Current Therapeutic Research-clinical and Experimental最新文献

英文中文

Effect of a Pleuran-Based Supplement on Salivary IgA Secretion in Children With Recurrent Respiratory Infections 胸脯糖对反复呼吸道感染患儿唾液IgA分泌的影响

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100780

Peter Kunc MD, PhD , Jaroslav Fabry MD, PhD , Michaela Matiscakova MD , Katarina Istvankova DVM , Zuzana Diamant MD, PhD , Juraj Majtan PhD, DSc , Milos Jesenak MD, PhD

Background

ß-glucans isolated from natural sources have demonstrated pluripotent immunomodulatory potential, making them a promising supportive treatment for the management of recurrent respiratory infections (RRIs) in children. This study aimed to evaluate the effects of a pleuran-based supplement (ß-glucan isolated from Pleurotus ostreatus in combination with vitamin D and zinc) on mucosal immunity –through modulating salivary secretory immunoglobulin A (sIgA) levels –in children with RRIs.

Methods

This monocentric, prospective, open-label pilot study investigated the effect of an orally administered pleuran/vitamin D/zinc supplement (1–2 chewable tablets daily depending on body weight) on the dynamics of sIgA secretion measured in saliva samples collected at three timepoints: at baseline and after 4–6 and 8–10 days.

Results

This study included 49 children aged 6-11 years (mean age: 8.2 ± 1.6 years) with a history of one or more of the following conditions in the inclusion criteria: RRIs, allergy, and asthma. After 8–10 days with daily administration of the chewable pleuran/vitamin D/zinc supplement, children exhibited a statistically significant increase in salivary sIgA concentrations compared with baseline (227 ± 211 µg/mL; P = 0.045). No adverse events were observed during the course of the study in relation to the administration of pleuran-based supplement.

Conclusions

We demonstrated the beneficial effects of the short-term administration of a pleuran-based chewable supplement on mucosal immunity through increasing salivatory sIgA levels. This study confirms the favourable safety profile of this pleuran/vitamin D/zinc combination, which could be beneficial for children with acute or recurrent respiratory infections, including children with allergies and/or asthma. Moreover, the significant increases in salivary sIgA concentrations that were observed after a few days of supplementation support the use of pleuran in not only the prevention but also the treatment of acute respiratory infections.

从天然来源分离的ß-葡聚糖已显示出多能性免疫调节潜力，使其成为治疗儿童复发性呼吸道感染（RRIs）的有希望的支持性治疗。本研究旨在通过调节RRIs患儿唾液分泌免疫球蛋白a （sIgA）水平，评估以胸脯蛋白为基础的补充剂（从平菇中分离的ß-葡聚糖与维生素D和锌联合使用）对粘膜免疫的影响。方法：这项单中心、前瞻性、开放标签的试点研究调查了口服胸膜酸/维生素D/锌补充剂（根据体重每天1-2片咀嚼片）对三个时间点唾液样本中sIgA分泌动态的影响：基线时、4-6天和8-10天后。结果本研究纳入49名年龄在6-11岁的儿童（平均年龄：8.2 ± 1.6岁），纳入标准中有以下一种或多种病史：RRIs、过敏和哮喘。每天服用可咀嚼胸膜聚糖/维生素D/锌补充剂8-10天后，与基线相比，儿童唾液sIgA浓度有统计学意义的增加(227 ± 211µg/mL； = 0.045页)。在研究过程中未观察到与胸膜基补剂有关的不良事件。结论：我们证实了短期服用胸膜基咀嚼补剂通过增加唾液sIgA水平对粘膜免疫的有益作用。这项研究证实了这种胸膜酸/维生素D/锌组合的良好安全性，它可能对患有急性或复发性呼吸道感染的儿童有益，包括过敏和/或哮喘儿童。此外，在补充几天后观察到唾液sIgA浓度的显著增加，支持胸膜炎不仅在预防而且在治疗急性呼吸道感染方面的使用。

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引用次数: 0

Randomized, Double-Blind, Crossover Study Comparing the Bioavailability of 4 Ashwagandha (Withania somnifera (L.) Dunal) Extracts in Healthy Adults Under Fasting Condition 随机、双盲、交叉研究比较4种印度稻（Withania somnifera）的生物利用度健康成人禁食条件下的杜纳尔提取物

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100805

Priyank Rathi MD , Se-Kwon Kim PhD

Background

Withania somnifera (L.) Dunal, commonly known as ashwagandha, is a well-known plant in ayurvedic medicine, widely valued for its therapeutic potential. Although numerous clinical studies have explored its diverse health benefits, limited data are available on the pharmacokinetic (PK) properties and comparative bioavailability of its key bioactive constituents in humans.

Objective

This study aimed to evaluate and compare the oral bioavailability of 4 commercially standardized ashwagandha extracts under fasting conditions in healthy adults.

Methods

This randomized, double-blind, 4-treatment, 4-period, 4-sequence, single dose, 4-way crossover study was conducted in 16 healthy human volunteers. Participants received a single oral dose of 1 of 4 ashwagandha extracts, with varying compositions of 35% (Withania somnifera [WS]-35) or 10% (WS-10) withanolide glycosides, or 5% (WS-5) or 2.5% (WS-2.5) withanolides, each standardized to deliver 185 mg of total withanolides. Seventeen blood samples were collected over a 24-hour period after dose administration. Plasma concentrations of withanolide A, withanoside IV, withaferin A, and total withanolides were quantified, and PK parameters were calculated.

Results

Withania somnifera-35 had significantly superior bioavailability compared with the other extracts. The AUC_0–t for total withanolides per gram of WS-35 was 118.28, 226.11, and 267.83 times better than WS-10, WS-5, and WS-2.5 respectively. Withania somnifera-35 exhibited a significantly higher C_max, longer half-life, extended mean residence time, and lower systemic clearance, attributable to its higher withanolide glycoside content.

Conclusions

These findings emphasize the critical role of withanolide glycosides in determining the PK performance of ashwagandha supplements. The enhanced bioavailability of WS-35 supports its preferential use in therapeutic applications and provides a strong rationale for further investigation into dose-response relationships and the long-term efficacy of standardized, high-bioavailability formulations. Clinical Trial Registry of India identifier: CTRI/2020/10/028397.

背景：withania somnifera （L.）杜鹃花，通常被称为阿育吠陀，是印度草药中著名的植物，因其治疗潜力而受到广泛重视。尽管许多临床研究已经探索了其多种健康益处，但关于其关键生物活性成分在人体中的药代动力学（PK）特性和比较生物利用度的数据有限。目的评价和比较4种市售标准ashwagandha提取物在健康成人空腹条件下的口服生物利用度。方法采用随机、双盲、4治疗、4周期、4序列、单剂量、4向交叉的方法对16名健康志愿者进行研究。参与者接受单次口服剂量的4种ashwagandha提取物中的1种，其不同成分为35% （Withania somnifera [WS]-35）或10% （WS-10）的withanolides苷，或5% （WS-5）或2.5% （WS-2.5）的withanolides，每种提取物的标准含量为185 mg总withanolides。在给药后24小时内采集17份血样。测定血药浓度，并计算药代动力学参数。结果与其他提取物相比，苦参-35具有显著的生物利用度。WS-35每克总戊内酯的AUC0-t分别比WS-10、WS-5和WS-2.5高118.28倍、226.11倍和267.83倍。Withania somnifera-35表现出较高的Cmax、较长的半衰期、较长的平均停留时间和较低的全身清除率，这主要归因于其较高的Withania somnifera-35的内酯苷含量。结论这些研究结果强调了缬草内酯苷在决定缬草补剂PK性能中的关键作用。WS-35提高的生物利用度支持其优先用于治疗应用，并为进一步研究标准化、高生物利用度制剂的剂量-反应关系和长期疗效提供了强有力的理论依据。印度临床试验注册编号：CTRI/2020/10/028397。

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引用次数: 0

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01

引用次数: 0

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01

引用次数: 0

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01

引用次数: 0

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01

引用次数: 0

A Clinical Nomogram for Predicting Substandard Serum Valproic Acid Concentrations in Chinese Patients With Epilepsy 预测中国癫痫患者血清丙戊酸浓度不达标的临床Nomogram。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2024.100771

Zi-Hao Duan MS , Chun-Yuan He MS , Jie Chen BS , Jun-Jie Jiang BS , Zhi-Xiang Zhu PhD , Jing Li MS , Fa-Cai Wang MD

Background

It is well-known that substandard serum valproic acid (VPA) concentrations may lead to treatment failure of epilepsy. However, there is still a lack of a quick method to predict whether a patient's serum VPA concentration will reach the standard.

Objective

The aims of this study were to investigate the factors leading to substandard serum VPA concentrations in Chinese patients with epilepsy and develop a related nomogram for risk prediction.

Methods

From January 2019 to March 2022, a total of 1143 serum VPA concentrations were collected from 630 hospitalized Chinese patients with epilepsy who were monitored by the Department of Pharmacy of Lu'an People's Hospital, and complete clinical data were collected from the corresponding patients for retrospective analysis. All monitored serum VPA concentrations were further divided into a training cohort and a validation cohort. For the training cohort, serum VPA concentrations below 50 µg/mL and between 50 and 100 µg/mL were classified into the subtherapeutic group and therapeutic group, respectively. The variables were selected from the clinical data, and differences between the variables of the subtherapeutic and therapeutic groups were analyzed. The influencing factors leading to substandard serum VPA concentrations were screened via logistic regression analysis, and the screened influencing factors were used to establish the nomogram prediction model.

Results

Multivariate logistic regression analysis revealed that the daily dose per unit of body weight (mg/kg/d), route of administration, presence of hepatic lesions, hypoalbuminemia, and combination with carbapenems or barbiturates were independent factors influencing the occurrence of substandard serum VPA concentrations. On the basis of the results of the multivariate logistic regression analysis, a nomogram risk prediction model for substandard serum VPA concentration was established. The values of the C-index and internal verification results indicated that the nomogram model had good accuracy and discrimination. The decision curve revealed that the nomogram that predicted the risk of substandard serum VPA concentration had a greater net benefit value (ranging from 12% to 94%), indicating that the model had a wide prediction interval.

Conclusions

Our study established a nomogram risk prediction model for substandard serum VPA concentrations in Chinese patients with epilepsy, which can help doctors or patients control the serum VPA concentration within the target concentration range as soon as possible.

背景：众所周知，血清丙戊酸（VPA）浓度不达标可能导致癫痫治疗失败。然而，目前仍缺乏一种快速预测患者血清VPA浓度是否达标的方法。目的：探讨导致中国癫痫患者血清VPA浓度不达标的因素，并建立相关的图图进行风险预测。方法：采集2019年1月至2022年3月六安市人民医院药剂科监测的630例中国住院癫痫患者血清VPA浓度1143份，收集完整的临床资料进行回顾性分析。所有监测的血清VPA浓度进一步分为训练组和验证组。对于训练组，血清VPA浓度低于50 µg/mL和在50 ~ 100 µg/mL之间分别被分为亚治疗组和治疗组。从临床资料中选取变量，分析亚治疗组和治疗组变量之间的差异。通过logistic回归分析筛选出导致血清VPA浓度不达标的影响因素，并利用筛选出的影响因素建立nomogram预测模型。结果：多因素logistic回归分析显示，单位体重日剂量（mg/kg/d）、给药途径、是否存在肝脏病变、低白蛋白血症、是否联用碳青霉烯类药物或巴比妥类药物是影响血清VPA浓度不达标的独立因素。在多元logistic回归分析结果的基础上，建立血清VPA浓度不达标的nomogram风险预测模型。c指数值和内部验证结果表明，模态图模型具有较好的准确性和鉴别性。决策曲线显示，预测血清VPA浓度不达标风险的nomogram具有较大的净效益值（范围为12% ~ 94%），说明该模型具有较宽的预测区间。结论：本研究建立了中国癫痫患者血清VPA浓度不达标的nomogram风险预测模型，可以帮助医生或患者尽快将血清VPA浓度控制在目标浓度范围内。

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引用次数: 0

The Effect of Berberis (Vulgaris and Integerrima) on Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus: A Systematic Review, Meta-Analysis, and GRADE Assessment 小檗（Vulgaris和Integerrima）对2型糖尿病患者心血管危险因素的影响：系统回顾、meta分析和GRADE评估

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100788

Vali Musazadeh , Niloofar Hamidi , Morvarid Noormohammadi , Farzad Shidfar

Introduction and Aim

Type 2 diabetes mellitus (T2DM) raises cardiovascular disease risk, but evidence on Berberis's impact is limited and inconsistent. This systematic review and meta-analysis aimed to assess effect of Berberis supplement on cardiovascular risk factors in patients with T2DM.

Materials and Methods

We extensively searched Embase, Web of Science, Scopus, PubMed, and the Cochrane Library for randomized controlled trials (RCTs) up to October 25, 2024. This study primarily assesses Berberis's impact on improving glycemic indices, with secondary measures including obesity, blood pressure and lipid profile parameters.

Findings

After reviewing 784 articles, we included data from eight RCTs involving 451 participants with T2DM. The results of meta-analysis indicated that Berberis administration significantly reduced weight (WMD: -2.25; 95% CI: -3.11 to -1.39), body mass index (BMI, WMD: -0.57; 95% CI: -0.98 to -0.17), TG (WMD: -19.32; 95% CI: -30.95 to -1.69), TC (WMD: -28.57; 95% CI: -30.22 to -21.51), LDL-C (WMD: -17.47; 95% CI: -24.18 to -10.75), FBS (WMD: -14.54; 95% CI: -23.83, -5.25), HbA1c (WMD: -0.65; 95% CI: -1.30, -0.00), HOMA-IR (WMD: -1.82; 95% CI: -3.60, -0.05), and insulin (WMD: -4.40; 95% CI: -7.15, -1.65). However, no statistically significant effect on blood pressure and HDL-C level was observed with Berberis intervention.

Conclusion

This meta-analysis hints at Berberis's potential benefits for T2DM. However, more extensive trials are needed to confirm its advantages definitively.

2型糖尿病（T2DM）增加心血管疾病风险，但小檗影响的证据有限且不一致。本系统综述和荟萃分析旨在评估小檗补充剂对T2DM患者心血管危险因素的影响。材料与方法我们广泛检索Embase、Web of Science、Scopus、PubMed、Cochrane Library，检索截止到2024年10月25日的随机对照试验（RCTs）。本研究主要评估了小檗对改善血糖指数的影响，次要指标包括肥胖、血压和血脂参数。研究结果：在回顾了784篇文章后，我们纳入了8项随机对照试验的数据，涉及451名T2DM患者。meta分析结果显示，小檗治疗组体重显著降低(WMD: -2.25；95% CI: -3.11 ~ -1.39)，体重指数(BMI, WMD: -0.57；95% CI: -0.98 ~ -0.17), TG (WMD: -19.32；95% CI: -30.95 ~ -1.69), TC (WMD: -28.57；95% CI: -30.22 ~ -21.51), LDL-C (WMD: -17.47；95% CI: -24.18 ~ -10.75), FBS (WMD: -14.54；95% CI: -23.83, -5.25), HbA1c (WMD: -0.65；95% ci: -1.30, -0.00), homa-ir (wmd: -1.82；95% CI: -3.60, -0.05)和胰岛素(WMD: -4.40；95% ci: -7.15, -1.65)。然而，小檗干预对血压和HDL-C水平没有统计学意义上的显著影响。结论：本荟萃分析提示小檗对2型糖尿病的潜在益处。然而，需要更广泛的试验来确定其优势。

{"title":"The Effect of Berberis (Vulgaris and Integerrima) on Cardiovascular Risk Factors in Patients With Type 2 Diabetes Mellitus: A Systematic Review, Meta-Analysis, and GRADE Assessment","authors":"Vali Musazadeh , Niloofar Hamidi , Morvarid Noormohammadi , Farzad Shidfar","doi":"10.1016/j.curtheres.2025.100788","DOIUrl":"10.1016/j.curtheres.2025.100788","url":null,"abstract":"<div><h3>Introduction and Aim</h3><div>Type 2 diabetes mellitus (T2DM) raises cardiovascular disease risk, but evidence on Berberis's impact is limited and inconsistent. This systematic review and meta-analysis aimed to assess effect of Berberis supplement on cardiovascular risk factors in patients with T2DM.</div></div><div><h3>Materials and Methods</h3><div>We extensively searched Embase, Web of Science, Scopus, PubMed, and the Cochrane Library for randomized controlled trials (RCTs) up to October 25, 2024. This study primarily assesses Berberis's impact on improving glycemic indices, with secondary measures including obesity, blood pressure and lipid profile parameters.</div></div><div><h3>Findings</h3><div>After reviewing 784 articles, we included data from eight RCTs involving 451 participants with T2DM. The results of meta-analysis indicated that Berberis administration significantly reduced weight (WMD: -2.25; 95% CI: -3.11 to -1.39), body mass index (BMI, WMD: -0.57; 95% CI: -0.98 to -0.17), TG (WMD: -19.32; 95% CI: -30.95 to -1.69), TC (WMD: -28.57; 95% CI: -30.22 to -21.51), LDL-C (WMD: -17.47; 95% CI: -24.18 to -10.75), FBS (WMD: -14.54; 95% CI: -23.83, -5.25), HbA1c (WMD: -0.65; 95% CI: -1.30, -0.00), HOMA-IR (WMD: -1.82; 95% CI: -3.60, -0.05), and insulin (WMD: -4.40; 95% CI: -7.15, -1.65). However, no statistically significant effect on blood pressure and HDL-C level was observed with Berberis intervention.</div></div><div><h3>Conclusion</h3><div>This meta-analysis hints at Berberis's potential benefits for T2DM. However, more extensive trials are needed to confirm its advantages definitively.</div></div>","PeriodicalId":10920,"journal":{"name":"Current Therapeutic Research-clinical and Experimental","volume":"102 ","pages":"Article 100788"},"PeriodicalIF":1.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144134708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety and Efficacy of a Mesenchymal Stem Cell Secretome Therapy (KPI-012) for Persistent Corneal Epithelial Defects: A Phase 1b Trial 间充质干细胞分泌组疗法（KPI-012）治疗持续性角膜上皮缺陷的安全性和有效性：1b期试验

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100799

Valeria Sánchez Huerta MD , Hugo Quiroz-Mercado MD , Enrique O. Graue-Hernández MD, MSc , Alejandro Navas MD, MSc , Spencer Alford PhD , Darius Kharabi JD, MBA , Stephen Pflugfelder MD

Background

Persistent corneal epithelial defect (PCED) is a condition often refractory to conventional treatments. KPI-012 is a topical mesenchymal stem cell secretome therapy under investigation for PCED management.

Objective

To assess the safety, tolerability, and corneal wound healing efficacy of KPI-012 in a phase 1b, proof-of-concept, open-label, single-arm clinical trial.

Methods

The safety profile and tolerability of topical self-administered KPI-012 therapy (twice daily, 1-week duration) were first evaluated in an initial safety cohort of participants with pre-existing permanent vision loss and no active corneal disease (n = 3). The safety profile and efficacy of KPI-012 were then assessed in participants with PCED of several etiologies (n = 9), who self-administered KPI-012 twice daily for up to 4 weeks with one participant self-administering for 8 weeks (efficacy cohort).

Results

KPI-012 was well tolerated in both the safety profile and efficacy cohorts. In the efficacy cohort (n = 9), 6 of 8 participants (75%) demonstrated complete healing of the lesion during the treatment period, with 4 of 8 (50%) achieving complete healing within 1 week of commencing KPI-012 therapy (a nontreatment-related adverse event meant 1 participant was withdrawn by the investigator). KPI-012 was well tolerated, with only 1 participant experiencing treatment-related adverse events. In patients who reported PCED-related ocular pain at baseline (n = 7), pain levels decreased in all participants after 1 week, and after 3 weeks, no participant reported ocular pain.

Conclusions

The results from this small phase 1b open-label trial suggest that in participants with PCED of multiple etiologic origin, twice daily KPI-012 therapy exhibits a favorable safety profile-efficacy profile and may promote rapid wound healing. The small sample size limits the generalizability of the findings, and thus a later-phase clinical investigation with a larger sample size is warranted to establish the statistically driven therapeutic effect.

背景：持续性角膜上皮缺损（PCED）是一种常规治疗难以治愈的疾病。KPI-012是一种局部间充质干细胞分泌组疗法，正在研究用于PCED治疗。目的在一项1b期、概念验证、开放标签、单臂临床试验中评估KPI-012的安全性、耐受性和角膜创面愈合效果。方法：首先在一个预先存在永久性视力丧失且无活动性角膜疾病（ = 3）的参与者的初始安全性队列中评估局部自我给药KPI-012治疗（每天两次，持续1周）的安全性和耐受性。然后在几种病因的PCED患者（n = 9）中评估KPI-012的安全性和有效性，这些患者每天两次自我服用KPI-012，持续4周，其中一名参与者自我服用8周（疗效队列）。结果skpi -012在安全性和有效性队列中均具有良好的耐受性。在疗效队列中（n = 9），8名参与者中有6名（75%）在治疗期间表现出病变完全愈合，8名参与者中有4名（50%）在开始KPI-012治疗后1周内实现完全愈合（非治疗相关不良事件意味着1名参与者被研究者撤回）。KPI-012耐受性良好，只有1名参与者出现与治疗相关的不良事件。在基线时报告pced相关眼部疼痛的患者中（n = 7），所有参与者的疼痛水平在1周后下降，3周后，没有参与者报告眼部疼痛。这项小型1b期开放标签试验的结果表明，对于多种病因的PCED患者，每天两次的KPI-012治疗显示出良好的安全性和有效性，并可能促进伤口快速愈合。小样本量限制了研究结果的普遍性，因此需要更大样本量的后期临床研究来确定统计学驱动的治疗效果。

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引用次数: 0

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01

引用次数: 0

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