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Drug-induced acute generalised exanthematous pustulosis: insights from FAERS data on a rare but severe cutaneous adverse reaction. 药物引起的急性全发性脓疱病:FAERS数据对罕见但严重的皮肤不良反应的见解。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-21 DOI: 10.1136/ejhpharm-2025-004806
Eleonora Castellana, Maria Rachele Chiappetta
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引用次数: 0
Vedolizumab trough concentrations and clinical outcomes in patients with Crohn's disease: a real-world observational study comparing intravenous and subcutaneous administration. Vedolizumab谷浓度和克罗恩病患者的临床结果:一项比较静脉和皮下给药的真实世界观察性研究
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-21 DOI: 10.1136/ejhpharm-2025-004618
Laura Moñino-Domínguez, Alicia Aguado-Paredes, Jaime Cordero-Ramos, Vicente Merino-Bohorquez

Objectives: To explore the relationship between vedolizumab trough concentrations and clinical and biochemical remission in patients with Crohn's disease (CD) receiving maintenance therapy, analysing intravenous and subcutaneous administration separately in a real-world clinical setting.

Methods: We conducted a retrospective observational study in 69 patients with CD receiving vedolizumab maintenance therapy. Plasma trough concentrations were measured by ELISA. Clinical remission (Harvey-Bradshaw Index <5) and biochemical remission (faecal calprotectin (FCP) <250 µg/g) were evaluated 6 months after trough level measurement. Patients were stratified according to administration route (intravenous and subcutaneous). Statistical analyses included Mann-Whitney tests, receiver operating characteristic (ROC) curves to determine predictive ability, and multiple linear regression to identify factors associated with vedolizumab exposure.

Results: Median vedolizumab trough concentrations were higher in patients achieving clinical remission compared with those without remission in both intravenous (16.4 vs 10.95 µg/mL, p=0.067) and subcutaneous (37.45 vs 23.05 µg/mL, p=0.134) groups, although differences were not statistically significant. ROC analyses revealed modest predictive capacity for the intravenous group (area under the curve (AUC)=0.676, optimal threshold=11.3 µg/mL, sensitivity=85.7%, specificity=58.3%) and strong predictive ability for the subcutaneous group (AUC=0.813, optimal threshold=25.35 µg/mL, sensitivity=83.3%, specificity=75%). Biochemical remission was not significantly associated with trough concentrations. In multivariable regression analysis, subcutaneous administration, higher albumin and lower FCP were significantly associated with increased vedolizumab concentrations, whereas C-reactive protein (CRP) showed a positive association.

Conclusion: Vedolizumab trough concentrations were numerically higher in patients achieving clinical remission, with stronger predictive ability for remission in the subcutaneous group. While isolated trough levels alone may not predict remission, interpretation alongside biomarkers and clinical context can inform therapeutic decisions. Further prospective studies are warranted to validate optimal therapeutic thresholds.

目的:探讨vedolizumab谷浓度与接受维持治疗的克罗恩病(CD)患者的临床和生化缓解之间的关系,在现实世界的临床环境中分别分析静脉和皮下给药。方法:我们对69例接受维多单抗维持治疗的CD患者进行了回顾性观察研究。ELISA法测定血药谷浓度。临床缓解(哈维-布拉德肖指数)结果:静脉注射组(16.4 vs 10.95µg/mL, p=0.067)和皮下注射组(37.45 vs 23.05µg/mL, p=0.134)中位vedolizumab谷浓度在达到临床缓解的患者中均高于未达到缓解的患者,但差异无统计学意义。ROC分析显示静脉组的预测能力一般(曲线下面积(area under the curve, AUC)=0.676,最佳阈值=11.3µg/mL,敏感性=85.7%,特异性=58.3%),而皮下组的预测能力较强(AUC=0.813,最佳阈值=25.35µg/mL,敏感性=83.3%,特异性=75%)。生化缓解与谷浓度无显著相关。在多变量回归分析中,皮下给药、白蛋白升高和FCP降低与维多单抗浓度升高显著相关,而c反应蛋白(CRP)呈正相关。结论:Vedolizumab谷浓度在达到临床缓解的患者中数值较高,对皮下组缓解有更强的预测能力。虽然单独的低谷水平可能无法预测缓解,但与生物标志物和临床背景一起解释可以为治疗决策提供信息。需要进一步的前瞻性研究来验证最佳治疗阈值。
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引用次数: 0
Hypoglycaemic coma induced by a falsified semaglutide product: a case report. 伪造的西马鲁肽产品致低血糖昏迷1例。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-21 DOI: 10.1136/ejhpharm-2025-004656
Giulia Antonacci, Erika Bortignon, Massimo Bolognesi, Salvatore Silvio Piano, Alessandro Cadore, Laura Camuffo, Francesca Venturini, Sonia Faoro, Donata Favretto, Antonietta Romano, Daniele Mengato

Semaglutide (Ozempic, Rybelsus, Wegovy) is a GLP-1 receptor agonist used for the treatment of type 2 diabetes and, more recently, weight management. Due to its efficacy in weight loss, semaglutide has gained worldwide popularity, particularly the branded version Ozempic, resulting in off-label use by people seeking rapid weight loss. The resulting high demand has led to an increase in falsified products sold by unregulated online marketplaces. We present a case of a 31-year-old woman who was admitted to the emergency room in a hypoglycaemic coma after self-administrating semaglutide (Ozempic) obtained from a website. Toxicological analysis showed that the vial contained insulin instead of semaglutide, therefore leading to severe hypoglycaemia. This case highlights the growing concern regarding falsified medicines sold in the online drug market and the associated risk of severe adverse events. We reported the case to the Italian Medicines Agency (AIFA) and local authorities. We propose regulatory measures to mitigate similar incidents in the future.

Semaglutide (Ozempic, Rybelsus, Wegovy)是一种GLP-1受体激动剂,用于治疗2型糖尿病,最近用于体重管理。由于其减肥功效,西马鲁肽在世界范围内广受欢迎,特别是品牌版本Ozempic,导致寻求快速减肥的人在标签外使用。由此产生的高需求导致不受监管的在线市场销售的假冒产品增加。我们报告了一例31岁的女性,她在自我服用从网站获得的西马鲁肽(Ozempic)后,因低血糖昏迷而被送往急诊室。毒理学分析表明,小瓶中含有胰岛素而不是semaglutide,因此导致严重的低血糖。这一案例凸显了人们对在线药品市场上销售的假药以及与之相关的严重不良事件风险的日益关注。我们向意大利药品管理局(AIFA)和地方当局报告了该病例。我们建议采取规管措施,以减少日后发生类似事件。
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引用次数: 0
Transitions of care: integrating pharmacists to prevent harm worldwide. 护理的转变:整合药剂师以预防全球伤害。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-20 DOI: 10.1136/ejhpharm-2025-004784
Esteban Zavaleta-Monestel, Josep María Guiu-Segura, Sebastian Arguedas-Chacon, Lars-Åke Suderlund
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引用次数: 0
Maintaining the stability of furosemide tablets during enteral feeding tube delivery using PVC and non-PVC tubes, in accordance with hospital protocols. 按照医院规程,在使用PVC和非PVC管的肠内喂食管期间维持呋塞米片的稳定性。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-17 DOI: 10.1136/ejhpharm-2025-004562
Maria Emília Pessoa Farias, Vitor Lima Mesquita, Suzzy Maria Carvalho Dantas, Angelo Roncalli Alves Silva, Alejandro Pedro Ayala, Yara Santiago de Oliveira, Milena Pontes Portela Beserra, Marta Maria de França Fonteles, Cristiani Lopes Capistrano Gonçalves Oliveira

Objectives: The administration of solid drugs via enteral feeding tubes is a common practice in hospitals. However, there is a paucity of literature about the stability of the drug and its interaction with medical devices. This study evaluated the sorption and content of furosemide tablets when administered through an enteral feeding tube, simulating a hospital clinical protocol.

Methods: In the laboratory, a high-performance liquid chromatography method for evaluating furosemide in tablets was validated with the simulation of the hospital protocol involving dispersing furosemide tablets in 10 mL of bottled water using syringes. The content was evaluated before and after passage through enteral feeding tubes made of three different materials (polyvinyl chloride-PVC, polyurethane and silicone). The sorption of furosemide in the tubes was evaluated by infrared spectrophotometry.

Results: The developed analytical method demonstrated selectivity, linearity within the 30-60 µg/mL range, as well as precision and accuracy. The stability of the furosemide in the syringes was also assessed, and no significant decay in content or formation of degradation products was observed during the 180 min exposure before passing through the enteral feeding tube. The simulation demonstrated that the furosemide content remained stable after passing through PVC (100.90%), polyurethane (98.58%) and silicone (99.56%) tubes. Furthermore, no sorption of furosemide was detected in any of the materials.

Conclusion: These results confirm the safety and stability of the hospital's protocol for administering furosemide via enteral feeding tube to the patient.

目的:通过肠内喂食管给药是医院常见的做法。然而,缺乏关于药物稳定性及其与医疗设备相互作用的文献。本研究模拟医院临床方案,评估通过肠内喂食管给药呋塞米片剂的吸收和含量。方法:在实验室模拟医院方案,用注射器将呋塞米片分散到10 mL瓶装水中,验证了高效液相色谱法评价呋塞米片剂中的含量。对三种不同材料(聚氯乙烯-聚氯乙烯、聚氨酯和硅酮)肠内饲管通过前后的含量进行了评价。用红外分光光度法测定了管中速尿的吸附性。结果:所建立的分析方法在30 ~ 60µg/mL范围内具有良好的选择性和线性,精密度和准确度较高。我们还评估了速尿在注射器中的稳定性,在通过肠内喂食管之前的180分钟内,没有观察到降解产物的含量或形成明显的衰减。模拟结果表明,通过PVC(100.90%)、聚氨酯(98.58%)和硅胶(99.56%)管后,速尿含量保持稳定。此外,在任何材料中均未检测到速尿的吸附。结论:这些结果证实了该院通过肠内喂养管给病人使用呋塞米方案的安全性和稳定性。
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引用次数: 0
Incidence of hypokalaemia in tazobactam/piperacillin-treated patients and identification of risk factors: a retrospective observational study. 他唑巴坦/哌拉西林治疗患者低钾血症发生率及危险因素的识别:一项回顾性观察性研究
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-17 DOI: 10.1136/ejhpharm-2025-004712
Kazutaka Uchida, Kenshiro Higashi, Yoshihiro Nakagawa, Kazutaka Oda

Background: Tazobactam/piperacillin (TAZ/PIPC), widely used for treating various infections, is often discontinued due to hypokalaemia, although the preventive measures remain unclear. This study aimed to identify the incidence, clinical characteristics and associated risk factors for TAZ/PIPC-induced hypokalaemia.

Methods: Hospitalised patients receiving TAZ/PIPC therapy for >2 days were included. The primary endpoint was the incidence of hypokalaemia (serum potassium level ≤3 mEq/L) and identification of associated risk factors. Survival classification and regression tree (CART) analyses were used to estimate HR (95% CI) and cut-off values for continuous variables.

Results: Of the 224 patients treated with TAZ/PIPC during the study period, 168 were included. The median time (min-max) to the incidence of hypokalaemia was 3 (2-14) days. Hypokalaemia was observed in 30 patients. Survival CART analysis identified baseline serum potassium level (cut-off value of 3.7 mEq/L) and diarrhoea as risk factors.

Conclusions: Monitoring serum potassium levels is recommended after treatment initiation of TAZ/PIPC therapy for patients with baseline serum potassium levels ≤3.7 mEq/L and diarrhoea.

背景:他唑巴坦/哌拉西林(TAZ/PIPC)广泛用于治疗各种感染,但经常因低钾血症而停用,尽管预防措施尚不清楚。本研究旨在确定TAZ/ pipc诱导的低钾血症的发生率、临床特征和相关危险因素。方法:住院患者接受TAZ/PIPC治疗bbb20 d。主要终点是低钾血症(血钾水平≤3 mEq/L)的发生率和相关危险因素的识别。使用生存分类和回归树(CART)分析来估计HR (95% CI)和连续变量的截止值。结果:在研究期间接受TAZ/PIPC治疗的224例患者中,有168例纳入研究。低钾血症发生的中位时间(min-max)为3(2-14)天。30例患者出现低钾血症。生存CART分析确定基线血清钾水平(临界值3.7 mEq/L)和腹泻是危险因素。结论:对于基线血钾水平≤3.7 mEq/L且腹泻的患者,建议在TAZ/PIPC治疗开始后监测血钾水平。
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引用次数: 0
Pharmaceutical validation of peripherally inserted central catheters: four years of implementation. 四周插入中心导管的药物验证:四年实施。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-08 DOI: 10.1136/ejhpharm-2025-004525
Virginie Tournayre, Julien Frandon, Maria Pitard, Virginie Chasseigne

Objectives: Peripherally inserted central catheters (PICCs) are used in clinical settings for mid- to long-term intravenous therapies, including chemotherapy and antibiotics. However, their use involves risks such as infections, thrombosis or occlusions. Pharmacist-led analysis and validation of PICC requests aims to optimise their use and reduce complications. This study evaluates the sustainability of pharmacist-led PICC analysis and validation in a university hospital and investigates the organisation of PICC management in French healthcare institutions.

Methods: A single-centre retrospective observational study was conducted, analysing PICC requests from April 2018 to October 2021. Pharmaceutical interventions (PIs) were categorised based on their targets: applicants, installers or users. A national survey was also conducted to assess PICC practices across French hospitals.

Results: Of the 5503 requests over a 42-month period, 59.9% (3297) required at least one PI, totalling 4406 PIs. Most were directed at installers (69.2%), followed by applicants (18.4%) and users (12.4%). Pharmacists refused 4.1% (223) of requests, mainly due to alternative functional access or contraindications. Despite pharmacist validation, 14.0% (771) of PICC placements were later cancelled by the medical team (ie, transfer of the patient). The national survey revealed limited adoption of pharmaceutical validation, with only two centres (5%) implementing it out of 37 respondents, even though 40 centres (98%) had over 2 years of experience with PICCs.

Conclusions: Pharmacist-led PICCs validation improves patient safety and optimises device use, demonstrating its value and sustainability in clinical practice. The percentage of refusals has remained stable since our pilot study in 2018 in the same centre, probably due to fast staff turnover. Wider implementation of this practice requires addressing resource limitations, raising awareness about the pharmacist's role in managing medical devices, and frequent training.

目的:外周插入中心导管(PICCs)用于临床中长期静脉注射治疗,包括化疗和抗生素。然而,它们的使用存在感染、血栓形成或闭塞等风险。药剂师主导的PICC请求分析和验证旨在优化其使用并减少并发症。本研究评估了一所大学医院药剂师主导的PICC分析和验证的可持续性,并调查了法国医疗机构PICC管理的组织。方法:进行单中心回顾性观察研究,分析2018年4月至2021年10月中国人民保险公司的申请。药物干预(pi)根据其目标进行分类:申请人,安装者或用户。还进行了一项全国调查,以评估法国各医院的人保业务。结果:在42个月期间的5503个请求中,59.9%(3297个)至少需要一个PI,总计4406个PI。大多数是针对安装人员(69.2%),其次是申请人(18.4%)和用户(12.4%)。药剂师拒绝了4.1%(223)的请求,主要是由于替代功能通道或禁忌症。尽管药剂师验证,14.0%(771)的PICC安置后来被医疗团队取消(即转移患者)。全国调查显示,药物验证的采用有限,在37个受访者中,只有两个中心(5%)实施了药物验证,尽管40个中心(98%)在picc方面有超过2年的经验。结论:药师主导的PICCs验证提高了患者的安全性,优化了器械的使用,证明了其在临床实践中的价值和可持续性。自2018年我们在同一中心进行试点研究以来,拒绝率一直保持稳定,这可能是由于员工流动迅速。更广泛地实施这种做法需要解决资源限制,提高对药剂师在管理医疗设备中的作用的认识,并经常进行培训。
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引用次数: 0
The future of pharmacy is already here: can we afford not to invest? Reflections from the seventh EAHP Synergy Certification Course 2025 in Bratislava. 制药行业的未来已经到来:我们能承担不起不投资的后果吗?在布拉迪斯拉发举办的第七届EAHP协同认证课程2025的思考。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-07 DOI: 10.1136/ejhpharm-2025-004717
Ľubica Slimáková, Slávka Porubcová, Nenad Miljković, Carlo Polidori, Anna Štricová, Hajnalka Komjáthy
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引用次数: 0
A bibliometric analysis of the application trends of information technology in antimicrobial stewardship within hospitals. 信息技术在医院抗菌药物管理中的应用趋势的文献计量学分析。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-07 DOI: 10.1136/ejhpharm-2025-004623
Yannan Ding, Ming Lei, Gang Yuan, Jinzhong Yu, Lili Wu, Jianwen Yang, Hong Zhang

Objectives: This study uses bibliometric analysis to systematically map research trends, knowledge structure and evolution of information technology (IT) in hospital antimicrobial stewardship (AMS) over the last 20 years.

Methods: A Web of Science Core Collection search (2000-2025) yielded 258 English-language publications on IT applications in hospital AMS. A bibliometric analysis, utilising CiteSpace and Bibliometrix, quantitatively evaluated domain evolution through temporal analysis, network mapping, keyword clustering, burst detection and examination of highly cited publications.

Results: The bibliometric analysis reveals a fluctuating yet overall increasing trend in annual publications, peaking at 49 articles in 2024. The US (131 publications) and European nations demonstrate significant research output (centrality >0.2), with major collaborative networks coalescing around institutions including Harvard University and Imperial College London. Keyword analysis identifies 'AMS' as a core theme, closely associated with technological keywords such as 'machine learning (ML)', 'clinical decision support systems (CDSS)', 'electronic health records (EHR)' and 'artificial intelligence (AI)'. Emerging trends suggest a shift in research focus from foundational strategies to data-driven prediction of antimicrobial resistance (AMR) and precision interventions. Highly cited literature emphasises the integration of EHR and ML technologies for optimising prescriptions and predicting resistance patterns.

Conclusions: IT-driven AMS research has shifted from empirical management to data science. Despite EHR integration, and ML and CDSS support, challenges remain in data standardisation, technical deployment and ethics. Future work must emphasise global collaboration, standardisation, design refinement and ethical guidelines, and provide clear algorithm explanations to enhance AMR mitigation.

目的:本研究采用文献计量学分析系统地绘制了近20年来医院抗菌药物管理(AMS)的研究趋势、知识结构和信息技术(IT)的演变。方法:检索Web of Science Core Collection(2000-2025),获得258篇关于IT在医院医疗辅助系统中的应用的英文出版物。利用CiteSpace和Bibliometrix进行文献计量分析,通过时间分析、网络映射、关键字聚类、突发检测和高被引出版物的检查,定量评估了领域演变。结果:文献计量分析显示,年发表量呈波动但总体上升的趋势,2024年达到49篇的峰值。美国(131篇论文)和欧洲国家的研究产出显著(中心性>.2),主要的合作网络围绕着哈佛大学和伦敦帝国理工学院等机构。关键词分析将“AMS”确定为核心主题,与“机器学习(ML)”、“临床决策支持系统(CDSS)”、“电子健康记录(EHR)”和“人工智能(AI)”等技术关键词密切相关。新兴趋势表明,研究重点从基础战略转向数据驱动的抗菌素耐药性预测和精确干预。高度引用的文献强调了电子病历和机器学习技术的整合,以优化处方和预测耐药性模式。结论:it驱动的AMS研究已经从经验管理转向数据科学。尽管有EHR集成、ML和CDSS支持,但在数据标准化、技术部署和道德规范方面仍然存在挑战。未来的工作必须强调全球合作、标准化、设计改进和道德准则,并提供明确的算法解释,以加强抗菌素耐药性缓解。
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引用次数: 0
Gender bias in biomedical research. 生物医学研究中的性别偏见。
IF 1.5 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-07 DOI: 10.1136/ejhpharm-2025-004713
Andrej Belančić, Ines Potočnjak, Florian Naudet
{"title":"Gender bias in biomedical research.","authors":"Andrej Belančić, Ines Potočnjak, Florian Naudet","doi":"10.1136/ejhpharm-2025-004713","DOIUrl":"https://doi.org/10.1136/ejhpharm-2025-004713","url":null,"abstract":"","PeriodicalId":12050,"journal":{"name":"European journal of hospital pharmacy : science and practice","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
European journal of hospital pharmacy : science and practice
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