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Patient Safety Incidents Involving Antipsychotics: A Cross-Sectional Study Based on the Danish Patient Safety Database 涉及抗精神病药物的患者安全事件:基于丹麦患者安全数据库的横断面研究
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-22 DOI: 10.1155/jcpt/2038343
Tara Hoffmann Faaborg, Mette Gibskov Fløe Andersen, Olga Alexandrovna Tchijevitch, Anne Estrup Olesen

Introduction and Purpose

Antipsychotics are commonly prescribed to treat mental illnesses, with usage increasing. Although they provide therapeutic benefits, these medications can be associated with errors, e.g., wrong dosages or administration to the wrong patient. Such errors can compromise patient safety and treatment outcomes. In Denmark, healthcare professionals must report patient safety incidents (PSIs) to the Danish Patient Safety Database (DPSD). This system aims to identify high-risk situations and facilitate learning. The goal of this study was to gain detailed insights into PSIs involving antipsychotics in the Danish primary healthcare and hospital sectors.

Methods

This descriptive cross-sectional study analyzed all reported moderate, severe, and fatal PSIs related to selected antipsychotics reported to the DPSD between January 2022 and December 2022. Data were categorized by two extractors using REDCap.

Results

A total of 7,042 PSIs were reported with 469 incidents classified as moderate, severe, or fatal. Thirty-four incidents were excluded. Quetiapine, olanzapine, and risperidone were the most frequently involved drugs (247/435, 56.8%). Most PSIs (372/435 85.5%) were of moderate severity. Errors most often occurred during administration (65.3%), with omissions, wrong dosage, and wrong-patient errors being the most common. Social housing (47.1%) and hospitals (25.5%) were the most frequently reported settings for PSIs.

Conclusions

This study highlights the need for targeted interventions to reduce medication errors and improve patient safety in both primary care and hospital settings in Denmark. Most errors occurred during administrations, and overall, the most frequent issues were omissions, incorrect dosages, and wrong-patient incidents. While PSIs related to antipsychotics remain a concern, reported severity indicates that they may not always result in significant clinical severity.

前言与目的抗精神病药物通常用于治疗精神疾病,其使用日益增加。虽然这些药物具有治疗效果,但也可能出现错误,例如错误的剂量或给错的病人。此类错误可能危及患者安全和治疗结果。在丹麦,医疗保健专业人员必须向丹麦患者安全数据库(DPSD)报告患者安全事件(psi)。该系统旨在识别高风险情况并促进学习。本研究的目的是详细了解丹麦初级保健和医院部门中涉及抗精神病药物的psi。方法:本描述性横断面研究分析了2022年1月至2022年12月期间报告给DPSD的所有与选定抗精神病药物相关的中度、重度和致死性PSIs。数据由两个使用REDCap的提取器分类。结果共报告了7042例PSIs,其中469例分为中度、重度或致命。34个事件被排除在外。喹硫平、奥氮平和利培酮是最常见的药物(247/435,56.8%)。大多数psi(372/435 85.5%)为中度严重程度。错误最常发生在给药期间(65.3%),其中遗漏、错误剂量和错误患者错误是最常见的。社会住房(47.1%)和医院(25.5%)是最常报告的社会服务提供者的场所。结论:本研究强调需要有针对性的干预措施,以减少用药错误,提高丹麦初级保健和医院环境中的患者安全。大多数错误发生在给药期间,总的来说,最常见的问题是遗漏、不正确的剂量和错误的患者事件。虽然与抗精神病药物相关的PSIs仍然令人担忧,但报告的严重程度表明,它们可能并不总是导致显著的临床严重程度。
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引用次数: 0
The Real-World Analysis of Adverse Events With Two Types of Single-Inhaler Triple Therapy: A VigiAccess Database Study 两种类型的单吸入器三联治疗不良事件的真实世界分析:一项VigiAccess数据库研究
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-14 DOI: 10.1155/jcpt/6677307
Baiquan Zhang, Jiayu Bai, Lu Zhou

Background

The advent of single-inhaler triple therapies (SITTs), including fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) and beclomethasone dipropionate/formoterol fumarate/glycopyrronium bromide (BDP/FOR/GLY), has expanded treatment options for chronic obstructive pulmonary disease (COPD). This study explores adverse drug reactions (ADRs) related to these SITTs using data from the WHO-VigiAccess database and compares their safety profiles.

Methods

A retrospective analysis was conducted using ADR reports associated with FF/UMEC/VI and BDP/FOR/GLY from the WHO-VigiAccess database. Data included patient demographics and reported adverse events (AEs). Disproportionality analysis was performed using the reporting odds ratio (ROR) and proportional reporting ratio (PRR) to assess the association between SITTs and specific AEs.

Results

A total of 21,539 AEs related to FF/UMEC/VI and BDP/FOR/GLY were identified in the VigiAccess database. Commonly reported ADRs included dyspnoea, cough, COPD, headache, dizziness and pneumonia. FF/UMEC/VI was more frequently associated with injuries, poisoning and procedural complications (39.46%), whereas BDP/FOR/GLY showed a higher incidence of respiratory, thoracic and mediastinal disorders (42.06%). Disproportionality analysis revealed an increased ROR (3.04) and PRR (2.76) for FF/UMEC/VI regarding injury-related events, indicating a stronger signal compared to BDP/FOR/GLY. These findings underscore the diversity of ADRs associated with SITTs and highlight the need for careful clinical monitoring. However, the voluntary nature of VigiAccess and inherent reporting biases, such as visibility and selection bias, may affect the completeness and reliability of the data.

Conclusion

analysis of WHO-VigiAccess reports reveals both shared and distinct ADRs between FF/UMEC/VI and BDP/FOR/GLY. Due to limitations, such as under-reporting and reporting bias inherent to spontaneous databases, these findings should be interpreted with caution. Clinicians are encouraged to tailor COPD treatment based on both efficacy and potential ADR profiles to ensure optimal and personalized care.

单吸入器三联疗法(SITTs)的出现,包括糠酸氟替卡松/乌莫替尼/维兰特罗(FF/UMEC/VI)和二丙酸倍氯米松/富马酸福莫特罗/溴化甘溴铵(BDP/FOR/GLY),扩大了慢性阻塞性肺疾病(COPD)的治疗选择。本研究利用来自世卫组织- viiaccess数据库的数据探讨了与这些sitt相关的药物不良反应(adr),并比较了它们的安全性概况。方法对WHO-VigiAccess数据库中FF/UMEC/VI和BDP/FOR/GLY相关的ADR报告进行回顾性分析。数据包括患者人口统计数据和报告的不良事件(ae)。使用报告优势比(ROR)和比例报告比(PRR)进行歧化分析,以评估sitt与特定ae之间的关联。结果在VigiAccess数据库中共鉴定出与FF/UMEC/VI和BDP/FOR/GLY相关的ae 21,539例。常见的不良反应包括呼吸困难、咳嗽、慢性阻塞性肺病、头痛、头晕和肺炎。FF/UMEC/VI更易发生损伤、中毒和手术并发症(39.46%),而BDP/FOR/GLY的呼吸、胸部和纵隔疾病发生率较高(42.06%)。歧化分析显示,FF/UMEC/VI在损伤相关事件上的ROR(3.04)和PRR(2.76)增加,表明与BDP/ for /GLY相比,信号更强。这些发现强调了与sitt相关的不良反应的多样性,并强调了仔细临床监测的必要性。然而,VigiAccess的自愿性质和固有的报告偏差,如可见性和选择偏差,可能会影响数据的完整性和可靠性。结论:对WHO-VigiAccess报告的分析显示,FF/UMEC/VI和BDP/FOR/GLY之间既有共同的adr,也有不同的adr。由于局限性,如自发性数据库固有的报告不足和报告偏倚,这些发现应谨慎解释。鼓励临床医生根据疗效和潜在不良反应概况定制COPD治疗,以确保最佳和个性化护理。
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引用次数: 0
A Systematic Review of Traditional Uses, Phytochemistry, and Pharmacology of Chinese Herb Medicine for Schizophrenia 中药治疗精神分裂症的传统用途、植物化学和药理学综述
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-13 DOI: 10.1155/jcpt/9996801
Sihan Zhao, Yonghou Zhao, Ming Yu, Jianbo Chai, Xinhui Yao

Ethnopharmacological Significance

Schizophrenia, a complex psychiatric disorder with multifactorial etiology, profoundly affects patients’ behavior, cognition, affect, and thought processes. Given the stagnation in novel drug development, notable treatment-related adverse effects, and suboptimal recovery rates, the identification of innovative therapeutic agents and strategies to mitigate side effects remains a critical unmet need. Preclinical advances have increasingly validated the scientific rationale for the clinical efficacy of medicinal plants. Consequently, the exploration of botanical antipsychotic agents has gained global traction due to their favorable safety profiles and emerging evidence of efficacy.

Objective of the Review

This review synthesizes a decade of preclinical and translational research on medicinal plants and traditional ethnomedicines for schizophrenia treatment. It provides a comprehensive analysis of the pharmacology and molecular mechanisms underlying the therapeutic potential of plant-derived active ingredients, serving as a foundational resource for future drug development and clinical translation efforts.

Materials and Methods

A systematic literature review was conducted using PubMed, Web of Science, Elsevier, Scopus, SciFinder, Springer, and the China National Knowledge Infrastructure (CNKI). Search terms included “schizophrenia,” “traditional medicinal plants,” “Chinese materia medica,” “active ingredients,” and “phytochemicals.” Studies were selected based on their focus on natural products and ethnopharmacological interventions for schizophrenia published in the last decade. Following rigorous screening, data were categorized by plant-derived bioactive compounds (e.g., flavonoids, polysaccharides, and alkaloids) and their mechanisms of action.

Conclusions

Natural products and traditional ethnomedicines constitute promising sources for novel antipsychotic drug development. Emerging evidence supports the translational potential of integrating phytotherapeutics into clinical practice, though significant gaps persist. Future research must prioritize comprehensive pharmacokinetic/toxicological profiling, standardized clinical trials, and mechanistic elucidation of plant-derived compounds to realize their full therapeutic potential.

精神分裂症是一种多因素致病的复杂精神障碍,深刻影响患者的行为、认知、情感和思维过程。鉴于新药开发停滞不前,显著的治疗相关不良反应,以及次优的恢复率,确定创新的治疗药物和策略以减轻副作用仍然是一个关键的未满足的需求。临床前研究的进展日益证实了药用植物临床疗效的科学依据。因此,植物性抗精神病药物的探索由于其良好的安全性和新出现的有效性证据而获得了全球的关注。本文综述了近十年来药用植物和传统民族药治疗精神分裂症的临床前和转化研究。它提供了植物源性活性成分潜在治疗潜力的药理学和分子机制的全面分析,为未来药物开发和临床转化工作提供了基础资源。材料与方法采用PubMed、Web of Science、Elsevier、Scopus、SciFinder、b施普林格和中国知网(CNKI)进行系统文献综述。搜索词包括“精神分裂症”、“传统药用植物”、“中药”、“有效成分”和“植物化学物质”。研究的选择是基于它们对过去十年发表的精神分裂症的天然产物和民族药理学干预的关注。经过严格筛选,数据按植物源性生物活性化合物(如类黄酮、多糖和生物碱)及其作用机制进行分类。结论天然产物和传统民族药是开发新型抗精神病药物的重要资源。新出现的证据支持将植物疗法纳入临床实践的转化潜力,尽管仍存在显着差距。未来的研究必须优先考虑全面的药代动力学/毒理学分析、标准化的临床试验和植物源性化合物的机制阐明,以充分发挥其治疗潜力。
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引用次数: 0
Determination of the 90% Effective Dose of Remimazolam in Combination With a Low Dose of Alfentanil for Suppressing Responses During Upper Gastrointestinal Endoscopy Insertion 雷马唑仑联合小剂量阿芬太尼抑制上消化道内窥镜插入时90%有效剂量的测定
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-11 DOI: 10.1155/jcpt/3473867
Pengfei Yin, Yifu Liang, Binwei Hu, Qing Xie, Mi Wang, Zhiying Feng, Xianhui Kang

Remimazolam has shown safety and efficacy in providing sedation during gastroscopy, but research on its specific clinical dosage is limited. This study aimed to determine the 90% effective dose (ED90) of remimazolam when used with a low dose of alfentanil for inducing sedation in adult patients undergoing gastroscopy. Fifty adult participants underwent upper gastrointestinal (GI) endoscopy with anesthesia via intravenous boluses of remimazolam and alfentanil (4 μg/kg). The initial remimazolam dose was 0.2 mg/kg, adjusted using the biased coin up-and-down (BCUD) sequential method. The ED90 of remimazolam, administered with 4 μg/kg alfentanil, was found to be 0.2375 mg/kg (95% CI: 0.1500–0.2725). Hemodynamics remained stable, with no significant adverse events and high satisfaction scores from patients, anesthesiologists, and endoscopists (4.90 ± 0.043, 4.92 ± 0.039, and 4.92 ± 0.039, respectively, on a 5-point scale). The combination of remimazolam and low-dose alfentanil is safe and effective for adult upper GI endoscopy.

Trial Registration: Chinese Registry of Clinical Trials: ChiCTR2200062535

雷马唑仑在胃镜检查中镇静的安全性和有效性已得到证实,但对其具体临床剂量的研究有限。本研究旨在确定雷马唑仑与低剂量阿芬太尼联合用于成人胃镜检查患者镇静时的90%有效剂量(ED90)。50名成年参与者在麻醉下静脉注射雷马唑仑和阿芬太尼(4 μg/kg),进行上消化道内镜检查。雷马唑仑初始剂量为0.2 mg/kg,采用偏置硬币上下(BCUD)顺序法进行调整。阿芬太尼4 μg/kg给药时,雷马唑仑的ED90为0.2375 mg/kg (95% CI: 0.1500 ~ 0.2725)。血流动力学保持稳定,无明显不良事件发生,患者、麻醉医师和内镜医师的满意度得分较高(5分制分别为4.90±0.043、4.92±0.039和4.92±0.039)。雷马唑仑联合小剂量阿芬太尼用于成人上消化道内镜检查安全有效。试验注册:中国临床试验注册中心:ChiCTR2200062535
{"title":"Determination of the 90% Effective Dose of Remimazolam in Combination With a Low Dose of Alfentanil for Suppressing Responses During Upper Gastrointestinal Endoscopy Insertion","authors":"Pengfei Yin,&nbsp;Yifu Liang,&nbsp;Binwei Hu,&nbsp;Qing Xie,&nbsp;Mi Wang,&nbsp;Zhiying Feng,&nbsp;Xianhui Kang","doi":"10.1155/jcpt/3473867","DOIUrl":"https://doi.org/10.1155/jcpt/3473867","url":null,"abstract":"<p>Remimazolam has shown safety and efficacy in providing sedation during gastroscopy, but research on its specific clinical dosage is limited. This study aimed to determine the 90% effective dose (ED<sub>90</sub>) of remimazolam when used with a low dose of alfentanil for inducing sedation in adult patients undergoing gastroscopy. Fifty adult participants underwent upper gastrointestinal (GI) endoscopy with anesthesia via intravenous boluses of remimazolam and alfentanil (4 μg/kg). The initial remimazolam dose was 0.2 mg/kg, adjusted using the biased coin up-and-down (BCUD) sequential method. The ED<sub>90</sub> of remimazolam, administered with 4 μg/kg alfentanil, was found to be 0.2375 mg/kg (95% CI: 0.1500–0.2725). Hemodynamics remained stable, with no significant adverse events and high satisfaction scores from patients, anesthesiologists, and endoscopists (4.90 ± 0.043, 4.92 ± 0.039, and 4.92 ± 0.039, respectively, on a 5-point scale). The combination of remimazolam and low-dose alfentanil is safe and effective for adult upper GI endoscopy.</p><p><b>Trial Registration:</b> Chinese Registry of Clinical Trials: ChiCTR2200062535</p>","PeriodicalId":15381,"journal":{"name":"Journal of Clinical Pharmacy and Therapeutics","volume":"2025 1","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1155/jcpt/3473867","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145521811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Interventions to Improve Standard Initiation of Long-Acting Injectable Antipsychotics in a University-Affiliated Psychiatric Hospital: A Quasiexperimental Study 提高大学附属精神病院长效注射抗精神病药物标准起始的干预措施:一项准实验研究
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-07 DOI: 10.1155/jcpt/9093978
Maryam Mousavi, Maryam Taghizadeh-Ghehi, Aarefeh Jafarzadeh Kohneloo, Zahra Mirsepassi, Ali-Akbar Nejatisafa

Introduction

Long-acting injectable antipsychotics (LAI-APs) were recommended to improve treatment adherence and reduce recurrence rates. Initiating LAI-APs can be challenging due to complexities in dosing schedules.

Aim

We aimed to assess the impact of multifaceted interventions on the initial dosing schedule of LAI-APs in a university-affiliated psychiatric hospital.

Methods

This study consisted of three phases: first, the preintervention baseline evaluation phase, followed by guideline development and active dissemination in the hospital (guideline presentation and educational session). Second, the 1 month peri-intervention phase, in which audit and feedback were performed. The postintervention phase consisted of a 3-month evaluation. All admitted patients for whom LAI-APs were initiated were identified and studied. The concordance with institutional guidelines was determined by considering the initial dose, initial interval, and oral overlap during three phases.

Results

In total, 101, 31, and 51 orders were evaluated in the study phases, respectively. Guideline-concordant orders increased from 2.1% in baseline to 48.4% and 64.5% before and after feedback in the peri-intervention phase, respectively, and decreased to 21.6% in the postintervention phase (p < 0.001). Nonconcordance initial dose decreased from 83.7% at baseline to 38.7% in the second phase and reached 62% in the last phase (p < 0.001). The frequency of LAI-AP and OAP mismatch was 67.6%, 10.5%, and 21.9% in the three study phases, respectively (p < 0.001). The academic level of the attending physician increased the odds of an appropriate initial dose by 3.92 times. The odds of a proper initial interval were higher when the attending physician had a higher academic level (OR = 2.53, 95% CI = 1.25–5.12, p = 0.01) and was female (OR = 2.4, 95% CI = 1.09–5.29, p = 0.029).

Conclusion

Concordance with the institutional guideline in LAI-APs dosing improved following multifaceted interventions; however, the improvement was not sustained. Therefore, continued audit and feedback might be necessary to maintain the effects.

推荐使用长效注射抗精神病药物,以提高治疗依从性,降低复发率。由于给药计划的复杂性,启动ai - ap可能具有挑战性。目的:我们旨在评估多方面干预对大学附属精神病院lai - ap初始给药计划的影响。方法本研究分为三个阶段:首先是干预前基线评估阶段,其次是指南制定和在医院的积极传播(指南发布和教育会议)。第二,为期1个月的围干预阶段,在此阶段进行审计和反馈。干预后阶段包括3个月的评估。所有开始使用LAI-APs的住院患者都被识别和研究。通过考虑三个阶段的初始剂量、初始间隔和口服重叠来确定与机构指南的一致性。结果在研究阶段共评估了101、31和51个订单。在干预期反馈前后,与指南一致的订单分别从基线的2.1%上升到48.4%和64.5%,在干预后阶段下降到21.6% (p < 0.001)。非一致性初始剂量从基线的83.7%下降到第二阶段的38.7%,最后阶段达到62% (p < 0.001)。在三个研究阶段,LAI-AP和OAP不匹配的频率分别为67.6%、10.5%和21.9% (p < 0.001)。主治医师的学术水平使初始剂量合适的几率增加了3.92倍。当主治医师的学术水平较高(OR = 2.53, 95% CI = 1.25-5.12, p = 0.01)且为女性(OR = 2.4, 95% CI = 1.09-5.29, p = 0.029)时,合适的初始间隔的几率更高。结论综合干预后,LAI-APs给药与机构指南的一致性得到改善;然而,这种改善并没有持续下去。因此,可能需要持续的审计和反馈来维持效果。
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引用次数: 0
Desensitization of Immunomodulating Agent–Related Hypersensitivity Reactions as a Means to Provide Therapeutic Options in the Management of Plasma Cell Disorders (DeHyperPCD) 免疫调节剂相关超敏反应的脱敏治疗为浆细胞疾病(DeHyperPCD)的治疗提供了一种选择
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-11-06 DOI: 10.1155/jcpt/6275323
Jack T. Seki, Eshetu G. Atenafu, Sita Bhella, Christine Chen, Suzanne Trudel, Chloe Yang, Donna Reece, Jesus Giovanni Piza Rodriguez, Harjot Vohra, Ritu Kushwaha, Anca Prica

Hypersensitivity reactions (HSRs) can be a significant barrier to a patient’s cancer treatment journey. HSRs caused by immunomodulating agents, specifically lenalidomide (LEN) can be overwhelmingly distressful, paradoxically depriving patients of access to a clinically meaningful drug. Based on our historical clinical experiences, we have learned that the rapid desensitization protocol (RDP), when executed precisely, can enable patients to successfully resume LEN treatment. This served as the impetus for initiating our prospective study. We consecutively enrolled 10 patients diagnosed with plasma cell disease who had experienced a previous HSR specifically with LEN. After fully recovering from their initial reactions, patients underwent a controlled 10–12 steps incremental increase in drug dosage administration, followed by daily resumption of LEN over a 90-day period. All 10 (100%) patients successfully completed the protocol and continued on further LEN treatment cycles, although 1 patient voluntarily chose to withdraw from the study due to recurrent symptoms after receiving 2 doses of LEN. Three (30%) patients remained symptom-free throughout the follow-up period. Six (60%) patients experienced mild and short-lived HSR reactivation; however, all had the ability to take LEN for the majority of the study period. RDP enables patients to continue taking LEN and maintains the health-related quality of life (HR-QoL) by reducing the occurrence of HSR. RDP empowers patients to participate in future clinical trialsinvolving novel treatments that contain LEN as a backbone therapy, opportunities they would have otherwise been ineligible for.

超敏反应(HSRs)可能是患者癌症治疗过程中的一个重大障碍。由免疫调节剂,特别是来那度胺(LEN)引起的hsr可能是非常痛苦的,矛盾的是剥夺了患者获得临床有意义的药物的机会。根据我们的历史临床经验,我们了解到快速脱敏方案(RDP),当精确执行时,可以使患者成功恢复LEN治疗。这是我们开始前瞻性研究的动力。我们连续招募了10例诊断为浆细胞病的患者,他们之前经历过HSR,特别是LEN。在完全从最初的反应中恢复后,患者接受10-12步的药物剂量递增控制,随后在90天内每天恢复LEN。所有10例(100%)患者都成功完成了方案,并继续进行了进一步的LEN治疗周期,尽管有1例患者在接受2剂LEN治疗后因症状复发而自愿退出研究。3例(30%)患者在随访期间无症状。6例(60%)患者出现轻度和短暂的HSR再激活;然而,在研究的大部分时间里,所有人都有能力参加LEN。RDP使患者能够继续服用LEN,并通过减少HSR的发生来维持与健康相关的生活质量(HR-QoL)。RDP使患者能够参与未来的临床试验,包括将LEN作为骨干疗法的新疗法,否则他们将没有资格获得这些机会。
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引用次数: 0
Impact of Different Diuretic Protocols on the Prevention of Renal Impairment and Extravasation Incidences During Short Hydration in Cisplatin Administration 不同利尿方案对预防顺铂短水合期肾损害和外渗的影响
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-30 DOI: 10.1155/jcpt/5568932
Sohei Ohshima, Takuya Araki, Hideaki Yashima, Reiko Sakurai, Yohei Ohsaki, Akemi Tsunoda, Hiromi Sekine, Koujirou Yamamoto, Norifumi Tsukamoto

The short hydration method using magnesium and diuretics has been widely adopted to prevent cisplatin-induced nephrotoxicity. Both mannitol and furosemide are commonly used as diuretics in this approach, but there is no clear consensus on the benefits or risks of combining the two. Mannitol is associated with a higher risk of vascular problems, such as extravascular leakage and vasculitis, owing to its high osmolality. In this study, we investigated the risk of vascular problems and cisplatin-induced nephrotoxicity in patients who underwent short hydration with both mannitol and furosemide and in those who underwent short hydration with furosemide alone during the administration of cisplatin. Propensity score matching was performed to control for background characteristics, and logistic regression analysis was conducted to identify risk factors. The use of both mannitol and furosemide was significantly associated with a higher risk of extravasation (odds ratio [OR] = 8.29) and vascular events (OR = 12.58) compared with the use of furosemide alone. In contrast, the degree of renal function decline and incidence of grade ≥ 2 nephrotoxicity did not significantly differ between the groups. These findings suggest that adding mannitol to furosemide does not provide an additional benefit in preventing cisplatin-induced nephrotoxicity but may increase the risk of vascular adverse events. Therefore, as a general rule, furosemide alone is recommended as the diuretic in the short hydration method to prevent cisplatin-induced nephrotoxicity as well as extravascular leakage and vasculitis.

镁和利尿剂的短水化法已被广泛应用于预防顺铂引起的肾毒性。甘露醇和呋塞米都是常用的利尿剂,但是对于两者联合使用的益处和风险还没有明确的共识。甘露醇具有较高的血管问题风险,如血管外渗漏和血管炎,由于其高渗透压。在这项研究中,我们调查了同时服用甘露醇和呋塞米短时间水合的患者和顺铂服用期间仅服用呋塞米短时间水合的患者发生血管问题和顺铂引起的肾毒性的风险。采用倾向评分匹配控制背景特征,采用logistic回归分析识别危险因素。与单独使用呋塞米相比,同时使用甘露醇和呋塞米与较高的外渗风险(优势比[OR] = 8.29)和血管事件(OR = 12.58)显著相关。相比之下,两组之间肾功能下降程度和≥2级肾毒性发生率无显著差异。这些发现表明,在呋塞米中加入甘露醇并不能在预防顺铂引起的肾毒性方面提供额外的益处,但可能会增加血管不良事件的风险。因此,一般建议在短水化法中单独使用速尿作为利尿剂,以防止顺铂引起的肾毒性以及血管外渗漏和血管炎。
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引用次数: 0
Assessing the Acceptability and Cost Consequences of Implementing Elastomeric Devices for Administration of Intravenous Antibiotics at Home: A Mixed-Methods Evaluation 评估弹性装置用于家庭静脉注射抗生素的可接受性和成本后果:混合方法评估
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-10-30 DOI: 10.1155/jcpt/6017010
Stephanie Howard Wilsher, Mary Onoja, Alan Bellinger, Debbie Pyne, Mikyung Kelly Seo, Katherine Cummergen, Elizabeth Kendrick, Saval Khanal

Introduction

Pressure on NHS services necessitates implementation of innovative solutions to provide appropriate and cost-effective care. This study evaluates the acceptability, feasibility and cost-effectiveness of implementing home medication preparation and elastomeric device filling for the administration of intravenous antibiotics from the UK NHS perspective, focusing on regional implementation.

Method

A mixed-methods design included a targeted literature review, routine patient data, questionnaires tailored to participant groups (community clinicians, remote monitoring clinicians, consultants and patients), and interviews with both patients and clinicians. A total of 24 patients were recruited in Hertfordshire between June and September 2024. Piperacillin with tazobactam (Tazocin) or flucloxacillin was prepared and administered at the patients’ home by trained nurses and delivered by the elastomeric pump over 24 h. Economic evaluations compared this home pathway against three alternative pathways using preprepared medications: hospital inpatient care (hospital), outpatient clinic visits (outpatient) and a hypothetical home visit (hypothetical).

Findings

Survey responses were collected from 14 clinicians, five patients and two carers, and interviews were conducted with six clinicians, one patient, and one carer. Patients and carers were satisfied with the home pathway because of the perceived safety and freedom it gave them. Clinicians expressed positive feedback and considered it feasible, provided there was sufficient support for themselves and patients. Concerns were raised about design, ease of filling the elastomeric device and monitoring flow of medication. Other issues related to the type of cannula and concentration of the vials, improvements for care packages, communication and training. The home pathway demonstrated cost savings, with a per-patient cost of £2507.54, significantly lower than the hospital pathway (£6122.70), outpatient pathway (£3603.76), and hypothetical pathway (£4373.37).

Conclusion

Overall, clinicians, patients and carers were pleased with the home pathway, with the additional benefit that the home pathway could be economically and realistically feasible to help the NHS meet the growing demand for high-quality care.

对NHS服务的压力需要实施创新的解决方案,以提供适当和具有成本效益的护理。本研究从英国NHS的角度评估实施家庭药物制备和弹性装置填充静脉注射抗生素的可接受性、可行性和成本效益,重点是区域实施。方法采用混合方法设计,包括有针对性的文献综述、常规患者数据、针对参与者群体(社区临床医生、远程监测临床医生、咨询医生和患者)量身定制的问卷调查,以及对患者和临床医生的访谈。2024年6月至9月期间,赫特福德郡共招募了24名患者。哌拉西林与他唑巴坦(他唑嗪)或氟氯西林在患者家中由训练有素的护士配制和给药,并通过弹性泵在24小时内给药。经济评估将这种家庭途径与三种使用预先准备药物的替代途径进行了比较:住院治疗(医院)、门诊就诊(门诊)和假设的家访(假设)。调查结果收集了14名临床医生、5名患者和2名护理人员的反馈,并对6名临床医生、1名患者和1名护理人员进行了访谈。病人和护理人员对回家的道路感到满意,因为它给了他们安全感和自由。临床医生表达了积极的反馈,并认为这是可行的,只要对自己和患者有足够的支持。人们提出了关于设计、填充弹性装置的便利性和监测药物流量的担忧。其他问题涉及导管的类型和小瓶的浓度,护理包的改进,沟通和培训。家庭途径显示出成本节约,每位患者的成本为2507.54英镑,显著低于医院途径(6122.70英镑)、门诊途径(3603.76英镑)和假设途径(4373.37英镑)。总体而言,临床医生、患者和护理人员对家庭路径感到满意,并且家庭路径在经济上和现实上可行,可以帮助NHS满足对高质量护理日益增长的需求。
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引用次数: 0
Effect of Two Different ART Regimens on AIDS Patients With Lymphoma 两种不同抗逆转录病毒治疗方案对艾滋病淋巴瘤患者的影响
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-09-24 DOI: 10.1155/jcpt/6644473
Guangjing Ruan, Qisi Su, Zhiman Xie, Huawei He, Yuming Lu, Ningmei Liu, Dandan Ni, Bin He

Objective: To explore the impact of two different ART regimens on AIDS patients with lymphoma.

Methods: A retrospective study was carried out involving 60 patients diagnosed with AIDS and lymphoma and treated in our hospital during the period from June 2022 to December 2023. All patients underwent DA-EPOCH chemotherapy. According to the differences in ART treatment regimens, patients receiving the DTG + lamivudine (3TC) regimen will be categorized into the DTG + 3TC group, and patients receiving the TDF + 3TC + efavirenz (EFV) regimen will be classified into the TDF + 3TC + EFV group, with 30 cases in each group. The HIV viral load was compared between the two groups pretreatment and posttreatment (at 12, 24, and 26 weeks). The immunological indices (CD4+ and CD8+), liver function indices (serum total bilirubin [TBIL], alanine transaminase [ALT], aspartate transaminase [AST], serum albumin [ALB], and prothrombin time [PT]), and blood creatinine (Scr) levels of the two groups were compared before and after treatment (at 36 weeks). The occurrence of adverse reactions was documented.

Results: After 12, 24, and 36 weeks of treatment, the HIV viral load in the DTG + 3TC group was consistently lower than that in the EFV + TDF + 3TC group (p < 0.05). At week 36 posttreatment, compared with the EFV + TDF + 3TC group, the DTG + 3TC group showed higher CD4+ counts and lower CD8+ counts (p < 0.05). Following treatment at week 36, levels of AST, ALT, TBiL, and PT were elevated in both groups but lower in the DTG + 3TC group (p < 0.05). The levels of ALB in both groups were decreased, but the DTG + 3TC group was significantly higher (p < 0.05). Additionally, at week 36 posttreatment, Scr levels were significantly better in the DTG + 3TC group compared to the EFV + TDF + 3TC group (p < 0.05). The incidence of adverse reactions in the DTG + 3TC group and EFV + TDF + 3TC group differed significantly, with rates of 13.33% and 23.33%, respectively (p > 0.05).

Conclusion: There is no difference in the safety of DTG + 3TC in the treatment of AIDS patients with ARL compared with TDF +3TC + EFV. However, the combination of DTG + 3TC simplified regimen is superior to the three-drug regimen of TDF + 3TC + EFV in reducing viral load and has positive effects on the improvement of liver function and blood creatinine, with no obvious side effects.

目的:探讨两种不同抗逆转录病毒治疗方案对艾滋病淋巴瘤患者的影响。方法:对2022年6月至2023年12月在我院治疗的60例艾滋病淋巴瘤患者进行回顾性研究。所有患者均接受DA-EPOCH化疗。根据ART治疗方案的差异,将接受DTG +拉米夫定(3TC)方案的患者分为DTG + 3TC组,接受TDF + 3TC +依非韦伦(EFV)方案的患者分为TDF + 3TC + EFV组,每组30例。比较两组治疗前和治疗后(12、24和26周)的HIV病毒载量。比较两组患者治疗前后(36周)免疫指标(CD4+、CD8+)、肝功能指标(血清总胆红素(TBIL)、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、血清白蛋白(ALB)、凝血酶原时间(PT))及血肌酐(Scr)水平。记录不良反应的发生情况。结果:治疗12、24、36周后,DTG + 3TC组的HIV病毒载量均低于EFV + TDF + 3TC组(p < 0.05)。治疗后第36周,与EFV + TDF + 3TC组比较,DTG + 3TC组CD4+计数较高,CD8+计数较低(p < 0.05)。治疗第36周后,两组患者AST、ALT、TBiL、PT水平均升高,DTG + 3TC组降低(p < 0.05)。两组ALB水平均降低,但DTG + 3TC组ALB水平显著升高(p < 0.05)。此外,在治疗后第36周,DTG + 3TC组的Scr水平显著高于EFV + TDF + 3TC组(p < 0.05)。DTG + 3TC组和EFV + TDF + 3TC组不良反应发生率差异有统计学意义,分别为13.33%和23.33% (p > 0.05)。结论:与TDF +3TC + EFV相比,DTG +3TC治疗艾滋病ARL患者的安全性无显著差异。但DTG + 3TC简化联合方案在降低病毒载量方面优于TDF + 3TC + EFV三药方案,对肝功能和血肌酐的改善均有积极作用,且无明显副作用。
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引用次数: 0
Real-World Data Analysis of Vascular and Lymphatic Adverse Events Associated With Antitumor Angiogenesis Drugs: A WHO-VigiAccess Study 与抗肿瘤血管生成药物相关的血管和淋巴不良事件的真实世界数据分析:一项WHO-VigiAccess研究
IF 2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pub Date : 2025-09-02 DOI: 10.1155/jcpt/9501977
Yue Zu, Lingling Dai, Peng Meng

Antiangiogenic therapy plays a critical role in cancer treatment. This study analyzed vascular and lymphatic adverse events linked to four FDA-approved agents—aflibercept, bevacizumab, olaratumab, and ramucirumab—using WHO-VigiAccess data. Disproportionality analysis (ROR and PRR) identified drug-specific risks, focusing on hypertension, hemorrhage, thrombosis, and flushing, to inform safer and personalized clinical use.

抗血管生成治疗在癌症治疗中起着关键作用。本研究使用WHO-VigiAccess数据分析了与fda批准的四种药物(阿非利塞普、贝伐单抗、奥拉拉单抗和雷穆单抗)相关的血管和淋巴不良事件。歧化分析(ROR和PRR)确定了药物特异性风险,重点是高血压、出血、血栓形成和潮红,为更安全和个性化的临床使用提供信息。
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引用次数: 0
期刊
Journal of Clinical Pharmacy and Therapeutics
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