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Perceived quality of life by patients with immune-mediated inflammatory diseases treated with biological therapies. SACVINFA study 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.2024.04.006
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:, Alberto Morell , Nuria Herrero , Bárbara Úbeda , Arantza Ais-Larisgoitia , Elena Lobato-Matilla , Álvaro Muñoz , Miguel Ángel Casado , Vicente Escudero-Vilaplana

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 for 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 analysed (inflammatory bowel disease = 25.3%; psoriasis = 19.7%; spondyloarthropathies = 18.7%; rheumatoid arthritis = 18.5%; psoriatic arthritis = 17.8%). The mean age (standard deviation) was 49.8 (12.3) years and 50.7% were male. The average score (standard deviation) for the global EQ-5D-5L was 0.771 (0.2) and the mean (standard deviation) 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 EQ5D-5L than psoriatic arthritis, rheumatoid arthritis, and spondyloarthropathies, p <.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=药物治疗)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/不适以及焦虑/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(标准差)为 49.8(12.3)岁,50.7% 为男性。总体 EQ-5D-5L 平均得分(标准差)为 0.771(0.2),视觉模拟量表平均得分(标准差)为 71.5(20.0)。免疫介导炎症疾病的类型与生活质量的差异有关,银屑病和炎症性肠病的 EQ5D-5L 值高于银屑病关节炎、类风湿性关节炎和脊柱关节病:免疫介导的炎症性疾病患者的生活质量明显受到影响,主要表现在疼痛/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患者。
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引用次数: 0
Effectiveness and safety of neoadjuvant therapy in triple-negative breast cancer in a real-world population 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.2024.03.014
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。
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引用次数: 0
[Translated article] Treatment of juvenile recurrent respiratory papillomatosis in a pediatric lung transplant recipient [译文]治疗一名小儿肺移植受者的幼年复发性呼吸道乳头状瘤病。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.04.013
Laura Gómez-Ganda , Ignacio Iglesias-Serrano , Carlos Javier Parramón-Teixidó , Laura Batlle-Masó , José Antonio Peña-Zarza , Ana Díez-Izquierdo
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引用次数: 0
[Translated article] Intrathecal injection of fluorescein for localisation of cerebrospinal fluid fistula [译文]鞘内注射荧光素定位脑脊液瘘。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.05.006
Isabel Carreño Dato , Carmen Matoses Chirivella , Lara Peral Ballester , Daniel García Sánchez , Sergio Maciá Soriano , Andrés Navarro Ruiz
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引用次数: 0
Tratamiento de la papilomatosis recurrente respiratoria juvenil en un paciente pediátrico receptor de trasplante pulmonar 治疗一名肺移植受体儿科患者的幼年复发性呼吸道乳头状瘤病。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.02.008
Laura Gómez-Ganda , Ignacio Iglesias-Serrano , Carlos Javier Parramón-Teixidó , Laura Batlle-Masó , José Antonio Peña-Zarza , Ana Díez-Izquierdo
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引用次数: 0
Administración intratecal de fluoresceína para la localización de las fístulas de líquido cefalorraquídeo 用于脑脊液瘘定位的鞘内荧光素注射。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.03.003
Isabel Carreño Dato , Carmen Matoses Chirivella , Lara Peral Ballester , Daniel García Sánchez , Sergio Maciá Soriano , Andrés Navarro Ruiz
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引用次数: 0
[Translated article] Implementation of a traceability and safe drug preparation system in a clean room [译文]在无尘室中实施可追溯和安全的药物制备系统。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-01 DOI: 10.1016/j.farma.2024.05.003
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 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 parameterised in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardised 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 standardised 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, and 32 low risk, and 13 quality controls.

Conclusions

The computerization of the production process has allowed the implementation of a traceability and secure 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。该软件程序整合了《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 个中风险和 32 个低风险以及 13 个质量控制:生产过程的计算机化使我们能够在受控环境中根据现行法律实施可追溯和安全的生产系统。
{"title":"[Translated article] Implementation of a traceability and safe drug preparation system in a clean room","authors":"Marta Echávarri de Miguel,&nbsp;Belén Riva de la Hoz,&nbsp;Margarita Cuervas-Mons Vendrell,&nbsp;Beatriz Leal Pino,&nbsp;Luis Fernandez Romero","doi":"10.1016/j.farma.2024.05.003","DOIUrl":"10.1016/j.farma.2024.05.003","url":null,"abstract":"<div><h3>Objective</h3><div>To describe the process of implementing a traceability and safe manufacturing system in the clean room of a pharmacy service to increase patient safety, in accordance with current legislation.</div></div><div><h3>Methods</h3><div>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 parameterised in the software program: personnel, facilities, equipment, starting materials, packaging materials, standardised work procedures, and quality controls.</div></div><div><h3>Results</h3><div>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 standardised 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, and 32 low risk, and 13 quality controls.</div></div><div><h3>Conclusions</h3><div>The computerization of the production process has allowed the implementation of a traceability and secure manufacturing system in a controlled environment in accordance with current legislation.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"48 6","pages":"Pages T290-T293"},"PeriodicalIF":1.0,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318553","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
[Translated article] Characteristics, clinical benefit, and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020 [译文]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.2024.07.006
Hilario Martínez-Barros , Álvaro Pousada-Fonseca , Jorge Pedreira-Bouzas , Ana Clopés-Estela

Objective

To describe the authorisations and funding resolutions for new onco-haematological 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-haematology 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. 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 tumours (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 40–66.3]. 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 年间西班牙对抗肿瘤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,纳入了2017年至2020年间欧洲药品管理局批准的肿瘤血液学药物。授权信息来自欧洲公共评估报告的主要研究。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 40-66.3]。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 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 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 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]: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,在获得批准时,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。
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引用次数: 0
[Translated article] A quarter of a century of the VIH-SEFH group: Transforming care, facing challenges and reaffirming commitment [译文]VIH-SEFH 小组成立四分之一世纪: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.2024.09.011
Ramón Morillo Verdugo , Pilar Taberner Bonastre
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引用次数: 0
Manejo terapéutico, adherencia y resultados clínicos de la insuficiencia cardiaca en Andalucía. Protocolo ANDALIC 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.2024.03.002
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 optimized 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。目标描述安达卢西亚心力衰竭患者队列的临床特征、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。设计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: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。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衰患者的临床特征、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以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
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FARMACIA HOSPITALARIA
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