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Medical Cannabis Dosing Trajectories of Patients: Evidence From Sales Data 医用大麻患者的用药轨迹:来自销售数据的证据。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2024-10-05 DOI: 10.1016/j.clinthera.2024.09.004
Alexandra F. Kritikos PhD , Myfanwy Graham MPharm , Dominic Hodgkin PhD , Rosalie Liccardo Pacula PhD

Purpose

Medical cannabis use is rising with limited high-quality clinical trial data to guide dosing. This study relies on real-world, longitudinal medical cannabis purchase data to provide information on Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) dosing trends for patients with qualifying medical conditions.

Methods

A retrospective study of purchases by 16,727 patients obtaining medical cannabis from dispensaries located in New York between 2016 and 2019, recorded in point-of-sale data. Group-based trajectory modeling was used to identify clusters of patients following similar progressions in dosing of THC and CBD over time. χ2 tests were performed to identify which patient characteristics and qualifying medical conditions were associated with membership in each trajectory group.

Findings

Six trajectory groups were identified that described different patterns in the THC and CBD doses that patients purchased over the whole time period. For THC, the majority of patients (62.6%) purchased a steady amount but at different levels: consistently low (4.1 mg) or moderate (7.4 mg). Three groups, representing 22.0% together, exhibited doses that either fluctuate or constantly increase over time (5–20 mg). A final group of patients (15.8%) exhibited constant decrease in dose from 11 to 5 mg. For CBD, the data show similar trajectories, but at the generally higher values (4–16 mg). Patients with chronic pain, neuropathy, and cancer were overrepresented in groups where higher doses of THC were purchased over time. Patients with epilepsy had a higher representation in groups with higher doses of CBD across time.

Implications

Results suggest heterogeneous dosing patterns and trajectories in the use of medical cannabis by patients with different medical conditions.
目的:医用大麻的使用在不断增加,但用于指导剂量的高质量临床试验数据却很有限。本研究利用真实世界的纵向医用大麻购买数据,为符合医疗条件的患者提供有关Δ-9-四氢大麻酚(THC)和大麻二酚(CBD)剂量趋势的信息:对 2016 年至 2019 年期间从纽约药房购买医用大麻的 16727 名患者的购买情况进行了回顾性研究,这些数据记录在销售点数据中。采用基于群体的轨迹建模来识别随着时间推移在四氢大麻酚和大麻二酚剂量上有类似进展的患者群组。进行了χ2检验,以确定哪些患者特征和合格医疗条件与每个轨迹组的成员资格相关:研究发现:六个轨迹组描述了患者在整个时间段内购买 THC 和 CBD 剂量的不同模式。就四氢大麻酚而言,大多数患者(62.6%)的购买量保持稳定,但剂量水平各不相同:持续低剂量(4.1 毫克)或中剂量(7.4 毫克)。三组患者(共占 22.0%)的剂量随时间波动或持续增加(5-20 毫克)。最后一组患者(15.8%)的剂量从 11 毫克持续减少到 5 毫克。对于 CBD,数据显示了类似的轨迹,但剂量普遍较高(4-16 毫克)。慢性疼痛、神经病变和癌症患者在购买较高剂量四氢大麻酚的群体中比例较高。癫痫患者在不同时期购买较高剂量 CBD 的群体中比例较高:结果表明,不同病症的患者使用医用大麻的剂量模式和轨迹各不相同。
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引用次数: 0
Experimental Evidence of Dexamethasone in Reversing Endothelial Dysfunction in COVID-19: Therapeutic Insights from Intranasal Administration 地塞米松逆转COVID-19内皮功能障碍的实验证据:鼻内给药的治疗见解
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-11 DOI: 10.1016/j.clinthera.2025.11.005
Celeste Trejo-Moreno DSc , Marisol Méndez-Martínez DSc , Zimri A. Alvarado-Ojeda MSc , Sergio Sifontes-Rodríguez PhD , Jaquelynne Cervantes-Torres DSc , Raul J. Bobes DSc , Juan P. Laclette PhD , Edda Sciutto DSc , Gladis Fragoso DSc , Gabriela Rosas-Salgado DSc

Purpose

Vascular endothelial dysfunction (ED) plays a critical role in the pathogenesis of severe COVID-19. Intranasal dexamethasone (IN-DXM) has been reported to improve clinical outcomes more efficiently than intravenous (IV-DXM) administration in hospitalized patients. This study compared the efficacy of both regimens in improving ED.

Methods

Hospitalized COVID-19 patients from the REVIVAL trial received either intranasal dexamethasone (IN-DXM) via a MAD-Nasal device (0.12 mg/kg for 3 days followed by 0.06 mg/kg for 7 days; n = 10) or intravenous dexamethasone (IV-DXM; 6 mg/day for 10 days; n = 7). Respiratory and inflammatory parameters were analyzed before and 10 days after treatment. Serum levels of IL-6, malondialdehyde (MDA), and nitric oxide (NO) metabolites (nitrites) were quantified, along with their effects on human microvascular endothelial cells (HMEC-1) incubated with patient or control sera.

Findings

COVID-19 infection significantly increased IL-6 and MDA and reduced NO levels. Only IN-DXM significantly improved respiratory parameters (FiO₂, SatO₂, pO₂) and reduced serum IL-6. Both regimens decreased peripheral inflammatory markers (C-reactive protein, neutrophil-to-lymphocyte ratio and fibrinogen) and increased NO approaching control levels, improving the vascular function. Notably, only sera from IN-DXM–treated patients normalized IL-6 levels in HMEC-1 supernatants to those of controls. Regardless of the administration route, supernatants from HMEC-1 cells incubated with sera from treated patients showed decreased MDA and increased NO compared with those obtained before treatment.

Implications

The IN-DXM regimen produced greater improvement in respiratory and inflammatory parameters than IV-DXM, supporting its potential as a practical and effective alternative for managing severe COVID-19–associated endothelial dysfunction.
目的:血管内皮功能障碍(ED)在重症COVID-19的发病机制中起关键作用。据报道,在住院患者中,鼻内地塞米松(in - dxm)比静脉注射(IV-DXM)更有效地改善临床结果。方法:来自REVIVAL试验的住院COVID-19患者通过madd - nasal装置接受鼻内地塞米松(in - dxm)治疗(0.12 mg/kg,连续3天,随后0.06 mg/kg,连续7天,n = 10)或静脉内地塞米松(IV-DXM, 6 mg/天,连续10天,n = 7)。分析治疗前和治疗后10天的呼吸和炎症参数。定量血清中IL-6、丙二醛(MDA)和一氧化氮(NO)代谢物(亚硝酸盐)的水平,以及它们对患者或对照血清培养的人微血管内皮细胞(HMEC-1)的影响。结果:COVID-19感染显著升高IL-6和MDA水平,降低NO水平。只有IN-DXM能显著改善呼吸参数(FiO₂、SatO₂、pO₂)和降低血清IL-6。两种方案都降低了外周炎症标志物(c反应蛋白、中性粒细胞与淋巴细胞的比率和纤维蛋白原),并使NO升高至接近控制水平,从而改善了血管功能。值得注意的是,只有接受in - ddxm治疗的患者血清中HMEC-1上清液中的IL-6水平高于对照组。无论给药途径如何,与治疗前相比,HMEC-1细胞与治疗患者血清孵育的上清液显示MDA降低,NO升高。意义:in - dxm方案比IV-DXM方案在呼吸和炎症参数方面产生了更大的改善,支持其作为治疗严重covid -19相关内皮功能障碍的实用有效替代方案的潜力。
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引用次数: 0
Recognizing Arthralgia as a Potential Adverse Effect of CFTR Modulators: A Case Report 认识到关节痛是CFTR调节剂的潜在不良影响:一个病例报告。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-05 DOI: 10.1016/j.clinthera.2025.11.007
Flora Charbonneau Pharm , Magali Dupuy-Grasset MD , Jeanne Languepin MD , Marie-Laure Laroche MD, PhD
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引用次数: 0
Exposure to Budesonide, Glycopyrronium, and Formoterol With a Next-Generation Propellant Does Not Exceed Exposure With Hydrofluoroalkane-134a Propellant When Administered Via Pressurized Metered-Dose Inhaler With a Spacer 通过带间隔剂的加压计量吸入器给药时,布地奈德、甘溴铵和福莫特罗与下一代推进剂的暴露不超过与氢氟烷烃-134a推进剂的暴露。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-04 DOI: 10.1016/j.clinthera.2025.10.011
Hitesh Pandya MBChB, MD , Mehul Patel MBBS, PhD, FRCP , Michael Gillen BS, PhD , Jitendar Reddy MPharm , Artur Bednarczyk MD , Marek Kokot MD, MBA , Yubo Tan MSc , Maria Heijer MSc , Magdalena Andersson MSc, MSBA , David Petullo MSc , Mandeep Jassal MD

Purpose

Hydrofluoroalkane-134a (HFA-134a), the propellant in the marketed budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) formulation, has a global warming potential (GWP) that falls above environmental regulation thresholds and therefore will be phased out. With global efforts to minimize carbon emissions, the hydrofluoroolefin-1234ze (HFO-1234ze) propellant, with a >99% lower GWP than HFA-134a, is in development for pressurized metered-dose inhalers (pMDIs). Spacers support drug delivery in patients with poor pMDI inhalation technique, but it is unknown if BGF exposure with HFO-1234ze exceeds that observed with HFA-134a when using a spacer.

Methods

This Phase I study assessed systemic BGF component exposure with HFO-1234ze versus HFA-134a when using a spacer, and for HFO-1234ze with and without a spacer. Participants (N = 42) were randomized to BGF with HFA-134a with a spacer (reference), HFO-1234ze with a spacer (test), and HFO-1234ze without a spacer (descriptive treatment) over 3 treatment periods in 1 of 6 sequences. As spacer devices help to increase exposure, the upper limit of the 90% confidence interval (CI) of geometric mean ratios (GMRs) was of interest, and bioequivalence was not included as a study objective.

Findings

Analyses demonstrated the upper 90% CI of the GMRs for maximum observed plasma concentration (Cmax) and area under the plasma concentration curve from time zero to the time of the last quantifiable concentration (AUClast) were <125% for all BGF components for HFO-1234ze versus HFA-134a when using a spacer, indicating exposure with HFO-1234ze did not exceed exposure with HFA-134a. Additionally, Cmax was increased for all BGF components with HFO-1234ze when using versus not using a spacer, with the largest increases observed among participants with the lowest exposure when not using a spacer, likely due to poor inhalation technique. No new safety findings, and no deaths or serious adverse events, occurred during the study.

Implications

These findings provide evidence that may help to support the future use of HFO-1234ze propellant in BGF pMDIs.
目的:已上市布地奈德/甘溴铵/富马酸福莫特罗二水合物(BGF)制剂中的推进剂氢氟烷烃-134a (HFA-134a)具有高于环境法规阈值的全球变暖潜能值(GWP),因此将被逐步淘汰。随着全球努力减少碳排放,正在开发用于加压计量吸入器(pmdi)的氢氟烯烃-1234ze (HFO-1234ze)推进剂,其全球升温潜能值比HFA-134a低约99%。在pMDI吸入技术不佳的患者中,隔离剂支持给药,但尚不清楚使用隔离剂时,HFO-1234ze是否会超过HFA-134a所观察到的BGF暴露量。方法:本I期研究评估了使用间隔剂时HFO-1234ze与HFA-134a的全身BGF成分暴露,以及使用和不使用间隔剂的HFO-1234ze。参与者(N = 42)被随机分为含有HFA-134a和间隔物的BGF组(参考组)、含有间隔物的HFO-1234ze组(测试组)和不含间隔物的HFO-1234ze组(描述性组),在6个序列中的1个治疗期间进行3次治疗。由于间隔装置有助于增加暴露,几何平均比率(GMRs)的90%置信区间(CI)的上限值得关注,生物等效性未被纳入研究目标。研究结果:分析表明,最大观察到的血浆浓度(Cmax)的gmr的上90% CI和从时间0到最后可量化浓度(AUClast)的血浆浓度曲线下面积是有意义的:这些发现提供了证据,可能有助于支持HFO-1234ze推进剂在BGF pmdi中的未来使用。
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引用次数: 0
Medical Cannabis Formulations, Administration Routes, and Dosing: Perspectives of Patients With Cancer Who Consume 医用大麻制剂,管理路线和剂量:癌症患者消费的观点。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-11 DOI: 10.1016/j.clinthera.2025.11.004
Manan M. Nayak PhD, MA , Peter R. Chai MD, MS , Stephanie Tung MD , Anna Revette PhD , Ilana M. Braun MD

Purpose

Medical cannabis (MC) is used by 1 in 3 patients with cancer. Scientific work suggests a disconnect between patients’ cannabis therapeutics practices and oncologists’ clinical preferences. This qualitative study explores the preferences of patients with cancer as they relate to MC formulations, administration routes, and dosing.

Methods

Semistructured interviews were conducted with patients with cancer consuming MC in 8 states and examined using thematic analysis.

Findings

Among study participants (N = 24), the mean age was 54 years, 67% were female, and 51% had metastatic disease. A powerful theme identified across interviews was of myriad MC dispensary product formulations, triggering astonishment and burden. Common strategies among participants included purchasing and sampling multiple store-bought formulations, modifying dispensary products, and altering intended routes of administration. Preferred dispensary products were not consistently available. Top-cited modes of administration included oral, followed by topical, sublingual, vaporization, combustion, and rectal suppository. Three-quarters of participants alternated between modes. Medical cannabis dosing imprecision represented another powerful theme due to the lack of dispensary quality assurance and accuracy in home measurements.

Implications

This investigation suggests that MC preparations, dosing, and administration routes vary among patients with cancer, and that common consumption patterns (for instance, reliance on multiple routes of cannabis administration) are not rooted in science. Although these findings should be further interrogated, they suggest a need for lay-facing cannabis therapeutics education and standardization of dispensary products to strengthen cannabis-related care.
目的:三分之一的癌症患者使用医用大麻。科学研究表明,患者的大麻治疗实践与肿瘤学家的临床偏好之间存在脱节。本定性研究探讨了癌症患者对MC配方、给药途径和剂量的偏好。方法:对8个州的癌症患者进行半结构化访谈,并采用主题分析进行检验。结果:在研究参与者(N = 24)中,平均年龄为54岁,67%为女性,51%患有转移性疾病。采访中发现的一个强有力的主题是无数MC药房产品配方,引发惊讶和负担。参与者的共同策略包括购买和抽样多种商店购买的配方,修改药房产品,以及改变预期的管理途径。首选的药房产品并不总是可用的。引用最多的给药方式包括口服,其次是局部、舌下、汽化、燃烧和直肠栓剂。四分之三的参与者在两种模式之间交替。由于药房缺乏质量保证和家庭测量的准确性,医用大麻剂量不精确是另一个强有力的主题。含义:这项调查表明,MC制剂、剂量和给药途径因癌症患者而异,常见的消费模式(例如,依赖多种大麻给药途径)没有科学依据。尽管这些发现还有待进一步研究,但它们表明,有必要开展面向普通人群的大麻治疗学教育和药房产品的标准化,以加强大麻相关护理。
{"title":"Medical Cannabis Formulations, Administration Routes, and Dosing: Perspectives of Patients With Cancer Who Consume","authors":"Manan M. Nayak PhD, MA ,&nbsp;Peter R. Chai MD, MS ,&nbsp;Stephanie Tung MD ,&nbsp;Anna Revette PhD ,&nbsp;Ilana M. Braun MD","doi":"10.1016/j.clinthera.2025.11.004","DOIUrl":"10.1016/j.clinthera.2025.11.004","url":null,"abstract":"<div><h3>Purpose</h3><div>Medical cannabis (MC) is used by 1 in 3 patients with cancer. Scientific work suggests a disconnect between patients’ cannabis therapeutics practices and oncologists’ clinical preferences. This qualitative study explores the preferences of patients with cancer as they relate to MC formulations, administration routes, and dosing.</div></div><div><h3>Methods</h3><div>Semistructured interviews were conducted with patients with cancer consuming MC in 8 states and examined using thematic analysis.</div></div><div><h3>Findings</h3><div>Among study participants (N = 24), the mean age was 54 years, 67% were female, and 51% had metastatic disease. A powerful theme identified across interviews was of myriad MC dispensary product formulations, triggering astonishment and burden. Common strategies among participants included purchasing and sampling multiple store-bought formulations, modifying dispensary products, and altering intended routes of administration. Preferred dispensary products were not consistently available. Top-cited modes of administration included oral, followed by topical, sublingual, vaporization, combustion, and rectal suppository. Three-quarters of participants alternated between modes. Medical cannabis dosing imprecision represented another powerful theme due to the lack of dispensary quality assurance and accuracy in home measurements.</div></div><div><h3>Implications</h3><div>This investigation suggests that MC preparations, dosing, and administration routes vary among patients with cancer, and that common consumption patterns (for instance, reliance on multiple routes of cannabis administration) are not rooted in science. Although these findings should be further interrogated, they suggest a need for lay-facing cannabis therapeutics education and standardization of dispensary products to strengthen cannabis-related care.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 51-56"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145741435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Letter to The Editor, Regarding “Indirect Comparison of Maralixibat and Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis” Recently Published by Lacey and Colleagues 致编辑的信,关于最近由Lacey和同事发表的“马拉利西巴和奥维西巴治疗进行性家族性肝内胆汁淤淤症的间接比较”。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-11-25 DOI: 10.1016/j.clinthera.2025.10.014
Emmanuelle Kaltenbach PharmD, MSc , Virginie Jacquemin PhD , Luis Briseño-Roa PhD , Andres Gomez-Lievano PhD , Marie-Cécile Fournier PhD , Fatine Elaraki MD
{"title":"Letter to The Editor, Regarding “Indirect Comparison of Maralixibat and Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis” Recently Published by Lacey and Colleagues","authors":"Emmanuelle Kaltenbach PharmD, MSc ,&nbsp;Virginie Jacquemin PhD ,&nbsp;Luis Briseño-Roa PhD ,&nbsp;Andres Gomez-Lievano PhD ,&nbsp;Marie-Cécile Fournier PhD ,&nbsp;Fatine Elaraki MD","doi":"10.1016/j.clinthera.2025.10.014","DOIUrl":"10.1016/j.clinthera.2025.10.014","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 127-128"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145631082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Multicenter, Randomized, Double-Blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension” (Clin Ther. 2025 Oct 28. [Epub ahead of print]) 《多中心、随机、双盲、平行、2期临床试验,比较和评估SPC1001和单药治疗原发性高血压患者的疗效和安全性》(临床杂志,2025年10月28日)的更正。[印前Epub])。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-15 DOI: 10.1016/j.clinthera.2025.11.011
Jinho Shin MD, PhD , Seong Hwan Kim MD, PhD , Ki Hoon Han MD, PhD , Moo Hyun Kim MD, PhD , Young Keun Ahn MD, PhD , Il Suk Sohn MD, PhD , Kwang Il Kim MD, PhD , Dong Hun Cha MD, PhD , Soon Jun Hong MD, PhD , Eun Joo Cho MD, PhD , Hae Young Lee MD, PhD , Wook Bum Pyun MD, PhD , Ho Joong Youn MD, PhD , Woo Shik Kim MD, PhD , Moo Yong Rhee MD, PhD , Jun Hee Lee MD, PhD , Jong Won Ha MD, PhD , Ji Yong Choi MD, PhD , Byung Su Yoo MD, PhD , Jin Ok Jeong MD, PhD , Chong Jin Kim MD, PhD
{"title":"Corrigendum to “Multicenter, Randomized, Double-Blind, Parallel, Phase 2 Clinical Trial to Compare and Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension” (Clin Ther. 2025 Oct 28. [Epub ahead of print])","authors":"Jinho Shin MD, PhD ,&nbsp;Seong Hwan Kim MD, PhD ,&nbsp;Ki Hoon Han MD, PhD ,&nbsp;Moo Hyun Kim MD, PhD ,&nbsp;Young Keun Ahn MD, PhD ,&nbsp;Il Suk Sohn MD, PhD ,&nbsp;Kwang Il Kim MD, PhD ,&nbsp;Dong Hun Cha MD, PhD ,&nbsp;Soon Jun Hong MD, PhD ,&nbsp;Eun Joo Cho MD, PhD ,&nbsp;Hae Young Lee MD, PhD ,&nbsp;Wook Bum Pyun MD, PhD ,&nbsp;Ho Joong Youn MD, PhD ,&nbsp;Woo Shik Kim MD, PhD ,&nbsp;Moo Yong Rhee MD, PhD ,&nbsp;Jun Hee Lee MD, PhD ,&nbsp;Jong Won Ha MD, PhD ,&nbsp;Ji Yong Choi MD, PhD ,&nbsp;Byung Su Yoo MD, PhD ,&nbsp;Jin Ok Jeong MD, PhD ,&nbsp;Chong Jin Kim MD, PhD","doi":"10.1016/j.clinthera.2025.11.011","DOIUrl":"10.1016/j.clinthera.2025.11.011","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Page 131"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145767421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Corrigendum to “Evaluating the Clinical and Economic Impact of Ceramide-Infused Skin Barriers in Patients With Intestinal and Urinary Stomas: A Systematic Review and Meta-Analysis” [Clin Ther. 2025;47:e21–e32] “评估神经酰胺注入皮肤屏障对肠和尿口患者的临床和经济影响:系统评价和荟萃分析”的更正[临床杂志];2025;47:e21-e32]。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-12-19 DOI: 10.1016/j.clinthera.2025.12.004
Rosario Caruso PhD, RN, FESNO, FAAN, Silvia Belloni PhD, RN, Beniamino Schiavone MD, Gianluca Conte PhD, RN, Cristina Di Pasquale RN, Arianna Magon PhD, RN, Cristina Arrigoni RN, MSc, Giuseppe Candilio MD, Francesco Stanzione MD, Alessandro Stievano PhD, MSN, MEd, FAAN, FEANS, FESNO, FFNMRCSI, FTNSS, Gennaro Rocco PhD, RN, FFNMRCSI, FESNO, FAAN, Maddalena De Maria PhD, RN, FESNO
{"title":"Corrigendum to “Evaluating the Clinical and Economic Impact of Ceramide-Infused Skin Barriers in Patients With Intestinal and Urinary Stomas: A Systematic Review and Meta-Analysis” [Clin Ther. 2025;47:e21–e32]","authors":"Rosario Caruso PhD, RN, FESNO, FAAN,&nbsp;Silvia Belloni PhD, RN,&nbsp;Beniamino Schiavone MD,&nbsp;Gianluca Conte PhD, RN,&nbsp;Cristina Di Pasquale RN,&nbsp;Arianna Magon PhD, RN,&nbsp;Cristina Arrigoni RN, MSc,&nbsp;Giuseppe Candilio MD,&nbsp;Francesco Stanzione MD,&nbsp;Alessandro Stievano PhD, MSN, MEd, FAAN, FEANS, FESNO, FFNMRCSI, FTNSS,&nbsp;Gennaro Rocco PhD, RN, FFNMRCSI, FESNO, FAAN,&nbsp;Maddalena De Maria PhD, RN, FESNO","doi":"10.1016/j.clinthera.2025.12.004","DOIUrl":"10.1016/j.clinthera.2025.12.004","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages 132-133"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145800057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Evaluation of the Application of Antimicrobial Stewardship on the Rational Use of Antibiotics and Overcoming Antimicrobial Resistance in Tertiary Hospitals: A Point Prevalence Survey 抗菌药物管理在三级医院抗菌药物合理使用和克服耐药性中的应用评价:一项点状流行调查。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-11-24 DOI: 10.1016/j.clinthera.2025.10.008
Sara Youssif Ibrahim PhD , Yara Ali BSc , Zohra Abdelfattah BSc , Amany Gad BSc , Nada Mohamed BSc , Nancy Mortada BSc , Omar Ahmed BSc , Ahmed Nabil BSc , Mahmoud Refay BSc , Ahmed Mohamed BSc , Mohamed Goda BSc , Ahmed Essam Abou Warda PhD , Salwa Selim Abougalambou PhD , Hadeer Ehab Barakat PhD

Purpose

Multidrug-resistant (MDR) microorganisms has emerged as a significant global health crisis leading to higher rates of morbidity. Antimicrobial resistance (AMR) presents a serious challenge in intensive care units (ICUs), where infections caused by MDR pathogens are common. Thus, implementation of antimicrobial stewardship programs (ASPs) ensures prudent antibiotic use and decreases AMR. Therefore, the current study evaluates the impact of ASP applications on empirical antibiotic prescribing practices and AMR through a Point Prevalence Survey (PPS) in ICU settings.

Methods

A prospective, multicentric, quasi-experimental study was conducted in various departments over a period of 12 weeks. Inpatients receiving antibiotics were surveyed before and after the implementation of ASP. These interventions included customizing ASP guidelines, training healthcare team, and auditing prescribing behaviors. Data was analyzed using SPSS, and outcomes evaluated included adherence to guidelines, prevalence of antibiotic use, and appropriateness of prescriptions.

Results

Of the 174 patients were surveyed across PPS. Escherichia coli showed the highest prevalence in PPS-1 (26%), while Klebsiella pneumoniae and Staphylococcus aureus showed the highest in PPS-2 (18%). Carbapenem-resistant Enterobacteriaceae decreased from 25% in PPS-1 to 8% in PPS-2. Guideline-inappropriate prescriptions and missing documentation of preparation or administration method declined from 27.3% to 5.2% (P = 0.000042) and from 78.5% to 56.2% (P = 0.002) respectively, reflecting improved prescribing quality and record-keeping. Although the proportion of prescriptions with improper antibiotic duration increased from 32.1% to 42.7% (P = 0.145), this trend may reflect evolving clinical decision-making rather than a decline in care quality.

Conclusion

The study suggests that ASP interventions were associated with improved antibiotic prescribing practices and adherence to guidelines in ICU settings, contributing to the fight against AMR. Given the study design and sample size, findings are exploratory and suggestive. Future work includes expanding ASP monitoring and education strategies with solutions focusing on antibiotic duration.
目的:耐多药(MDR)微生物已成为导致更高发病率的重大全球健康危机。抗菌素耐药性(AMR)对重症监护病房(icu)构成严重挑战,在重症监护病房中,耐多药病原体引起的感染很常见。因此,抗菌素管理计划(asp)的实施可确保谨慎使用抗生素并减少抗生素耐药性。因此,本研究通过ICU环境中的点患病率调查(PPS)评估ASP应用对经验性抗生素处方实践和AMR的影响。方法:前瞻性、多中心、准实验研究在不同科室进行,为期12周。对ASP实施前后住院患者抗生素使用情况进行调查。这些干预措施包括定制ASP指南、培训医疗团队和审核处方行为。使用SPSS对数据进行分析,结果评估包括对指南的遵守、抗生素使用的流行程度和处方的适当性。结果:174例患者通过PPS进行了调查。PPS-1中大肠杆菌感染率最高(26%),而PPS-2中肺炎克雷伯菌和金黄色葡萄球菌感染率最高(18%)。耐碳青霉烯肠杆菌科从PPS-1的25%下降到PPS-2的8%。处方不规范和制剂或给药方法文件缺失分别从27.3%下降到5.2% (P = 0.000042)和78.5%下降到56.2% (P = 0.002),反映了处方质量和记录保存水平的提高。虽然处方中抗生素持续时间不当的比例从32.1%上升到42.7% (P = 0.145),但这一趋势可能反映了临床决策的演变,而不是护理质量的下降。结论:该研究表明,ASP干预措施与ICU环境中改进的抗生素处方实践和遵守指南有关,有助于对抗AMR。考虑到研究设计和样本量,研究结果是探索性和启发性的。未来的工作包括扩大ASP监测和教育战略,重点关注抗生素持续时间的解决方案。
{"title":"Evaluation of the Application of Antimicrobial Stewardship on the Rational Use of Antibiotics and Overcoming Antimicrobial Resistance in Tertiary Hospitals: A Point Prevalence Survey","authors":"Sara Youssif Ibrahim PhD ,&nbsp;Yara Ali BSc ,&nbsp;Zohra Abdelfattah BSc ,&nbsp;Amany Gad BSc ,&nbsp;Nada Mohamed BSc ,&nbsp;Nancy Mortada BSc ,&nbsp;Omar Ahmed BSc ,&nbsp;Ahmed Nabil BSc ,&nbsp;Mahmoud Refay BSc ,&nbsp;Ahmed Mohamed BSc ,&nbsp;Mohamed Goda BSc ,&nbsp;Ahmed Essam Abou Warda PhD ,&nbsp;Salwa Selim Abougalambou PhD ,&nbsp;Hadeer Ehab Barakat PhD","doi":"10.1016/j.clinthera.2025.10.008","DOIUrl":"10.1016/j.clinthera.2025.10.008","url":null,"abstract":"<div><h3>Purpose</h3><div>Multidrug-resistant (MDR) microorganisms has emerged as a significant global health crisis leading to higher rates of morbidity. Antimicrobial resistance (AMR) presents a serious challenge in intensive care units (ICUs), where infections caused by MDR pathogens are common. Thus, implementation of antimicrobial stewardship programs (ASPs) ensures prudent antibiotic use and decreases AMR. Therefore, the current study evaluates the impact of ASP applications on empirical antibiotic prescribing practices and AMR through a Point Prevalence Survey (PPS) in ICU settings.</div></div><div><h3>Methods</h3><div>A prospective, multicentric, quasi-experimental study was conducted in various departments over a period of 12 weeks. Inpatients receiving antibiotics were surveyed before and after the implementation of ASP. These interventions included customizing ASP guidelines, training healthcare team, and auditing prescribing behaviors. Data was analyzed using SPSS, and outcomes evaluated included adherence to guidelines, prevalence of antibiotic use, and appropriateness of prescriptions.</div></div><div><h3>Results</h3><div>Of the 174 patients were surveyed across PPS. <em>Escherichia coli</em> showed the highest prevalence in PPS-1 (26%), while <em>Klebsiella pneumoniae</em> and <em>Staphylococcus aureus</em> showed the highest in PPS-2 (18%). Carbapenem-resistant Enterobacteriaceae decreased from 25% in PPS-1 to 8% in PPS-2. Guideline-inappropriate prescriptions and missing documentation of preparation or administration method declined from 27.3% to 5.2% (<em>P</em> = 0.000042) and from 78.5% to 56.2% (<em>P</em> = 0.002) respectively, reflecting improved prescribing quality and record-keeping. Although the proportion of prescriptions with improper antibiotic duration increased from 32.1% to 42.7% (<em>P</em> = 0.145), this trend may reflect evolving clinical decision-making rather than a decline in care quality.</div></div><div><h3>Conclusion</h3><div>The study suggests that ASP interventions were associated with improved antibiotic prescribing practices and adherence to guidelines in ICU settings, contributing to the fight against AMR. Given the study design and sample size, findings are exploratory and suggestive. Future work includes expanding ASP monitoring and education strategies with solutions focusing on antibiotic duration.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 1","pages":"Pages e1-e9"},"PeriodicalIF":3.6,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145602763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of CRRT Timing on Mortality in Oliguric Sepsis-Associated Acute Kidney Injury: A Propensity Score Matching Cohort Study Crrt时间对少尿败血症相关急性肾损伤死亡率的影响:一项倾向评分匹配队列研究。
IF 3.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2026-01-01 Epub Date: 2025-11-21 DOI: 10.1016/j.clinthera.2025.10.012
Jing Li MM , Caiyun Xu MM , Zhe Huang MM , Lan Yao MM , Huayun Liu MM , Fuxing Deng MD , Can Zhu MM , Qinjuan Jiang MM

Purpose

This study aims to evaluate how the timing of continuous renal replacement therapy (CRRT) initiation influences survival outcomes in oliguric patients with sepsis-associated acute kidney injury (S-AKI) admitted to the intensive care unit (ICU).

Methods

Using the MIMIC-IV database, we conducted a retrospective analysis of 2,131 ICU patients with oliguric S-AKI who had CRRT records. Patients were categorized into 2 groups according to the timing of CRRT initiation: early initiation within 48 hours (n = 1,222) and delayed initiation after 48 hours (n = 909) following the onset of oliguria. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were applied to adjust for confounding factors. Baseline characteristics, physiological parameters, and laboratory findings were compared between the 2 groups. Survival outcomes were analyzed using Kaplan-Meier curves and log-rank tests, with a primary focus on 90-day mortality.

Findings

Patients who initiated CRRT more than 48 hours after oliguria onset had significantly longer ICU stays compared to those who received early CRRT (17.6 vs. 11.5 days, P < 0.001) and exhibited higher SOFA scores (11.5 vs. 9.14, P < 0.001). After PSM, delayed CRRT was associated with decreased 90-day survival among patients with oliguria, as demonstrated by Kaplan-Meier analysis (P < 0.05). Causal inference showed a 10% increase in the 90-day mortality rate for patients who started CRRT after 48 hours (ATE 0.11, 95% CI: 0.02 - 0.19, P = 0.01).

Implications

Early initiation of CRRT, within 48 hours of oliguria onset, in S-AKI patients is associated with improved 90-day survival. These findings suggest that earlier CRRT initiation may be beneficial for improving survival outcomes in this patient population.
目的:本研究旨在评估持续肾脏替代治疗(CRRT)起始时间对入住重症监护病房(ICU)的脓毒症相关急性肾损伤(S-AKI)少尿患者的生存结局的影响。方法:使用MIMIC-IV数据库,我们对2131例有CRRT记录的低尿酸S-AKI ICU患者进行回顾性分析。根据CRRT启动时间将患者分为两组:发生少尿后48小时内早期启动(n = 1222)和48小时后延迟启动(n = 909)。采用倾向得分匹配(PSM)和处理加权逆概率(IPTW)来调整混杂因素。比较两组患者的基线特征、生理参数和实验室结果。使用Kaplan-Meier曲线和log-rank检验分析生存结果,主要关注90天死亡率。结果:少尿发作后超过48小时开始CRRT的患者与早期接受CRRT的患者相比,ICU住院时间明显更长(17.6天对11.5天,P < 0.001), SOFA评分更高(11.5比9.14,P < 0.001)。Kaplan-Meier分析显示,PSM后,延迟CRRT与少尿患者90天生存率降低相关(P < 0.05)。因果推断显示,48小时后开始CRRT的患者90天死亡率增加10% (ATE 0.11, 95% CI: 0.02 - 0.19, P = 0.01)。意义:S-AKI患者早期开始CRRT,在少尿发作后48小时内,与提高90天生存率相关。这些发现表明,早期开始CRRT可能有利于改善这类患者的生存结果。
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Clinical therapeutics
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