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Base de données Enthalpies : évidence et théorie appliquée à la pratique en stérilisation [焓:应用于消毒实践的证据和理论]。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.pharma.2024.04.002
<div><h3>Objectifs</h3><p>Afin de partager leurs connaissances, les responsables d’unités de stérilisation publient les résultats de leurs travaux dans des revues ou lors de congrès scientifiques. Enthalpies a pour objectif de répertorier l’ensemble de ces travaux dans une base de données unique. Le travail présenté décrit la construction de cette base et l’évaluation de la faisabilité de sa mise en place pour l’étape du lavage.</p></div><div><h3>Méthodes</h3><p>La première étape a consisté à réaliser une revue de la littérature. Seuls les articles publiés sur 10<!--> <!-->ans (2013–2023) en lien avec l’étape de lavage ont été inclus. Ensuite, chaque publication a été catégorisée, codée, gradée et résumée par un binôme pharmacien-interne. L’ensemble de ces données a été colligé dans un tableur Excel® puis à partir de la catégorisation des données, une arborescence a été créée permettant d’appréhender l’interface entre l’utilisateur et la plateforme devant héberger Enthalpies.</p></div><div><h3>Résultats</h3><p>Quatre-vingt et une publications ont été identifiées. Celles-ci ont été catégorisées en 6 thèmes et 27 sous-thèmes. Pour chaque publication, une grille de lecture a été rédigée. Genially®, plateforme en ligne, a été choisi pour héberger notre base de données.</p></div><div><h3>Conclusion</h3><p>Enthalpies n’a pas été conçu pour émettre des recommandations de bonne pratique. Cependant, cet outil permet en colligeant les données scientifiques publiées d’aider à la prise de décision. Il représente une solution innovante pour mettre à disposition une revue de la littérature dans le domaine de la stérilisation hospitalière.</p></div><div><h3>Objectives</h3><p>In order to share their knowledge, sterilization unit managers publish the results of their work in journals or at scientific conferences. The aim of Enthalpies is to list all such work in a single database. The work presented describes the construction of this database and the assessment of its feasibility for the washing step.</p></div><div><h3>Methods</h3><p>The first step was to carry out a literature review. Only articles published over 10<!--> <!-->years (2013–2023) in connection with the ten-year washing stage were included. Then, each publication was categorized, coded, graded and summarized by a pharmacist-internal pair. All this data was collated in an Excel® spreadsheet, and from the data categorization a tree structure was created, enabling the interface between the user and the platform hosting Enthalpies to be understood.</p></div><div><h3>Results</h3><p>Eighty-one publications were identified. These were categorized into 6 themes and 27 sub-themes. A reading grid was drawn up for each publication. Genially®, an online platform, was chosen to host our database.</p></div><div><h3>Conclusion</h3><p>Enthalpies was not designed to issue recommendations for best practice. However, by collating published scientific data, this tool can be used to assist decision-making. It represents
目标为了分享知识,灭菌装置的管理人员会在期刊或科学会议上发表他们的工作成果。Enthalpies 的目的是在一个数据库中列出所有这些工作成果。本文介绍的工作描述了该数据库的构建过程,以及为清洗阶段建立该数据库的可行性评估。只有在 10 年内(2013-2023 年)发表的与洗涤阶段有关的文章才被纳入其中。然后,由一名实习药剂师对每篇文章进行分类、编码、分级和总结。所有数据均整理在 Excel® 电子表格中,并根据数据分类创建了一个树形结构,为用户和 Enthalpies 托管平台之间提供了一个界面。这些出版物被分为 6 个主题和 27 个子主题。为每份出版物绘制了阅读网格。我们选择了在线平台 Genially® 作为数据库的主机。然而,通过整理已发表的科学数据,该工具可以帮助决策。目的为了分享知识,消毒单位管理人员会在期刊或科学会议上发表他们的工作成果。Enthalpies的目的是在一个数据库中列出所有此类工作。本文介绍了该数据库的构建过程以及对其在清洗步骤中可行性的评估。只有在 10 年内(2013-2023 年)发表的与 10 年洗涤阶段相关的文章才被纳入其中。然后,由一对药剂师内部人员对每篇出版物进行分类、编码、分级和汇总。所有这些数据都整理在 Excel® 电子表格中,并根据数据分类创建了树形结构,以便了解用户与 Enthalpies 托管平台之间的界面。这些出版物被分为 6 个主题和 27 个子主题。为每份出版物绘制了阅读网格。结论 "焓 "并不是为了提出最佳实践建议而设计的。不过,通过整理已发表的科学数据,该工具可用于协助决策。它是提供医院消毒领域文献综述的创新解决方案。
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引用次数: 0
Urinary cytomegalovirus excretion: The unresolved issues 尿液巨细胞病毒排泄:悬而未决的问题。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.pharma.2024.03.004

Cytomegalovirus (CMV) excretion in urine is frequently observed in clinical practice. However, the specific circumstances and pathophysiological mechanisms underlying this shedding remain largely unknown. Here, we address some of the key questions regarding urinary CMV excretion, focusing on new hypotheses raised by recent advances in the field. Cellular origins of CMV shedding, clinical contexts of occurrence, systemic spread of the virus versus compartmentalization in the urinary tract, and clinical impact are successively discussed.

Le cytomégalovirus (CMV) est fréquemment détecté dans l’urine mais les circonstances cliniques et les mécanismes physiopathologiques qui sous-tendent cette virurie restent mal compris. Dans cette revue, nous cherchons à répondre aux principales questions soulevées par cette excrétion urinaire de CMV, en appréhendant successivement: l’origine cellulaire de l’excrétion virale au sein de l’arbre urinaire, le contexte clinique sous-jacent, la distinction entre diffusion systémique du virus et compartimentation et l’impact clinique de ces viruries à CMV.

临床上经常观察到巨细胞病毒(CMV)从尿液中排出。然而,这种脱落的具体情况和病理生理机制在很大程度上仍不为人所知。在此,我们将探讨有关尿液中 CMV 排泄的一些关键问题,重点关注该领域最新进展提出的新假设。我们将依次讨论 CMV 脱落的细胞起源、发生的临床背景、病毒在全身的传播与在泌尿道的分隔以及临床影响。
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引用次数: 0
Development of mucoadhesive microspheres for intranasal delivery of fluconazole as an alternative treatment of cryptococcal meningitis infection in patients with acquired immunodeficiency 开发用于鼻内给药氟康唑的黏附性微球,作为获得性免疫缺陷患者隐球菌脑膜炎感染的替代治疗方法。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.pharma.2024.04.001
<div><h3>Introduction</h3><p>Cryptococcal meningitis is a deadly disease with few treatment options. Its incidence is still high and closely linked to the HIV/AIDS epidemic. This study aimed to develop a mucoadhesive microsphere delivery system for fluconazole for the intranasal route.</p></div><div><h3>Method</h3><p>Microspheres of mucoadhesive fluconazole formulation variables such as different amounts of drug concentration and polymer concentration were prepared by a simple emulsion-crosslinking method. The prepared microspheres’ surface was characterised by SEM (Scanning electron microscopy) and evaluated for particle size, entrapment efficiency, production yield, infrared spectroscopic study, in-vitro muco-adhesion, and in-vitro drug release.</p></div><div><h3>Results</h3><p>The results showed that formula 1 is the optimal mucoadhesive microsphere preparation, with a particle size of 56.375<!--> <!-->m, a spherical surface shape, an entrapment efficiency of 99.96%, and a greater mucoadhesive capability during 6-hour evaluation. Furthermore, wash-off examination revealed that the mucoadhesive ability of this delivery system has a long duration and may release the active material at the right time.</p></div><div><h3>Conclusion</h3><p>The result of the researches suggesting that the formulation of mucoadhesive microspheres of fluconazole could be used to treat cryptococcal meningitis infection in HIV/AIDS patients.</p></div><div><h3>Introduction</h3><p>La méningite à cryptocoque est une maladie mortelle avec peu d’options de traitement. Son incidence est encore élevée et étroitement liée à l’épidémie de VIH/sida. Cette étude visait à développer un système d’administration de microsphère muco-adhésif pour le fluconazole par voie intranasale.</p></div><div><h3>Méthode</h3><p>Des microsphères de variables de formulation de fluconazole mucoadhesives telles que différentes quantités de concentration de médicament et de concentration de polymère ont été préparées par une méthode simple de réticulation d’émulsion. La surface des microsphères préparées a été caractérisée par SEM (microscopie électronique à balayage) et évaluée pour la taille des particules, l’efficacité du piégeage, le rendement de la production, l’étude spectroscopique infrarouge, la muco-adhésion in vitro et la libération de médicaments in vitro.</p></div><div><h3>Résultats</h3><p>Les résultats ont montré que la formule (1) est la préparation optimale de la microsphère muco-adhésive, avec une taille de particule de 56,375<!--> <!-->m, une forme de surface sphérique, une efficacité de piégeage de 99,96 % et une plus grande capacité de muco-adhésive pendant 6<!--> <!-->h d’évaluation. De plus, l’examen de lavage a révélé que la capacité muco-adhésive de ce système d’administration a une longue durée et peut libérer le matériau actif au bon moment.</p></div><div><h3>Conclusion</h3><p>Le résultat des recherches suggère que la formulation de microsphères muco-adhésives du fluconazole pour
导言加密球菌脑膜炎是一种致命疾病,治疗方法很少。其发病率仍然很高,与艾滋病毒/艾滋病的流行密切相关。本研究旨在开发一种用于鼻内给药途径的氟康唑粘附性微球给药系统。方法采用简单的乳液交联法制备粘附性氟康唑配方变量(如不同的药物浓度和聚合物浓度)的微球。结果结果表明,配方 1 是最佳的黏附性微球制剂,其粒径为 56.375 m,表面呈球形,黏附效率为 99.96%,在 6 小时评估中具有更强的黏附能力。研究结果表明,氟康唑粘附微球制剂可用于治疗艾滋病毒/艾滋病患者的隐球菌脑膜炎感染。隐球菌性脑膜炎是一种致命疾病,治疗方法很少,发病率仍然很高,与艾滋病毒/艾滋病的流行密切相关。本研究旨在开发一种用于鼻内注射氟康唑的粘附性微球给药系统。方法采用简单的乳液交联法制备粘附性氟康唑制剂变体微球,如不同量的药物浓度和聚合物浓度。用 SEM(扫描电子显微镜)对制备的微球表面进行了表征,并对粒度、包埋效率、产量、红外光谱研究、体外粘附性和体外药物释放进行了评估。结果结果表明,式(1)是粘附性微球的最佳制备方法,其粒径为 56.375 m,表面呈球形,夹持效率为 99.96%,在 6 小时评估期间具有更强的粘附能力。结论 研究结果表明,氟康唑的粘附微球制剂可用于治疗艾滋病毒/艾滋病患者的隐球菌脑膜炎感染。
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引用次数: 0
Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form. 经验证的绿色和白色 RP-HPLC 法,用于估算市售剂型中的佐米曲普坦。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-31 DOI: 10.1016/j.pharma.2024.08.010
Channabasavaiah Naveenaradhya, Veeresh Prabhakar Veerapur, Ranganatha Puttaraju, Kodigenahalli Balarajagupta Ajaykumar, DeviReddy Prashanthi, Varsha D Savanth, Mathud Shivamurthaiah Chaithanya, Bychapur Siddaiah Gowrishankar

Objective: To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.

Material and method: RP-HPLC method was developed using Luna (C18) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.

Results: The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q2 R1 guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R2 of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.

Conclusion: The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.

材料和方法: - 采用 Luna (C18) (4.6 x 250 mm, 5 µm)色谱柱和磷酸钠缓冲液(pH 4.7),以甲醇[75:25, v/v]为流动相,流速为 1.0 mL/min:流动相为甲醇[75: 25, v/v],流速为 1.0 mL/min。检测波长为 227 纳米。此外,还通过绿色和白色工具对优化分析方法的环保性、生产率和性能进行了评估:- 佐米曲普坦的保留时间为 3.25 分钟,色谱参数可接受。经AES、AGREE、GAPI和RGB工具确认,优化后的RP-HPLC方法比已报道的方法更环保、高效、通量大且实用。此外,该分析方法的所有验证参数均在 ICH Q2 R1 指南的接受范围内。线性回归分析表明,在 10 至 120 μg/mL 浓度范围内线性响应良好,R2 为 0.99998。佐米格-5 毫克片剂中佐米曲普坦的含量百分比和测定百分比分别为 103.36 ± 0.356 % 和 97.86 ± 0.693 %。
{"title":"Validated green and white RP-HPLC method for the estimation of Zolmitriptan in marketed dosage form.","authors":"Channabasavaiah Naveenaradhya, Veeresh Prabhakar Veerapur, Ranganatha Puttaraju, Kodigenahalli Balarajagupta Ajaykumar, DeviReddy Prashanthi, Varsha D Savanth, Mathud Shivamurthaiah Chaithanya, Bychapur Siddaiah Gowrishankar","doi":"10.1016/j.pharma.2024.08.010","DOIUrl":"10.1016/j.pharma.2024.08.010","url":null,"abstract":"<p><strong>Objective: </strong>To develop and validate a rapid, accurate, economical, effective and greenery RP-HPLC method for the determination of Zolmitriptan in tablet dosage form.</p><p><strong>Material and method: </strong>RP-HPLC method was developed using Luna (C<sub>18</sub>) (4.6×250mm, 5μm) column and Sodium phosphate buffer (pH 4.7): Methanol [75: 25, v/v] was used as mobile phase at a flow rate of 1.0mL/min. The detection was carried out at 227nm. Further, eco-friendliness, productivity and performance of the optimized analytical method were assessed by green and white tools.</p><p><strong>Results: </strong>The retention time of Zolmitriptan was found to be 3.25min with acceptable chromatographic parameters. The optimized RP-HPLC method was more eco-friendly, efficient, throughput and practicable than the reported methods as confirmed by AES, AGREE, GAPI and RGB tools. Further, the proposed analytical method showed all the validation parameters within the acceptance limit of ICH Q<sub>2</sub> R<sub>1</sub> guidelines. The linear regression analysis indicated a good linear response in the 10 to 120μg/mL concentration range with R<sup>2</sup> of 0.99998. The percentage content and percentage assay of Zolmitriptan in Zomig-5mg tablet was found to be 103.36±0.356% and 97.86±0.693%.</p><p><strong>Conclusion: </strong>The developed and validated method has several advantages compared to the reported HPLC methods and is useful in the systematic analysis of Zolmitriptan in its dosage form.</p>","PeriodicalId":8332,"journal":{"name":"Annales pharmaceutiques francaises","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142118883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
AQbD-guided development and validation of an innovative extraction procedure and stability-indicating RP-HPLC method for quantification of posaconazole in tablet formulation. 在 AQbD 指导下,开发并验证用于片剂中泊沙康唑定量的创新萃取程序和稳定性指示 RP-HPLC 方法。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-26 DOI: 10.1016/j.pharma.2024.07.003
Surajkumar Dilip Jadhav, Shailesh Waders

Objective: The objective of this work is to develop a stability-indicating HPLC method for the quantification of posaconazole (PCZ) in tablet formulation using an Analytical Quality by Design (AQbD) approach.

Materials and methods: The development process involved the Design of Experiments (DOE) utilizing distinctive constraints mixture design for mobile phase ratio optimization and a 2-level factorial design for selection of extraction diluent compositions. Key responses measured included % assay and system suitability parameters. Method operable design regions (MODR) were determined, and final optimum conditions were selected. Forced degradation studies were conducted to assess method stability.

Results: The optimized HPLC method employed a Zorbax C18 column with a mobile phase consisting of pH 3.5 10mM phosphate buffer, acetonitrile, and methanol in a ratio of 30:53:17% v/v/v. The method demonstrated stability-indicating capabilities, with PCZ degradation observed in acidic and oxidative environments, while remaining stable in alkali. Peak purity analysis from Empower software confirmed the absence of interaction with degradants. Validation according to ICH Q2 (R2) guidelines showed precision, linearity over the range of 0.25 to 376μg/mL, and accuracy demonstrated through recovery studies from 50 to 150%.

Conclusion: The developed HPLC method utilizing AQbD approach is specific, robust, precise, and accurate for the quantification of PCZ in tablet formulations, thus suitable for routine analysis.

目的:本研究的目的是采用分析质量设计(AQbD)方法,开发一种用于片剂中泊沙康唑(PCZ)定量的稳定性指示高效液相色谱法:开发过程包括实验设计(DOE),利用独特的约束混合物设计优化流动相比例,并利用 2 级因子设计选择萃取稀释剂成分。测量的主要反应包括检测率和系统适用性参数。确定了方法可操作设计区域(MODR),并选择了最终最佳条件。进行了强制降解研究,以评估方法的稳定性:优化后的高效液相色谱法采用 Zorbax C18 色谱柱,流动相为 pH 3.5 10mM 磷酸盐缓冲液、乙腈和甲醇,三者的比例为 30:53:17 % v/v/v。该方法具有稳定性指示能力,在酸性和氧化环境中观察到 PCZ 降解,而在碱性环境中保持稳定。Empower 软件进行的峰纯度分析表明,该方法没有与降解剂发生相互作用。根据 ICH Q2 (R2) 指南进行的验证表明,该方法在 0.25 µg/mL 至 376 µg/mL 的范围内具有良好的精密度和线性,并通过 50% 至 150% 的回收率研究证明了其准确性:采用 AQbD 方法开发的高效液相色谱法具有特异性、稳健性、精确性和准确性,适用于片剂中 PCZ 的定量分析。
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引用次数: 0
Application progress of nanomaterials in the treatment of prostate cancer. 纳米材料在前列腺癌治疗中的应用进展。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-24 DOI: 10.1016/j.pharma.2024.08.009
Xuewu Wu, Longtu Ma, Yang Zhang, Shuai Liu, Long Cheng, Chengyu You, Zhilong Dong

Prostate cancer is one of the most common malignant tumors in men, which seriously threatens the survival and quality of life of patients. At present, there are serious limitations in the treatment of prostate cancer, such as drug tolerance, drug resistance and easy recurrence. Sonodynamic therapy and chemodynamic therapy are two emerging tumor treatment methods, which activate specific drugs or sonosensitizers through sound waves or chemicals to produce reactive oxygen species and kill tumor cells. Nanomaterials are a kind of nano-scale materials with many excellent physical properties such as high targeting, drug release regulation and therapeutic monitoring. Sonodynamic therapy and chemodynamic therapy combined with the application of nanomaterials can improve the therapeutic effect of prostate cancer, reduce side effects and enhance tumor immune response. This article reviews the application progress of nanomaterials in the treatment of prostate cancer, especially the mechanism, advantages and challenges of nanomaterials in sonodynamic therapy and chemodynamic therapy, which provides new ideas and prospects for research in this field.

前列腺癌是男性最常见的恶性肿瘤之一,严重威胁着患者的生存和生活质量。目前,前列腺癌的治疗存在耐药性、抗药性、易复发等严重局限性。声动力疗法和化学动力疗法是两种新兴的肿瘤治疗方法,通过声波或化学物质激活特定药物或声敏剂,产生活性氧,杀死肿瘤细胞。纳米材料是一种纳米尺度的材料,具有高靶向性、药物释放调控和治疗监测等多种优异的物理特性。声动力学治疗和化学动力学治疗结合纳米材料的应用,可以提高前列腺癌的治疗效果,减少副作用,增强肿瘤免疫反应。本文综述了纳米材料在前列腺癌治疗中的应用进展,尤其是纳米材料在声动力治疗和化学动力治疗中的作用机制、优势和挑战,为该领域的研究提供了新的思路和展望。
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引用次数: 0
Therapeutic Effects of Stevia Aqueous Extract Alone or in Combination with Metformin in Induced Polycystic Ovary Syndrome Rats: Gene Expression, Hormonal Balance, and Metabolomics Aspects. 甜叶菊水提取物单独或与二甲双胍联合使用对诱导多囊卵巢综合征大鼠的治疗效果:基因表达、激素平衡和代谢组学方面。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-23 DOI: 10.1016/j.pharma.2024.08.008
Alireza Saedi, Sadegh Zarei, Mahboubeh Vatanparast, Mohammad Reza Hajizadeh, Reza Hosseiniara, Ozra Sadat Esmaeili, Maryam Mohammad-Sadeghipour, Zahra Mirzaei, Mehdi Mahmoodi

Objectives: This study aimed to assess the individual and combined effects of SAE and Met on the expression of genes related to insulin signaling, oxidative stress, hormonal imbalance, insulin resistance, and dyslipidemia in rats with induced PCOS.

Methods: The estrous cycle of 50 adult Wistar female rats was monitored through vaginal smears. Subsequently, the rats were randomly assigned into five groups of 10, including control (receiving 1 ml of carboxymethyl cellulose for 49 days), induction (letrozole at 1 mg/kg/d for 21 days), SAE, Met, and SAE/Met. SAE and Met were orally administered at doses of 400 mg/kg/d and 250 mg/kg/d on day 22 and continued for an additional 28 days. Vaginal smears were analyzed, and gene expression levels of GLUT4, SIRT1, TNF-α, and INSR were evaluated using RT-qPCR. Antioxidant parameters were assessed using detection kits.

Results: Treatment with SAE and Met restored a regular estrous cycle pattern in PCOS rats. Furthermore, SAE and Met treatment improved hormonal balance, dyslipidemia, and hyperglycemia in the rats. Administration of SAE and Met significantly elevated levels of antioxidant enzymes SOD and GPx in ovarian tissue (P<0.001). Additionally, mRNA levels of GLUT4, SIRT1, and INSR were significantly increased in ovarian tissue following SAE and Met treatment, while TNF-α gene expression decreased significantly (P<0.0001).

Conclusion: The findings suggest that SAE and Met aqueous extract exert protective effects on letrozole-induced PCOS in rats by modulating gene expression associated with insulin signaling and oxidative stress.

研究目的本研究旨在评估SAE和Met对诱导多囊卵巢综合征大鼠胰岛素信号转导、氧化应激、内分泌失调、胰岛素抵抗和血脂异常相关基因表达的单独和联合影响:方法:通过阴道涂片监测50只成年Wistar雌性大鼠的发情周期。随后,大鼠被随机分为5组,每组10只,包括对照组(接受1毫升羧甲基纤维素,共49天)、诱导组(来曲唑,1毫克/千克/天,共21天)、SAE组、Met组和SAE/Met组。第22天开始口服SAE和Met,剂量分别为400毫克/千克/天和250毫克/千克/天,并持续28天。对阴道涂片进行分析,并使用 RT-qPCR 评估 GLUT4、SIRT1、TNF-α 和 INSR 的基因表达水平。使用检测试剂盒评估了抗氧化参数:结果:用SAE和Met治疗后,多囊卵巢综合征大鼠恢复了正常的发情周期模式。此外,SAE 和 Met 治疗还改善了大鼠的激素平衡、血脂异常和高血糖。服用 SAE 和 Met 能明显提高卵巢组织中抗氧化酶 SOD 和 GPx 的水平(PC 结论:研究结果表明,SAE 和 Met 能提高卵巢组织中抗氧化酶 SOD 和 GPx 的水平:研究结果表明,SAE和Met水提取物通过调节与胰岛素信号传导和氧化应激相关的基因表达,对来曲唑诱导的多囊卵巢综合征大鼠具有保护作用。
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引用次数: 0
Risk analysis applied to the process of managing medical single use devices in a hospital pharmacy department. 将风险分析应用于医院药剂科的医疗器械管理过程。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-22 DOI: 10.1016/j.pharma.2024.08.006
Aymen Ben Salem, Fatma Sellami, Ahlem Ben Cheikh Brahim, Yosr Krichen, Aimen Abbassi

Introduction: During the COVID-19 pandemic, single use medical devices' supply (SUMD) was marked by repetitive and unforeseen interruptions. The present study aimed to determine the risks related to the processes of management of medical devices in our CHU according to a method of failure mode, effect and criticality analysis (FMECA).

Methods: Qualified healthcare professionals were recruited to form a multidisciplinary consensus committee. By analyzing the process map, all failure modes, causes and consequences were identified through brainstorming meetings. They were then classified taking into account the criticality index (CI) calculated according to three parameters: frequency, severity, and detectability. The prioritization was carried out by considering the mean and the median values of the CI as limits. Corrective and preventive actions were then proposed.

Results: A total of 49 failure modes were identified, accumulating 4466 criticality points. The most critical step is that relating to the inter-depot order with a CI equal to 783 points. An action plan was developed, allows us to control 64% of the overall criticality of the risks linked to the process. Three main lines of action have been proposed: continuous training, especially for managerial and administrative tasks, logistical improvement (architectural reorganization and implementation of systems for securing the circuit of SUMDs) and support for the digitization of hospital pharmacy.

Conclusion: The FMECA is a consensual method, which makes it possible to propose actions in order to reduce the risks linked to the process of managing medical devices. Optimizing the estimation of needs, strengthening communication with stakeholders and securing the circuit are essential to guarantee the availability of SUMDs for the benefit of the patient.

导言:在 COVID-19 大流行期间,一次性使用医疗器械(SUMD)的供应出现了反复和不可预见的中断。本研究旨在根据失效模式、影响和关键性分析(FMECA)方法,确定本医疗中心医院医疗器械管理流程的相关风险:方法:招募合格的医护人员组成多学科共识委员会。通过分析流程图,在头脑风暴会议上确定了所有失效模式、原因和后果。然后,根据频率、严重程度和可探测性三个参数计算出的关键性指数(CI)对它们进行分类。将 CI 的平均值和中位值作为界限,对其进行优先排序。然后提出了纠正和预防措施:结果:共确定了 49 种故障模式,累计 4466 个关键点。最关键的步骤是与工厂间订单有关的步骤,其临界点为 783 点。制定的行动计划使我们能够控制与流程相关的风险中 64% 的总体临界点。我们提出了三条行动主线:持续培训,尤其是管理和行政任务方面的培训;后勤改进(结构重组和实施系统,以确保 SUMDs 的线路安全);以及支持医院药房的数字化:FMECA 是一种协商一致的方法,可以提出行动建议,以降低与医疗设备管理过程相关的风险。优化需求评估、加强与利益相关者的沟通以及确保电路安全,对于保证医疗设备的可用性以造福患者至关重要。
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引用次数: 0
Harmonization of regulatory frameworks for medical devices in BRICS countries: A path to enhanced trade and investment. 金砖国家医疗器械监管框架的协调:加强贸易和投资之路。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-22 DOI: 10.1016/j.pharma.2024.08.007
Himanshu Pawar, Mital Patel

The study is designed to advocate for a harmonized medical device regulatory framework throughout the BRICS countries with a view to facilitating trade, attracting investments and safeguarding patients' health. The development of the medical devices industry in BRICS countries is impeded by a lack of standardized regulation. A harmonized framework would facilitate the approval process, promotion of innovation and wider access for patients to modern medical technologies. The paper analyses existing regulatory frameworks for medical devices in BRICS countries and identifies their strengths and weaknesses. Specific measures to harmonize such as standardization of technology, interoperability and the implementation of transparent licensing procedures are also proposed. The study indicates that a joint committee should be set up to supervise legal harmonization, standardization of classification and development of specific technical specifications. It also provides information about the regulatory framework in different countries, such as Brazil, Russia, India, China and South Africa, on classification of medical devices. Report emphasizes the need for a harmonized regulatory framework to rapidly introduce new healthcare technologies. It suggests that the BRICS countries can create a more conducive environment for the medical device industry, ultimately benefiting patients, manufacturers and the overall healthcare system by aligning their legislation.

这项研究旨在倡导在金砖五国建立统一的医疗器械监管框架,以促进贸易、吸引投资和保障患者健康。缺乏标准化的监管阻碍了金砖国家医疗器械行业的发展。一个统一的框架将促进审批程序,推动创新,让患者更广泛地获得现代医疗技术。本文分析了金砖国家现有的医疗器械监管框架,并指出了其优缺点。还提出了具体的协调措施,如技术标准化、互操作性和实施透明的许可程序。研究指出,应成立一个联合委员会来监督法律协调、分类标准化和具体技术规格的制定。报告还介绍了巴西、俄罗斯、印度、中国和南非等不同国家在医疗器械分类方面的监管框架。报告强调有必要建立统一的监管框架,以快速引入新的医疗保健技术。报告建议,金砖国家可以通过统一立法,为医疗器械行业创造更有利的环境,最终使患者、制造商和整个医疗系统受益。
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引用次数: 0
[Evaluation of medication self-administration feasibility in a university hospital: Clinical audits and recommendations]. [大学医院药物自助管理可行性评估:临床审计和建议]。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-08-21 DOI: 10.1016/j.pharma.2024.08.004
Cyril Baudrier, Victoire Petitcuenot, Nacima Oussedik, William Champeau, Rouba Alarab, Anne-Laure Lefebvre, Yara Rahma, Cecile Bottois, Ornella Conort

The French Health Authority recently published guidelines about patient self-administration of medications for voluntary hospitalized patients under medical supervision. This study aimed to assess medication management practices in our hospital and provide recommendations for self-administration medication. A prospective monocentric study was performed from January to June 2023, involving patient and nurse surveys based on the guidelines from the French Health Authority. A total of 207 patients participated in the survey, with a mean age of 59.6years. Among them, 56% were inclined to self-manage treatments initiated during hospitalization. Among patients with regular treatments, 62% were inclined to self-manage them in the hospital. In weekday hospitalization units, 92% of patients were inclined to self-manage their regular treatments, and 75% of those initiated during hospitalization. Among the 26 surveyed nurses, 71% reported patient autonomy for taking drugs in narrative transmissions, and 88% verified medication intake through self-administration, while 96% digitally traced it. The concept of self-administration of medication appears promising, especially within weekday hospitalization units, particularly for patients with a good understanding of their treatment. Nurses currently assess patient autonomy without specific monitoring tools. Collaborative efforts among healthcare professionals, with pharmacists playing a central role, are essential for the success of this innovative approach.

法国卫生局最近发布了关于自愿住院患者在医生指导下自行用药的指南。这项研究旨在评估我院的用药管理实践,并为患者自行用药提供建议。2023年1月至6月期间,我们根据法国卫生局的指南开展了一项前瞻性单中心研究,对患者和护士进行了问卷调查。其中,56%的患者倾向于自我管理住院期间开始的治疗。在定期接受治疗的患者中,62%的人倾向于在住院期间自行管理治疗。在平日住院的病房中,92% 的患者倾向于自我管理常规治疗,75% 的患者倾向于在住院期间开始自我管理治疗。在接受调查的 26 名护士中,71% 的护士在叙述性转述中报告了病人服药的自主性,88% 的护士通过自我服药核实了药物摄入量,96% 的护士通过数字追踪核实了药物摄入量。目前,护士在评估患者自主性时并没有特定的监测工具。医护人员之间的合作对于这种创新方法的成功至关重要,而药剂师则扮演着核心角色。
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引用次数: 0
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Annales pharmaceutiques francaises
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