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Relationship between Lactate Dehydrogenase and survival in patients with non-small cell lung cancer receiving immunotherapy. 接受免疫疗法的非小细胞肺癌患者乳酸脱氢酶与生存期的关系。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 DOI: 10.1016/j.farma.2024.09.003
Claudia Rosique-Aznar, Alejandro Valcuende-Rosique, Dolores Rosique-Robles, Agustín Sánchez-Alcaraz

Objective: The expression level of programmed death ligand 1 (PD-L1) is the only approved biomarker for predicting response to immunotherapy, yet its efficacy is not always consistent. Lactate dehydrogenase (LDH) has been associated with tumor aggressiveness and poorer prognosis across various cancer types and may serve as a useful biomarker for monitoring treatment response. The objective of this study is to analyze the relationship between LDH levels prior to the start of treatment with immune checkpoint inhibitors (ICIs) and clinical outcomes in patients with non-small cell lung cancer (NSCLC).

Method: A retrospective study was conducted including patients diagnosed with NSCLC who were treated with at least three cycles of immunotherapy. Data on demographics, clinical and pathological characteristics, treatment received, pre-treatment LDH levels, and clinical outcomes such as treatment response and overall survival (OS) were analyzed.

Results: A total of 181 patients diagnosed with NSCLC were included. Elevated pre-treatment LDH levels (more than 244 U/l) were associated with significantly reduced OS. The median survival was 548 days in patients with LDH less than 244 U/l, compared to 332 days in those with LDH more than 244 U/l (p = 0.037). Among men, OS was greater in the LDH less than 244 U/l group (623 days) versus 332 days in the LDH more than 244 U/l group (p = 0.043). In patients with metastatic disease, OS was higher in those with LDH less than 244 U/l (474 days) compared to 249 days in those with LDH more than 244 U/l (p = 0.023). In patients receiving both immunotherapy and chemotherapy, OS was greater in those with LDH less than 244 U/l (623 days) compared to 281 days in the LDH more than 244 U/l group (p = 0.042).

Conclusions: High levels of LDH prior to the start of treatment with ICIs are associated with lower treatment efficacy and a worse prognosis of the disease, especially in male, metastatic patients with a PD-L1 expression level less than 1%.

目的程序性死亡配体 1(PD-L1)的表达水平是唯一获准用于预测免疫疗法反应的生物标志物,但其疗效并不总是一致的。乳酸脱氢酶(LDH)与各种癌症类型的肿瘤侵袭性和较差的预后有关,可作为监测治疗反应的有用生物标志物。本研究旨在分析非小细胞肺癌(NSCLC)患者开始接受免疫检查点抑制剂(ICIs)治疗前的LDH水平与临床预后之间的关系:方法:我们进行了一项回顾性研究,研究对象包括确诊为非小细胞肺癌并接受了至少三个周期免疫疗法治疗的患者。分析了人口统计学、临床和病理学特征、接受的治疗、治疗前 LDH 水平以及治疗反应和总生存期(OS)等临床结果:结果:共纳入181名确诊为NSCLC的患者。治疗前LDH水平升高(超过244 U/l)与OS显著降低有关。LDH低于244 U/l的患者的中位生存期为548天,而LDH高于244 U/l的患者的中位生存期为332天(P = 0.037)。在男性患者中,LDH低于244 U/l组的OS(623天)大于LDH高于244 U/l组的332天(P = 0.043)。在转移性疾病患者中,LDH 低于 244 U/l(474 天)的患者的 OS 较高,而 LDH 高于 244 U/l(249 天)的患者的 OS 较低(p = 0.023)。在同时接受免疫疗法和化疗的患者中,LDH低于244 U/l组的患者的OS更长(623天),而LDH高于244 U/l组的患者的OS仅为281天(p = 0.042):结论:开始使用 ICIs 治疗前 LDH 水平较高与治疗效果较差和疾病预后较差有关,尤其是在 PD-L1 表达水平低于 1%的男性转移性患者中。
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引用次数: 0
Health-Related Quality of Life and Associated Factors in Patients Undergoing Kidney Replacement Therapies. 接受肾脏替代疗法的患者与健康相关的生活质量及相关因素。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-17 DOI: 10.1016/j.farma.2024.08.008
Alfonso Pereira-Céspedes, Alberto Jiménez-Morales, Aurora Polo-Moyano, Elizabeth Spruce-Esparza, Magdalena Palomares-Bayo, Fernando Martínez-Martínez, Miguel Ángel Calleja-Hernández

Objective: Characterize the health-related quality of life among patients undergoing kidney replacement therapy and to explore associated factors.

Method: A descriptive observational study was conducted using the Kidney Disease Quality of Life Short Form questionnaire to assess health-related quality of life. The Dader Method was employed to evaluate negative outcomes associated with medications. Face-to-face interviews and clinical records were utilized to collect sociodemographic and clinical data from patients undergoing kidney replacement therapy at the Nephrology Department of Virgen de las Nieves University Hospital (Granada, Spain). We explored the association between independent variables (clinical and demographic factors) and dependent variables (Mental Component Score and Physical Component Score) using the linear regression method.

Results: Ninety-one participants were included, 47 (48.35%) were females. The mean age was 62 years, 52 patients (57.14%) were on hemodialysis, 13 patients (14.29%) on peritoneal dialysis, and 26 patients (28.57%) on other forms of kidney replacement therapy. The study revealed a mean Physical Component Score of 40.89 and a Mental Component Score of 47.19. Additionally, 98.90% of the patients experienced negative outcomes associated with medications. Influential factors include age, comorbid conditions, the number of medications, and clinical parameters such as vitamin D and calcium levels.

Conclusions: This study underscores significant findings in patients undergoing kidney replacement therapy, indicating low Mental Component Score and Physical Component Score, accompanied by negative outcomes associated with medications.

目的描述接受肾脏替代治疗的患者的健康相关生活质量,并探讨相关因素:采用肾脏疾病生活质量简表问卷评估与健康相关的生活质量,进行了一项描述性观察研究。采用达德法评估与药物治疗相关的负面结果。我们利用面对面访谈和临床记录收集了在 Virgen de las Nieves 大学医院(西班牙格拉纳达)肾脏科接受肾脏替代治疗的患者的社会人口学和临床数据。我们采用线性回归法探讨了自变量(临床和人口学因素)与因变量(心理成分得分和生理成分得分)之间的关联:91名参与者中有47名女性(48.35%)。平均年龄为 62 岁,52 名患者(57.14%)接受血液透析,13 名患者(14.29%)接受腹膜透析,26 名患者(28.57%)接受其他形式的肾脏替代治疗。研究显示,患者的平均身体成分得分为 40.89 分,精神成分得分为 47.19 分。此外,98.90% 的患者经历了与药物相关的负面结果。影响因素包括年龄、合并症、药物数量以及维生素 D 和钙水平等临床参数:本研究强调了在接受肾脏替代治疗的患者中的重要发现,表明患者的心理成分得分和身体成分得分较低,并伴有与药物相关的负面结果。
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引用次数: 0
National Survey and consensus document on dosing strategies for beta-lactam antibiotics against multidrug-resistant gram-negative bacilli (MDR-GNB) in critically ill patients undergoing extracorporeal life support techniques: The DOSEBL study protocol. 关于接受体外生命支持技术治疗的重症患者使用β-内酰胺类抗生素抗耐多药革兰氏阴性杆菌(MDR-GNB)的剂量策略的全国调查和共识文件:DOSEBL 研究方案。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-16 DOI: 10.1016/j.farma.2024.07.010
Alba Pau-Parra, María Núñez-Núñez, Svetlana Sadyrbaeva-Dolgova, Laura Doménech Moral, Eva Campelo Sánchez, Leonor Del Mar Periañez Parraga, Khalid Saeed Khan, Sònia Luque Pardos

Introduction: Infections caused by multidrug-resistant gram-negative bacilli (MDR-GNB) in critically ill patients present a challenge for timely and appropriate antibiotic treatment. This is particularly important in patients undergoing extracorporeal life support techniques such as renal replacement therapy and extracorporeal membrane oxygenation. These techniques can introduce additional pharmacokinetic alterations, potentially leading to suboptimal exposure to antibiotics. This study aims to outline dosing strategies and therapeutic drug monitoring protocols for new β-lactam antibiotics effective against MDR-GNB in critically ill patients undergoing extracorporeal life support techniques at a national level. Additionally, the study seeks to develop a consensus document, based on available evidence.

Methods: The project will comprise two main phases: I) A national survey, and II) the development of a consensus document. This consensus document, undertaken according to ACCORD guidelines, will encompass: a) establishment of a multidisciplinary panel of experts, b) prospective registration of the consensus, c) evidence synthesis, d) modified Delphi rounds. The antimicrobials to be included will be: meropenem, ceftazidime/avibactam, ceftolozane/tazobactam, cefiderocol, meropenem/vaborbactam, imipenem/relebactam, and aztreonam. Extracorporeal life support techniques will include continuous renal replacement therapy, conventional intermittent hemodialysis, and extracorporeal membrane oxygenation.

Discussion: The availability of extracorporeal life support techniques has expanded significantly in recent years, alongside a rise in the prevalence of infections caused by multidrug-resistant gram-negative bacilli (MDR-GNB). There is a need to develop evidence-based tools of high quality to standardize dosing and monitoring strategies for new β-lactam antibiotics.

导言:重症患者中由耐多药革兰氏阴性杆菌(MDR-GNB)引起的感染给及时、适当的抗生素治疗带来了挑战。这对于接受体外生命支持技术(如肾脏替代疗法和体外膜氧合)的患者尤为重要。这些技术会带来额外的药代动力学改变,有可能导致抗生素暴露于次优状态。本研究旨在从国家层面概述对接受体外生命支持技术治疗的重症患者有效的新型β-内酰胺类抗生素的剂量策略和治疗药物监测方案。此外,该研究还试图在现有证据的基础上制定一份共识文件:该项目将包括两个主要阶段:方法:该项目将包括两个主要阶段:I)全国调查;II)制定一份共识文件。该共识文件根据 ACCORD 指南编写,将包括:a) 成立一个多学科专家小组;b) 对共识进行前瞻性登记;c) 证据综合;d) 改良德尔菲轮。将包括的抗菌药物有:美罗培南、头孢唑肟/阿维巴坦、头孢洛氮烷/他唑巴坦、头孢克洛、美罗培南/伐硼巴坦、亚胺培南/雷巴坦和阿兹曲南。体外生命支持技术包括持续肾脏替代疗法、常规间歇性血液透析和体外膜氧合:讨论:近年来,随着耐多药革兰氏阴性杆菌(MDR-GNB)感染率的上升,体外生命支持技术的可用性也显著增加。有必要开发高质量的循证工具,以规范新型β-内酰胺类抗生素的剂量和监测策略。
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引用次数: 0
[Translated article] Therapeutic Drug Monitoring of antibiotic and antifungical drugs in paediatric and newborn patients. Consensus Guidelines of the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Paediatric Infectious Diseases (SEIP) [儿科和新生儿患者抗生素和抗真菌药物的治疗药物监测。西班牙医院药学协会(SEFH)和西班牙儿科传染病协会(SEIP)共识指南
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.02.013
Sonia Luque , Natalia Mendoza-Palomar , David Aguilera-Alonso , Beatriz Garrido , Marta Miarons , Ana Isabel Piqueras , Enrique Tévar , Eneritz Velasco-Arnaiz , Aurora Fernàndez-Polo

Therapeutic monitoring of antibiotics and antifungals based on pharmacokinetic and pharmacodynamic (PK/PD) parameters is a strategy increasingly used for the optimization of therapy to improve efficacy, reduce the occurrence of toxicities, and prevent the selection of antimicrobial resistance, particularly in vulnerable patients including neonates and the critical or immunocompromised paediatric host.

In neonates and children, infections account for a high percentage of hospital admissions, and anti-infectives are the most used drugs. However, paediatric PK/PD studies and the evidence regarding the efficacy and safety of some newly marketed antibiotics and antifungals—usually used off-label in paediatrics—to determine the optimal drug dosage regimens are limited. It is widely known that this population presents important differences in the PK parameters (especially in drug clearance and volume of distribution) in comparison with adults that may alter antimicrobial exposure and, therefore, compromise treatment success. In addition, paediatric patients are more susceptible to potential adverse drug effects and they need closer monitoring.

The aim of this document, developed jointly by the Spanish Society of Hospital Pharmacy and the Spanish Society of Paediatric Infectious Diseases, is to describe the available evidence on the indications for therapeutic drug monitoring (TDM) of antibiotics and antifungals in newborn and paediatric patients, and to provide practical recommendations for TDM in routine clinical practice to optimise their dosing, efficacy and safety. Of antibiotics and antifungals in the paediatric population.

根据药代动力学和药效学(PK/PD)参数对抗生素和抗真菌药物进行治疗监测,是一种越来越多地用于优化治疗的策略,以提高疗效,减少毒性反应的发生,并防止抗菌药物耐药性的产生,尤其是在包括新生儿和危重或免疫力低下的儿科易感患者中。然而,儿科 PK/PD 研究以及一些新上市的抗生素和抗真菌药物(通常在儿科标签外使用)的疗效和安全性方面的证据有限,无法确定最佳的药物剂量方案。众所周知,与成人相比,儿科患者在 PK 参数(尤其是药物清除率和分布容积)方面存在很大差异,这可能会改变抗菌药物的暴露量,从而影响治疗效果。本文件由西班牙医院药剂学会和西班牙儿科传染病学会联合编写,旨在介绍有关新生儿和儿科患者抗生素和抗真菌药物治疗药物监测(TDM)适应症的现有证据,并为常规临床实践中的 TDM 提供实用建议,以优化药物剂量、疗效和安全性。儿科抗生素和抗真菌药物。
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引用次数: 0
Salud digital para promover la adherencia al tratamiento antirretroviral en pacientes con VIH/sida: metarevisión 数字健康促进艾滋病毒/艾滋病患者坚持抗逆转录病毒治疗:元综述。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.02.005

Introduction

Digital health or “e-Health” is a set of applications based on Information and Communication Technologies that can be used to promote self-care and medication adherence in patients with chronic diseases. The aim of this study was to carry out a review of systematic reviews (meta-review) on efficacy studies of e-Health interventions to promote adherence to antiretroviral therapy in people living with HIV/AIDS.

Method

A review of systematic reviews (“meta-review”) was performed using the Medline-PubMed database on efficacy studies of e-Health components to promote adherence to antirretroviral therapy, in patients with HIV/AIDS, proposing a structured search strategy (PICO question). A selection process for systematic reviews was conducted based on inclusion and exclusion criteria. Subsequently, the corresponding data were extracted, and the analysis was accomplished in descriptive tables.

Results

A total of 29 systematic reviews were identified, from which 11 were selected. These reviews comprised 55 randomized controlled therapies with different e-Health interventions and enrolled a total of 15,311 HIV/AIDS patients. Studies included a total of 66 comparisons (experimental group vs. control group) in indirect adherence measurements based on different measurement techniques (36 statistically significant); 21 comparisons of viral load measurements (10 statistically significant); and 8 comparisons of CD4 + cell count measurements (3 statistically significant). m-Health was the most studied component followed by the telephone call and e-Learning.

Conclusions

Evidence was found that supports that some e-Health interventions are effective in promoting adherence to antirretroviral therapy and improving health outcomes in patients with HIV/AIDS, although it is identified that more studies are needed for more robust evidence.

引言数字健康或 "电子健康 "是一套基于信息和通信技术的应用程序,可用于促进慢性病患者的自我保健和坚持用药。本研究的目的是对促进艾滋病毒/艾滋病感染者坚持抗逆转录病毒治疗的电子健康干预措施的疗效研究进行系统综述("元综述"):使用 Medline-PubMed 数据库对促进艾滋病毒/艾滋病患者坚持抗逆转录病毒疗法的电子健康干预措施的疗效研究进行了系统综述("元综述"),并提出了结构化搜索策略(PICO 问题)。根据纳入和排除标准对系统综述进行了筛选。随后,提取了相应的数据,并通过描述性表格进行了分析:结果:共确定了 29 篇系统综述,并从中筛选出 11 篇。这些综述包括 55 项采用不同电子健康干预措施的随机对照疗法,共纳入 15,311 名艾滋病毒/艾滋病患者。研究共包括 66 项基于不同测量技术的间接依从性测量比较(实验组与对照组)(36 项有统计学意义);21 项病毒载量测量比较(10 项有统计学意义);8 项 CD4+ 细胞计数测量比较(3 项有统计学意义):有证据表明,一些电子健康干预措施能有效促进艾滋病毒/艾滋病患者坚持抗逆转录病毒治疗并改善其健康状况,但还需要更多的研究来提供更有力的证据。
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引用次数: 0
Proceso para el acceso y formación del farmacéutico a la residencia en Farmacia Hospitalaria en Argentina 阿根廷医院药房药剂师的准入和培训程序。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.02.001

Hospital Pharmacy worldwide has proven to be a crucial element in healthcare. In Latin America, it draws inspiration from two main models: United States, which promoted clinical pharmacy and later pharmaceutical care, and Spain, which shares similar healthcare practices and the added advantage of a common language. Both models influenced the implementation of Hospital Pharmacy residencies in Argentina since the 1980s.

Hospital Pharmacy residencies in Argentina constitute a paid system of intensive postgraduate training on a full-time basis with exclusive dedication. They are carried out in 11 provinces across Argentina in services with recognized teaching experience. Currently, there are 46 locations with a total of 75 annual vacancies for applicants.

The objective of Hospital Pharmacy residencies is to train pharmaceutical professionals with the necessary competencies to ensure the care of patients through the optimization of the safe, effective, and efficient use of medications and healthcare products tailored to each patient’s individual therapy.

Hospital Pharmacy residencies have demonstrated that pharmacists acquire specialized training that can be decisive in influencing healthcare policies related to the safe use of medications and healthcare products. Therefore, actions to promote and encourage interest in this field among pharmaceutical professionals are necessary, involving scientific societies, universities, pharmaceutical associations, and the political sphere.

事实证明,世界各地的医院药房都是医疗保健的重要组成部分。在拉丁美洲,医院药房从两种主要模式中汲取灵感:美国推广临床药学,后来又推广药品护理,西班牙则拥有类似的医疗保健实践和共同语言的额外优势。自 20 世纪 80 年代以来,这两种模式都对阿根廷医院药学实习生的实施产生了影响。阿根廷的医院药学实习是一种带薪的全日制研究生强化培训制度,由专人负责。培训在阿根廷全国 11 个省的具有公认教学经验的服务机构中进行。目前,共有 46 个实习点,每年共有 75 个职位空缺。医院药剂实习的目的是培养具备必要能力的药剂专业人员,通过优化安全、有效和高效地使用药物和保健产品,确保对患者的护理符合每位患者的个体治疗需求。医院药学实习证明,药剂师所接受的专业培训可以对与安全使用药物和保健产品相关的医疗保健政策产生决定性影响。因此,有必要在科学协会、大学、医药协会和政治领域采取行动,促进和鼓励医药专业人员对这一领域的兴趣。
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引用次数: 0
El rol de la inteligencia artificial en la publicación científica: perspectivas desde la farmacia hospitalaria 人工智能在科学出版中的作用:来自医院药房的观点。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.06.002

The article examines the impact of artificial intelligence on scientific writing, with a particular focus on its application in hospital pharmacy. It analyzes artificial intelligence tools that enhance information retrieval, literature analysis, writing quality, and manuscript drafting.

Chatbots like Consensus, along with platforms such as Scite and SciSpace, enable precise searches in scientific databases, providing evidence-based responses and references. SciSpace facilitates the generation of comparative tables and the formulation of queries regarding studies, while ResearchRabbit maps the scientific literature to identify trends. Tools like DeepL and ProWritingAid improve writing quality by correcting grammatical, stylistic, and plagiarism errors. A.R.I.A. enhances reference management, and Jenny AI assists in overcoming writer's block. Python libraries such as LangChain enable advanced semantic searches and the creation of agents.

Despite their benefits, artificial intelligence raises ethical concerns including biases, misinformation, and plagiarism. The importance of responsible use and critical review by experts is emphasized. In hospital pharmacy, artificial intelligence can enhance efficiency and precision in research and scientific communication. Pharmacists can use these tools to stay updated, enhance the quality of their publications, optimize information management, and facilitate clinical decision-making.

In conclusion, artificial intelligence is a powerful tool for hospital pharmacy, provided it is used responsibly and ethically.

文章探讨了人工智能对科学写作的影响,尤其关注其在医院药学中的应用。文章分析了能提高信息检索、文献分析、写作质量和稿件起草的人工智能工具。Consensus等聊天机器人以及Scite和SciSpace等平台可以在科学数据库中进行精确搜索,提供基于证据的回复和参考文献。SciSpace 可帮助生成比较表并提出有关研究的询问,而 ResearchRabbit 则可绘制科学文献地图以确定趋势。DeepL 和 ProWritingAid 等工具可以纠正语法、文体和抄袭错误,从而提高写作质量。A.R.I.A.可加强参考文献管理,而 Jenny AI 则可帮助克服写作障碍。LangChain等Python库可以进行高级语义搜索并创建代理。尽管人工智能好处多多,但它也会引发道德问题,包括偏见、错误信息和剽窃。专家们强调了负责任地使用和严格审查的重要性。在医院药房,人工智能可以提高研究和科学交流的效率和精确度。药剂师可以利用这些工具随时更新信息,提高出版物的质量,优化信息管理,促进临床决策。总之,人工智能是医院药学的强大工具,但前提是必须以负责任和合乎道德的方式使用。
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引用次数: 0
Concordance between two models of stratification for patients living with HIV infection to providing pharmaceutical care 为艾滋病毒感染者提供药物治疗的两种分层模式之间的一致性。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.01.009

Objective

To determine the degree of agreement of 2 differents stratification models for pharmaceutical care to people living with HIV.

Methods

This was a single-center observational prospective cohort study of patients with regular follow-up in pharmaceutical care consultations according to the Capacity–Motivation–Opportunity methodology, conducted between January 1 and March 31, 2023.

Patients received the pharmacotherapeutic interventions applied routinely to ambulatory care patients according to this model. As part of the usual clinical practice, the presence or absence of the variables that apply to both stratification models were collected.

The scores obtained and the corresponding stratification level were collected for each patient according to both stratification models published (ST-2017 and ST-2022).

To analyze the reliability between the measurements of 2 numerical score models of the stratification level with both tools, their degree of concordance was calculated using the intraclass correlation coefficient. Likewise, reliability was also evaluated from a qualitative perspective by means of Cohen's Kappa coefficient.

Additionally, the existence of correlation between the scores of the 2 models was assessed by calculating Pearson's correlation coefficient.

Results

Of the total of 758 patients being followed in the cohort, finally, 233 patients were enrolled. The distribution of patients for each stratification model was: ST-2017: 59.7% level-3, 25.3% level-2, and 15.0% level-1, while for ST-2022: 60.9% level-3, 26.6% level-2, and 12.4% level-1.

It was observed that the reclassification was symmetrical (P = .317). The qualitative analysis of the agreement between the models showed a good Cohen's kappa value, (K = 0.66). A value of 0.563 was found as the intraclass correlation coefficient.

Finally, the correlation analysis between the quantitative scores of the 2 models yielded a Pearson correlation coefficient of 0.86.

Conclusions

The concordance between the 2 models was good, which confirms that the multidimensional adaptation and simplification of the model were correct and that its use can be extended in routine clinical practice.

目的确定两种不同的艾滋病病毒感染者药物治疗分层模型的一致程度:这是一项单中心观察性前瞻性队列研究,研究对象是根据 "能力-动机-机会 "方法定期接受药物治疗咨询的患者,研究时间为 2023 年 1 月 1 日至 3 月 31 日。根据这一模式,患者接受了对门诊病人常规应用的药物治疗干预。作为常规临床实践的一部分,我们收集了两种分层模型所适用的变量是否存在。根据已发布的两种分层模型(ST-2017 和 ST-2022),收集每位患者获得的分数和相应的分层级别。为了分析使用两种工具测量分层水平的两个数字评分模型之间的可靠性,使用类内相关系数计算了它们的一致程度。同样,还通过科恩卡帕系数(Cohen's Kappa coefficient)从定性角度对可靠性进行了评估。此外,还通过计算皮尔逊相关系数来评估两种模型得分之间是否存在相关性:共有 758 名患者接受了队列随访,最终有 233 名患者入选。每个分层模型的患者分布情况如下ST-2017:59.7%为3级,25.3%为2级,15.0%为1级;ST-2022:60.9%为3级,26.6%为2级,12.4%为1级。据观察,重新分类是对称的(P=.317)。对模型间一致性的定性分析显示,科恩卡帕值良好(K=0.66)。类内相关系数为 0.563。最后,对 2 个模型的定量评分进行相关分析,得出的皮尔逊相关系数为 0.86:两个模型之间的一致性很好,这证实了模型的多维调整和简化是正确的,可以在常规临床实践中推广使用。
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引用次数: 0
Documento nacional de consenso de monitorización terapéutica de antibióticos y antifúngicos en el paciente pediátrico y neonatal de la Sociedad Española de Farmacia Hospitalaria (SEFH) y la Sociedad Española de Infectología Pediátrica (SEIP) 西班牙医院药剂学协会 (SEFH) 和西班牙儿科传染病协会 (SEIP) 关于儿科和新生儿患者抗生素和抗真菌药物治疗监控的国家共识文件。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.02.012
Sonia Luque , Natalia Mendoza-Palomar , David Aguilera-Alonso , Beatriz Garrido , Marta Miarons , Ana Isabel Piqueras , Enrique Tévar , Eneritz Velasco-Arnaiz , Aurora Fernàndez-Polo

Therapeutic monitoring of antibiotics and antifungals based on pharmacokinetic and pharmacodynamic parameters, is a strategy increasingly used for the optimization of therapy to improve efficacy, reduce the occurrence of toxicities, and prevent the selection of antimicrobial resistance, particularly in vulnerable patients including neonates and the critical or immunocompromised host.

In neonates and children, infections account for a high percentage of hospital admissions and anti-infectives are the most used drugs. However, pediatric pharmacokinetic and pharmacodynamic studies and the evidence regarding the efficacy and safety of some newly marketed antibiotics and antifungals -usually used off-label in pediatrics- to determine the optimal drug dosage regimens are limited. It is widely known that this population presents important differences in the pharmacokinetic parameters (especially in drug clearance and volume of distribution) in comparison with adults that may alter antimicrobial exposure and, therefore, compromise treatment success. In addition, pediatric patients are more susceptible to potential adverse drug effects and they need closer monitoring.

The aim of this document, developed jointly between the Spanish Society of Hospital Pharmacy (SEFH) and the Spanish Society of Pediatric Infectious Diseases (SEIP), is to describe the available evidence on the indications for therapeutic drug monitoring of antibiotics and antifungals in newborn and pediatric patients and to provide practical recommendations for therapeutic drug monitoring in routine clinical practice to optimize pharmacokinetic and pharmacodynamic parameters, efficacy and safety of antibiotics and antifungals in the pediatric population.

根据药代动力学和药效学参数对抗生素和抗真菌药物进行治疗监测,是一种越来越多地用于优化治疗的策略,以提高疗效,减少毒性反应的发生,并防止抗菌药物耐药性的产生,尤其是在包括新生儿和危重或免疫功能低下的宿主在内的易感患者中。在新生儿和儿童中,感染占住院人数的很高比例,而抗感染药物是最常用的药物。然而,儿科药代动力学和药效学研究以及一些新上市的抗生素和抗真菌药物(通常在儿科非标示使用)的疗效和安全性方面的证据有限,无法确定最佳的药物剂量方案。众所周知,与成人相比,儿科患者的药代动力学参数(尤其是药物清除率和分布容积)存在很大差异,这可能会改变抗菌药物的暴露量,从而影响治疗效果。此外,儿科患者更容易受到药物潜在不良反应的影响,因此需要对他们进行更严密的监测。本文件由西班牙医院药学协会(SEFH)和西班牙儿科感染性疾病协会(SEIP)共同编写,旨在描述新生儿和儿科患者抗生素和抗真菌药物治疗药物监测适应症的现有证据,并为常规临床实践中的治疗药物监测提供实用建议,以优化儿科抗生素和抗真菌药物的药代动力学和药效学参数、疗效和安全性。
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引用次数: 0
[Artículo traducido] Asciminib para el tratamiento de la leucemia mieloide crónica en tercera línea: análisis coste-efectividad basado en el enfoque de remisión libre de tratamiento 阿西米尼用于慢性髓性白血病的三线治疗:基于无治疗缓解方法的成本效益分析。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-01 DOI: 10.1016/j.farma.2024.06.004
Antonio García Molina

Introduction

The first targeted therapy in oncology, imatinib, revolutionized chronic myeloid leukemia (CML) treatment and spurred research in targeted therapies for various cancers. CML results from a chromosomal translocation, forming the BCR-ABL1 fusion gene. Asciminib has been recently approved for 3rd-line refractory or intolerant patients. Treatment-free remission (TFR) is attainable with sustained deep molecular response (DMR) and this approach could be incorporated into pharmacoeconomic models.

Aims

To establish a cost-effectiveness model comparing asciminib to approved third-generation tyrosine kinase inhibitors (TKIs) (bosutinib and ponatinib) with a focus on achieving TFR. Additionally, the budgetary impact of incorporating asciminib as a therapeutic alternative is assessed.

Methods

This model is based on a Markov chain with seven states. The condition for achieving TFR is to remain for 5 years in DMR state. Efficacy of the model was measured in QALYs, and the costs included in the base case analysis are based in Spain. A probabilistic (PSA) and deterministic analysis (DSA) were carried out to assess the variability of the model. There were achieved two independent models comparing asciminib vs. bosutinib and asciminib vs. ponatinib.

Results

Asciminib, when compared with ponatinib, is a cost-saving alternative, as efficacy is similar between alternatives, and asciminib has a lower cost of 30,275 €. Asciminib showed 4.33 more QALYs and a higher cost (203,591 €) than bosutinib, resulting in an ICER of €47,010.49 per QALY. PSA shows that the parameters with higher influence in the variability of the model were the probability of transitioning to BP and probabilities of achieving MMR and DMR. A one-way analysis reports that the drug cost has a higher influence on both models, and the discount rate significantly affects the asciminib vs. bosutinib model.

Conclusion

Asciminib broadens therapeutic choices for patient’s refractory or intolerant to two prior lines of treatment in a cost-effective manner. The costs of drugs significantly impact the overall cost of the disease, emphasizing the importance of the selected discount rates for each drug. Given the relatively low incidence of CML, the introduction of asciminib has a limited budgetary impact, warranting individualized decisions based on patient`s clinical characteristics.

简介肿瘤学领域的首个靶向疗法--伊马替尼彻底改变了慢性髓性白血病(CML)的治疗,并推动了各种癌症靶向疗法的研究。慢性髓性白血病是由染色体易位导致的BCR-ABL1融合基因。阿昔米尼最近被批准用于三线难治或不耐受患者的治疗。目的:建立一个成本效益模型,将阿西米尼与已获批的第三代酪氨酸激酶抑制剂(TKIs)(博苏替尼和泊纳替尼)进行比较,重点关注实现无治疗缓解(TFR)。此外,还评估了将 asciminib 作为替代治疗药物的预算影响:该模型基于马尔可夫链,共有七个状态。实现 TFR 的条件是在 DMR 状态下保持 5 年。该模型的疗效以 QALY 衡量,基础病例分析中的成本以西班牙为基础。为评估模型的可变性,进行了概率分析(PSA)和确定性分析(DSA)。在两个独立模型中,阿西米尼与博苏替尼、阿西米尼与波那替尼进行了比较:结果:与波那替尼相比,阿西米尼是一种节约成本的替代疗法,因为两种替代疗法的疗效相似,而阿西米尼的成本更低,仅为30,275欧元。与博舒替尼相比,阿西米尼的QALYs增加了4.33,而成本(203,591欧元)却更高,因此每QALY的ICER为47,010.49欧元。PSA 显示,对模型变异性影响较大的参数是转为 BP 的概率以及达到 MMR 和 DMR 的概率。单向分析表明,药物成本对两个模型的影响都较大,而贴现率对阿西米尼与博舒替尼模型的影响较大:阿西米尼为难治性或不耐受两线治疗的患者提供了更多的治疗选择,且具有成本效益。药物成本对疾病的总体成本有重大影响,这就强调了为每种药物选择贴现率的重要性。鉴于 CML 的发病率相对较低,引入 asciminib 对预算的影响有限,因此需要根据患者的临床特征做出个性化决定。
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引用次数: 0
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FARMACIA HOSPITALARIA
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