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[Artículo traducido] Predicción de reacciones adversas a medicamentos en pacientes geriátricos ingresados en unidades de cuidados intensivos 预测入住重症监护室的老年病人的药物不良反应。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.05.014
Fabiana Angelo Marques Carizio , Isabella do Vale de Souza , Thalita Zago Oliveira , Luana Sueli Silva , Natalia Chaguri Alves Rodrigues , Maria Olívia Barbosa Zanetti , Fabiana Rossi Varallo , Leonardo Régis Leira-Pereira

Introduction

Intensive Care Units (ICUs) pose challenges in managing critically-ill patients with polypharmacy, potentially leading to Adverse Drug Reactions (ADRs), particularly in the elderly.

Objective

To evaluate whether the severity and clinical prognosis scores used in ICUs correlate with the prediction of ADRs in aged patients admitted to an ICU.

Methods

A cohort study was conducted in a Brazilian University Hospital ICU. APACHE II and SAPS 3 assessed clinical prognosis, while GerontoNet ADR Risk Score and BADRI evaluated ADR risk at ICU admission. Severity of the patients' clinical conditions was evaluated daily based on the SOFA score. Adverse Drug Reaction (ADR) screening was performed daily through the identification of ADR triggers.

Results

1295 triggers were identified (median 30 per patient, IQR = 28), with 15 suspected ADRs. No correlation was observed between patient severity and ADRs at admission (p = 0.26), during hospitalization (p = 0.91), or at follow-up (p = 0.77). There was also no association between death and ADRs (p = 0.28) or worse prognosis and ADRs (p > 0.05). Higher BADRI scores correlated with more ADRs (p = 0.001).

Conclusions

The data suggest that employing the severity and clinical prognosis scores used in Intensive Care Units is not sufficient to direct active pharmacovigilance efforts, which are therefore indicated for critically ill patients.
导言:重症监护病房(ICU)在管理使用多种药物的重症患者方面面临挑战:重症监护病房(ICU)在管理使用多种药物的危重病人时面临挑战,这可能导致药物不良反应(ADR),尤其是在老年人中:评估重症监护室使用的严重程度和临床预后评分是否与重症监护室收治的老年患者的药物不良反应预测相关:方法: 在巴西一所大学医院的重症监护室进行了一项队列研究。APACHE II和SAPS 3评估了临床预后,而GerontoNet ADR风险评分和BADRI评估了入住重症监护室时的ADR风险。每天根据 SOFA 评分评估患者临床状况的严重程度。每天通过识别药物不良反应(ADR)触发因素进行药物不良反应筛查:结果:共识别出 1295 个诱发因素(中位数为每位患者 30 个,IQR = 28),其中有 15 个疑似 ADR。入院时(P=0.26)、住院期间(P=0.91)或随访时(P=0.77),患者病情严重程度与 ADR 之间均未发现相关性。死亡与 ADRs(P=0.28)或预后恶化与 ADRs(P>0.05)之间也没有关联。BADRI评分越高,ADR越多(p=0.001):这些数据表明,采用重症监护病房使用的严重程度和临床预后评分不足以指导积极的药物警戒工作,因此重症患者需要积极的药物警戒。
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引用次数: 0
Un cuarto de siglo del grupo VIH-SEFH: transformando la atención, afrontando retos y reafirmando el compromiso VIH-SEFH 集团走过了四分之一个世纪:转变护理方式,迎接挑战,重申承诺。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.09.010
Ramón Morillo Verdugo , Pilar Taberner Bonastre
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引用次数: 0
[Artículo traducido] Exploración del impacto de la farmacogenética en la medicina personalizada: una revisión sistemática 探索药物基因学对个性化医疗的影响:系统综述。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.03.010
Laura Amaro-Álvarez, Jaime Cordero-Ramos, Miguel Ángel Calleja-Hernández

Introduction

Pharmacogenetics evaluates how genetic variations influence drug responses. Nowadays, genetic tests have advanced, becoming more affordable, and its integration is supported by stronger clinical evidence. Guidelines such as those from CPIC (Clinical Pharmacogenetics Implementation Consortium) and resources like PharmGKB facilitate genotype-based prescribing; and organizations like the FDA promote genetic testing before initiating certain medications. Preventive pharmacogenetic panels seem promising, but further research on biomarkers and diverse populations is needed. The aim of this review is to analyze recent evidence on the genotype-drug response relationship to examine how the genetic profile of patients influences the clinical response to treatments, and analyze the areas of research that need further study to advance towards a genetic-based precision medicine.

Materials and methods

A systematic search was conducted on PubMed to identify articles investigating the genotype-drug response relationship. The search strategy included terms such as “pharmacogenetics”, “personalized treatment”, “precision medicine”, “dose adjustment”, “individualized dosing”, “clinical routine” and “clinical practice.” Clinical trials, observational studies, and meta-analyses published in English or Spanish between 2013 and 2023 were included. The initial search resulted in a total of 136 articles for analysis.

Results

49 articles were included for the final analysis following review by two investigators. A relationship between genetic polymorphisms and drug response or toxicity was found for drugs such as opioids, GLP-1 agonists, tacrolimus, oral anticoagulants, antineoplastics, atypical antipsychotics, efavirenz, clopidogrel, lamotrigine, anti-TNF-α agents, voriconazole, antidepressants, or statins. However, for drugs like metformin, quetiapine, irinotecan, bisoprolol, and anti-VEGF agents, no statistically significant association between genotype and response was found.

Conclusion

The studies analyzed in this review suggest a strong correlation between genetic variability and individual drug responses, supporting the use of pharmacogenetics for treatment optimization. However, for certain drugs like metformin or quetiapine, the influence of genotype on their response remains unclear. More studies with larger sample sizes, greater ethnic diversity, and consideration of non-genetic factors are needed. The lack of standardization in analysis methods and accessibility to genetic testing are significant challenges in this field. As a conclusion, pharmacogenetics shows immense potential in personalized medicine, but further research is required.
介绍:药物遗传学评估基因变异如何影响药物反应。如今,基因检测技术不断进步,价格越来越低廉,其整合也得到了更多临床证据的支持。CPIC(临床药物遗传学实施联盟)等指南和 PharmGKB 等资源促进了基于基因型的处方;FDA 等组织提倡在开始使用某些药物前进行基因检测。预防性药物基因面板似乎很有前景,但还需要对生物标志物和不同人群进行进一步研究。本综述旨在分析基因型与药物反应关系的最新证据,研究患者的基因特征如何影响对治疗的临床反应,并分析需要进一步研究的领域,以推进基于基因的精准医疗:在 PubMed 上进行了系统搜索,以确定研究基因型与药物反应关系的文章。搜索策略包括 "药物遗传学"、"个性化治疗"、"精准医学"、"剂量调整"、"个体化用药"、"临床常规 "和 "临床实践 "等术语。2013年至2023年期间用英语或西班牙语发表的临床试验、观察性研究和荟萃分析均被纳入其中。初步检索结果显示,共有 136 篇文章可供分析:结果:经两名研究人员审查后,49 篇文章被纳入最终分析。在阿片类药物、GLP-1 促效剂、他克莫司、口服抗凝药、抗肿瘤药、非典型抗精神病药、依非韦伦、氯吡格雷、拉莫三嗪、抗肿瘤坏死因子-α制剂、伏立康唑、抗抑郁药或他汀类药物中,发现了基因多态性与药物反应或毒性之间的关系。然而,对于二甲双胍、喹硫平、伊立替康、比索洛尔和抗血管内皮生长因子药物等药物,未发现基因型与反应之间有统计学意义的关联:本综述分析的研究表明,基因变异与个体药物反应之间存在密切联系,支持利用药物遗传学优化治疗。然而,对于某些药物,如二甲双胍或喹硫平,基因型对其反应的影响仍不明确。需要进行更多样本量更大、种族更多样化以及考虑非遗传因素的研究。分析方法缺乏标准化以及基因检测的可及性是该领域面临的重大挑战。总之,药物基因学在个性化医疗方面显示出巨大的潜力,但还需要进一步的研究。
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引用次数: 0
Prediction of adverse drug reactions in geriatric patients admitted to intensive care units 预测入住重症监护室的老年病人的药物不良反应。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.03.004
Fabiana Angelo Marques Carizio , Isabella do Vale de Souza , Thalita Zago Oliveira , Luana Sueli Silva , Natalia Chaguri Alves Rodrigues , Maria Olívia Barbosa Zanetti , Fabiana Rossi Varallo , Leonardo Régis Leira-Pereira

Introduction

Intensive care units (ICUs) pose challenges in managing critically ill patients with polypharmacy, potentially leading to adverse drug reactions (ADRs), particularly in the elderly.

Objective

To evaluate whether the severity and clinical prognosis scores used in ICUs correlate with the prediction of ADRs in aged patients admitted to an ICU.

Methods

A cohort study was conducted in a Brazilian University Hospital ICU. APACHE II and SAPS 3 assessed clinical prognosis, while GerontoNet ADR Risk Score and BADRI evaluated ADR risk at ICU admission. Severity of the patients' clinical conditions was evaluated daily based on the SOFA score. ADR screening was performed daily through the identification of ADR triggers.

Results

1295 triggers were identified (median 30 per patient, IQR = 28), with 15 suspected ADRs. No correlation was observed between patient severity and ADRs at admission (p = 0.26), during hospitalization (p = 0.91), or at follow-up (p = 0.77). There was also no association between death and ADRs (p = 0.28) or worse prognosis and ADRs (p > 0.05). Higher BADRI scores correlated with more ADRs (p = 0.001).

Conclusions

These data suggest that employing the severity and clinical prognosis scores used in ICUs is not sufficient to direct active pharmacovigilance efforts, which are therefore indicated for critically ill patients.
导言:重症监护病房(ICU)在管理使用多种药物的重症患者时面临挑战,这可能导致药物不良反应(ADR),尤其是在老年人中:评估重症监护室使用的严重程度和临床预后评分是否与重症监护室收治的老年患者的药物不良反应预测相关:方法: 在巴西一所大学医院的重症监护室进行了一项队列研究。APACHE II和SAPS 3评估了临床预后,而GerontoNet ADR风险评分和BADRI评估了入住重症监护室时的ADR风险。每天根据 SOFA 评分评估患者临床状况的严重程度。每天通过识别 ADR 触发因素进行 ADR 筛查:结果:共识别出 1295 个诱发因素(中位数为每位患者 30 个,IQR=28),其中有 15 个疑似 ADR。在入院时(P=0.26)、住院期间(P=0.91)或随访时(P=0.77),均未观察到患者严重程度与 ADR 之间的相关性。死亡与 ADRs(P=0.28)或预后恶化与 ADRs(P>0.05)之间也没有关联。BADRI评分越高,ADR越多(p=0.001):这些数据表明,采用重症监护室中使用的严重程度和临床预后评分不足以指导积极的药物警戒工作,因此,重症患者应进行药物警戒。
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引用次数: 0
Características, beneficio clínico y financiación de las nuevas autorizaciones de fármacos oncohematológicos en España entre 2017 y 2020 2017 年至 2020 年西班牙血液病药物新授权的特点、临床疗效和报销情况。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.04.022
Hilario Martínez-Barros , Álvaro Pousada-Fonseca , Jorge Pedreira-Bouzas , Ana Clopés-Estela

Objective

To describe the authorisations and funding resolutions for new onco-hematological drugs in Spain between 2017 and 2020, as well as the results of their main trials.

Methods

Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-hematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report (EPAR). Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement.

Results

Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumors (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% (IQI 40.0-66.3). In those authorised on the basis of surrogate time-to-event endpoints, the median Hazard Ratio was 0.54 (IQI 0.38-0.57), and among those using overall survival was 0.71 (IQI 0.59-0.77). Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months (IQI 3.6-16.7). One third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months (IQI 11.4-29.3).

Conclusions

Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.
目的描述 2017 年至 2020 年间西班牙肿瘤血液学新药的授权和资助决议,以及主要试验结果:观察性、横断面、描述性研究,2022 年 10 月至 12 月间进行。根据EFPIA患者W.A.I.T指标2021年调查,2017年至2020年期间欧洲药品管理局批准的肿瘤血液学药物被纳入研究范围。授权信息来自欧洲公共评估报告(EPAR)的主要研究。收集的数据包括药品、授权和主要研究、显示的益处、成本、报销状态和时间:结果:确定了 49 种适应症的 41 种新药。一半以上(58.5%)为靶向疗法,61.2%用于治疗实体瘤(61.2%)。大多数药物具有姑息治疗目的(71.4%),适用于复发或难治性疾病(55.1%)。在临床试验中,57.1%为III期试验,63.3%为随机试验。16.3%的临床试验的主要终点是总生存期,在随机临床试验中,这一比例上升到25.8%。根据应答率计算的授权药物的应答率中位数为 56.4%(IQI 40.0-66.3)。在根据替代时间终点获得授权的药物中,危险比中位数为0.54(IQI为0.38-0.57),在使用总生存期的药物中,危险比中位数为0.71(IQI为0.59-0.77)。在全球范围内,22.4%的患者在总生存期方面获益,中位获益时间为4个月(IQI为3.6-16.7)。根据欧洲肿瘤内科学会临床获益程度量表(European Society for Medical Oncology Magnitude of Clinical Benefit Scale),三分之一(33.3%)的可评估适应症显示出实质性临床获益。75.5%的适应症获得了资助,其中一半(48.6%;占总数的36.7%)受到了限制。获得资助的中位时间为 19.5 个月(IQI 11.4-29.3):结论:西班牙批准的大多数肿瘤血液学新药的主要临床试验都采用了替代性主要终点,在批准时,很少有临床试验显示能延长总生存期。超过三分之一的临床试验未进行对照。
{"title":"Características, beneficio clínico y financiación de las nuevas autorizaciones de fármacos oncohematológicos en España entre 2017 y 2020","authors":"Hilario Martínez-Barros ,&nbsp;Álvaro Pousada-Fonseca ,&nbsp;Jorge Pedreira-Bouzas ,&nbsp;Ana Clopés-Estela","doi":"10.1016/j.farma.2024.04.022","DOIUrl":"10.1016/j.farma.2024.04.022","url":null,"abstract":"<div><h3>Objective</h3><div>To describe the authorisations and funding resolutions for new onco-hematological drugs in Spain between 2017 and 2020, as well as the results of their main trials.</div></div><div><h3>Methods</h3><div>Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-hematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report (EPAR). Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement.</div></div><div><h3>Results</h3><div>Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumors (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% (IQI 40.0-66.3). In those authorised on the basis of surrogate time-to-event endpoints, the median Hazard Ratio was 0.54 (IQI 0.38-0.57), and among those using overall survival was 0.71 (IQI 0.59-0.77). Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months (IQI 3.6-16.7). One third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months (IQI 11.4-29.3).</div></div><div><h3>Conclusions</h3><div>Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"48 6","pages":"Pages 272-277"},"PeriodicalIF":1.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141155439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Toxicity of the FOLFOX-6 regimen, with or without 5-fluorouracil bolus, in metastatic colorectal cancer. 在转移性结直肠癌中使用或不使用 5-氟尿嘧啶栓剂的 FOLFOX-6 方案的毒性。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-30 DOI: 10.1016/j.farma.2024.09.008
María Teresa Garrido Martínez, María Rodríguez Jorge, Ignacio García Giménez, María Isabel Guzmán Ramos, Salvador Grutzmancher Sáiz, Victoria Aviñó Tarazona

Objective: Standard treatment of metastatic colorectal cancer includes oxaliplatin and 5-fluorouracil in continuous infusion. Although FOLFOX-6 is the reference combination, it is aggressive and has high toxicity. Variants such as the TTD regimen, which does not include folinic acid or 5-fluorouracil bolus, are used. This study evaluates the toxicity of FOLFOX-6 and TTD in first line treatment for metastatic colorectal cancer and its effectiveness.

Method: Retrospective observational study with patients who started treatment with FOLFOX-6 and TTD, for three years. Demographic and clinical data were collected (age, sex, chronic pathologies, molecular profile, laterality, ECOG classification and stage), as well as treatment variables (previous adjuvant chemotherapy, intentionality, number of cycles, duration and pharmacogenetic aspects) and toxicity. Objective response rate and progression-free survival were calculated.

Results: The study included 71 patients, 35 treated with FOLFOX-6 and 36 with TTD. Both groups showed similar overall toxicity profiles. FOLFOX-6 had a higher incidence of neutropenia (46% vs. 8%; p < 0.01) and mucositis (51% vs. 22%; p < 0.013). In addition, there were more treatment delays (40% vs. 11%; p < 0.05) and 5-fluorouracil dose reductions (22% vs. 14%; p < 0.05) in the FOLFOX-6 group. Deaths due to toxicity were only recorded in the FOLFOX-6 group. Effectiveness was similar in both groups.

Conclusions: The TTD regimen could be a beneficial first-line option for metastatic colorectal cancer, with lower toxicity and effectiveness comparable to FOLFOX-6. It is a safe alternative for elderly or frail patients, suitable for reduced-dose 5-fluorouracil regimen with oxaliplatin.

目的:转移性结直肠癌的标准治疗方法包括持续输注奥沙利铂和 5-氟尿嘧啶。虽然 FOLFOX-6 是参考组合,但它具有侵袭性和高毒性。目前使用的变异方案包括 TTD 方案,该方案不包括亚叶酸或 5-氟尿嘧啶栓剂。本研究评估了 FOLFOX-6 和 TTD 在转移性结直肠癌一线治疗中的毒性及其有效性:方法:对开始接受 FOLFOX-6 和 TTD 治疗的患者进行为期三年的回顾性观察研究。研究收集了人口统计学和临床数据(年龄、性别、慢性病变、分子特征、侧位、ECOG分类和分期),以及治疗变量(既往辅助化疗、意向性、周期数、持续时间和药物遗传学方面)和毒性。计算了客观反应率和无进展生存期:研究共纳入71名患者,其中35人接受FOLFOX-6治疗,36人接受TTD治疗。两组患者的总体毒性情况相似。FOLFOX-6 中性粒细胞减少症的发生率更高(46% 对 8%;P 结论:TTD 方案可用于治疗中性粒细胞减少症:TTD方案可作为转移性结直肠癌的一线治疗方案,毒性较低,疗效与FOLFOX-6相当。对于老年或体弱患者来说,这是一种安全的替代方案,适合使用奥沙利铂的减量 5-氟尿嘧啶方案。
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引用次数: 0
Activities of the clinical pharmacist in the intensive care units. 重症监护室临床药剂师的活动。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-21 DOI: 10.1016/j.farma.2024.09.004
Fernando Becerril-Moreno, Marta Valera-Rubio, Irene Aquerreta-González, Esther Domingo-Chiva, Laura Doménech-Moral, María Martín-Cerezuela, Edurne Fernández de Gamarra-Martínez, Sara Cobo-Sacristán

The main objective of the activity carried out in an intensive care unit and in general in all hospitalization units, is to provide all the human and material resources to offer the best therapeutic care to admitted patients. Work in multidisciplinary teams, made up of specialists in Intensive Care Medicine as those responsible for the patients, doctors from other specialties, specialized nursing, physiotherapists, nutritionists and clinical pharmacists is an optimal approach to achieve the proposed objective. The activities of the clinical pharmacist can be developed at different levels (basic, intermediate and excellent) depending on the degree of involvement, the time dedicated, the training and the available resources. This article aims to establish an initial work guide, through recommendations aimed at the activity to be developed by the clinical pharmacist in the ICU in relation to critical patient care and quality improvement, which serves as a reference for those pharmacists who go to develop pharmaceutical care activities in critical patients.

在重症监护室和所有住院部开展活动的主要目的是提供所有人力和物力资源,为住院病人提供最佳治疗护理。由负责病人的重症监护医学专家、其他专业的医生、专业护理人员、理疗师、营养师和临床药剂师组成的多学科团队是实现拟议目标的最佳方法。临床药剂师的活动可以根据参与程度、投入时间、培训和可用资源的不同而分为不同级别(基础、中级和高级)。本文旨在通过针对重症监护室临床药师在危重病人护理和质量改进方面应开展的活动提出建议,建立一个初步的工作指南,为那些在危重病人中开展药物护理活动的药师提供参考。
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引用次数: 0
Drug dosing in obese critically ill patients, a literature review. 肥胖重症患者的药物剂量,文献综述。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-16 DOI: 10.1016/j.farma.2024.09.001
Hector Carlos García-Díaz, Pablo Sánchez-Sancho, Pilar Lalueza-Broto, Xavier Nuvials, María Queralt Gorgas-Torner, Laura Doménech-Moral

Introduction: The prevalence of obesity represents a significant global public health challenge, and the available evidence concerning the appropriate dosing of pharmaceutical in patients with obesity is limited. It is uncommon for clinical trials in critically ill patients to include obese individuals, which results in a lack of specific dosing information in product data sheets. The objective of this literature review is to provide clinicians with efficacious and secure guidelines for this cohort of patients.

Methods: A multidisciplinary team comprising pharmacists specialized in hospital pharmacy and physicians with expertise in intensive care medicine was established. The therapeutic groups and, in particular, the most commonly used active ingredients within the Intensive Care Unit were identified and subjected to detailed analysis. The following terms were included in the search: "obese", "overweight", "critical illness", "drug dosification", and "therapeutic dose monitoring". All the information was then evaluated by the working group, which reached a consensus on the dosing recommendations for each drug in obese critically ill patients.

Results: A total of 83 drugs belonging to the following therapeutic groups were identified: antivirals, antibacterials, antifungals, immunosuppressants, antiepileptics, vasopressors, anticoagulants, neuromuscular blocking agents and sedatives. A table was produced containing the consensus dosing recommendations for each of the aforementioned drugs following a review of the available evidence.

Conclusions: Drug dosing in obese patients, both in critical and noncritical settings, remains an area with significant uncertainty. This review provides comprehensive and up-to-date information on the dosing of the main therapeutic groups in obese critically ill patients, offering a valuable resource physicians in critical care units and clinical pharmacists in their practice in this setting.

简介肥胖症的流行是一项重大的全球公共卫生挑战,而有关肥胖症患者适当用药剂量的现有证据却很有限。在重症患者的临床试验中,肥胖患者并不常见,这导致产品数据表中缺乏具体的剂量信息。本文献综述旨在为临床医生提供针对这类患者的有效、安全的指导原则:方法:成立了一个由医院药学专业药剂师和重症监护医学专业医生组成的多学科团队。确定了治疗组,特别是重症监护病房最常用的活性成分,并对其进行了详细分析。搜索包括以下术语:"肥胖"、"超重"、"危重病"、"药物剂量 "和 "治疗剂量监测"。然后,工作组对所有信息进行了评估,并就肥胖危重病人使用每种药物的剂量建议达成了共识:结果:共确定了属于以下治疗组的 83 种药物:抗病毒药、抗菌药、抗真菌药、免疫抑制剂、抗癫痫药、血管加压药、抗凝血剂、神经肌肉阻断剂和镇静剂。在对现有证据进行审查后,编制了一份表格,其中包含对上述每种药物的一致剂量建议:在危重和非危重情况下,肥胖患者的用药剂量仍然存在很大的不确定性。本综述提供了肥胖重症患者主要治疗组用药剂量的全面和最新信息,为重症监护病房的医生和临床药剂师在该领域的实践提供了宝贵资源。
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引用次数: 0
Should the funding of laxatives be reconsidered? Problems in the complex chronic and palliative pediatric patient. 是否应重新考虑对泻药的资助?复杂慢性病和姑息治疗儿科病人的问题。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-10 DOI: 10.1016/j.farma.2024.07.012
Lucía Hernández Peláez, José Vicente Serna Berná, María de Castro Julve, Alba Pérez Contel
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引用次数: 0
High-risk pediatric medications: A listing proposal by interdisciplinary consensus technique. 高风险儿科药物:通过跨学科共识技术提出的列表建议。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-08 DOI: 10.1016/j.farma.2024.09.002
Yolanda Hernández Gago, Pedro J Alcalá Minagorre, Belén Rodríguez Marrodán, Laura Hernández Sabater, María José Cabañas Poy, Cristina Martínez Roca, Jimena Pérez Moreno

Introduction: Pediatric patients are more likely to experience medication-related errors and serious associated harms. The identification of high-risk medications (HRM) and their study in special populations, such as children with excess body weight, is a part of safety improvement strategies.

Objective: To generate, through a consensus technique structured by an interdisciplinary group of pediatricians and hospital pharmacists, an operational and updated list of HRM for hospital use in children over 2 years of age. The document was part of a collaboration project between the Spanish Society of Hospital Pharmacists and the Spanish Society of Pediatric Hospital Medicine.

Methods: The study was carried out in two sequential phases: a) preparation of a preliminary list of HRM through bibliographic review and b) subsequent application of the double-round Delphi method to agree on a definitive list of HRM. The results obtained were validated by calculating the probability of chance agreement and the modified Kappa statistic for each drug.

Results: The original list obtained by bibliographic review included 26 pharmacological classes and 96 drugs. Of the total of 37 experts, 32 (86.4%) completed both rounds of the Delphi. The final consensus list of HRM incorporated 24 pharmacological classes and 100 drugs. The modified Kappa statistic reflected a high percent agreement (94.9%) in the consensus reached by the participants.

Conclusion: This list can establish a tool for future studies and interventions to improve the safety of medications in general pediatric population, as well as in high-risk subgroups, such as pediatric patients with excess body weight.

导言:儿科患者更容易出现用药错误和严重的相关伤害。识别高风险药物(HRM)并对其在特殊人群(如体重超标儿童)中的应用进行研究,是安全改进战略的一部分:目的:由儿科医生和医院药剂师组成的跨学科小组通过共识技术,制定出一份可操作的最新高危药品清单,供医院用于 2 岁以上儿童。该文件是西班牙医院药剂师协会和西班牙儿科医院医学协会合作项目的一部分:研究分两个阶段依次进行:a) 通过书目审查编制一份初步的 HRM 清单;b) 随后采用双轮德尔菲法商定一份确定的 HRM 清单。通过计算每种药物的偶然一致概率和修正的 Kappa 统计量,对所获得的结果进行了验证:结果:通过文献综述获得的原始清单包括 26 个药理类别和 96 种药物。在总共 37 位专家中,32 位(86.4%)完成了两轮德尔菲法。人力资源管理局的最终共识清单包括 24 个药理类别和 100 种药物。修改后的卡帕统计反映出参与者达成的共识具有很高的一致性(94.9%):该清单可为今后的研究和干预提供工具,以改善普通儿科人群以及高风险亚群(如体重超标的儿科患者)的用药安全。
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FARMACIA HOSPITALARIA
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