Current Therapeutic Research-clinical and Experimental最新文献

Facts and Issues of Submitting Applications (Public Knowledge-Based Applications) for Unapproved and Off-label Drugs With High Medical Needs in Japan 日本高医疗需求的未批准和标签外药物提交申请（基于公共知识的申请）的事实和问题

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2026-01-02 DOI: 10.1016/j.curtheres.2025.100819

Akiko Hinomura MA , Daisuke Obata MD, PhD , Jun Matsubayashi MS, MPH , Mayumi Yamanaka MPH , Koji Yamada MS , Rumiko Hosoki PhD , Hiromu Kutsumi MD, PhD , Shin-ya Morita PhD , Shu Kasama MD, PhD

Background

In Japan, to promote the development and application of unapproved and off-label drugs, a review pathway known as the “public knowledge-based application” was established in 1999. This pathway allows companies to submit applications without clinical trials if the drug has publicly known efficacy and safety and is deemed highly necessary for medical purposes.

Objective

The aim of this study is to analyze information published on government websites and to clarify what the criteria for “public knowledge” or “medically necessary” that apply to “public knowledge-based application” that are not yet clear.

Methods

We analyzed the correlation between the evidence presented in applications and the progression from the determination of high medical needs to regulatory approval for unapproved and off-label drugs requested for development by patient groups and academic societies in Japan between August 2013 and March 2022.

Results

Of the 171 requests, 54 were judged to meet the criteria for medical necessity, and 25 of these were judged to meet the criteria for public knowledge-based application. Of the requests that did not meet the criteria for medical necessity, 90% involved existing domestic therapies. Seventy-two percent of requests meeting the public knowledge-based application criteria involved drugs with standard use in 6 Western countries.

Conclusion

This study suggests that the availability of existing domestic therapies and the approval or standard use status of a drug in the 6 Western countries influence the judgment of the applicability of public knowledge-based applications.

在日本，为了促进未经批准和超说明书药物的开发和应用，1999年建立了一种被称为“公共知识应用”的审查途径。这一途径允许制药公司在没有临床试验的情况下提交申请，前提是该药物的有效性和安全性已为公众所知，并且被认为对医疗目的非常必要。目的本研究的目的是分析政府网站公布的资讯，厘清“公共知识”或“医疗必需”的标准是否适用于“公共知识应用”，目前尚不明确。方法：我们分析了2013年8月至2022年3月期间，日本患者团体和学术团体要求开发的未批准和超说明书药物从确定高医疗需求到监管批准的进展与申请中提供的证据之间的相关性。结果171份申请中，54份符合医疗需要标准，25份符合公共知识应用标准。在不符合医疗需要标准的请求中，90%涉及现有的国内疗法。符合公共知识申请标准的申请中，72%涉及6个西方国家标准使用的药物。结论本研究提示，国内现有疗法的可及性以及药物在西方6个国家的批准或标准使用状态会影响对公共知识应用适用性的判断。

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引用次数: 0

Understanding Pharmacokinetic-Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2024 to Better Manage the Risk of Drug Interactions With Concomitant Medications: A Review of Clinical Data From New Drug Applications 了解2024年美国食品和药物管理局批准的药物的药代动力学-药物相互作用，以更好地管理药物与伴随药物相互作用的风险：新药申请的临床数据综述

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-12-16 DOI: 10.1016/j.curtheres.2025.100818

Jingjing Yu MD, PhD, Sophie Argon PharmD, Katie Owens BPharm, PhD, Yan Wang MS, Isabelle Ragueneau-Majlessi MD, MS

Objective

This analysis aimed to provide a mechanistic understanding and an evaluation of the clinical relevance of pharmacokinetic drug-drug interactions (DDIs) associated with drugs approved by the Food and Drug Administration in 2024.

Methods

Drug metabolism, transport, and absorption-based DDI data available in New Drug Applications (NDAs) of small molecular drugs approved (n = 34) was analyzed. The mechanism and clinical outcome of these interactions were characterized based on in vitro, in silico, and clinical data.

Results

As objects, 11 drugs were identified as clinical substrates. Of these, 7 drugs were substrates of CYP3A, 3 of CYP2C9, one of CYP1A2, and one of CYP2C8, including the sensitive substrates vanzacaftor (CYP3A) and vorasidenib (CYP1A2). As precipitants, 6 drugs (acoramidis, cefepime/enmetazobactam, givinostat, lazertinib, mavorixafor, and resmetirom) were clinical inhibitors of CYP enzymes (2C8, 2C9, 2D6, 2E1, and 3A), with mavorixafor being a CYP2D6 strong inhibitor. Two drugs (elafibranor and tovorafenib) showed weak induction of CYP3A. Regarding transporter data, 3 drugs were substrates of transporters, including seladelpar (BCRP and OAT3), sulopenem (OAT3), and vadadustat (OAT1/3), and 8 drugs (arimoclomol, danicopan, givinostat, lazertinib, mavorixafor, resmetirom, vadadustat, and vazacaftor/tezacaftor/deutivacaftor) were inhibitors of transporters. All clinical DDIs with AUC changes ≥ 2-fold triggered labeling recommendations. Several DDIs with an AUC change <2 also had labeling recommendations, pertaining most often to the concomitant use of drugs with a narrow therapeutic index.

Conclusions

Mechanistic DDI insights from newly approved therapies can be extrapolated to inform the management of commonly co-administered drugs, supporting a safer and more effective use of new drug products in the context of polypharmacy.

目的本分析旨在对2024年fda批准的药物的药代动力学药物相互作用（ddi）的临床相关性提供机制理解和评价。方法对已获批的34个小分子药物新药申请（NDAs）中基于药物代谢、转运和吸收的DDI数据进行分析。这些相互作用的机制和临床结果基于体外、计算机和临床数据进行了表征。结果11种药物被确定为临床底物。其中7种药物为CYP3A底物，3种为CYP2C9底物，1种为CYP1A2底物，1种为CYP2C8底物，包括敏感底物vanzacaftor （CYP3A）和vorasidenib （CYP1A2）。作为沉淀剂，6种药物（acoramidis、头孢吡肟/恩美唑巴坦、吉维司他、拉泽替尼、马伏里沙福、雷司替龙）是CYP酶（2C8、2C9、2D6、2E1、3A）的临床抑制剂，其中马伏里沙福是CYP2D6强抑制剂。两种药物（elafbranor和tovorafenib）对CYP3A的诱导作用较弱。在转运体数据方面，有3种药物是转运体的底物，包括seladelpar （BCRP和OAT3）、sulopenem （OAT3）和vadadustat (OAT1/3)， 8种药物是转运体的抑制剂（阿莫洛莫、达尼可泮、吉维司他、lazertinib、mavorixafor、resmetirom、vadadustat和vazacaftor/tezacaftor/ detivacaftor）。所有AUC变化≥2倍的临床ddi均触发标签推荐。一些AUC改变的ddi也有标签建议，最常见的是伴随使用治疗指数较窄的药物。结论从新批准的治疗方法中推断出DDI的机制，可以为共同给药药物的管理提供信息，支持在多药环境下更安全、更有效地使用新药。

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引用次数: 0

Insomnia and Its Therapeutic Approaches Among University Students in Madrid 马德里大学生失眠症及其治疗方法

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-11-17 DOI: 10.1016/j.curtheres.2025.100815

Alejandro Martínez Lledín MD , Marta Mora Massó MD , Ana Oliva Sánchez MD, PhD , Sandra Pérez Hernández MD , Paula Prada Sanz MD , Francisco Abad-Santos MD, PhD

Purpose

Insomnia is a common sleep disorder that affects students’ academic performance and quality of life. This study aims to assess the prevalence of insomnia among students from various degrees enrolled at several universities in Madrid, examine the factors influencing its prevalence, and evaluate the different methods students use to alleviate the problem.

Methods

We conducted a cross-sectional study using an anonymous “Google Forms” survey that included a validated insomnia questionnaire and additional relevant questions. The survey was distributed online, and we collected 414 responses, of which 408 were valid.

Findings

Of these, 44 students (10.8%) reported moderate insomnia, and 3 (0.7%) severe insomnia. Insomnia was more frequent among women (13.8% of 298 women) compared to men (4.6% of 108 men) (P = 0.01). There were no significant differences between different degree programs or between lower and higher year students. Academic performance and mood were lower in students with insomnia. Thirty students (7.4%) reported using medications to aid sleep, such as melatonin or benzodiazepines; 66 (16.2%) used herbal products, and 24 (5.9%) used both. Of the students with insomnia, 28 (59.6%) used medications or herbal products, compared to 92 (25.5%) of those without insomnia (P < 0.001).

Implications

We conclude that 11.5% of students suffer from insomnia, and 40% of them do not receive any treatment, indicating a need for improved diagnostic measures and increased treatment options.

目的：失眠是一种常见的睡眠障碍，影响学生的学习成绩和生活质量。本研究旨在评估马德里几所大学不同学位学生的失眠症患病率，研究影响其患病率的因素，并评估学生使用不同的方法来缓解这个问题。方法采用匿名“谷歌表格”进行横断面研究，包括一份经过验证的失眠问卷和其他相关问题。本次调查通过网络发布，共收到414份回复，其中有效回复408份。在这些学生中，44人（10.8%）报告中度失眠，3人（0.7%）报告重度失眠。女性（298名女性中的13.8%）比男性（108名男性中的4.6%）失眠更频繁（P = 0.01）。不同学位课程之间、低年级学生与高年级学生之间无显著差异。失眠症学生的学习成绩和情绪都较差。30名学生（7.4%）报告使用褪黑激素或苯二氮卓类药物等帮助睡眠的药物；66人（16.2%）使用草药产品，24人（5.9%）两者都使用。在失眠的学生中，有28人（59.6%）使用药物或草药产品，而无失眠的学生中有92人（25.5%）使用药物或草药产品（P < 0.001）。我们得出结论，11.5%的学生患有失眠症，其中40%的人没有接受任何治疗，这表明需要改进诊断措施和增加治疗选择。

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引用次数: 0

Evaluation of Adverse Effects and Tolerability of Dietary Ginger Supplementation in Patients With Functional Dyspepsia 功能性消化不良患者膳食补充生姜的不良反应和耐受性评价

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100792

Lemlem Gebremariam Aregawi PhD , Csiki Zoltan MD, PhD

Background

Functional dyspepsia (FD) is a prevalent upper gastrointestinal disorder characterized by chronic or recurrent symptoms, including epigastric pain, bloating, and nausea. Ginger (Zingiber officinale), a natural dietary supplement traditionally used to relieve gastrointestinal discomfort, has limited evidence regarding its safety and tolerability in patients with FD.

Objective

To evaluate the safety, tolerability, and adverse effects of ginger supplementation in patients with FD.

Methods

This open-label clinical trial was conducted at the Internal Medicine Outpatient Department, University of Debrecen. This study was conducted in full compliance with the ethical principles outlined in the Declaration of Helsinki. The study protocol was reviewed and approved by the Ethics Committee of the University of Debrecen (registry reference number: DE RKEB/IKEB 5622-2020). All participants provided written informed consent prior to their inclusion in the study. Fifty patients with FD were initially enrolled, and 47 participants completed the study. Ginger supplementation was administered at a dose of 1080 mg/d in divided doses over 8 weeks. Adverse effects were assessed weekly through clinical evaluations and self-reports, and tolerability was rated by participants at the end of the trial.

Results

The study included 47 patients with FD who completed the trial, with a mean (SD) age of 51.49 (14.64) years. Of the participants, 78.7% were females. Ginger supplementation was well tolerated, with mild and transient adverse effects reported, including bloating (14.9%), heartburn (12.8%), and diarrhea (10.6%). None of these adverse events necessitated discontinuation of the treatment. Tolerability was rated as good or excellent by 87.2% of participants, and no severe adverse events were observed.

Conclusions

Preliminary findings suggest ginger is well tolerated and may be a viable complementary dietary therapy, though further research is needed. ClinicalTrials.gov identifier: NCT06313814.

背景：功能性消化不良（FD）是一种常见的上消化道疾病，其特征是慢性或复发性症状，包括胃脘痛、腹胀和恶心。生姜（Zingiber officinale）是一种天然膳食补充剂，传统上用于缓解胃肠道不适，关于其在FD患者中的安全性和耐受性的证据有限。目的评价FD患者补充生姜的安全性、耐受性和不良反应。方法本开放临床试验在德布勒森大学内科门诊部进行。这项研究是在完全遵守《赫尔辛基宣言》中概述的伦理原则的情况下进行的。研究方案由德布勒森大学伦理委员会审查并批准（注册参考号：DE RKEB/IKEB 5622-2020）。所有参与者在纳入研究之前都提供了书面知情同意书。最初招募了50名FD患者，47名参与者完成了研究。补充生姜的剂量为1080mg /d，分次服用，持续8周。每周通过临床评估和自我报告评估不良反应，并在试验结束时由参与者评估耐受性。结果该研究包括47例FD患者，他们完成了试验，平均（SD）年龄为51.49（14.64）岁。在参与者中，78.7%是女性。生姜补充剂耐受性良好，报告有轻微和短暂的不良反应，包括腹胀（14.9%）、胃灼热（12.8%）和腹泻（10.6%）。这些不良事件都不需要停止治疗。87.2%的参与者的耐受性被评为良好或优秀，没有观察到严重的不良事件。结论初步研究结果表明，生姜具有良好的耐受性，可能是一种可行的膳食补充疗法，但仍需进一步研究。ClinicalTrials.gov识别码：NCT06313814。

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引用次数: 0

Tarlatamab and the Future of Immunotherapy: A New Approach to Small Cell Lung Cancer 塔拉他单抗和免疫治疗的未来：治疗小细胞肺癌的新途径。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2024.100773

Raza Ur Rehman MBBS, Ahmad Furqan Anjum MBBS, Rida Fatima MBBS

引用次数: 0

Pumpkin Seeds as a Natural Remedy for Anemia: Nutritional Insights and Therapeutic Potential 南瓜籽作为贫血的天然疗法：营养见解和治疗潜力

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100797

Andugula Swapna Kumari MSc , Gowrishankar Arumugam MD , Shyamaladevi Babu MPhil, PhD , Madhan Krishnan MSc, PhD , Nohini Sandhya Singampalli M.Sc , Jayanthi Chandramohan M.Sc

Anemia is a widespread global health concern characterized by reduced hemoglobin levels and diminished oxygen-carrying capacity of the blood. According to the World Health Organization, anemia affects 40% of children aged 6 to 59 months, 37% of pregnant women, and 30% of women aged 15 to 49 years globally. The condition is primarily linked to iron deficiency, particularly in low- and middle-income countries, although other factors such as vitamin B12 insufficiency, parasitic infections, chronic diseases, and genetic disorders also contribute. The socioeconomic and health impacts of anemia highlight the need for effective prevention and management strategies. Dietary interventions play a critical role in addressing iron deficiency, with functional foods gaining prominence for their sustainable and cost-effective potential. Among these, pumpkin seeds (Cucurbita spp) stand out due to their rich nutrient profile and potential health benefits. This review explores the global and Indian prevalence of anemia, the nutritional complexity of the condition, and the therapeutic potential of pumpkin seeds. It discusses their nutritional composition, mechanisms of action, and current evidence supporting their role in combating anemia while identifying research gaps and future directions for establishing standardized dietary recommendations. Much literature and scientific research underscore the importance of nutrient-dense foods such as pumpkin seeds, which are rich in essential micronutrients such as iron, zinc, magnesium, and bioactive compounds that support hematopoiesis and overall health. Leveraging the therapeutic potential of these natural alternatives, alongside fortified food programs and precise monitoring methods, can significantly contribute to anemia reduction and improve public health outcomes.

贫血是一种普遍的全球健康问题，其特征是血红蛋白水平降低和血液携氧能力减弱。根据世界卫生组织的数据，全球40%的6至59个月大的儿童、37%的孕妇和30%的15至49岁的妇女患有贫血。这种情况主要与缺铁有关，特别是在低收入和中等收入国家，尽管维生素B12不足、寄生虫感染、慢性病和遗传疾病等其他因素也有影响。贫血的社会经济和健康影响突出表明需要有效的预防和管理战略。饮食干预在解决缺铁问题方面发挥着关键作用，功能性食品因其可持续和具有成本效益的潜力而备受关注。其中，南瓜籽（葫芦科）因其丰富的营养成分和潜在的健康益处而脱颖而出。这篇综述探讨了全球和印度贫血的患病率，营养复杂性的条件，和南瓜籽的治疗潜力。它讨论了它们的营养成分、作用机制以及支持它们在对抗贫血中的作用的现有证据，同时确定了研究空白和建立标准化饮食建议的未来方向。许多文献和科学研究都强调了营养丰富的食物的重要性，比如南瓜籽，它富含必需的微量营养素，如铁、锌、镁，以及支持造血和整体健康的生物活性化合物。利用这些天然替代品的治疗潜力，加上强化食品计划和精确的监测方法，可以显著有助于减少贫血并改善公共卫生结果。

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引用次数: 0

Cognitive Effect of Levetiracetam in Patients with Alzheimer’s Disease or Mild Cognitive Impairment: A Systematic Review 左乙拉西坦对阿尔茨海默病或轻度认知障碍患者认知效果的系统评价

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100798

Mohamad Hosein Mohamadi MD , Amir Bavafa PhD , Sahar Salehi PhD , Mahsa Abedi MSc , Fahimeh Shahabi MSc , Sana Jafarlou MD , Pirhossein Kolivand PhD , Sajad Sahab-Negah PhD

Background

Various therapeutic interventions have been investigated for cognitive impairment, a common problem in Alzheimer’s disease (AD). Levetiracetam (LEV), an antiepileptic drug, has been shown to alleviate cognitive impairment.

Objective

The present systematic review aimed to evaluate the cognitive effects of LEV in patients with AD or mild cognitive impairment (MCI).

Methods

We searched PubMed/MEDLINE, Scopus, Web of Sciences, and Embase databases for all studies on LEV and cognitive impairment. After multistep screening, we identified qualified interventional studies and performed further data extraction. We reviewed the methodological diversity across the studies and assessed the quality of each study using the critical appraisal of the Joanna Briggs Institute checklist (the risk of bias assessment).

Results

Of the 1091 publications, only 5 articles were qualified for review. All studies enrolled patients with AD or MCI, and at least 1 arm of the trial involved LEV therapy. Four of 5 studies reported significant cognitive improvement in patients with AD or MCI after the LEV trials, whereas 1 study found no significant change in cognitive status. The risk of bias assessment revealed that 4 studies had a low risk of bias. Among them, 3 showed significant improvement, whereas 1 did not report a significant change in cognitive function.

Conclusions

The efficacy of LEV therapy for cognitive impairment varies across studies owing to different methodologies, dosages, treatment durations, and outcome assessment tools. This study suggests that LEV may exert a beneficial impact on cognitive function in patients with AD or MCI. However, a quantitative comparison or meta-analysis is essential to draw definitive conclusions about the cognitive effects of LEV in AD and MCI.

认知障碍是阿尔茨海默病（AD）的一个常见问题，人们已经研究了各种治疗干预措施。左乙拉西坦（LEV）是一种抗癫痫药物，已被证明可以减轻认知障碍。目的评价LEV对AD或轻度认知障碍（MCI）患者认知功能的影响。方法检索PubMed/MEDLINE、Scopus、Web of Sciences和Embase数据库中所有关于LEV和认知障碍的研究。经过多步筛选，我们确定了合格的介入研究，并进行了进一步的数据提取。我们回顾了研究方法的多样性，并使用乔安娜布里格斯研究所清单（偏见风险评估）的关键评估来评估每项研究的质量。结果1091篇文献中，仅有5篇符合评审条件。所有的研究都纳入了AD或MCI患者，并且至少有一个组的试验涉及LEV治疗。5项研究中有4项报告了LEV试验后AD或MCI患者的认知能力有显著改善，而1项研究发现认知状态没有显著变化。偏倚风险评估显示，4项研究偏倚风险较低。其中3例有明显改善，1例认知功能无明显改变。由于不同的方法、剂量、治疗持续时间和结果评估工具，LEV治疗认知障碍的疗效在不同的研究中存在差异。本研究提示LEV可能对AD或MCI患者的认知功能产生有益影响。然而，定量比较或荟萃分析对于得出关于LEV对AD和MCI的认知影响的明确结论至关重要。

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引用次数: 0

Effect of Emblica officinalis (Amla) Extract Versus Exercise on Lipid Levels in Participants With Abnormal Lipid Levels: An Open-Label Clinical Study officinalis （Amla）提取物与运动对血脂水平异常参与者血脂水平的影响：一项开放标签临床研究

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100800

Kiran Jagalurappa MD , Giriraja Kanakapura Vrushabaiah MD , Suman Govindaraj BDS

<div><h3>Background</h3><div>Dyslipidemia, marked by abnormal lipid levels, significantly increases the risk of cardiovascular diseases. Effective management of these lipid abnormalities is essential for reducing cardiovascular risk. <em>Emblica officinalis</em>, known as amla in Ayurveda, is traditionally considered the best fruit due to its numerous health benefits.</div></div><div><h3>Objective</h3><div>To evaluate the efficacy and tolerability of amla extract on participants with abnormal lipid levels and compare with the effect of physical activity in reducing atherogenic factors.</div></div><div><h3>Methods</h3><div>Forty-five inactive participants having abnormal lipid levels were selected and instructed to initiate lifestyle changes, including a healthy diet and aerobic exercise for 14 days. Thirty-nine participants who met the study criteria even after exercise were allocated a 500 mg capsule of amla extract (Tri-Low®) twice daily for 90 days. The effect of amla extract on lipid parameters, atherogenic index of plasma (AIP), apolipoprotein (Apo) B/Apo A ratio, high-sensitivity C-reactive protein, coenzyme Q10, and hydroxy methylglutaryl coenzyme A reductase levels was studied and compared with the effect of physical activity or exercise on these parameters. Laboratory parameters, global tolerability, and treatment-emergent adverse events were evaluated for the assessment of safety profile of amla extract.</div></div><div><h3>Results</h3><div>Amla extract over a period of 90 days significantly reduced triglyceride (<em>P</em> = 0.007), total cholesterol (<em>P</em> < 0.001), LDL (<em>P</em> = 0.006), VLDL (<em>P</em> = 0.014), and AIP (<em>P</em> < 0.001) but reported no significant effect on HDL (<em>P</em> = 0.967) and fasting blood sugar (<em>P</em> = 1.00). Varying the intensity of exercise from low to moderate and high had no significant effect on triglyceride (<em>P</em> = 0.516), total cholesterol (<em>P</em> = 0.676), LDL (<em>P</em> = 0.511), VLDL (<em>P</em> = 0.454), or AIP (<em>P</em> = 0.472). However, LDL exhibited a significant reduction with amla extract, combined with exercise (<em>P</em> < 0.001). Apolipoprotein B/Apo A1 ratio exhibited a trend toward significance (<em>P</em> = 0.061). Weight and reductions were statistically significant with amla extract and exercise, after 45 days (<em>P</em> < 0.001) and 90 days (<em>P</em> = 0.002). Hydroxy methylglutaryl coenzyme A, Apo B, and coenzyme Q10 exhibited no significant changes. Overall, it was evident that the significant changes in lipid parameters are attributable to amla extract rather than physical activity alone. All other factors are not affected by exercise intensity, and the significant changes observed are purely due to the effect of amla extract.</div></div><div><h3>Conclusions</h3><div>Exercise alone is often insufficient for optimal cardiovascular health. The supplementation of amla extract (Tri-Low®) from this study reported significant potential

背景：以脂质水平异常为标志的血脂异常会显著增加心血管疾病的风险。有效管理这些脂质异常对于降低心血管风险至关重要。在阿育吠陀语中，Emblica officinalis被称为amla，传统上被认为是最好的水果，因为它对健康有很多好处。目的评价枸杞提取物对血脂异常患者的疗效和耐受性，并与体育锻炼对降低动脉粥样硬化因子的影响进行比较。方法选择45名血脂水平异常的非运动参与者，指导他们开始改变生活方式，包括健康饮食和有氧运动14天。39名即使在运动后也符合研究标准的参与者每天两次服用500毫克的amla提取物胶囊（Tri-Low®），持续90天。研究了木树提取物对血脂参数、血浆动脉粥样硬化指数（AIP）、载脂蛋白（Apo） B/Apo A比值、高敏c反应蛋白、辅酶Q10和羟甲基戊二酰辅酶A还原酶水平的影响，并与体育锻炼对这些参数的影响进行了比较。实验室参数，整体耐受性和治疗中出现的不良事件进行评估，以评估amla提取物的安全性。结果samla提取物在90天内显著降低甘油三酯（P = 0.007）、总胆固醇(P <；0.001),低密度脂蛋白(P = 0.006),VLDL (P = 0.014),和航(P & lt;0.001)，但对HDL （P = 0.967）和空腹血糖（P = 1.00）无显著影响。不同强度的运动从低到中等和高甘油三酯无显著影响(P = 0.516)、总胆固醇(P = 0.676),低密度脂蛋白(P = 0.511),VLDL (P = 0.454),或AIP (P = 0.472)。然而，与运动相结合的amla提取物显著降低了LDL (P <；0.001)。载脂蛋白B/载脂蛋白A1比值有显著性趋势（P = 0.061）。45天后，服用苦参提取物和运动的患者体重和减轻程度均有统计学意义(P <；0.001)和90天（P = 0.002）。羟甲基戊二酰辅酶A、载脂蛋白B和辅酶Q10无显著变化。总的来说，很明显，脂质参数的显著变化可归因于amla提取物，而不仅仅是身体活动。所有其他因素不受运动强度的影响，观察到的显著变化纯粹是由于amla提取物的作用。结论单纯运动不足以达到最佳的心血管健康状态。本研究报告了补充amla提取物（Tri-Low®）在改善脂质谱和其他动脉粥样硬化因素方面的显著潜力，从而为心血管健康管理提供了一种全面的策略。临床试验注册印度临床试验注册中心（CTRI/2017/02/007829）。

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引用次数: 0

Compatibility and Stability of Cipepofol (Ciprofol) and Etomidate Mixture for Intravenous Anesthesia 西泊酚（环丙酚）与依托咪酯复合静脉麻醉的相容性及稳定性

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100810

Linzhong Zhang MD , Lingchun Kong MA , Qi Deng MS , Yukai Chao MA , Chibing Fu MA , Yutong Meng MA

Objective

To evaluate the physical and chemical compatibility and stability of a cipepofol (ciprofol) and etomidate (EC) mixture for intravenous anesthesia and assess the physiochemical stability of the drugs during co-administration through the same intravenous line.

Methods

High-performance liquid chromatography and other analytical techniques were employed to investigate the stability of the EC mixture. The mixture was prepared and stored at 4°C, 25°C, or 37°C for 24 h, and its appearance, pH, osmotic pressure, particle size, zeta potential, drug content, and related substances were evaluated at 0, 1, 3, 6, 12, and 24 h.

Results

The EC mixture maintained physical stability, with no significant changes in appearance, pH (fluctuation, ≤0.07 units), osmotic pressure (relative standard deviation [RSD] < 2.0%), or particle size observed over 24 h. Zeta potential remained within acceptable limits (ranging from −40 to −30 mV), indicating good colloidal stability. Chemically, drug content remained at ≥99.9% of the initial level (RSD < 1.2%), and impurity levels stayed within the specified limits (maximum single impurity ≤ 0.13%, total impurities ≤ 0.37%).

Conclusions

The findings suggest that the EC mixture was physically and chemically compatible and stable for up to 24 h at various temperatures, making this regimen a potentially safe and effective option for intravenous anesthesia. This finding is significant for improving patient comfort and reducing adverse drug reactions during anesthesia induction and maintenance.

目的评价西泊酚（环丙酚）与依托咪酯（EC）复合静脉麻醉的理化相容性和稳定性，评价两种药物在同一静脉给药过程中的理化稳定性。方法采用高效液相色谱法等分析技术对复方乙醛的稳定性进行考察。分别于4°C、25°C、37°C条件下保存24 h，分别于0、1、3、6、12、24 h评价其外观、pH、渗透压、粒径、zeta电位、药物含量及相关物质。结果EC混合物保持物理稳定性，外观、pH（波动≤0.07单位）、渗透压（相对标准偏差[RSD] = 2.0%）、pH值（波动≤0.07单位）、渗透压（相对标准偏差[RSD] = 2.0%）、Zeta电位保持在可接受的范围内（范围从- 40到- 30 mV），表明良好的胶体稳定性。化学上，药物含量保持在初始水平的≥99.9% (RSD < 1.2%)，杂质水平保持在规定的限度内（最大单一杂质≤0.13%，总杂质≤0.37%）。研究结果表明，EC混合物在不同温度下具有物理和化学相容性和长达24小时的稳定性，使该方案成为静脉麻醉的潜在安全有效的选择。这一发现对于改善麻醉诱导和维持过程中患者的舒适度和减少药物不良反应具有重要意义。

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引用次数: 0

Determination of the Accuracy of Thyromental Height Test for Predicting Difficult Laryngoscopy in Obstetric Patients Who Are Candidates for Cesarean Section: An Observational Study 确定甲状腺高度测试预测剖宫产产科患者喉镜检查困难的准确性：观察研究

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100784

Saghar Samimi Sadeh MD , Babak Moayer MD , Masoomeh Natajmajd MD , Parisa Kianpour PharmD , Kousha Farhadi MD , Mahgol Etezadi PharmD , Mojgan Rahimi MD , Farhad Etezadi MD

Background

Pregnant women frequently have face and upper airway edema, which makes managing the airways during anesthesia difficult and increases the risk of mask breathing complications and intubation failure. This necessitates an investigation into the sensitivity of various airway tests in predicting difficult intubation.

Objective

To assess the accuracy of the thyromental height test (TMHT) in predicting difficult laryngoscopy in obstetric patients undergoing cesarean section and to compare its effectiveness with other airway assessment methods.

Methods

We included a cohort of obstetric patients, approved by the Ethics Committee of Tehran University of Medical Sciences, scheduled for elective cesarean sections. During laryngoscopy, preoperative evaluations of the airway were done. The primary aim was to determine the relationship between TMHT (the distance between mentum and the thyroid cartilage) and the Cormack-Lehane (which categories laryngoscopy view from fully observable vocal cords to nonvisible epiglottis) classification, which indicates the level of difficulty in laryngoscopy.

Results

After eligibility assessment, 156 patients entered the study, of which 16 had Cormack-Lehane grades III and IV and were considered difficult laryngoscopy. The TMHT demonstrated a higher Matthews correlation coefficient (0.695), sensitivity (0.75), and specificity (0.96) compared with other tests, suggesting that TMHT has the potential to serve as a dependable predictor of challenging laryngoscopy.

Conclusions

The use of TMHT can improve patient outcomes and the preoperative evaluation process, making it a valuable tool for anesthesiologists managing obstetric patients. The TMHT could be considered a complementary tool to existing airway assessment methods, particularly in obstetric patients, due to its high predictive accuracy and ease of use.

This study is registered at Iranian Registry of Clinical Trial (IRCT) under identifier code of IR.TUMS.SINAHOSPITAL.REC.1399.061.

孕妇经常出现面部和上气道水肿，这使得麻醉期间气道管理困难，增加了面罩呼吸并发症和插管失败的风险。这就需要对各种气道试验在预测插管困难方面的敏感性进行研究。目的评价甲状腺高度试验（TMHT）预测产科剖宫产患者喉镜检查困难的准确性，并与其他气道评估方法进行比较。方法纳入一组经德黑兰医科大学伦理委员会批准，计划择期剖宫产的产科患者。在喉镜检查期间，对气道进行术前评估。主要目的是确定TMHT（颏部与甲状软骨之间的距离）与Cormack-Lehane（将喉镜视点从完全可见的声带到不可见的会厌）分类之间的关系，这表明喉镜检查的难度程度。结果经过资格评估，156例患者进入研究，其中16例为Cormack-Lehane III级和IV级，被认为喉镜检查困难。与其他测试相比，TMHT显示出更高的马修斯相关系数（0.695）、敏感性（0.75）和特异性（0.96），这表明TMHT有可能作为喉镜检查的可靠预测指标。结论使用TMHT可以改善患者预后和术前评估过程，使其成为麻醉师管理产科患者的有价值的工具。TMHT可被视为现有气道评估方法的补充工具，特别是在产科患者中，由于其预测准确性高且易于使用。本研究已在伊朗临床试验登记处（IRCT）注册，识别码为IR.TUMS.SINAHOSPITAL.REC.1399.061。

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引用次数: 0