Current Therapeutic Research-clinical and Experimental最新文献

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Pharmacodynamics, Safety, and Tolerability of Pyridostigmine Bromide in Heart Failure 吡哆斯的明治疗心力衰竭的药效学、安全性和耐受性

IF 1.5 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100814

Randal Goldberg MD , Lucy Norcliffe-Kaufmann PhD , Horacio Kaufmann MD , Ikoa Jeschke-Lopez MD , Yu Guo MS , Judy Zhong PhD , Kenneth I. Berger MD , Roberta M. Goldring MD , David S. Goldstein MD, PhD , Carey Pope PhD , Lara Maxwell DVM, PhD , Manushree Bharadwaj PhD , Alex Reyentovich MD , Stuart D. Katz MD, MS

Background

Pyridostigmine bromide is a short-acting carbamate acetylcholinesterase inhibitor that has been shown to acutely augment parasympathetic signaling in cardiovascular disease populations.

Objective

This study was undertaken to characterize pharmacodynamics, safety, and tolerability of pyridostigmine during repeated dosing in patients with heart failure.

Methods

A prospective ascending-dose, forced titration, double-blind Phase II randomized clinical trial was conducted to compare the effects of pyridostigmine bromide (15, 30, and 60 mg TID over 8 weeks) versus matching placebo on red blood cell (RBC) acetylcholinesterase activity, cholinergic side effects, and physiologic measures of parasympathetic heart rate modulation and sympathovagal balance in ambulatory patients with chronic systolic heart failure.

Results

Fifty subjects were screened, and 33 eligible subjects were randomly assigned (mean age, 55 years; mean left ventricular ejection fraction, 23%). Pyridostigmine bromide significantly decreased RBC acetylcholinesterase activity (P < 0.02 vs placebo) and increased the frequency of participant-reported cholinergic excess symptoms (P < 0.001 vs placebo). Physiologic measures of parasympathetic heart rate modulation and sympathovagal balance did not differ between treatment groups. In the pyridostigmine bromide group, RBC acetylcholinesterase activity was not significantly associated with postexercise parasympathetic heart modulation.

Conclusions

Pyridostigmine bromide administered over 8 weeks was associated with a significant reduction of RBC acetylcholinesterase activity and relatively mild symptoms of cholinergic excess, but changes in parasympathetic signaling in the sinoatrial node previously reported after acute administration were not observed. Further investigations are needed to delineate pharmacodynamic and pathobiological factors contributing to these findings. ClinicalTrials.gov identifier: NCT01415921.

背景：吡哆斯的明溴是一种短效氨基甲酸酯类乙酰胆碱酯酶抑制剂，已被证明在心血管疾病人群中急性增强副交感神经信号。目的：研究吡哆斯的明在心力衰竭患者中反复给药的药效学、安全性和耐受性。方法采用前瞻性上升剂量、强制滴定、双盲II期随机临床试验，比较吡多斯的明溴（15、30和60 mg TID， 8周）与对照安慰剂对慢性收缩期心力衰竭门诊患者红细胞乙酰胆碱酯酶活性、胆碱能副作用、副交感神经心率调节和交感迷走神经平衡的生理指标的影响。结果50名受试者被筛选，33名符合条件的受试者被随机分配（平均年龄55岁，平均左室射血分数23%）。吡哆斯的明溴显着降低RBC乙酰胆碱酯酶活性（P <； 0.02与安慰剂相比），并增加参与者报告的胆碱能过量症状的频率（P <； 0.001与安慰剂相比）。副交感心率调节和交感迷走神经平衡的生理测量在治疗组之间没有差异。在吡哆斯的明组，红细胞乙酰胆碱酯酶活性与运动后副交感神经心脏调节无显著相关。结论溴化spyrido斯的明给药超过8周可显著降低红细胞乙酰胆碱酯酶活性和相对轻微的胆碱能过量症状，但未观察到先前报道的急性给药后窦房结副交感神经信号的变化。需要进一步的研究来描述促成这些发现的药效学和病理生物学因素。ClinicalTrials.gov识别码：NCT01415921。

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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

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

The Effect of Stem Cell Secretome on the Improvement of Diabetic Wound Recovery: A Systematic Review and Meta-Analysis of In Vivo Studies 干细胞分泌组对改善糖尿病伤口恢复的作用：体内研究的系统回顾和荟萃分析

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2025.100778

Cecep Suhandi MSc , Gofarana Wilar PhD , Khaled M. Elamin PhD , Audry Rahma Dewayani BSc , Salsabil Ghaliya BSc , Astriani Abdullah BSc , Nasrul Wathoni PhD

Background

Diabetic wounds, characterized by their chronic nature, represent a critical challenge for patients with diabetes, often leading to amputation and mortality. Although stem cells show great promise, their use is limited by challenges related to stability and tumorigenicity. The secretome of stem cells, comprising molecules released by these cells, offers a potential alternative to the challenges associated with stem cell therapy and provides a promising solution for diabetic wound healing.

Objective

We conducted a systematic review and meta-analysis of relevant preclinical studies to evaluate the effectiveness of stem cell secretomes in treating diabetic wounds.

Methods

The protocol registration for this systematic review and meta-analysis was recorded in the PROSPERO database (CRD42023473726). Databases were searched from their inception until November 20, 2023. The quality assessment of the included studies was performed utilizing the CAMARADES 10-item Quality Checklist. Statistical analyses were conducted using a random-effects model to calculate standardized mean differences (SMD) and 95% confidence intervals (CI), with heterogeneity assessed via the I² statistic. The primary outcome evaluated was the wound closure rate, while secondary outcomes included parameters such as the number of fibroblasts, neutrophils, and macrophages.

Results

Twenty studies were included, comprising 382 animal subjects, and five of which were eligible for quantitative evaluation in a meta-analysis. The stem cell secretome significantly improved the wound closure rate (SMD = 9.63; 95% CI = 2.01 −17.25; P = 0.01, I² = 76%) and reduced the number of neutrophils (SMD = −8.47; 95% CI = −13.05 to −3.90; P = 0.0003) and macrophages (SMD = −5.32; 95% CI = −9.09 to −1.55; P = 0.006).

Conclusion

This review suggests that stem cell secretomes have potential as a novel therapeutic strategy for diabetic wound healing, enhancing wound closure rates and reducing inflammation. These findings support the use of stem cell secretomes as a safer and more stable alternative to direct stem cell therapy, but further clinical studies are needed to confirm these results in human patients.

糖尿病伤口以其慢性性质为特征，对糖尿病患者来说是一个严峻的挑战，经常导致截肢和死亡。尽管干细胞显示出巨大的前景，但其应用受到稳定性和致瘤性方面的挑战的限制。干细胞分泌组由这些细胞释放的分子组成，为干细胞治疗相关的挑战提供了一个潜在的替代方案，并为糖尿病伤口愈合提供了一个有希望的解决方案。目的对相关临床前研究进行系统回顾和荟萃分析，评价干细胞分泌组治疗糖尿病创面的有效性。方法本系统评价和荟萃分析的方案注册记录在PROSPERO数据库（CRD42023473726）中。数据库从建立到2023年11月20日被搜索。采用CAMARADES 10项质量检查表对纳入的研究进行质量评估。采用随机效应模型进行统计分析，计算标准化平均差异（SMD）和95%置信区间（CI），并通过I²统计量评估异质性。评估的主要结局是伤口愈合率，次要结局包括成纤维细胞、中性粒细胞和巨噬细胞数量等参数。结果纳入20项研究，包括382名动物受试者，其中5项符合meta分析的定量评价标准。干细胞分泌组显著提高创面愈合率(SMD = 9.63；95% ci = 2.01−17.25；P = 0.01, I2 = 76%)，中性粒细胞数量减少(SMD =−8.47；95% CI =−13.05 ~−3.90；P = 0.0003)和巨噬细胞(SMD =−5.32；95% CI =−9.09 ~−1.55；p = 0.006)。结论干细胞分泌组有潜力作为糖尿病创面愈合的新治疗策略，提高创面愈合率，减少炎症。这些发现支持使用干细胞分泌组作为直接干细胞治疗的更安全、更稳定的替代方法，但需要进一步的临床研究来证实这些结果在人类患者中的应用。

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引用次数: 0

Effect of Hematopoietic Stem Cell Transplantation Regimen on Tacrolimus Pharmacokinetics 造血干细胞移植方案对他克莫司药代动力学的影响。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental

Pub Date : 2025-01-01 DOI: 10.1016/j.curtheres.2024.100775

Haruno Oku BS , Saki Yoshida BS , Takumi Hotta BS , Hirohito Muroi BS , Keizo Fukushima PhD , Kei Irie PhD , Tatsuya Hirano BS , Yoshimitsu Shimomura MD , Takayuki Ishikawa MD, PhD , Hiroaki Ikesue PhD , Nobuyuki Muroi PhD , Tohru Hashida PhD , Nobuyuki Sugioka PhD

Objectives

Treatment with tacrolimus requires strict control of the whole-blood concentration in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). In patients undergoing cord blood transplantation (CBT), there is a negative correlation between volume of distribution of tacrolimus and hemoglobin levels, which reflect the red blood cell (RBC) count. In this study, we evaluated the influence of the conditioning regimen (myeloablative and reduced-intensity conditioning) or donor source (cord blood, bone marrow, and peripheral blood stem cells) on the pharmacokinetics of tacrolimus in patients undergoing HSCT, including those undergoing CBT. We also examined applicability of dosing strategy of tacrolimus considering the RBC count.

Methods

We retrospectively analyzed clinical data—including whole-blood tacrolimus concentrations—from patients with HSCT. The observation period spanned from first continuous intravenous infusions until switch to oral medication, transfer to another hospital, relapse, or death. Population pharmacokinetic analysis was performed on whole-blood tacrolimus concentrations obtained from therapeutic drug monitoring during the observation period. Patient characteristics and laboratory data were evaluated as covariates.

Results

We enrolled 91 patients undergoing HSCT (CBT: n = 56; bone marrow transplantation: n = 22; and peripheral blood stem cell transplantation: n = 13); 58 and 33 patients received myeloablative conditioning and reduced-intensity conditioning, respectively. Whole-blood tacrolimus concentrations were accurately captured (n = 1,658 measurements) using a one-compartment and additive error model. The conditioning regimen and donor source did not have an impact on the pharmacokinetics of tacrolimus. Therefore, these factors were not considered when forming the dosing strategy. Nevertheless, a negative correlation between volume of distribution and hemoglobin level was confirmed, indicating that monitoring the RBC count is useful in assessing the dosing strategy.

Conclusions

A tacrolimus dosing strategy that considers the variability in hemoglobin levels applies to all patients undergoing HSCT.

目的：他克莫司治疗需要严格控制异基因造血干细胞移植（HSCT）患者的全血浓度。在接受脐带血移植（CBT）的患者中，他克莫司的分布容积与反映红细胞（RBC）计数的血红蛋白水平呈负相关。在这项研究中，我们评估了调节方案（清髓和低强度调节）或供体来源（脐带血、骨髓和外周血干细胞）对他克莫司在接受HSCT患者（包括接受CBT的患者）中的药代动力学的影响。我们还研究了考虑红细胞计数的他克莫司给药策略的适用性。方法：我们回顾性分析了HSCT患者的临床资料，包括他克莫司全血浓度。观察期从第一次连续静脉输注到改用口服药物、转院、复发或死亡。对观察期间治疗药物监测所得的他克莫司全血浓度进行群体药动学分析。患者特征和实验室数据作为协变量进行评估。结果：我们招募了91例接受HSCT的患者(CBT: n = 56；骨髓移植：n = 22；外周血干细胞移植：n = 13)；58例和33例患者分别接受清骨髓调节和降低强度调节。使用单室加性误差模型准确捕获全血他克莫司浓度（n = 1,658个测量值）。调理方案和供体来源对他克莫司的药代动力学没有影响。因此，在制定给药策略时没有考虑这些因素。然而，体积分布和血红蛋白水平之间的负相关被证实，这表明监测红细胞计数对评估给药策略是有用的。结论：考虑血红蛋白水平变化的他克莫司给药策略适用于所有接受造血干细胞移植的患者。

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