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[Translated article] Activities of clinical pharmacists in intensive care units.
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-24 DOI: 10.1016/j.farma.2024.12.004
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 (ICU) 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.

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引用次数: 0
[Translated article] The relevance of therapeutic positioning in the post-approval evaluation of new drugs.
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-23 DOI: 10.1016/j.farma.2024.10.011
Emilio Jesús Alegre-Del Rey, Silvia Fénix-Caballero, María Dolores Fraga Fuentes, Manuel Jesús Cárdenas Aranzana, Eduardo Lopez-Briz, Francesc Puigventós Latorre, Carmen María Domínguez-Santana

The objective of regulatory authorities is to ensure a favourable risk-benefit balance for medicines in their licenced indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licenced indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatment(s); moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties. Many cases highlight the need to establish a more specific therapeutic benefit scenario than the licenced indication. For example, abemaciclib was approved in the adjuvant setting for high-risk patients with early breast cancer, but the appropriate level of risk and how to assess it needs to be specified. Also, pembrolizumab is approved for neoadjuvant plus adjuvant treatment in lung cancer; but it remains to be analysed whether it is superior to nivolumab in neoadjuvant treatment alone, which involves less treatment and economic burden. As therapeutic positioning is always a necessary decision, whether made at a national, regional, local, or individual level, it must be made in the most appropriate way. The absence of a multidisciplinary discussion and consensus, relying only on individual decisions to determine positioning from the outset, underestimates information gaps, inter-individual variability, and the influence of drug promotion. It can be harmful and costly. To properly manage the introduction of new medicines, it is essential to establish their benefit scenario in a multidisciplinary way. This, together with consideration of the clinical benefit provided versus the appropriate alternatives and the uncertainties of the benefit, constitutes the objective of the clinical assessment and the basis for designing a well-focused economic analysis. This allows policy-makers to make the most appropriate decisions on pricing and funding new treatments. In an ideal situation, the benefit scenario considered for the new medicine would coincide with the one established for funding, but costs that are difficult to bear may lead to restrictions and affect the final positioning after the economic and budgetary impact assessment.

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引用次数: 0
[Translated article] Protocol for the adaptation and consensus of the Community Pharmacy Survey on Patient Safety Culture to hospital pharmacy in Spain.
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-22 DOI: 10.1016/j.farma.2024.12.008
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.

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引用次数: 0
[Translated article] Prospective observational follow-up study of psychoactive drug treatment initiated in the intensive care unit. 在重症监护病房开展精神活性药物治疗的前瞻性观察性随访研究。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-20 DOI: 10.1016/j.farma.2024.12.003
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 analyse 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 multicentre 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 programmes, 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,重症监护病房(ICU)谵妄的治疗和预防在患者护理中占有重要地位。一些研究将谵妄与死亡风险增加、住院时间延长和机械通气天数增加联系起来。本研究旨在分析在ICU开始使用精神药物和出院后继续使用精神药物,并评估其对多重用药的贡献和相关的临床不良反应。方法:设计多中心前瞻性观察性病例研究,研究对象为18岁以上 岁以上ICU住院并接受精神药物治疗的患者。将收集人口统计数据、与入院和精神药物治疗有关的变量以及临床结果和不良反应的数据。在其他变量中,将测量在ICU开始并在从ICU和医院出院后继续进行精神药物治疗的频率。将通过审查电子病历和处方方案收集数据,并将使用IBM SPSS 20.0统计软件包进行分析。讨论:谵妄在ICU患者中很常见,并伴有长期的不良后果。虽然抗精神病药物用于治疗谵妄,但长期使用会产生不良反应,并且在ICU出院后继续使用会导致多重用药。本研究旨在提供在ICU开始使用精神药物及其出院后继续使用的信息,以确定干预的机会并减少这些药物的不必要使用。
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引用次数: 0
[Translated article] High-risk pediatric medications: A listing proposal by interdisciplinary consensus technique. [翻译文章]高危儿科药物:跨学科共识技术的上市建议。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-02 DOI: 10.1016/j.farma.2024.11.006
Yolanda Hernández Gago, Pedro 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 (EBW), 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 2 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 101 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 EBW.

儿科患者更有可能经历药物相关错误和严重的相关危害。高危药物(HRM)的识别及其在特殊人群中的研究,如超重儿童(EBW),是安全性改进策略的一部分。目的:通过一个由儿科医生和医院药剂师组成的跨学科小组构建的共识技术,生成一个可操作的、更新的人力资源管理清单,供2岁以上 岁的儿童医院使用。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之间合作项目的一部分。方法:该研究分两个连续阶段进行:(a)通过文献审查编制人力资源管理的初步清单;(b)随后应用双轮德尔菲法,就人力资源管理的最终清单达成一致。通过计算每种药物的机会一致性概率和修正Kappa统计量对所得结果进行验证。结果:经文献复习获得的原始目录包括26个药理学类,96种药物。在37位专家中,32位(86.4%)完成了两轮德尔菲。人力资源管理的最终共识清单包括24个药理学类和101种药物。修正后的Kappa统计数据反映了参与者达成共识的高百分比一致性(94.9%)。结论:该清单可为今后的研究和干预提供工具,以提高一般儿科人群以及EBW患儿等高危亚群的用药安全性。
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引用次数: 0
Priorización de iniciativas 2024–2027 del mapa estratégico de atención farmacéutica al paciente externo de la Sociedad Española de Farmacia Hospitalaria 西班牙医院药剂学协会门诊药物护理战略地图 2024-2027 年优先倡议。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-01 DOI: 10.1016/j.farma.2024.03.013
Ramón Morillo Verdugo , Beatriz Bernardez Ferrán , Aurora Fernández Polo , Luis Margusino Framiñan , José Manuel Martínez Sesmero , Manuel Vélez-Díaz-Pallarés , Esther Vicente-Escrig

Objective

To prioritize the initiatives to be developed for the development of the Strategic Map of Outpatient Care (MAPEX) project to improve the quality of care and Pharmaceutical Care for patients seen in Hospital Pharmacy outpatient clinics in the period 2024–2027 in Spain.

Method

The study was carried out in 4 phases between January and December 2023.
For phase 1, a literature review of the evolution of the project was carried out by the coordinating committee with the aim of establishing a basis on which to define a new proposal for initiatives. In addition, an analysis was made of the health trends that will have an impact in the coming years.
In phase 2, a working group of 19 specialists from all the autonomous communities was created, who were called regional ambassadors. They all made a preliminary proposal of initiatives and established revisions for their adjustment and final version both online and in telematic meetings.
In phase 3, a consensus was established based on the Delphi-Rand/UCLA methodology with two rounds of online voting to select the initiatives classified as: priority and key or breakthrough.
Between the first and second round of voting, a face-to-face “Consensus Conference” was held, where the results of the first round were presented.
In phase 4, a public presentation was made in scientific forums and through the web.

Results

Ten trends in the health sector were identified. A list of 34 initiatives grouped into five lines of work was established. A total of 103 panelists participated in the first round and 76 in the second. Finally, five initiatives were established as priority and 29 as key. Among those prioritized were external visibility, adaptations to the CMO methodology, strengthening certification and improving training.

Conclusions

The initiatives agreed upon as priorities were aimed at improving professional visibility, broadening the methodology of care work, expanding the quality of care, enhancing the training of professionals and the voice of patients.
目标:为制定门诊病人护理战略地图(MAPEX)项目,在 2024-2027 年期间改善西班牙医院药房门诊病人的护理和药物护理质量,确定应优先采取的措施:研究在 2023 年 1 月至 12 月期间分 4 个阶段进行。在第 1 阶段,协调委员会对该项目的发展历程进行了文献回顾,目的是为确定新的倡议提案奠定基础。此外,还对未来几年将产生影响的健康趋势进行了分析。在第二阶段,成立了一个由来自所有自治区的 19 名专家组成的工作组,他们被称为地区大使。他们都提出了初步的倡议建议,并在网上和远程会议上对其进行调整和定稿。在第三阶段,根据德尔菲-兰德/加州大学洛杉矶分校的方法达成共识,通过两轮在线投 票选出优先、关键或突破性倡议。在第一轮和第二轮投票之间,举行了一次面对面的 "共识会议",会上介绍了第一轮投票的结果。在第四阶段,通过科学论坛和网络进行了公开展示:结果:确定了卫生领域的十大趋势。结果:确定了卫生领域的十大趋势,并将 34 项倡议分为五个工作重点。共有 103 名专家组成员参加了第一轮讨论,76 名专家组成员参加了第二轮讨论。最后,确定了 5 项优先行动和 29 项关键行动。被列为优先事项的举措包括外部能见度、调整 CMO 方法、加强认证和改进培训:结论:商定的优先举措旨在提高专业知名度、拓宽护理工作方法、提高护理质量、加强专业人员培训和患者的呼声。
{"title":"Priorización de iniciativas 2024–2027 del mapa estratégico de atención farmacéutica al paciente externo de la Sociedad Española de Farmacia Hospitalaria","authors":"Ramón Morillo Verdugo ,&nbsp;Beatriz Bernardez Ferrán ,&nbsp;Aurora Fernández Polo ,&nbsp;Luis Margusino Framiñan ,&nbsp;José Manuel Martínez Sesmero ,&nbsp;Manuel Vélez-Díaz-Pallarés ,&nbsp;Esther Vicente-Escrig","doi":"10.1016/j.farma.2024.03.013","DOIUrl":"10.1016/j.farma.2024.03.013","url":null,"abstract":"<div><h3>Objective</h3><div>To prioritize the initiatives to be developed for the development of the Strategic Map of Outpatient Care (MAPEX) project to improve the quality of care and Pharmaceutical Care for patients seen in Hospital Pharmacy outpatient clinics in the period 2024–2027 in Spain.</div></div><div><h3>Method</h3><div>The study was carried out in 4 phases between January and December 2023.</div><div>For phase 1, a literature review of the evolution of the project was carried out by the coordinating committee with the aim of establishing a basis on which to define a new proposal for initiatives. In addition, an analysis was made of the health trends that will have an impact in the coming years.</div><div>In phase 2, a working group of 19 specialists from all the autonomous communities was created, who were called regional ambassadors. They all made a preliminary proposal of initiatives and established revisions for their adjustment and final version both online and in telematic meetings.</div><div>In phase 3, a consensus was established based on the Delphi-Rand/UCLA methodology with two rounds of online voting to select the initiatives classified as: priority and key or breakthrough.</div><div>Between the first and second round of voting, a face-to-face “Consensus Conference” was held, where the results of the first round were presented.</div><div>In phase 4, a public presentation was made in scientific forums and through the web.</div></div><div><h3>Results</h3><div>Ten trends in the health sector were identified. A list of 34 initiatives grouped into five lines of work was established. A total of 103 panelists participated in the first round and 76 in the second. Finally, five initiatives were established as priority and 29 as key. Among those prioritized were external visibility, adaptations to the CMO methodology, strengthening certification and improving training.</div></div><div><h3>Conclusions</h3><div>The initiatives agreed upon as priorities were aimed at improving professional visibility, broadening the methodology of care work, expanding the quality of care, enhancing the training of professionals and the voice of patients.</div></div>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":"49 1","pages":"Pages 3-10"},"PeriodicalIF":1.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140869326","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
Administración segura de noradrenalina por vía periférica: una revisión sistemática 通过外周途径安全使用去甲肾上腺素:系统综述。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-01 DOI: 10.1016/j.farma.2024.04.003
F. Dámaso Fernández-Ginés , María T. Gómez Sánchez , Marina Sánchez Valera , Beatriz Tauste Hernández , Marta Garrido Ortiz , Manuel Cortiñas-Sáenz

Purpose

To review and analyze the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety.

Methods

Systematic review on the databases PubMed, ISI Web of Science, SCOPUS and Science Direct, using the following search terms: (“Noradrenaline” [Mesh]) AND (“Norepinephrine” [Mesh]) AND (“Vasopressors” [Mesh]) AND (“Peripheral infusions” [Mesh]) OR (“Extravasations” [Mesh]). A total of 1,040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included.

Results

NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischemia and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA.

Conclusions

Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.
目的:回顾并分析有关外周给药去甲肾上腺素(NA)的现有文献,旨在为确保正确使用和患者安全提供建议:使用以下检索词对 PubMed、ISI Web of Science、SCOPUS 和 Science Direct 等数据库进行系统综述:("去甲肾上腺素"[Mesh])和("去甲肾上腺素"[Mesh])和("血管加压剂"[Mesh])和("外周输注"[Mesh])或("外渗"[Mesh])。共鉴定出 1,040 篇文章。排除了动物研究和以英语以外语言撰写的研究。最后,纳入了 83 篇文章:结果:NA 可以经外周给药。应考虑到外渗的风险,酚妥拉明是第一种药物治疗方法。它还与血栓性静脉炎、蜂窝组织炎、组织坏死、肢体缺血和坏疽的出现有关,尽管其发生率似乎很低。在儿童中使用外周 NA 似乎没有明显的并发症。建议使用标准浓度以减少出错的风险。建议使用0.9%生理盐水作为外周NA的默认稀释液:结论:在早期复苏中,外周输注NA是一种安全、有益的选择,但前提是必须遵守一些准则,以降低与这种途径相关的并发症发生的可能性。
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引用次数: 0
[Translated article] Knowledge of biological therapy in patients with immune-mediated diseases. BIOINFO study [译文]免疫介导疾病患者的生物疗法知识。BIOINFO 研究。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-01 DOI: 10.1016/j.farma.2024.08.002
Carlos Seguí-Solanes , Lidia Estrada , Esther Ramírez Herráiz , Silvia Ruiz-García , Tomás Palanques-Pastor , Vicente Merino Bohórquez , Cristina Capilla Montes , Joaquín Borras-Blasco

Objective

To determine the degree of knowledge about biological therapy and biosimilars in patients with immune-mediated inflammatory diseases treated in Outpatient Pharmaceutical Care Units.

Methods

Observational, prospective, and multicenter study during the period May 2020–March 2021. A survey (9 questions) was conducted before starting treatment in which the patients' level of knowledge about biological therapy and biosimilars was assessed.

Results

A total of 169 patients were included in the study. The average value for the different questions was 3.3 ± 0.6 out of 5, while the average final result was 29.4 points out of 45. 64.5% of the patients had an acceptable level before starting the medication (> 27 points). The multivariate analysis showed a statistically significant correlation (p < .05) with a better score at the beginning of treatment in those patients whose prescribing service was Rheumatology.

Conclusions

In general, the level of knowledge prior to biological therapy in patients is acceptable, being higher in dosage and administration technique related-factors and what is related to the dosage and administration technique and where to find information related to the medication; the worst rated were those on biosimilars-related. The factor of being followed by rheumatology, was associated with better knowledge.
目的确定在门诊医药护理病房接受治疗的免疫介导炎症性疾病患者对生物疗法和生物仿制药的了解程度:2020年5月至2021年3月期间的观察性、前瞻性和多中心研究。在开始治疗前进行一项调查(9 个问题),评估患者对生物疗法和生物仿制药的了解程度:结果:共有 169 名患者参与了研究。不同问题的平均值为(3.3±0.6)分(满分 5 分),最终平均结果为 29.4 分(满分 45 分)。64.5%的患者在开始服药前的血糖水平为可接受水平(>27 分)。多变量分析显示,两者之间存在统计学意义上的显著相关性(p 结论:总体而言,患者在接受生物治疗前的知识水平是可以接受的,但在剂量和给药技术相关因素、剂量和给药技术相关内容以及在哪里可以找到与药物相关的信息方面的知识水平较高;评分最差的是与生物仿制药相关的知识。由风湿病学专家跟踪服务这一因素与更好的知识有关。
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引用次数: 0
[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma [译文]nivolumab 对复发或难治性典型霍奇金淋巴瘤患者的实际有效性和安全性。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-01 DOI: 10.1016/j.farma.2024.09.006
Laura Lorente Fernández , Samuel Romero Domínguez , Asunción Albert Marí , Esperanza Núñez Benito , Eduardo López Briz , José Luis Poveda Andrés

Objective

The primary objective is to describe the real-life effectiveness and safety of nivolumab treatment in patients with relapsed or refractory classical Hodgkin's lymphoma. The secondary objective is to describe the therapeutic management after nivolumab monotherapy.

Method

Observational, retrospective, multidisciplinary study including all patients with relapsed or refractory classical Hodgkin's lymphoma treated with nivolumab monotherapy from November 2015 to March 2023. Patient and treatment-related variables were collected. Effectiveness was measured as overall response rate, progression-free survival, and overall survival. Safety was measured as percentage of patients with adverse effects and severity.

Results

Thirteen patients were included, median age 37.5 years (RIQ: 25.3–54.7), 84.6% male. The median number of previous lines of therapy was 3 (RIQ: 2–4.5), including autologous haematopoietic stem cell transplantation (84.6%) and brentuximab vedotin (100%). All received nivolumab 3 mg/kg/14 days, with a median of 11 cycles (RIQ: 6.5–20.5) per patient. Median time on treatment was 4.9 months (RIQ: 3–9.6) and median follow-up time was 9.2 months (RIQ: 5.6–32.3).
Complete response was achieved by 3 patients (23.1%), partial response by 3 (23.1%), stable disease by 3 (23.1%), and progression by 4 (30.8%). The objective response rate was 46.2%. Median progression-free survival was 23.9 months (95% CI: 0–49.1), median overall survival was not reached. At the study cut-off date, 5 patients had died (38.5%), 4 were in complete remission without active treatment (30.8%), and 4 were continuing treatment (30.8%).
Adverse events occurred in 76.9% of patients, 44% of severity ≥ 3, the most frequent being hypothyroidism and hepatotoxicity. One patient discontinued treatment due to pneumonitis, 2 suffered treatment delays (thrombocytopenia and hypertransaminemia), and 1 changed the regimen to monthly (pulmonary toxicity).

Conclusions

Nivolumab in the treatment of relapsed or refractory classical Hodgkin's lymphoma has confirmed favourable effectiveness data in the study sample, expressed as objective response rate of 46.2% and a clinical benefit rate of 69.2%. Safety was acceptable, manageable, and consistent with that described in the literature.
研究目的主要目的是描述nivolumab治疗复发或难治性经典型霍奇金淋巴瘤患者的实际有效性和安全性。次要目标是描述 nivolumab 单药治疗后的治疗管理:观察性、回顾性、多学科研究,包括2015年11月至2023年3月期间接受nivolumab单药治疗的所有复发或难治性经典型霍奇金淋巴瘤患者。研究收集了患者和治疗相关变量。疗效以总反应率、无进展生存期和总生存期来衡量。安全性以出现不良反应的患者比例和严重程度来衡量:共纳入 13 名患者,中位年龄为 37.5 岁(RIQ:25.3-54.7),84.6% 为男性。既往治疗方案的中位数为3种(RIQ:2-4.5),包括自体造血干细胞移植(84.6%)和布伦妥昔单抗维多汀(100%)。所有患者都接受了3 mg/kg/14天的尼夫单抗治疗,每位患者的中位治疗周期为11个周期(RIQ:6.5-20.5)。中位治疗时间为4.9个月(RIQ:3-9.6),中位随访时间为9.2个月(RIQ:5.6-32.3)。3名患者(23.1%)获得完全应答,3名患者(23.1%)获得部分应答,3名患者(23.1%)病情稳定,4名患者(30.8%)病情进展。客观反应率为46.2%。无进展生存期中位数为23.9个月(95% CI:0-49.1),总生存期中位数未达到。在研究截止日期,5名患者死亡(38.5%),4名患者在未接受积极治疗的情况下完全缓解(30.8%),4名患者仍在继续治疗(30.8%)。76.9%的患者出现了不良反应,44%的不良反应严重程度≥3,最常见的是甲状腺功能减退和肝毒性。1名患者因肺炎中断治疗,2名患者治疗延迟(血小板减少和高转氨酶血症),1名患者将治疗方案改为每月一次(肺毒性):Nivolumab治疗复发或难治性典型霍奇金淋巴瘤的疗效数据在研究样本中得到了证实,客观反应率为46.2%,临床获益率为69.2%。安全性可接受、可控,与文献中描述的一致。
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引用次数: 0
[Translated article] Patient-reported outcome measures for assessing atopic dermatitis in clinical practice [译文]在临床实践中评估特应性皮炎的患者报告结果测量法。
IF 1 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2025-01-01 DOI: 10.1016/j.farma.2024.08.004
Gabriel Mercadal-Orfila , Carlos Seguí-Solanes , Nuria Rudi-Sola , Maria Eugenia Escriva-Sancho , Rosa Taberner-Ferrer
Atopic dermatitis is a chronic skin condition that affects up to 20% of children and 10% of adults worldwide. Due to the high burden of dermatological signs and symptoms, atopic dermatitis has a significant impact on the quality of life of patients and their families. In the absence of objective measures to accurately assess severity and symptom burden, patient-reported outcome measures are essential to monitor the impact and progression of the disease, as well as the efficacy of treatments. Although there are currently no standardised guidelines for their use in clinical practice, there are some initiatives, such as the Harmonise Outcome Measures for Eczema and Vivir con Dermatitis Atópica, that can provide guidance. As healthcare systems move toward value-based healthcare models, patient-reported measures are becoming increasingly important for incorporating the patient perspective and improving the quality of healthcare services. The use of these measures can help monitor disease activity and guide treatment decisions. This article discusses the impact of atopic dermatitis and describes the patient-reported outcome measures commonly used in atopic dermatitis and the recommendations of the initiatives that have selected a core set of measures to best assess atopic dermatitis in clinical practice. Considering the recommendations of these initiatives and based on our experience in clinical practice, we propose the use of the Dermatology Life Quality Index to assess the impact of the disease on quality of life, the Patient-Oriented Eczema Measure to assess symptom severity, and the Numerical Rating Scale or the Visual Analogue Scale to measure itch intensity. To systematise the administration of these measures and to integrate them into hospital information systems and medical records, we emphasise the importance of telemedicine platforms that allow the electronic administration of these instruments.
特应性皮炎是一种慢性皮肤病,全世界有多达 20% 的儿童和 10% 的成年人患有这种疾病。由于特应性皮炎的皮肤症状和体征较多,因此对患者及其家人的生活质量有很大影响。由于缺乏准确评估严重程度和症状负担的客观测量方法,患者报告的结果测量对于监测疾病的影响和进展以及治疗效果至关重要。虽然目前还没有在临床实践中使用这些指标的标准化指南,但一些倡议,如 "湿疹结果衡量标准协调 "和 "湿疹患者的生活",可以提供指导。随着医疗保健系统向以价值为基础的医疗保健模式转变,患者报告的衡量标准对于纳入患者观点和提高医疗保健服务质量变得越来越重要。使用这些指标有助于监测疾病活动并指导治疗决策。本文讨论了特应性皮炎的影响,并介绍了特应性皮炎常用的患者报告结果测量方法,以及为在临床实践中更好地评估特应性皮炎而选择了一套核心测量方法的倡议建议。考虑到这些倡议的建议,并根据我们在临床实践中的经验,我们建议使用皮肤科生活质量指数(Dermatology Life Quality Index)来评估疾病对生活质量的影响,使用患者导向湿疹测量法(Patient-Oriented Eczema Measure)来评估症状的严重程度,使用数字评分量表(Numerical Rating Scale)或视觉模拟量表(Visual Analogue Scale)来测量瘙痒的强度。为了使这些测量方法的实施系统化,并将其纳入医院信息系统和医疗记录,我们强调了远程医疗平台的重要性,该平台允许以电子方式实施这些工具。
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