,可以获得更有效的提取物。
    This study aimed to evaluate the potential of Hedera colchica as an alternative to Hedera helix species for the treatment of mild inflammatory conditions of the upper respiratory tract and chronic inflammatory bronchial diseases. The H. colchica extract with the highest saponin content (C3S; 468.19 ± 16.01 mg HE/g dry weight) and the extract with the highest total phenol content (C1F; 108.60 ± 5.61 mg GAE/g dry weight). Chemical analysis and standardisation of the extract with the highest selective COX-2 inhibitory effect was performed using the LC-MS/MS technique. It was determined that the substances found in the highest ratio in the C1F extract were quinic acid (45.909 µg/g extract) and hesperidin (37.077 µg/g extract). As a result, secondary metabolites, in addition to saponins, found in Hedera species may also contribute to the extract\'s effectiveness, more potent extracts can be obtained compared to the total extract-containing preparations available in the market.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    使用细胞外囊泡(EV)的临床研究的标准化主要集中在分离和表征所采用的程序;然而,样品收集的分析前方面,处理和储存也显著影响结果的可重复性。我们在GEIVEX(GrupoEspañoldeInvestigaciónVesiculasExtracelulares)成员中进行了基于SPREC(标准预分析代码)的在线调查,以探讨不同实验室如何处理用于EV分析的流体生物标本。我们收到了来自43个不同实验室的70项调查:44%的调查集中在血浆上,9%的血清和16%的尿液。调查表明,分析前方法的变异性达到94%。此外,在某些情况下,研究人员无法获得样品的所有相关分析前细节,某些样本方面对EV隔离/表征有潜在影响,但未在当前版本的SPREC中编码。我们的研究强调了使用通用标准操作程序(SOP)控制分析前条件的重要性。SPREC的应用代表了一种编码和配准分析前条件的合适方法。将SPREC集成到实验室/生物库的SOP中,将提供有价值的信息来源,并通过提高可重复性和可信性,为EV研究提供了进步。
    The standardization of clinical studies using extracellular vesicles (EVs) has mainly focused on the procedures employed for their isolation and characterization; however, preanalytical aspects of sample collection, handling and storage also significantly impact the reproducibility of results. We conducted an online survey based on SPREC (Standard PREanalytical Code) among members of GEIVEX (Grupo Español de Investigación en Vesiculas Extracelulares) to explore how different laboratories handled fluid biospecimens destined for EV analyses. We received 70 surveys from forty-three different laboratories: 44% focused on plasma, 9% on serum and 16% on urine. The survey indicated that variability in preanalytical approaches reaches 94%. Moreover, in some cases, researchers had no access to all relevant preanalytical details of samples, with some sample aspects with potential impact on EV isolation/characterisation not coded within the current version of SPREC. Our study highlights the importance of working with common standard operating procedures (SOP) to control preanalytical conditions. The application of SPREC represents a suitable approach to codify and register preanalytical conditions. Integrating SPREC into the SOPs of laboratories/biobanks will provide a valuable source of information and constitute an advance for EV research by improving reproducibility and credibility.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景 薄荷倡议,在国际呼吸研究协会内成立,介绍了薄荷协议,旨在解决不同呼吸采样技术和分析平台结果缺乏可比性的呼吸分析基准测试工作。但是,以前已经报道了使用薄荷的气相色谱-离子迁移谱(GC-IMS)的基准,微热脱附(µTD)与GC-IMS的耦合还没有,已成为呼吸分析的基准。
目标
使用薄荷协议对µTD-GC-IMS进行呼气分析。 方法 10名健康参与者(4名男性和6名女性,20-73岁),通过改良的薄荷协议,将六个呼气样本放入纳洛芬袋中。摄入薄荷后的呼吸采样在t=60、120、200、280和360分钟的6小时内进行。呼吸样品(120cm3)在转移到GC-IMS中用于检测之前在μTD中预浓缩。数据使用VOCal处理,包括背景减法,峰值体积测量,和室内空气评估。 结果 薄荷冲刷期间,桉树脑的浓度水平变化最大,其次是α-pine烯和β-pine烯。通过构建对数冲洗曲线证明了呼吸分析技术的可重复性,平均线性系数R2=0.99。桉树脑冲洗的基线(基准)值的时间为1111分钟(95%CI:529-1693分钟),通过外推平均对数冲刷曲线获得。 结论 使用薄荷协议,我们证明了μTD-GC-IMS是可重现的,适用于呼气分析。我们获得了μTD-GC-IMS为1111分钟(95%CI:529-1693分钟)的桉树醇的基准值(桉树醇洗脱),与黄金标准GC-MS相当。 .
    The Peppermint Initiative, established within the International Association of Breath Research, introduced the peppermint protocol, a breath analysis benchmarking effort designed to address the lack of inter-comparability of outcomes across different breath sampling techniques and analytical platforms. Benchmarking with gas chromatography-ion mobility spectrometry (GC-IMS) using peppermint has been previously reported however, coupling micro-thermal desorption (µTD) to GC-IMS has not yet, been benchmarked for breath analysis. To benchmarkµTD-GC-IMS for breath analysis using the peppermint protocol. Ten healthy participants (4 males and 6 females, aged 20-73 years), were enrolled to give six breath samples into Nalophan bags via a modified peppermint protocol. Breath sampling after peppermint ingestion occurred over 6 h att= 60, 120, 200, 280, and 360 min. The breath samples (120 cm3) were pre-concentrated in theµTD before being transferred into the GC-IMS for detection. Data was processed using VOCal, including background subtractions, peak volume measurements, and room air assessment. During peppermint washout, eucalyptol showed the highest change in concentration levels, followed byα-pinene andβ-pinene. The reproducibility of the technique for breath analysis was demonstrated by constructing logarithmic washout curves, with the average linearity coefficient ofR2= 0.99. The time to baseline (benchmark) value for the eucalyptol washout was 1111 min (95% CI: 529-1693 min), obtained by extrapolating the average logarithmic washout curve. The study demonstrated thatµTD-GC-IMS is reproducible and suitable technique for breath analysis, with benchmark values for eucalyptol comparable to the gold standard GC-MS.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    间充质基质细胞(MSC)是有前途的再生疗法,主要通过分泌的细胞外囊泡(EV)发挥其作用。这些电动汽车-体积小,没有生命-更容易处理,并且比细胞产品具有优势。因此,越来越多地研究MSC-EV的治疗潜力.然而,由于MSC-EV制造战略的变化,MSC-EV产品应被视为高度多样化。此外,用于MSC-EV表征的各种EV表征技术进一步使已发表数据的可靠实验室间比较复杂化.因此,这项研究旨在建立一种通用方法,该方法可供各种MSC-EV研究人员轻松使用,以表征MSC-EV制剂,以促进实验室间比较。为此,我们使用一种新型的基于多重珠子的EV流式细胞术检测小组进行了全面的实验室间评估.这项评估涉及来自五个不同MSC来源的实验室的11种不同的MSC-EV产品,文化条件,和EV制备方法。通过这个试验小组,涵盖了一系列主要与MSC相关的标志物,我们确定了一组细胞表面标志物始终阳性(CD44,CD73和CD105)或阴性(CD11b,CD45和CD197)在所有探索的MSC-EV制剂的EV上。分层聚类分析揭示了与特定制备过程和实验室条件相关的不同表面标记特征。我们建议CD73,CD105和CD44作为稳健的阳性标志物,用于最低限度地识别MSC衍生的EV和CD11b,CD14、CD19、CD45和CD79为靠得住的阴性标记物。此外,我们强调培养基成分的影响,特别是人类血小板裂解物,在EV表面标记轮廓上,强调培养条件对最终电动汽车产品的影响。这种标准化的MSC-EV表面标记谱分析方法为临床前和临床研究中制造的EV产品的常规表征提供了工具。加强MSC-EV制剂的质量控制,并有望为新兴的治疗性MSC-EV领域的更高一致性和可重复性铺平道路。
    Mesenchymal stromal cells (MSCs) are promising regenerative therapeutics that primarily exert their effects through secreted extracellular vesicles (EVs). These EVs - being small and non-living - are easier to handle and possess advantages over cellular products. Consequently, the therapeutic potential of MSC-EVs is increasingly investigated. However, due to variations in MSC-EV manufacturing strategies, MSC-EV products should be considered as highly diverse. Moreover, the diverse array of EV characterisation technologies used for MSC-EV characterisation further complicates reliable interlaboratory comparisons of published data. Consequently, this study aimed to establish a common method that can easily be used by various MSC-EV researchers to characterise MSC-EV preparations to facilitate interlaboratory comparisons. To this end, we conducted a comprehensive inter-laboratory assessment using a novel multiplex bead-based EV flow cytometry assay panel. This assessment involved 11 different MSC-EV products from five laboratories with varying MSC sources, culture conditions, and EV preparation methods. Through this assay panel covering a range of mostly MSC-related markers, we identified a set of cell surface markers consistently positive (CD44, CD73 and CD105) or negative (CD11b, CD45 and CD197) on EVs of all explored MSC-EV preparations. Hierarchical clustering analysis revealed distinct surface marker profiles associated with specific preparation processes and laboratory conditions. We propose CD73, CD105 and CD44 as robust positive markers for minimally identifying MSC-derived EVs and CD11b, CD14, CD19, CD45 and CD79 as reliable negative markers. Additionally, we highlight the influence of culture medium components, particularly human platelet lysate, on EV surface marker profiles, underscoring the influence of culture conditions on resulting EV products. This standardisable approach for MSC-EV surface marker profiling offers a tool for routine characterisation of manufactured EV products in pre-clinical and clinical research, enhances the quality control of MSC-EV preparations, and hopefully paves the way for higher consistency and reproducibility in the emerging therapeutic MSC-EV field.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    法国国家计量研究所(LNE)发起了一系列活动,以确定测试方法的优先事项及其协调,直接满足纳米医学的监管需求。其中一个题为“纳米医学国际标准化路线图”的研讨会于2023年10月举行(巴黎,法国)召集了表征纳米药物和含有纳米材料的医疗产品的关键专家,包括欧盟委员会联合研究中心,SINTEF工业和法国计量机构,英国,美国和加拿大,欧盟委员会的两项旗舰举措(PHOENIX和SAFE-n-MEDTECH开放式创新测试床),欧洲药品质量局(EDQM)mRNA疫苗工作组的代表以及国际标准化和规范前组织的成员(包括CEN,ISO,ASTM,VAMAS)。讨论中出现了两个带回家的消息。首先,开发纳米药物的标准测试方法和参考材料(RM)是欧盟委员会和各种利益相关者的关键优先事项。此外,人们一致认识到标准化委员会之间需要统一的方法,监管机构和纳米医学界。在美国,加拿大和欧洲水平,已经讨论了成功案例和未来倡议的例子。未来的前景包括在CEN/TC352下成立一个专门的工作组,以巩固努力并制定纳米医学标准化路线图。
    The French National Metrology Institute (LNE) initiated a series of events to identify priorities for test methods and their harmonisation that directly address regulatory needs in Nanomedicine. One of these workshops entitled \"The International Standardisation Roadmap for Nanomedicine\" held in October 2023 (Paris, France) brought together key experts in the characterisation of nanomedicines and medical products containing nanomaterials, including the Joint Research Centre of the European Commission, SINTEF Industry and the metrology institutes of France, the UK, the USA and Canada, two flagship initiatives of the European Commission (PHOENIX and SAFE-n-MEDTECH Open Innovation Test Beds), representatives of a working party on mRNA vaccines at the European Directorate for the Quality of Medicines (EDQM) and members of international standardisation and pre-normative organisations (including CEN, ISO, ASTM, VAMAS). Two take-home message came out from the discussion. First, developing standard test methods and Reference Materials (RMs) for nanomedicines is a key priority for the European Commission and various stakeholders. Furthermore, there was a unanimous recognition of the need for a unified approach between standardisation committees, regulators and the nanomedicine community. At the USA, Canadian and European level, examples of success stories and of future initiative have been discussed. Future perspectives include the creation of a dedicated Working Group under CEN/TC 352 to consolidate efforts and develop a nanomedicine standardisation roadmap.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    对于目前文献中存在的每种结肠切除术对应的肿瘤切除类型的定义,没有国际共识。目的是为文献中描述的每个结肠切除术定义:胚胎解剖平面,进行中央结扎的血管蒂,结肠切除术的程度,以及切除更大势头的需要。专家的共识是通过Delphi方法,通过西班牙外科医生协会的结肠直肠学部进行两轮。研究期间:2021年11月至2023年1月。对120名专家进行了调查。共识度:非常强:>90%,强:80-90%,中度:50-80%,没有共识:<50%。每个肿瘤结肠切除术的定义是由非常强大的,和强烈的建议。每个肿瘤结肠切除术被确定为右半结肠切除术(RHC),RHC与D3淋巴结清扫术,扩展RHC,横结肠节段结肠切除术,脾曲节段结肠切除术,结肠次全切除术,全结肠切除术,左半结肠切除术(LHC),扩展的LHC,乙状结肠切除术.
    There is no international consensus on the definition of the type of oncological resection that corresponds to each of the colectomies existing in the current literature. The objective is to define for each colectomy described in the literature: embryological dissection plane, vascular pedicles in which to perform central ligation, the extent of the colectomy, and the need for resection of the greater momentum. A consensus of experts is carried out through the Delphi methodology through two rounds from the Coloproctology Section of the Spanish Association of Surgeons. Study period: November 2021-January 2023. 120 experts were surveyed. Degrees of consensus: Very strong: >90%, Strong: 80-90%, Moderate: 50-80%, No consensus: <50%. The definition for each oncological colectomy was established by very strong, and strong recommendations. Each oncological colectomy was established as Right hemicolectomy (RHC), RHC with D3 lymphadenectomy, Extended-RHC, transverse colon segmental colectomy, splenic flexure segmental colectomy, subtotal colectomy, total colectomy, left hemicolectomy (LHC), extended-LHC, sigmoidectomy.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    人体生理学研究的前提是探索多方面的系统,同时确定一个或几个感兴趣的结果。因此,控制潜在的混杂变量需要仔细考虑控制的程度和标准化的复杂性。在测试前控制的一个常见因素是饮食,由于食物和液体供应可能偏离参与者的习惯性饮食,然而,自我报告和复制方法可能因报告不足而存在缺陷。研究人员可能还需要考虑身体活动的标准化,无论是通过熟悉试验,冲洗期,或在试验前要达到的身体活动水平的指导。在药物方面,标准化的伦理影响要求研究人员仔细考虑药物,咖啡因消费和口服避孕药处方可能会影响研究。对于女性的研究,应该考虑参与者之间或参与者内部月经周期阶段的标准化是否最相关.相对于各种其他日常事件的测量定时与所有生理研究相关,因此在进行测量时标准化可能是重要的。这篇综述总结了标准化领域,我们希望这些领域对参与人体生理学研究的任何人都有用。包括何时以及如何将标准化应用于各种环境。
    The premise of research in human physiology is to explore a multifaceted system whilst identifying one or a few outcomes of interest. Therefore, the control of potentially confounding variables requires careful thought regarding the extent of control and complexity of standardisation. One common factor to control prior to testing is diet, as food and fluid provision may deviate from participants\' habitual diets, yet a self-report and replication method can be flawed by under-reporting. Researchers may also need to consider standardisation of physical activity, whether it be through familiarisation trials, wash-out periods, or guidance on levels of physical activity to be achieved before trials. In terms of pharmacological agents, the ethical implications of standardisation require researchers to carefully consider how medications, caffeine consumption and oral contraceptive prescriptions may affect the study. For research in females, it should be considered whether standardisation between- or within-participants in regards to menstrual cycle phase is most relevant. The timing of measurements relative to various other daily events is relevant to all physiological research and so it can be important to standardise when measurements are made. This review summarises the areas of standardisation which we hope will be considered useful to anyone involved in human physiology research, including when and how one can apply standardisation to various contexts.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

公众号