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[Translated article] National registry and analysis of pharmaceutical interventions in critical care units: PHARMACRITIC study. [译文]重症监护室药物干预的国家登记和分析:PHARMACRITIC 研究。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-15 DOI: 10.1016/j.farma.2024.10.003
María Martín Cerezuela, Fernando Becerril Moreno, Miguel Ángel Amor García, Carla Bastida Fernández, Irene Aquerreta González, Sara Cobo Sacristán, Amaia Egüés Lugea, Marta Albanell Fernández, Laura Doménech Moral, Aurora Fernández Polo, Tatiana Betancor García, Sara Ortiz Pérez, Esther Domingo Chiva

Objective: To design a homogeneous methodology for the registration and analysis of pharmaceutical interventions performed in spanish intensive adults care units (ICUs).

Method: Observational, prospective, and multicentre study. In the first stage, a national registry of pharmaceutical interventions will be agreed upon and subsequently, all the pharmaceutical interventions performed on adult patients admitted to Spanish ICUs during 8 weeks will be recorded. Variables related to the type of ICU, the drug involved in the intervention, type of intervention (indication, effectiveness, safety), recommendation made by the pharmacist, and the degree of acceptance will be evaluated. Risk and incidence will be calculated for each of the medication errors detected. The χ2-squared test or Fisher exact test will be used for categorical variables and Mann-Whitney U or Kruskal-Wallis test for continuous variables. All tests will be performed with a significance level α=0.05 and confidence intervals with confidence 1-α.

Discussion: The results obtained from this project will make it possible to obtain a homogeneous classification of the pharmaceutical interventions performed in ICUs, a national registry record, and an evaluation of the weak points with the aim of developing strategies for improvement in the pharmaceutical care of the critically ill patient.

目的设计一种统一的方法,用于登记和分析西班牙重症成人护理病房(ICU)中实施的药物干预措施:观察性、前瞻性和多中心研究。方法:观察性、前瞻性和多中心研究。在第一阶段,将商定一个全国药物干预登记册,随后将记录 8 周内对西班牙重症监护病房收治的成人患者实施的所有药物干预。将对重症监护病房的类型、干预所涉及的药物、干预类型(适应症、有效性、安全性)、药剂师的建议以及接受程度等相关变量进行评估。将计算所发现的每种用药错误的风险和发生率。分类变量将采用 χ2 平方检验或费雪精确检验,连续变量将采用 Mann-Whitney U 或 Kruskal-Wallis 检验。所有检验的显著性水平均为α=0.05,置信区间为 1-α:该项目的研究结果将有助于对重症监护病房的药物干预措施进行统一分类,建立全国登记记录,并对薄弱环节进行评估,从而制定改善重症患者药物治疗的策略。
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引用次数: 0
Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic non- small cell lung cancer: Protocol for a hospital pharmacy-based real-world study. 局部晚期或转移性非小细胞肺癌患者坚持口服化疗的情况:基于医院药房的真实世界研究方案。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-07 DOI: 10.1016/j.farma.2024.10.004
Irene Mangues-Bafalluy, Beatriz Bernárdez, José Manuel Martínez-Sesmero, Andres Navarro-Ruiz, Ana Rosa Rubio-Salvador, Maria Teresa Martín-Conde

Objective: This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain.

Methods: This multicenter, observational, prospective study will be conducted by six hospital pharmacists from six Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including four study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence greater than80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis.

Conclusions: We expect that our study will provide initial information on key aspects of adherence to OCT (measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.

目的:本文介绍了一项评估西班牙局部晚期或转移性非小细胞肺癌(NSCLC)患者坚持口服化疗(OCT)情况的研究方案:本文介绍了一项评估西班牙局部晚期或转移性非小细胞肺癌(NSCLC)患者口服化疗(OCT)依从性的研究方案:这项多中心、观察性、前瞻性研究将由来自西班牙六家医院的六位医院药剂师进行。研究对象包括年龄在 18 岁或以上、确诊为局部晚期或转移性 NSCLC、正在接受治疗或已被处方 OCT 的男性和女性患者。一旦纳入,我们将对患者进行为期 3 个月的积极和前瞻性随访,包括 4 次研究访问,以记录社会人口学变量、抗肿瘤治疗和依从性、药物护理、临床变量和患者报告结果 (PRO) (3 级版 EQ-5D、EORTC 核心生活质量问卷、简短疾病感知问卷、药物治疗满意度问卷和 PRO 版不良事件通用术语标准)等信息。在患者入组 12 个月后,我们将记录患者的疾病进展状况和处方配药信息。主要结果是治疗依从性的百分比,将根据药片计数计算如下:将已配药片数减去未使用药片数的差值除以治疗天数,再乘以肿瘤专家开出的药片/天数;将此商乘以 100,得出依从性的百分比。根据药片数量核对结果,坚持治疗的百分比大于 80% 的患者将主要归类为坚持治疗者。其次,还将根据覆盖天数比例和 4 项 Morisky Green Levine 用药依从性量表计算治疗依从性。为了分析患者和治疗特征对依从性的影响,将使用不同的依从性临界点进行双变量分析。为了评估无进展生存期对治疗效果的影响,我们将使用 Kaplan-Meier 方法,并将其与对数秩检验和单变量 Cox 回归分析进行比较:我们希望我们的研究能提供有关 OCT 依从性的关键方面(测量、促进因素和障碍)及其与 NSCLC 患者和临床相关结果之间关系的初步信息,这些信息将有助于设计药物干预措施以提高依从性。
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引用次数: 0
Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in the therapy of hemophilia A in clinical practice. 在临床实践中,在药代动力学指导下将标准半衰期因子 VIII 转换为延长半衰期的聚乙二醇化因子 VIII 治疗甲型血友病。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-05 DOI: 10.1016/j.farma.2024.10.005
Maria Choví-Trull, Juan Eduardo Megías-Vericat, Santiago Bonanad Boix, Saturnino Haya Guaita, Ana Rosa Cid Haro, Marta Aguilar Rodriguez, Jose Luis Poveda Andrés

Objective: To analyze the differences in pharmacokinetic and clinical parameters (bleeding rates and joint health) before and after switching from standard half-life factor VIII (FVIII) to extended half-life pegylated FVIII in patients with severe/moderate hemophilia A on prophylaxis, one year before and after the switch in real-life.

Method: This is a single-center, comparative, observational, sequential, retrospective, and multidisciplinary study. Population pharmacokinetic models from the WAPPS-Hemo® application were used to calculate pharmacokinetic parameters and individualize prophylaxis. The annual rate of total and joint bleeds, joint health (Hemophilia Joint Health Score), plasma half-life and area under the curve ratios, FVIII consumption, administration frequency, and cost were analyzed.

Results: Thirty-eight adult patients with hemophilia A who switched from standard half-life FVIII to extended half-life pegylated FVIII were analyzed. Significant improvements (p < 0.05) were observed in all pharmacokinetic parameters, with plasma half-life and area under the curve improvement ratios of 1.5 and 1.9, respectively, as well as reductions in annual total and joint bleeding rates were registered. A higher number of patients with zero total (16.0 vs. 29.0) and joint bleeds (23.0 vs. 33.0) was also observed. The median reductions in administration frequency and dose/kg/week were 30.0% and 19.7%, respectively, avoiding 44.3 infusions/patient/year, resulting in savings of 20,843 €/patient/year. Furthermore, joint health improved (23.0 vs. 21.0; p = 0.017), and target joints resolved after the switch.

Conclusions: The pharmacokinetically guided switch from standard half-life FVIII to pegylated FVIII demonstrated significant clinical benefits with reduced bleeding rates and improvements in joint health. Additionally, improvements in pharmacokinetic parameters were observed, allowing for reduced treatment burden by decreasing administration frequency, as well as lower consumption and costs.

目的分析正在接受预防治疗的重度/中度甲型血友病患者从标准半衰期因子 VIII (FVIII) 转换为延长半衰期聚乙二醇 FVIII 前后一年的药代动力学和临床参数(出血率和关节健康状况)的差异:这是一项单中心、比较性、观察性、顺序性、回顾性和多学科研究。使用 WAPPS-Hemo® 应用程序中的群体药代动力学模型计算药代动力学参数,并制定个体化预防方案。研究分析了总出血和关节出血的年发生率、关节健康状况(血友病关节健康评分)、血浆半衰期和曲线下面积比、FVIII 消耗量、给药频率和成本:对 38 名从标准半衰期 FVIII 转为延长半衰期聚乙二醇化 FVIII 的成年 A 型血友病患者进行了分析。结果:分析了从标准半衰期 FVIII 转用长半衰期聚乙二醇 FVIII 的 30 名成年 A 型血友病患者的情况:在药代动力学指导下,从标准半衰期 FVIII 转换为聚乙二醇化 FVIII 的临床疗效显著,出血率降低,关节健康得到改善。此外,还观察到药代动力学参数的改善,通过减少给药频率减轻了治疗负担,降低了消耗和成本。
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引用次数: 0
Prospective observational follow-up study of psychoactive drugs treatment initiated in the intensive care unit. 对在重症监护室开始的精神药物治疗进行前瞻性观察随访研究。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-05 DOI: 10.1016/j.farma.2024.09.007
Laura Doménech-Moral, Javier Santader-Reboreda, Meri Martin-Cerezuela, Amaia Egüés Lugea, Marcos Buj Vicente, Sofía Contreras Medina

Objective: The treatment and prevention of delirium in the intensive care unit (ICU) have gained significant importance in patient care in recent years. Some studies have linked delirium with increased risks of mortality, prolonged hospital stay, and more days of mechanical ventilation. This study aims to analyze the use of psychotropic drugs initiated in the ICU and their continuation upon hospital discharge, as well as to evaluate their contribution to polypharmacy and associated adverse clinical effects.

Method: A multicenter prospective observational case study was designed, focusing on patients over 18 years old admitted to the ICU and treated with psychotropic drugs. Data on demographics, variables related to admission and psychotropic drug treatment, as well as clinical outcomes and adverse effects, will be collected. Among other variables, the frequency of psychotropic treatments initiated in the ICU and continued upon discharge from the ICU and the hospital will be measured. Data collection will be performed through review of electronic medical records and prescription programs, and IBM SPSS 20.0 statistical package will be used for analysis.

Discussion: Delirium is common in ICU patients and is associated with long-term negative consequences. Although antipsychotics are used to treat delirium, their prolonged use can have adverse effects, and their continuation after ICU discharge contributes to polypharmacy. This study aims to provide information on the use of psychotropic drugs initiated in the ICU and their continuation upon discharge, with the goal of identifying opportunities for intervention and reducing unnecessary use of these medications.

目的:近年来,重症监护室(ICU)中谵妄的治疗和预防在患者护理中变得越来越重要。一些研究表明,谵妄与死亡率增加、住院时间延长和机械通气天数增加有关。本研究旨在分析在重症监护室开始使用的精神药物及其出院后的继续使用情况,并评估这些药物对多重用药的影响以及相关的不良临床效应:方法:设计了一项多中心前瞻性病例观察研究,重点关注入住重症监护室并接受精神药物治疗的 18 岁以上患者。将收集有关人口统计学、入院和精神药物治疗相关变量以及临床结果和不良反应的数据。除其他变量外,还将测量在重症监护室开始并在出院后继续接受精神药物治疗的频率。数据收集将通过查阅电子病历和处方程序进行,并将使用 IBM SPSS 20.0 统计软件包进行分析:讨论:谵妄在重症监护室患者中很常见,并会带来长期的负面影响。虽然抗精神病药物可用于治疗谵妄,但长期使用会产生不良影响,而且在 ICU 出院后继续使用会导致多重用药。本研究旨在提供有关在重症监护室开始使用精神药物以及出院后继续使用这些药物的信息,目的是找出干预机会并减少这些药物的不必要使用。
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引用次数: 0
Protocol for the adaptation and consensus of the Community Pharmacy Survey on Patient Safety Culture to hospital pharmacy in Spain. 西班牙医院药房患者安全文化社区药房调查的调整和共识协议。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-05 DOI: 10.1016/j.farma.2024.10.002
Juan Manuel Rodríguez-Camacho, José Manuel Caro-Teller, Sergio Plata-Paniagua, Juan Alfredo Montero-Delgado, Inés Jiménez-Lozano, Carmen María Cuadros-Martínez

Introduction: The Community Pharmacy Survey on Patient Safety Culture (CPSOPSC) is a tool created by the Agency for Healthcare Research and Quality and used in the United States to assess the patient safety culture among community pharmacy workers. This survey has been adapted for use in hospital pharmacies in other countries. However, it has not yet been implemented in Spanish hospital pharmacies due to the lack of an applicable version in Spain. This project aims to adapt and reach a consensus on the CPSOPSC for its subsequent use as a tool to improve patient safety in hospital pharmacies in Spain.

Methods: This non-clinical study will be developed in different phases: obtaining the necessary permissions, reviewing the literature to identify studies on the use of the CPSOPSC in hospital pharmacies, adapting the survey's questions to the sociocultural context, reaching a consensus on the questions using the Delphi-Rand/UCLA methodology with a panel of patient safety experts. These experts, who are hospital pharmacists, will evaluate the adapted survey in several rounds, using a Likert scale and telematic workshops to adjust the questions. Finally, a software application will be developed for the implementation, completion, and data management of the survey.

Discussion: Adapting the CPSOPSC to hospital pharmacies in Spain may be a useful tool for measuring the patient safety culture in this context. Through the Delphi-Rand/UCLA methodology, expert consensus and the relevance of the survey are ensured. Additionally, the creation of a computer application will facilitate data collection and analysis, promoting its use among professionals. The resulting survey from this project can identify specific needs and areas for improvement in Spanish hospital pharmacies, being useful for future actions aimed at improving patient safety.

简介:社区药房患者安全文化调查(CPSOPSC)是由美国医疗保健研究与质量机构(Agency for Healthcare Research and Quality)开发的一种工具,用于评估社区药房工作人员的患者安全文化。这项调查已被其他国家的医院药房采用。然而,由于西班牙缺乏适用的版本,该调查尚未在西班牙医院药房实施。本项目旨在对 CPSOPSC 进行改编并达成共识,以便随后将其用作改善西班牙医院药房患者安全的工具:这项非临床研究将分不同阶段进行:获得必要的许可,查阅文献以确定有关在医院药房使用 CPSOPSC 的研究,根据社会文化背景调整调查问题,使用德尔菲-兰德/UCLA 方法与患者安全专家小组就问题达成共识。这些专家都是医院药剂师,他们将使用李克特量表和远程研讨会对经过调整的调查表进行多轮评估,以调整问题。最后,还将开发一款应用软件,用于调查的实施、完成和数据管理:讨论:将 CPSOPSC 改用于西班牙的医院药房,可能是在这种情况下衡量患者安全文化的有用工具。通过德尔菲-兰德/加州大学洛杉矶分校的方法,确保了专家共识和调查的相关性。此外,计算机应用程序的创建将为数据收集和分析提供便利,促进专业人员的使用。该项目的调查结果显示,西班牙医院药房的具体需求和需要改进的地方,有助于今后采取旨在改善患者安全的行动。
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引用次数: 0
Exploring the impact of pharmacogenetics on personalized medicine: A systematic review 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.2023.12.004
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”, “individualizing 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 2 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-TNFα 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。检索策略包括 "药物遗传学"、"个性化治疗"、"精准医学"、"剂量调整"、"个体化给药"、"临床常规 "和 "临床实践 "等术语。2013年至2023年期间以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药物、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存在统计学意义上的显著关联: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
Implantación de un sistema de trazabilidad y elaboración segura de medicamentos en la sala blanca 在无尘室中实施可追溯系统和安全生产药物。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.03.005
Marta Echávarri de Miguel, Belén Riva de la Hoz, Margarita Cuervas-Mons Vendrell, Beatriz Leal Pino, Luis Fernandez Romero

Objective

To describe the process of implementing a traceability and safe drug manufacturing system in the clean room of a Pharmacy Service to increase patient safety, in accordance with current legislation.

Methods

The process was carried out between September 2021 and July 2022. The software program integrated all the recommended stages of the manufacturing process outlined in the “Good Practices Guide for Medication Preparation in Pharmacy Services” (GBPP). The following sections were parameterized in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardized work procedures, and quality controls.

Results

A total of 50 users, 4 elaboration areas and 113 equipments were included. 435 components were parameterized (195 raw materials and 240 pharmaceutical specialties), 54 packaging materials, 376 standardized work procedures (123 of them corresponding to sterile medicines and 253 to non-sterile medicines, of which 52 non-sterile were dangerous), in addition 17 were high risk, 327 medium risk, 32 low risk, and 13 quality controls.

Conclusions

The computerization of the production process has allowed the implementation of a traceability and secure drug manufacturing system in a controlled environment in accordance with current legislation.
目的描述在药房无尘室实施可追溯性和安全药物生产系统的过程,以根据现行法律提高患者安全:方法:该过程在 2021 年 9 月至 2022 年 7 月期间进行。该软件程序集成了《药房服务药物制剂良好操作指南》(GBPP)中列出的生产流程的所有推荐阶段。软件程序对以下部分进行了参数化:人员、设施、设备、起始材料、包装材料、标准化工作程序和质量控制:结果:共包括 50 个用户、4 个加工区和 113 台设备。参数化了 435 种成分(195 种原材料和 240 种药品专用品)、54 种包装材料、376 个标准化工作程序(其中 123 个与无菌药品相对应,253 个与非无菌药品相对应,其中 52 个非无菌药品具有危险性),此外还有 17 个高风险、327 个中风险、32 个低风险和 13 个质量控制:生产流程的计算机化使药品生产系统在受控环境中的可追溯性和安全性得以实现,符合现行法律规定。
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引用次数: 0
[Translated article] Therapeutic management, adherence, and clinical outcomes of heart failure in Andalucía. ANDALIC Protocol [安达卢西亚心力衰竭的治疗管理、依从性和临床结果。安达卢西亚协议》。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.05.011
Héctor Rodríguez-Ramallo , Nerea Báez-Gutiérrez , Didiana Jaramillo-Ruiz , Gabriel Sanfélix-Gimeno , Román Villegas-Portero , José Luis Jiménez-Murillo , Carlos Hernández-Quiles , Bernardo Santos-Ramos
Heart failure is a prevalent syndrome with high mortality rates, representing a significant economic burden in terms of healthcare. The lack of systematic information about the treatment and adherence of patients with heart failure limits the understanding of these aspects and potentially the improvement of clinical outcomes.

Objective

To describe the clinical characteristics, therapeutic management, adherence, persistence, and clinical results, as well as the association between these variables, in a cohort of patients with heart failure in Andalusia.

Design

This study will be an observational, population-based, retrospective cohort study. Data of patients discharged from an Andalusian hospital with a diagnosis of heart failure between 2014 and 2023 will be extracted from the Andalusian population health database.

Analysis

The statistical analysis will incorporate the following strategies: (1) Descriptive analysis of the characteristics of the population cohort, adherence measures, and clinical outcomes. (2) Bivariate analyses to study the association of covariates with adherence, persistence, and clinical results. (3) Multivariate logistic regression and Cox regression analysis including relevant covariates. (4) To evaluate changes over time, multivariate Poisson regression models will be used.
By conducting this comprehensive study, we aim to gain valuable insights into the clinical characteristics, treatment management, and adherence of heart failure patients in Andalusia, as well as to identify factors that may influence clinical outcomes. These findings could be critical both for the development of optimised strategies that improve medical care and quality of life of patients and for mitigating the health burden of HF in the region.
心力衰竭是一种死亡率很高的常见综合征,在医疗保健方面造成了巨大的经济负担。由于缺乏有关心力衰竭患者的治疗和依从性的系统信息,限制了对这些方面的了解,从而无法改善临床结果:描述安达卢西亚地区一组心力衰竭患者的临床特征、治疗管理、依从性、持续性和临床结果,以及这些变量之间的关联:本研究将是一项基于人群的回顾性队列观察研究。将从安达卢西亚人口健康数据库中提取 2014 年至 2023 年期间从安达卢西亚一家医院出院并诊断为心力衰竭的患者数据:统计分析将采用以下策略:(1)对人群特征、依从性测量和临床结果进行描述性分析。(2) 二变量分析,研究协变量与依从性、持续性和临床结果的关系。(3) 包括相关协变量在内的多变量逻辑回归和 Cox 回归分析。(4) 为了评估随时间的变化,将使用多变量泊松回归模型。通过开展这项综合研究,我们旨在深入了解安达卢西亚地区心力衰竭患者的临床特征、治疗管理和依从性,并找出可能影响临床结果的因素。这些发现对于制定优化策略,改善医疗护理和患者生活质量,以及减轻该地区心力衰竭的健康负担都至关重要。
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引用次数: 0
[Artículo traducido] Efectividad y seguridad del tratamiento neoadyuvante del cáncer de mama triple negativo en la vida real 真实世界人群中三阴性乳腺癌新辅助治疗的有效性和安全性。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.06.007
Cristina Galindo García , Rocío Díaz Acedo , Silvia Artacho Criado , María Rodríguez de la Borbolla Artacho

Objective

Triple-negative breast cancer is a subtype of aggressive breast cancer. Our aim is to evaluate the effectiveness and safety of neoadjuvant treatment in early-stage triple-negative breast cancer and to identify predictors of pathological complete response.

Methods

This is a single-center, retrospective study involving 79 patients with triple-negative breast cancer who initiated neoadjuvant treatment between January 2017 and October 2022. Descriptive analyses were performed as appropriate. Statistical analysis utilized bivariate logistic regression to explore the presence of factors related to pathological complete response, and the Kaplan–Meier method was employed for survival analysis.

Results

In the overall population, 27 patients (n = 78; 34.6%) achieved pathological complete response in the breast and axillary lymph nodes, and 31 (n = 73; 42.5%) achieved a grade 5 pathological complete response in the breast, according to the Miller and Payne classification. The addition of platinum to standard therapy improved both breast and axillary lymph node pathological complete response rates. Age less than 40 years was identified as a predictor of pathological complete response in our study population through bivariate analysis, while Ki67 levels lower than 70% were associated with a lower pathological complete response rate. Adverse events were reported in 72 patients (91.1%), with grade 3–5 adverse events observed in 33 (41.8%). There was a particularly notable increase in gastrointestinal and hematological adverse events when platinum was added.

Conclusions

In this population, we observed moderate rates of pathological complete response with acceptable chemotherapy tolerance. Platinum-based chemotherapy appears to enhance the likelihood of achieving pathological complete response, albeit with a less favorable safety profile. Therefore, evaluating the benefit–risk balance is crucial when selecting the optimal chemotherapy regimen for individual patients.
目的:三阴性乳腺癌是侵袭性乳腺癌的一种亚型:三阴性乳腺癌是侵袭性乳腺癌的一种亚型。我们的目的是评估早期三阴性乳腺癌新辅助治疗的有效性和安全性,并确定病理完全反应的预测因素:这是一项单中心回顾性研究,涉及79名在2017年1月至2022年10月期间开始新辅助治疗的三阴性乳腺癌患者。酌情进行了描述性分析。统计分析采用双变量逻辑回归来探讨是否存在与病理完全反应相关的因素,并采用Kaplan-Meier法进行生存分析:根据米勒和佩恩的分类,在所有患者中,有27名患者(n = 78;34.6%)获得了乳腺和腋窝淋巴结病理完全反应,31名患者(n = 73;42.5%)获得了乳腺5级病理完全反应。在标准治疗的基础上加用铂类药物可提高乳腺和腋窝淋巴结的病理完全反应率。通过双变量分析,我们发现年龄小于40岁是病理完全反应的预测因素,而Ki67水平低于70%与较低的病理完全反应率有关。72名患者(91.1%)出现了不良反应,其中33名患者(41.8%)出现了3-5级不良反应。加入铂后,胃肠道和血液不良事件增加尤为明显:结论:在这一人群中,我们观察到中等程度的病理完全反应率和可接受的化疗耐受性。以铂为基础的化疗似乎提高了获得病理完全反应的可能性,但安全性较差。因此,在为患者选择最佳化疗方案时,评估收益与风险的平衡至关重要。
{"title":"[Artículo traducido] Efectividad y seguridad del tratamiento neoadyuvante del cáncer de mama triple negativo en la vida real","authors":"Cristina Galindo García ,&nbsp;Rocío Díaz Acedo ,&nbsp;Silvia Artacho Criado ,&nbsp;María Rodríguez de la Borbolla Artacho","doi":"10.1016/j.farma.2024.06.007","DOIUrl":"10.1016/j.farma.2024.06.007","url":null,"abstract":"<div><h3>Objective</h3><div>Triple-negative breast cancer is a subtype of aggressive breast cancer. Our aim is to evaluate the effectiveness and safety of neoadjuvant treatment in early-stage triple-negative breast cancer and to identify predictors of pathological complete response.</div></div><div><h3>Methods</h3><div>This is a single-center, retrospective study involving 79 patients with triple-negative breast cancer who initiated neoadjuvant treatment between January 2017 and October 2022. Descriptive analyses were performed as appropriate. Statistical analysis utilized bivariate logistic regression to explore the presence of factors related to pathological complete response, and the Kaplan–Meier method was employed for survival analysis.</div></div><div><h3>Results</h3><div>In the overall population, 27 patients (<em>n</em> = 78; 34.6%) achieved pathological complete response in the breast and axillary lymph nodes, and 31 (<em>n</em> = 73; 42.5%) achieved a grade 5 pathological complete response in the breast, according to the Miller and Payne classification. The addition of platinum to standard therapy improved both breast and axillary lymph node pathological complete response rates. Age less than 40 years was identified as a predictor of pathological complete response in our study population through bivariate analysis, while Ki67 levels lower than 70% were associated with a lower pathological complete response rate. Adverse events were reported in 72 patients (91.1%), with grade 3–5 adverse events observed in 33 (41.8%). There was a particularly notable increase in gastrointestinal and hematological adverse events when platinum was added.</div></div><div><h3>Conclusions</h3><div>In this population, we observed moderate rates of pathological complete response with acceptable chemotherapy tolerance. Platinum-based chemotherapy appears to enhance the likelihood of achieving pathological complete response, albeit with a less favorable safety profile. Therefore, evaluating the benefit–risk balance is crucial when selecting the optimal chemotherapy regimen for individual patients.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"48 6","pages":"Pages T278-T285"},"PeriodicalIF":1.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617383","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
[Artículo traducido] Calidad de vida percibida por pacientes con enfermedades inflamatorias inmunomediadas tratados con terapias biológicas. Estudio SACVINFA 接受生物疗法治疗的免疫介导炎症性疾病患者的生活质量感知。SACVINFA 研究。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.07.005
Esther Chamorro-de-Vega , Alberto Calvo , María Fernández-Pacheco , Belén Hernández-Muniesa , Rosa Romero-Jiménez , Araceli Casado-Gómez , Esther Ramírez , Grupo de Trabajo Estudio SACVINFA

Objectives

To evaluate health-related quality of life perceived by patients with the most prevalent immune-mediated inflammatory diseases in Spain: inflammatory bowel disease (IBD), psoriasis (Ps), psoriatic arthritis (AP), rheumatoid arthritis (RA), and spondyloarthropathies (SpAs), and to determine the factors that influence patient quality of life.

Methods

The SACVINFA study (SA = satisfaction, CV = quality of life, IN = immune-mediated, FA = pharmacy) consisted of an observational study conducted in 4 hospitals in the Community of Madrid. A cross-sectional analysis was made of adult patients diagnosed with an immune-mediated inflammatory disease who attended the Pharmacy Service. Quality of life was assessed using the EQ-5D-5L questionnaire (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and specific questionnaires: SIBDQ-9, DLQI, PsAQoL, QoL-RA and ASQoL.

Results

A total of 578 patients were analyzed (inflammatory bowel disease = 25.3%; psoriasis = 19.7%; spondyloarthropathies = 18.7%; rheumatoid arthritis = 18.5%; psoriatic arthritis = 17.8%). The mean age (SD) was 49.8 (12.3) years and 50.7% were male. The average score (SD) for the global EQ-5D- 5 L was 0.771 (0.2) and the mean (SD) visual analogue scale score was 71.5 (20.0). Type of immune-mediated inflammatory diseases was associated with differences in quality of life showing psoriasis and inflammatory bowel disease higher values of EQ-5D-5L than psoriatic arthritis, rheumatoid arthritis and spondyloarthropathies, p < 0,05 in all comparisons. Patients with RA, IBD, and Ps achieved 70% of the maximum score, while patients with PsA and SpAs did not reach 50% of the maximum possible score.
Female gender, a state of moderate/severe disease severity, an older age and a higher number of previous treatments were correlated with worse quality of life. Conversely, persistence to current treatment correlated with better quality of life.

Conclusions

Patients with immune-mediated inflammatory diseases have markedly affected quality of life, mainly in the pain/discomfort dimension, especially in those immune-mediated inflammatory diseases with a rheumatological component.
目的评估西班牙最常见的免疫介导炎症性疾病(炎症性肠病(IBD)、银屑病(Ps)、银屑病关节炎(AP)、类风湿性关节炎(RA)和脊柱关节病(SpAs))患者的健康相关生活质量,并确定影响患者生活质量的因素:SACVINFA研究(SA=满意度,CV=生活质量,IN=免疫介导,FA=药学)是一项观察性研究,在马德里社区的4家医院进行。该研究对被诊断患有免疫介导的炎症性疾病并在药房就诊的成年患者进行了横断面分析。生活质量通过 EQ-5D-5L 问卷(行动能力、自理能力、日常活动、疼痛/不适和焦虑/抑郁)和特定问卷进行评估:SIBDQ-9、DLQI、PsAQoL、QoL-RA 和 ASQoL:共分析了 578 名患者(炎症性肠病 = 25.3%;银屑病 = 19.7%;脊柱关节病 = 18.7%;类风湿性关节炎 = 18.5%;银屑病关节炎 = 17.8%)。平均年龄(标清)为 49.8(12.3)岁,50.7% 为男性。总体 EQ-5D- 5 L 平均得分(标清)为 0.771(0.2),视觉模拟量表平均得分(标清)为 71.5(20.0)。免疫介导的炎症性疾病的类型与生活质量的差异有关,显示银屑病和炎症性肠病的 EQ-5D-5L 值高于银屑病关节炎、类风湿性关节炎和脊柱关节病,P 结论:免疫介导的炎症性疾病患者的生活质量明显受到影响,主要体现在疼痛/不适方面,尤其是那些含有风湿成分的免疫介导的炎症性疾病。
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引用次数: 0
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FARMACIA HOSPITALARIA
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