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Two-Drug Combination Antiretroviral Therapy for HIV-1: Case Series and Literature Review. 治疗 HIV-1 的两药联合抗逆转录病毒疗法:病例系列和文献综述。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-05 DOI: 10.1177/00185787241293374
Timothy James Martley, Frank Fanizza, Christopher Penn, Madeline Burling

Background: Doravirine (DOR) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for use in combination antiretroviral therapy (cART) for treatment of human immunodeficiency virus (HIV) in treatment-naive patients. Doravirine-based regimens are an option for patients with limited alternatives due to drug-drug interactions, toxicities, or resistance. A paucity of data exists for use of two-drug DOR-based regimens in treatment-experienced individuals. Methods: This is a retrospective case series of two treatment-experienced HIV-1 infected patients switched to two-drug doravirine-based regimens. Baseline HIV-RNA and CD4 cell count were measured at the time of switch to the DOR-based regimen. HIV-RNA and CD4 cell count were measured again more than a month after initiating therapy to determine efficacy of the DOR-based regimens. Results: Patient 1 was transitioned to once daily DOR and darunavir with cobicistat (DRV/c). The baseline HIV-RNA was 370,070 copies/mL and CD4 cell count was 196 cells/mm3. After 2 years of treatment, the viral load was less than 30 copies/mL and the CD4 cell count was 239 cells/mm3. Patient 2 was transitioned to once daily DOR and dolutegravir (DTG). The baseline HIV-RNA was <30 copies/mL and CD4 cell count was 229 cells/mm3. After 11 months of therapy, the patient's HIV viral load remained <30 copies/mL and the CD4 cell count was stable at 236 cells/mm3. Conclusions: Two-drug cART including DOR appears to be an acceptable option for patients who may be limited to alternative ART regimens due to drug-drug interactions, resistance mutations, or toxicities. Additional evidence from case reports or clinical trials are needed to further evaluate the long-term efficacy and safety of DOR as part of a two-drug cART regimen.

背景:多拉韦林(DOR)是一种非核苷类逆转录酶抑制剂(NNRTI),已被批准用于抗逆转录病毒联合疗法(cART),用于治疗人类免疫缺陷病毒(HIV)的非耐药患者。由于药物间相互作用、毒性或耐药性等原因,患者只能选择多拉韦林治疗方案。在治疗经验丰富的患者中使用基于多拉韦林的双药方案的数据很少。方法:这是一个回顾性病例系列,研究了两名转用多拉韦林双药治疗方案的治疗经验丰富的 HIV-1 感染者。在改用基于多拉韦林的方案时测量了基线 HIV-RNA 和 CD4 细胞计数。在开始治疗一个多月后再次测量 HIV-RNA 和 CD4 细胞计数,以确定基于 DOR 方案的疗效。结果患者 1 转为使用每日一次的 DOR 和达芦那韦加科比司他(DRV/c)。基线 HIV-RNA 为 370,070 拷贝/毫升,CD4 细胞计数为 196 cells/mm3。治疗 2 年后,病毒载量小于 30 copies/mL,CD4 细胞计数为 239 cells/mm3。患者 2 过渡到每日一次的 DOR 和多鲁替拉韦(DTG)治疗。基线 HIV-RNA 为 3。治疗 11 个月后,患者的 HIV 病毒载量仍为 3。结论对于因药物间相互作用、耐药性突变或毒性而只能选择其他抗逆转录病毒疗法的患者来说,包括 DOR 在内的双药联合抗逆转录病毒疗法似乎是一种可以接受的选择。还需要病例报告或临床试验提供更多证据,以进一步评估 DOR 作为双药联合抗逆转录病毒疗法一部分的长期疗效和安全性。
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引用次数: 0
Safety of Beta-Blocker Administration in STEMI Patients With Risk Factors for Cardiogenic Shock. 对具有心源性休克风险因素的 STEMI 患者使用β-受体阻滞剂的安全性。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-11-04 DOI: 10.1177/00185787241295969
Nicole Castoro, Ashley E Woodruff, Lauren Lacoursiere, Kevin Mills, Maya R Chilbert

Beta-blockers are recommended in the first 24 hours after ST-segment elevation myocardial infarction (STEMI) except in those at risk of cardiogenic shock. This retrospective cohort study aimed to assess if early beta-blocker use was associated with cardiogenic shock development in STEMI patients. Cardiogenic shock was assessed in adult patients with STEMI undergoing percutaneous coronary intervention (PCI) with guideline defined risk factors for shock (age above 70 years, systolic blood pressure below 120 mmHg, and heart rate above 120 bpm or below 60 bpm) who did or did not receive a beta-blocker within 24 hours of PCI. Multivariable logistic regression was used to assess the association between cardiogenic shock development and early beta-blocker administration. A total of 216 patients were included, 85 with early beta-blocker administration and 131 without. Patients who received an early beta-blocker versus those who did not had a median (interquartile range) age of 63 (52-71) versus 66 (54-76; P = .2260) and peak troponin of 58.3 (15.0-132.4) ng/mL versus 51.6 (16.6-139.5; P = .9884). Cardiogenic shock occurred in 4.7% (n = 4) patients with early beta-blocker use versus 12.2% (n = 16; P = .0909) without. After backward stepwise logistic regression, early beta-blocker use was not associated with cardiogenic shock (adjusted odd ratio [aOR] 0.334, 95% confidence interval (CI) 0.106-1.047; P = .0599), but those with a peak troponin over 56 ng/mL had an over three-fold increased risk of developing cardiogenic shock (aOR 3.434, 95% CI 1.191-9.902; P = .0224) regardless of beta blocker administration. Early beta-blocker administration in STEMI patients may not be associated with shock development.

建议在 ST 段抬高型心肌梗死(STEMI)发生后的 24 小时内使用β-受体阻滞剂,有心源性休克风险的患者除外。这项回顾性队列研究旨在评估 STEMI 患者早期使用β-受体阻滞剂是否与心源性休克的发生有关。研究评估了接受经皮冠状动脉介入治疗(PCI)的 STEMI 成人患者的心源性休克情况,这些患者具有指南定义的休克风险因素(年龄大于 70 岁、收缩压低于 120 mmHg、心率高于 120 bpm 或低于 60 bpm),且在 PCI 术后 24 小时内接受或未接受β-受体阻滞剂治疗。多变量逻辑回归用于评估心源性休克的发生与早期使用β-受体阻滞剂之间的关系。共纳入了 216 例患者,其中 85 例接受了早期β-受体阻滞剂治疗,131 例未接受治疗。接受早期β-受体阻滞剂治疗的患者与未接受早期β-受体阻滞剂治疗的患者的中位(四分位间距)年龄分别为 63(52-71)岁与 66(54-76;P = .2260)岁,肌钙蛋白峰值分别为 58.3(15.0-132.4)纳克/毫升与 51.6(16.6-139.5;P = .9884)纳克/毫升。早期使用β受体阻滞剂的患者中发生心源性休克的比例为4.7%(n = 4),而未使用β受体阻滞剂的患者中发生心源性休克的比例为12.2%(n = 16;P = .0909)。经过后向逐步逻辑回归,早期使用β受体阻滞剂与心源性休克无关(调整后奇异比 [aOR] 0.334,95% 置信区间 (CI) 0.106-1.047;P = .0599),但肌钙蛋白峰值超过 56 纳克/毫升的患者发生心源性休克的风险增加了三倍多(aOR 3.434,95% CI 1.191-9.902;P = .0224),与是否使用β受体阻滞剂无关。STEMI 患者早期使用β受体阻滞剂可能与休克的发生无关。
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引用次数: 0
Clinical Outcomes Associated with the Implementation of a Dedicated Clinical Pharmacy Service in a Resource-Limited Neurocritical Intensive Care Unit. 在资源有限的神经重症加护病房实施专门临床药学服务的相关临床结果。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-31 DOI: 10.1177/00185787241286721
Eunyoung Sa, Yoonsook Cho, Sung Yun Suh, Tae Eun Park, Sandy Jeong Rhie

Background: Patients in neurocritical care units are particularly vulnerable to medication errors and adverse drug events, necessitating specialized care and comprehensive pharmacological management. Despite this need, the scarcity of clinical pharmacist specialists in South Korean hospitals results in limited direct patient care within multidisciplinary teams. Objective: This study aimed to evaluate the impact of a dedicated pharmacy service program in the neurocritical care intensive care unit (neuro-ICU) on patient outcomes and to propose a clinical pharmacy service model tailored for resource-limited settings. Methods: We conducted a retrospective cohort study comparing neuro-ICU mortality rates and length of stay between periods with and without the presence of a dedicated neurocritical care pharmacist (d-NCP) from May 1, 2016, to December 31, 2017. The study also assessed the frequency and nature of pharmacy interventions alongside factors associated with patient outcomes. Results: The analysis included 769 patients in the group with d-NCP and 676 patients in the group without d-NCP. The presence of a d-NCP was associated with significantly shorter neuro-ICU stays (3.4 ± 8 days vs 3.5 ± 6.4 days, P = .012). Multivariate analysis indicated that the involvement of a d-NCP correlated with reduced length of neuro-ICU stay (β coefficient -0.077, 95% CI: -0.148 to -0.006, P = .033), whereas the number of prescribed medications was linked to longer stays (β coefficient 0.004, 95% CI: 0.014 to 0.005, P < .001). Conclusion: The implementation of a dedicated pharmacy service program in the neuro-ICU leads to improved patient outcomes and mitigates drug-related complications. This model offers a feasible and effective approach for enhancing care in hospitals with limited resources.

背景:神经重症监护病房的患者特别容易出现用药错误和药物不良事件,因此需要专门的护理和全面的药物管理。尽管有此需求,但由于韩国医院临床药剂师专家稀缺,导致多学科团队对患者的直接护理有限。研究目的本研究旨在评估神经重症监护病房(neuro-ICU)中专门的药学服务项目对患者预后的影响,并提出适合资源有限环境的临床药学服务模式。方法:我们进行了一项回顾性队列研究,比较了从 2016 年 5 月 1 日至 2017 年 12 月 31 日期间有专职神经重症监护药剂师(d-NCP)和没有专职神经重症监护药剂师(d-NCP)的神经重症监护病房死亡率和住院时间。研究还评估了药学干预的频率和性质,以及与患者预后相关的因素。研究结果分析包括有 d-NCP 组的 769 名患者和没有 d-NCP 组的 676 名患者。有 d-NCP 的患者在神经重症监护室的住院时间明显缩短(3.4 ± 8 天 vs 3.5 ± 6.4 天,P = .012)。多变量分析表明,d-NCP 的参与与神经重症监护病房住院时间的缩短相关(β 系数 -0.077,95% CI:-0.148 至 -0.006,P = .033),而处方药物的数量与住院时间的延长相关(β 系数 0.004,95% CI:0.014 至 0.005,P 结论:神经重症监护病房的住院时间与处方药物的数量相关,而处方药物的数量与住院时间的延长相关(β 系数 0.004,95% CI:0.014 至 0.005,P = .033):在神经重症监护病房实施专门的药学服务项目可改善患者的预后并减少与药物相关的并发症。这种模式为资源有限的医院加强护理提供了一种可行而有效的方法。
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引用次数: 0
Exploring Pharmacists' Perceptions of Text-Based Artificial Intelligence in Resident and Student Education. 探索药剂师对住院医师和学生教育中基于文本的人工智能的看法。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-28 DOI: 10.1177/00185787241293389
Keaton S Smetana, Scott Postema, Megan E Smetana

Introduction: As artificial intelligence (AI) becomes increasingly integrated into various professional fields, understanding its impact on pharmacy education is crucial. This study explores pharmacists' perceptions of AI's role in enhancing educational and professional practices, particularly focusing on the generation of educational content and analytical tasks. Objectives: The primary objective was to assess pharmacists' concerns and perceived benefits regarding the use of AI in pharmacy education, examining variations across different age groups and years of practice. Methods: A cross-sectional survey was completed by 446 pharmacists who actively precept pharmacy residents and students. Respondents practiced across 35 states with over half (53.4%) being in Ohio. The survey included items on concerns about AI's quality and accuracy, human interaction, plagiarism, and its potential benefits in data analysis and research literature summarization. Responses were analyzed to identify trends across demographic categories, including age and years in practice. Results: Of the respondents, 67.9% expressed concerns about the quality and accuracy of AI-generated content, while 50.9% were concerned about plagiarism. Younger pharmacists (73.8% of those aged 20-29) showed heightened concern about accuracy compared to older groups (56.8% of those aged 60+). In contrast, 57.8% of respondents recognized AI's potential benefits for data analysis, with experienced pharmacists (>20 years in practice) being more likely to see these advantages (62.2%). Conclusion: The findings indicate a need for targeted educational strategies to address AI literacy and ethical use in pharmacy education. Integrating AI tools that support educational objectives while addressing these concerns could enhance the efficacy and acceptance of AI in pharmacy practice. Further research should explore the development of training programs that align with the evolving expectations and technological competencies of different pharmacist demographics.

导言:随着人工智能(AI)日益融入各个专业领域,了解其对药学教育的影响至关重要。本研究探讨了药剂师对人工智能在加强教育和专业实践中的作用的看法,尤其侧重于教育内容的生成和分析任务。目标:主要目的是评估药剂师对在药学教育中使用人工智能的担忧和感知到的益处,研究不同年龄组和从业年限的差异。方法446 名积极指导住院药师和学生的药剂师完成了一项横向调查。受访者在 35 个州执业,其中一半以上(53.4%)在俄亥俄州。调查项目包括对人工智能质量和准确性的担忧、人机交互、剽窃以及人工智能在数据分析和研究文献总结方面的潜在优势。我们对回答进行了分析,以确定不同人口统计类别的趋势,包括年龄和从业年限。结果:67.9%的受访者对人工智能生成内容的质量和准确性表示担忧,50.9%的受访者对抄袭表示担忧。与年龄较大的群体(60 岁以上的占 56.8%)相比,年轻药剂师(20-29 岁的占 73.8%)对准确性的关注度更高。相比之下,57.8% 的受访者认识到人工智能在数据分析方面的潜在优势,而经验丰富的药剂师(从业时间超过 20 年)更有可能认识到这些优势(62.2%)。结论研究结果表明,有必要制定有针对性的教育策略,以解决人工智能素养和在药学教育中的道德使用问题。整合支持教育目标的人工智能工具,同时解决这些问题,可以提高人工智能在药学实践中的功效和接受度。进一步的研究应探讨如何制定培训计划,以满足不同药剂师群体不断发展的期望和技术能力。
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引用次数: 0
Risk factors for Relative and Absolute Hypoglycemia in Patients Treated for Diabetic Ketoacidosis and Hyperosmolar Hyperglycemic Syndrome. 糖尿病酮症酸中毒和高渗性高血糖综合征患者发生相对和绝对低血糖的风险因素。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-27 DOI: 10.1177/00185787241286871
Anastasia Engeleit, Eljim Tesoro, Nishita Gandhi, Scott Benken

Introduction: Glycemic management in the intensive care unit is an evolving practice area. This evolution has included the refinement of blood glucose targets, matching glycemic management to premorbid status, and investigations into the impact of glycemic variability and relative hypoglycemia on ICU outcomes. The interplay between these phenomena and absolute hypoglycemia has yet to be investigated in hyperglycemic emergencies. Objectives: To examine the incidence of and risk factors for relative hypoglycemia and absolute hypoglycemia in patients admitted to an intensive care unit for the management of hyperglycemic emergencies. Methods: This was a retrospective, single-center, exploratory analysis of adults admitted to the medical intensive care unit for diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome. The primary outcome was the incidence of relative hypoglycemia, defined as a blood glucose level 30% lower than baseline. The baseline was determined by the estimated average blood glucose calculated from hemoglobin A1c within 3 months of index admission. Secondary outcomes were ICU length of stay, glycemic variability, and incidence of absolute hypoglycemia.Results: Relative hypoglycemia was observed in 60% of patients in the cohort. Longer insulin infusion duration and higher hemoglobin A1c levels were found to statistically increase the risk of developing relative hypoglycemia. Higher glycemic variability and longer ICU length of stay were associated with the risk of developing absolute hypoglycemia. Conclusions: Relative hypoglycemia is a frequent occurrence in this patient population. Hemoglobin A1c and duration of the insulin infusion statistically influenced the risk of developing relative hypoglycemia. Higher glycemic variability and longer ICU stay were significantly associated with developing absolute hypoglycemia. While relative hypoglycemia is common in hyperglycemic emergencies, the clinical impact remains uncertain and warrants additional investigation.

简介:重症监护病房的血糖管理是一个不断发展的实践领域。这一演变包括血糖目标的完善、血糖管理与病前状态的匹配,以及血糖变化和相对低血糖对重症监护室预后影响的研究。在高血糖急症中,这些现象与绝对低血糖之间的相互作用还有待研究。研究目的研究入住重症监护病房治疗高血糖急症的患者中相对低血糖和绝对低血糖的发生率和风险因素。研究方法这是对因糖尿病酮症酸中毒或高渗性高血糖综合征入住内科重症监护室的成人进行的一项回顾性、单中心、探索性分析。主要结果是相对低血糖的发生率,即血糖水平比基线低 30%。基线由入院 3 个月内根据血红蛋白 A1c 计算得出的估计平均血糖确定。次要结果为重症监护室住院时间、血糖变异性和绝对低血糖发生率:结果:60%的患者出现了相对低血糖。研究发现,胰岛素输注时间越长、血红蛋白 A1c 水平越高,发生相对低血糖的风险就越大。较高的血糖变异性和较长的重症监护室住院时间与发生绝对低血糖的风险有关。结论相对低血糖症在这类患者中经常发生。血红蛋白 A1c 和胰岛素输注持续时间对发生相对低血糖的风险有统计学影响。血糖变异性较高和重症监护室住院时间较长与发生绝对低血糖显著相关。虽然相对低血糖症在高血糖急症中很常见,但其临床影响仍不确定,需要进一步研究。
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引用次数: 0
Implementation of a Telemedicine Direct Oral Anticoagulant Monitoring Program at a Safety-Net Hospital. 在一家安全网医院实施远程医疗直接口服抗凝剂监测计划。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-27 DOI: 10.1177/00185787241293356
Stacey Cohen Kaplon, Sumaia Aqtash, David Gilbride, Chris Chan, Rami Farjo

Purpose: Direct oral anticoagulants (DOACs) are the preferred choice of anticoagulation therapy for nonvalvular atrial fibrillation and venous thromboembolism. Inadequate monitoring of patients on DOACs may lead to suboptimal outcomes and safety concerns. This project aimed to implement a standardized telemedicine-based DOAC monitoring service and track pharmacist-based interventions. Methods: This project was conducted at a safety-net hospital over 6 months. Anticoagulation pharmacists developed a scheduling process for telemedicine DOAC follow-up appointments, integrated them into the electronic health record, and implemented standardized protocols and documentation tools. Outcomes of interest included the average number of pharmacist interventions per encounter and per patient. Results: One hundred sixty-four encounters involving 120 patients were included in the analysis. 92.7% of encounters resulted in at least 1 intervention, with 73.8% involving an education intervention. The average number of interventions per patient was 2.0, with 37.2% of encounters having multiple interventions. Conclusion: Implementation of a standardized telemedicine-based monitoring service allowed for pharmacist identification and management of issues related to DOAC therapy. These findings emphasize the importance of pharmacist-led interventions and telemedicine-based follow-up of DOAC therapy.

目的:直接口服抗凝剂(DOAC)是治疗非瓣膜性心房颤动和静脉血栓栓塞的首选抗凝疗法。如果对使用 DOACs 的患者监测不足,可能会导致疗效不佳和安全问题。本项目旨在实施基于远程医疗的标准化 DOAC 监测服务,并跟踪基于药剂师的干预措施。方法:该项目在一家安全网医院进行,为期 6 个月。抗凝药剂师为远程医疗 DOAC 随访制定了日程安排流程,将其整合到电子病历中,并实施了标准化协议和文档工具。研究结果包括药剂师对每位患者和每次就诊的平均干预次数。结果:共分析了 120 名患者的 164 次就诊。92.7% 的会诊至少进行了一次干预,其中 73.8% 涉及教育干预。每名患者的平均干预次数为 2.0 次,37.2% 的患者接受了多次干预。结论基于远程医疗的标准化监测服务的实施使药剂师能够识别和管理与 DOAC 治疗相关的问题。这些发现强调了药剂师主导的干预和基于远程医疗的 DOAC 治疗随访的重要性。
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引用次数: 0
Donepezil and Memantine-Induced Second-Degree Atrioventricular Block: A Case Report. 多奈哌齐和美金刚诱发二度房室传导阻滞:病例报告。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-24 DOI: 10.1177/00185787241287368
Manjappa Mahadevappa, Sakeer Hussain, Shivananda Manohar

Donepezil and memantine are second-generation antipsychotics widely used in the management of mild to moderate Alzheimer's disease. These drugs are highly selective for the central nervous system, targeting different neural pathways to mitigate cognitive decline. Donepezil is a reversible and specific acetylcholinesterase inhibitor, while memantine is an NMDA receptor antagonist which modulates glutamatergic activity. Although these medications are safe, they are associated with adverse effects, and cardiovascular complications are rare. The reported cardiac adverse drug reactions include bradycardia, atrioventricular block, and prolonged QT interval. We are reporting a case of an 81-year-old male patient with schizophrenia, Alzheimer's disease and bilateral sensorineural deafness receiving oral donepezil and memantine presented with second-degree atrioventricular block. The patient's atrioventricular block recovered completely in 2 to 3 weeks after the discontinuation of donepezil-memantine and with a short course of sympathomimetic drugs.

多奈哌齐和美金刚是第二代抗精神病药物,广泛用于治疗轻度至中度阿尔茨海默病。这些药物对中枢神经系统具有高度选择性,可针对不同的神经通路缓解认知能力下降。多奈哌齐是一种可逆的特异性乙酰胆碱酯酶抑制剂,而美金刚则是一种 NMDA 受体拮抗剂,可调节谷氨酸能活动。虽然这些药物是安全的,但也会产生不良反应,而心血管并发症则很少见。已报道的心脏不良药物反应包括心动过缓、房室传导阻滞和 QT 间期延长。我们报告了一例 81 岁的男性患者,患有精神分裂症、阿尔茨海默病和双侧感音神经性耳聋,口服多奈哌齐和美金刚,出现二度房室传导阻滞。停用多奈哌齐-美金刚和短期交感神经药物后,患者的房室传导阻滞在 2 至 3 周内完全恢复。
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引用次数: 0
Validation of an UPLC-PDA Method for the Simultaneous Quantification of Phenol and Iomeprol in a Sterile Parenteral Preparation Used for Coeliac Plexus Block, and Its Application to a Pharmaceutical Stability Study. 用于无菌腹腔神经丛阻滞的肠外制剂中苯酚和碘美醇同时定量的 UPLC-PDA 方法的验证及其在药物稳定性研究中的应用。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-18 DOI: 10.1177/00185787241289023
Sjoerd D Meenks, Anne J A Drost-Wijnne, Ralph A C van Wezel, Hans J A van Suijlekom, Willemijn Jansen, Arne A L Rutgers, Mieke W de Blois, Maarten J Deenen

Objectives: A commonly applied analgesic therapy for patients with severe abdominal pain due to cancer-related pain in the upper abdomen, is coeliac plexus neurolysis (CPN). Herein, a combination product of phenol and an iodine contrast agent are injected simultaneously. The chemical stability of such a combination product is unknown, and no chromatographic method is yet available that describes the simultaneous quantification of phenol and iomeprol. The aim of this study was to develop and validate a stability-indicating UPLC method for the simultaneous quantification of both phenol and iomeprol and to determine the chemical stability of a sterile 100 mg/mL phenol in 350 mg I/mL iomeprol solution for injection during shelf life. Methods: The product was compounded and sterilized in a GMP certified facility. The pharmaceutical analysis was validated by determination of the accuracy, precision, specificity, selectivity, carry-over and linearity. Pharmaceutical product stability was determined before and after sterilization, and during shelf life of 36 months at 25°C ± 2°C. Results: The accuracy for phenol and iomeprol was 97.1% to 99.3% and 100.0% to 100.2%, respectively. The RSD for repeatability and reproducibility for phenol were 0.65% and 1.17%, and for iomeprol 0.61% and 1.49%, respectively. All other tested parameters met the predefined validation criteria. All concentrations at all tested time points remained within ±2% of the initial concentrations for phenol and ±4% for iomeprol. No additional peaks were visible on the chromatograms. Conclusion: A stability-indicating method for the simultaneous quantification of phenol and iomeprol in a parental pharmaceutical preparation was developed and validated. This method was used to demonstrate the chemical stability of a newly developed sterile solution of 100 mg/mL phenol and 350 mg I/mL iomeprol. Chemical product stability was demonstrated during shelf life of up to 36 months.

目的:腹腔神经丛神经溶解术(CPN)是治疗上腹部癌症相关性剧烈腹痛患者的常用镇痛疗法。在这种疗法中,需要同时注射苯酚和碘造影剂。这种混合产物的化学稳定性尚不清楚,也没有色谱法可同时定量分析苯酚和碘甲醇。本研究旨在开发并验证一种同时定量苯酚和碘美醇的稳定性指示 UPLC 方法,并确定注射用 350 毫克 I/ 毫升碘美醇溶液中 100 毫克/毫升无菌苯酚在保质期内的化学稳定性。方法产品在通过 GMP 认证的工厂进行配制和灭菌。通过测定准确度、精密度、特异性、选择性、携带性和线性,对药物分析进行了验证。测定了灭菌前后以及在 25°C ± 2°C 下 36 个月保质期内药品的稳定性。结果表明苯酚和碘甲醇的准确度分别为 97.1%至 99.3%和 100.0%至 100.2%。苯酚的重复性和再现性 RSD 分别为 0.65% 和 1.17%,碘甲醇的 RSD 分别为 0.61% 和 1.49%。所有其他测试参数均符合预定的验证标准。在所有测试时间点,苯酚和碘甲醇的浓度均保持在初始浓度的 ±2% 和 ±4% 范围内。色谱图上没有出现额外的峰值。结论建立并验证了同时定量母体药物制剂中苯酚和碘美醇的稳定性指示方法。该方法用于验证新开发的 100 mg/mL 苯酚和 350 mg I/mL 碘美醇无菌溶液的化学稳定性。结果表明,产品在长达 36 个月的保质期内具有化学稳定性。
{"title":"Validation of an UPLC-PDA Method for the Simultaneous Quantification of Phenol and Iomeprol in a Sterile Parenteral Preparation Used for Coeliac Plexus Block, and Its Application to a Pharmaceutical Stability Study.","authors":"Sjoerd D Meenks, Anne J A Drost-Wijnne, Ralph A C van Wezel, Hans J A van Suijlekom, Willemijn Jansen, Arne A L Rutgers, Mieke W de Blois, Maarten J Deenen","doi":"10.1177/00185787241289023","DOIUrl":"10.1177/00185787241289023","url":null,"abstract":"<p><p><b>Objectives:</b> A commonly applied analgesic therapy for patients with severe abdominal pain due to cancer-related pain in the upper abdomen, is coeliac plexus neurolysis (CPN). Herein, a combination product of phenol and an iodine contrast agent are injected simultaneously. The chemical stability of such a combination product is unknown, and no chromatographic method is yet available that describes the simultaneous quantification of phenol and iomeprol. The aim of this study was to develop and validate a stability-indicating UPLC method for the simultaneous quantification of both phenol and iomeprol and to determine the chemical stability of a sterile 100 mg/mL phenol in 350 mg I/mL iomeprol solution for injection during shelf life. <b>Methods:</b> The product was compounded and sterilized in a GMP certified facility. The pharmaceutical analysis was validated by determination of the accuracy, precision, specificity, selectivity, carry-over and linearity. Pharmaceutical product stability was determined before and after sterilization, and during shelf life of 36 months at 25°C ± 2°C. <b>Results:</b> The accuracy for phenol and iomeprol was 97.1% to 99.3% and 100.0% to 100.2%, respectively. The RSD for repeatability and reproducibility for phenol were 0.65% and 1.17%, and for iomeprol 0.61% and 1.49%, respectively. All other tested parameters met the predefined validation criteria. All concentrations at all tested time points remained within ±2% of the initial concentrations for phenol and ±4% for iomeprol. No additional peaks were visible on the chromatograms. <b>Conclusion:</b> A stability-indicating method for the simultaneous quantification of phenol and iomeprol in a parental pharmaceutical preparation was developed and validated. This method was used to demonstrate the chemical stability of a newly developed sterile solution of 100 mg/mL phenol and 350 mg I/mL iomeprol. Chemical product stability was demonstrated during shelf life of up to 36 months.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787241289023"},"PeriodicalIF":0.8,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619214","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
Impact of Methicillin-Resistant Staphylococcus aureus Nasal Polymerase Chain Reaction Screening Tests on Duration of Vancomycin Therapy for Skin and Soft Tissue Infections. 耐甲氧西林金黄色葡萄球菌鼻聚合酶链反应筛查试验对万古霉素治疗皮肤和软组织感染持续时间的影响。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-17 DOI: 10.1177/00185787241289281
Aleesha Jantzen, Nathan Woolever, Megan Treu, Jaclyn Stakston, Songlin Cai, Jennifer Tempelis, Richard Charles Kujak, Ross A Dierkhising, Ala S Dababneh, Sarah Lessard

Background: Recent literature demonstrated a 24-hour reduction in vancomycin duration of therapy (DOT) for skin and soft tissue infections (SSTIs) with a negative methicillin-resistant staphylococcus aureus (MRSA) nasal screening versus a positive nasal screening. Objective of this study was to investigate vancomycin DOT in patients with SSTIs who received MRSA nasal polymerase chain reaction (PCR) screening versus those who did not receive MRSA nasal PCR screening. Methods: A retrospective, multi-center, cohort study was completed in admitted adult patients on vancomycin for SSTI from 01/01/2020 to 09/30/2022. Hospital policy permits any clinician to order a MRSA nasal PCR screening test for various indications, including SSTIs, pneumonia and sepsis. Results: One-hundred-fifty-one patients were included, of which 71 had MRSA nasal PCR screening tests obtained, and 80 did not. The median vancomycin DOT in patients with MRSA nasal PCR screening tests was 19.9 versus 36.7 hours (P = .014) in patients without screening tests. Conclusion: Patients with SSTIs who receive MRSA nasal PCR screening tests have a shortened vancomycin DOT. These results contribute to current data in support of the efficacy and clinical utility of obtaining MRSA nasal PCR screening tests for SSTIs.

背景:近期文献显示,耐甲氧西林金黄色葡萄球菌(MRSA)鼻腔筛查阴性与鼻腔筛查阳性的皮肤和软组织感染(SSTI)患者的万古霉素疗程(DOT)缩短了 24 小时。本研究旨在调查接受 MRSA 鼻腔聚合酶链反应(PCR)筛查与未接受 MRSA 鼻腔 PCR 筛查的 SSTI 患者的万古霉素 DOT 情况。研究方法对 2020 年 1 月 1 日至 2022 年 9 月 30 日期间因 SSTI 而使用万古霉素的入院成人患者进行回顾性、多中心、队列研究。医院政策允许任何临床医生针对各种适应症(包括 SSTI、肺炎和败血症)进行 MRSA 鼻腔 PCR 筛查试验。结果:共纳入 151 名患者,其中 71 人接受了 MRSA 鼻腔 PCR 筛查测试,80 人未接受测试。进行了 MRSA 鼻腔 PCR 筛查测试的患者万古霉素 DOT 中位数为 19.9 小时,而未进行筛查测试的患者 DOT 中位数为 36.7 小时(P = .014)。结论:接受 MRSA 鼻腔 PCR 筛查测试的 SSTI 患者的万古霉素 DOT 时间较短。这些结果为目前支持针对 SSTIs 进行 MRSA 鼻腔 PCR 筛查试验的有效性和临床实用性的数据做出了贡献。
{"title":"Impact of Methicillin-Resistant <i>Staphylococcus aureus</i> Nasal Polymerase Chain Reaction Screening Tests on Duration of Vancomycin Therapy for Skin and Soft Tissue Infections.","authors":"Aleesha Jantzen, Nathan Woolever, Megan Treu, Jaclyn Stakston, Songlin Cai, Jennifer Tempelis, Richard Charles Kujak, Ross A Dierkhising, Ala S Dababneh, Sarah Lessard","doi":"10.1177/00185787241289281","DOIUrl":"10.1177/00185787241289281","url":null,"abstract":"<p><p><b>Background:</b> Recent literature demonstrated a 24-hour reduction in vancomycin duration of therapy (DOT) for skin and soft tissue infections (SSTIs) with a negative methicillin-resistant staphylococcus aureus (MRSA) nasal screening versus a positive nasal screening. Objective of this study was to investigate vancomycin DOT in patients with SSTIs who received MRSA nasal polymerase chain reaction (PCR) screening versus those who did not receive MRSA nasal PCR screening. <b>Methods:</b> A retrospective, multi-center, cohort study was completed in admitted adult patients on vancomycin for SSTI from 01/01/2020 to 09/30/2022. Hospital policy permits any clinician to order a MRSA nasal PCR screening test for various indications, including SSTIs, pneumonia and sepsis. <b>Results:</b> One-hundred-fifty-one patients were included, of which 71 had MRSA nasal PCR screening tests obtained, and 80 did not. The median vancomycin DOT in patients with MRSA nasal PCR screening tests was 19.9 versus 36.7 hours (<i>P</i> = .014) in patients without screening tests. <b>Conclusion:</b> Patients with SSTIs who receive MRSA nasal PCR screening tests have a shortened vancomycin DOT. These results contribute to current data in support of the efficacy and clinical utility of obtaining MRSA nasal PCR screening tests for SSTIs.</p>","PeriodicalId":13002,"journal":{"name":"Hospital Pharmacy","volume":" ","pages":"00185787241289281"},"PeriodicalIF":0.8,"publicationDate":"2024-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142619156","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
Evaluation of Timing of Pharmacologic Venous Thromboembolism Prophylaxis Initiation in Trauma Patients at a Level One Trauma Center. 评估一级创伤中心创伤患者开始静脉血栓栓塞预防药物治疗的时机。
IF 0.8 Q4 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-15 DOI: 10.1177/00185787241289289
Taylor A Holder, Cory B McGinnis, Abby L Chiappelli

Background: Major trauma is a risk factor for venous thromboembolism (VTE). Trauma guidelines recommend prompt initiation of pharmacologic VTE prophylaxis. While early initiation is recommended, delays in therapy can occur. Objective: The aim of this study was to evaluate the compliance of pharmacologic VTE prophylaxis initiation timing with trauma guidelines and impact on rates of VTE, bleeding and in-hospital mortality. Methods: This retrospective cohort study included patients admitted to a trauma unit between January 1, 2020 and December 1, 2021. Patients were stratified by injury type and categorized as either compliant or non-compliant based on timing of initiation. Rates of VTE, bleeding, and in-hospital mortality were collected. Results: Of the 300 patients, 259 (86.3%) were compliant. Reasons for non-compliance included bleeding (19.5%) and pending evaluation for intervention such as nerve block procedure (12.2%) and surgical operation (4.9%). There were no differences in VTE (4.8% vs 1.2%, P = .139) or bleeding (4.6% vs 0%, P = N/A) between groups. There was a higher rate of in-hospital mortality in the non-compliant group (12.2% vs 2.3%, P = .009). Upon multivariate logistic regression, the ICU setting was identified as a risk factor for noncompliance (P = .020, OR = .45). Conclusion: Initiating pharmacologic VTE prophylaxis in concordance with trauma guidelines led to low observed rates of VTE and bleeding. In evaluating reasons for noncompliance, we identified areas of improvement for initiation including minimizing inappropriate delays in therapy.

背景:重大创伤是静脉血栓栓塞症(VTE)的一个危险因素。创伤指南建议及时启动药物性 VTE 预防。虽然建议尽早开始治疗,但也可能出现治疗延误。研究目的本研究旨在评估药物预防 VTE 的启动时间是否符合创伤指南,以及对 VTE 发生率、出血率和院内死亡率的影响。研究方法:这项回顾性队列研究纳入了 2020 年 1 月 1 日至 2021 年 12 月 1 日期间入住创伤科的患者。根据受伤类型对患者进行分层,并根据开始治疗的时间将患者分为合规和不合规两类。收集了 VTE 发生率、出血率和院内死亡率。结果:在 300 名患者中,259 人(86.3%)符合要求。未遵医嘱的原因包括出血(19.5%)和等待干预评估,如神经阻滞术(12.2%)和外科手术(4.9%)。VTE(4.8% vs 1.2%,P = .139)或出血(4.6% vs 0%,P = N/A)在各组间无差异。违规组的院内死亡率更高(12.2% vs 2.3%,P = .009)。多变量逻辑回归结果显示,重症监护室环境是导致不达标的风险因素(P = .020,OR = .45)。结论根据创伤指南启动 VTE 药物预防可降低 VTE 和出血的发生率。在评估未遵医嘱的原因时,我们发现了需要改进的地方,包括尽量减少不适当的治疗延迟。
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引用次数: 0
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Hospital Pharmacy
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