The study will be a randomized, cross-over study of THAM followed by saline or saline followed by THAM in human non-CF and CF subjects to assess nasal colonization

开始日期2017-06-15

申办/合作机构

University of Iowa

EUCTR2016-001863-35-AT

/ Unknown status临床4期IIT

Effects of Tromethamine on Cerebral Oxygenation and Metabolism in Patients Suffering Intractable Intracranial Hypertension – an exploratory study. - Effect of Tromethamine on Cerebral Oxygenation

开始日期2016-06-21

申办/合作机构-

JPRN-UMIN000021756

/ SuspendedN/AIIT

Effect of correction of metabolic acidosis on respiration and hemodynamics in acute respiratory distress syndrome (ARDS) patients during mechanical ventilation: A randomized comparison of sodium bicarbonate and Tris-hydroxymethyl aminomethane (THAM). - Effect of correction of metabolic acidosis in ARDS patients: A RCT of sodium bicarbonate and THAM.

开始日期2016-05-01

申办/合作机构

Osaka University Hospital

100 项与氨丁三醇相关的临床结果

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100 项与氨丁三醇相关的转化医学

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100 项与氨丁三醇相关的专利（医药）

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8,985

项与氨丁三醇相关的文献（医药）

2025-12-31·Journal of Enzyme Inhibition and Medicinal Chemistry

Discovery of novel biphenyl compounds bearing hydroxamic acid moiety as the first PD-L1/class I HDACs dual inhibitors

Article

作者: Deng, Changchun ; Huang, Yudan ; Yuan, Dandan ; Wu, Xingye ; Ma, Junjie ; Li, Jin ; Liu, Jieqing ; Xia, Lin ; Liu, Han ; Ding, Xueyan ; Gao, Yali ; Dai, Wenqi

Herein, we firstly reported a series of biphenyl compounds bearing hydroxamic acid moiety as PD-L1/class I HDACs dual inhibitors. Among them, compound 14 displayed the strongest inhibitory activity in vitro against HDAC2 and HDAC3 with IC₅₀ values of 27.98 nM and 14.47 nM, and had an IC₅₀ value of 88.10 nM for PD-1/PD-L1 interaction. Importantly, 14 could upregulate the expression of PD-L1 and CXCL10 in a PD-L1 low-expression cancer cell line (MCF-7), highlighting the potential to enhance efficacy by recruiting T-cell infiltration into TME and improving the response of PD-1/PD-L1 inhibitor associated with PD-L1 low-expression. Besides, we identified another compound, 22, which possessed the strongest inhibitory activity against PD-1/PD-L1 interaction with an IC₅₀ value of 12.47 nM, and effectively inhibited the proliferation of three cancer cell lines. Our results suggest that compounds 14 and 22 can be served as lead compounds of PD-L1/class I HDACs dual inhibitors for further optimisation.

2025-08-01·Talanta

Development of a regression equation to estimate a quantifiable basic compound by the reduction prepeak measurement of quinone derived from surplus acid

Article

作者: Machida, Koichi ; Hakamata, Hideki ; Yamamoto, Kazuhiro ; Kubo, Hinako ; Kotani, Akira

We have previously reported the electrochemical analysis that is coupled with the concept of acid-base back titration and the electrochemical sensing for acids based on the reduction of 3,5-di-tert-butyl-1,2-benzoquinone (DBBQ) for determining inorganic basic compounds and amino acids. The purpose of this study is to develop a regression equation to estimate quantifiable basic compounds by this electrochemical analysis. Through the analysis of 23 compounds with various basic and acidic groups, we found that there are some quantifiable and non-quantifiable basic compounds. For example, 4-aminophenol is quantifiable because the reduction prepeak current height of DBBQ derived from surplus HCl after neutralization with 4-aminophenol was linearly decreased with increasing 4-aminophenol concentration (r² = 0.988). In contrast, 4-aminobenzoic acid is non-quantifiable because the above voltammetric behaviors were not observed. From the relationships between the predicted pK_b and pK_a values of the quantifiable and non-quantifiable compounds, we found that a quantifiable basic compound without an acidic group satisfies pK_b < 12, and a quantifiable basic compound with an acidic group satisfies the following equation: pK_b < -0.0399(pK_a)² + 1.25pK_a + 2.12. These findings are useful to predict interfering substances in analyses of real samples with complicated matrixes and to estimate quantifiable basic compounds by this electrochemical analysis.

2025-07-01·Separation and Purification Technology

Impact of graphitic carbon nitride/polydopamine on permeance and antifouling performance of reverse osmosis membranes

作者: Huang, Zhuo ; Ge, Mengni ; Gao, Zhuofan ; Zhao, Yan ; Li, Gaiye ; Qi, Yuanyuan ; Zhang, Jianfeng ; der Bruggen, Bart Van ; Zhang, Lin

Nanotechnol. advancements have significantly contributed to the development of thin-film nanocomposite (TFN) reverse osmosis membranes for addressing global water scarcity through more efficient separation and purification processes.However, the impact of nanomaterials on membrane preparation, structure, and performance remains insufficiently understood.In this study, graphitic carbon nitride/polydopamine (g-C₃N₄/PDA) incorporated TFN membrane was proposed and systematically investigated through exptl. methods and mol. dynamics (MD) simulations.The incorporation of g-C₃N₄/PDA increased the resistance to MPD diffusion during the interfacial polymerization process, the obtained TFN membrane displayed a thinner, smoother active layer and enhanced hydrophilicity.Therefore, the membrane exhibited a remarkable water flux of 53.43 L·m^-2·h^-1, triple that of the conventional membrane, with a NaCl rejection of 98.9%.Meanwhile, the TFN membrane displayed excellent antifouling properties against both organic, inorganic and mixed foulants, maintaining a high flux recovery rate during long-term operation.MD simulation further revealed the stable interaction between g-C₃N₄/PDA nanocomposites and the polyamide matrix, enhancing structural compatibility and improving membrane performance.This study provides insights into the role of nanomaterials in the active layer of the membrane, offering both theor. and practical guidance for the design of advanced TFN membranes with enhanced water permeance and antifouling performance.

项与氨丁三醇相关的新闻（医药）

2025-03-11

·参天公司

参天公司他氟噻吗滴眼液“港澳药械通”上市许可申请获批

2025年3月11日，广东 — 参天公司宣布他氟噻吗滴眼液泰浦康® (TAPCOM®)的“港澳药械通”上市许可申请已获广东药品监督管理局（GDMPA）批准，得益于“港澳药械通”政策，泰浦康® (TAPCOM®)可由香港引进到粤港澳大湾区内地9市的45家医院使用。拟定的适用范围为用于降低开角型青光眼或高眼压症成年患者的眼压（IOP），用于对局部单独使用β-受体阻滞剂或前列腺素衍生物疗效不佳而需要联合治疗的患者。本品不含防腐剂，可增加患者的获益。青光眼是全球第一位不可逆性致盲性眼病。中国的青光眼患者占全球的1/4，是全球青光眼患者最多的国家，也是青光眼视力损害患者最多的国家。青光眼发病隐匿，早期诊断困难，大量患者疾病意识不足，三分之二的青光眼患者初诊时已发展到中晚期。青光眼需要长期终身治疗，局部滴用降眼压药物是重要手段[1-3]。本次申报产品——不含防腐剂的0.0015%他氟前列素和0.5%马来酸噻吗洛尔固定剂量复方滴眼液，含有两种对房水动力学有不同作用机制的有效成分，每日滴眼1次即可达到与联合用药相同的有效性和安全性。相比联用两种滴眼液，它进一步提高了患者用药的便利性、依从性及生活质量。向宇博士参天公司中国区总裁青光眼是影响中国居民眼健康的主要疾病之一，参天公司持续关注和推动青光眼的诊疗。我们非常高兴分享他氟噻吗滴眼液泰浦康® (TAPCOM®)被获批准入大湾区使用的好消息，加速创新药更早惠及中国患者，是参天践行‘以患者为中心’长期承诺的重要体现。未来希望通过“港澳药械通”政策引进更多的产品，为中国的眼科疾病患者带来更多的希望。参考文献 1. Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. 2 2. Sun Y, Chen A, Zou M, et al. Disease Burden of Glaucoma in China: Findings from the Global Burden of Disease 2019 Study[J]. Clin Epidemiol, 2022, 14: 827-834. 3. 中华医学会眼科学分会青光眼学组,等.中国青光眼指南[M].Buclas.布克.2022. 关于参天作为一家专注于视觉健康的公司，参天致力于通过为全球的患者、消费者以及医疗人士提供有价值的产品和服务，以实现参天的世界愿景“Happiness with Vision”。自创立之日起拥有超过130年的历史，公司始终坚持「天機に参与する」（意思是：“参悟天地万物之规律，为增进人类健康做贡献”）这一核心理念，致力于维护和改善人们的视觉健康。参天主要从事眼科药品的研发、生产、销售和推广活动，为全球60多个国家和地区约超过5000万人提供视觉健康的支持。公司的使命是利用我们在眼科医疗领域的专业知识，从患者的角度出发，提供各种产品和服务，持续不断地在眼部疾病预防、诊断和治疗等方面为患者和社会提供重要的价值。为了让更多的患者过上幸福美满的生活，参天致力于实现世界愿景“Happiness with Vision”—“通过创造最佳的视觉体验，让每个人拥有最幸福的生活”。如需了解更多信息，请访问参天公司的网站：http://www.santen-china.com.cn

上市批准临床研究申请上市临床结果CSCO会议

2025-01-30

·Business Wire

A.forall Announces First US Launch with Coveted Competitive Generic Therapy (CGT) Exclusivity of Tromethamine Injection 18GM/500mL

WHITE BEAR LAKE, Minn.--( BUSINESS WIRE )--A.forall announced through its U.S. subsidiary, Milla Pharmaceuticals Inc. , that it has received Abbreviated New Drug Application (ANDA) approval by the U.S. Food and Drug Administration (FDA) for a generic version of THAM Solution Tromethamine Injection 18GM/500mL marketed by Hospira Inc, a Pfizer company. Tromethamine Injection is indicated for prevention and correction of metabolic acidosis. This marks the 6 th overall ANDA approval for A.forall and another instance where Competitive Generic Therapy (CGT) eligibility has been granted. Moreover, Milla Pharmaceuticals is commercializing Tromethamine Injection using their own label and their expanded US market presence, offering more direct access to customers and patients. “As this product was previously reported in shortage in the U.S. for multiple years, the approval and launch of Tromethamine Injection reinforce our mission of making affordable medicines available to all, by continuing the expansion of high-quality generic injectables supply throughout and beyond the U.S. market,” commented Erik Lazarich, A.forall’s President of U.S. Operations. Commercialization is currently underway, with a 180-day exclusivity as from launch. Please see link for Full Prescribing Information. About A.forall & Milla Pharmaceuticals At A.forall, our mission is all about Making Affordable Medicines Available To All: we develop value-added generic pharmaceuticals, solve product shortages and fill unmet medical needs so that patients can continue their treatment. At the same time, we are reducing costs to the healthcare system and increasing customer convenience for a more sustainable world. Milla Pharmaceuticals Inc., the U.S. subsidiary of A.forall, is engaged in the development, licensing, acquisition, and commercialization of generic prescription drugs for the U.S. market, focusing on niche injectable and solution products for hospitals and clinics. More info: About – A.forall & About - Milla Pharmaceuticals

上市批准

2024-10-30

·药明康德

每天一小时，显著提高老年痴呆患者自理能力，突破性疗法最新临床试验结果发布

▎药明康德内容团队编辑 Cognito Therapeutics今日在第17届阿尔茨海默病临床试验大会（CTAD）上，展示了在研疗法Spectris的最新数据。试验结果显示，Spectris可显著降低轻度至中度阿尔茨海默病患者的阿尔茨海默病依赖性评分（Alzheimer's Disease Dependence Score）。这一结果来自2期临床试验OVERTURE，显示了Spectris在改善患者预后和减轻护理人员负担方面的潜力。阿尔茨海默病依赖性评分是一种13项量表，用于评估因疾病进展导致患者所需他人帮助的程度。该评分与患者的认知衰退、护理人员负担和医疗成本密切相关。 OVERTURE试验在随机对照的环境中评估了Spectris的疗效，随后进行了为期12个月的开放标签扩展研究。完成初始试验的参与者共有44人，其中39人在9个月时进行了评估，22人在18个月时进行了评估。分析结果显示，在18个月内，活性治疗组的阿尔茨海默病依赖性评分比对照组低56.4%（p=0.0396）。在18个月时，活性治疗组的评分变化估计为+0.96（95% CI：0.47–1.44），对照组则为+2.20（95% CI：1.17–3.24）。安全性方面，Spectris表现出良好的安全性和耐受性，在开放标签扩展研究中，未报告与淀粉样蛋白相关的影像异常（ARIA）病例，且未出现严重的治疗相关不良事件。 Cognito Therapeutics公司是由麻省理工学院的光遗传学先驱Ed Boyden教授和研究阿尔茨海默病的蔡立慧教授联合创建。蔡立慧教授团队在《细胞》和Neuron上发表的论文显示，利用频率为40赫兹（Hz）的声光刺激，可以在阿尔茨海默病小鼠模型中激发小胶质细胞的反应，帮助清除淀粉样蛋白，而且还可以维持神经突触的数量和健康。基于这一研究，Cognito公司开发了在人类中使用的声光刺激设备Spectris，它的使用非常便捷，可以让患者在家中自己使用，每天只需一个小时的治疗。这款医疗器械已经获得美国FDA授予的突破性医疗器械认定。 ▲40Hz的声音刺激和声光刺激在小鼠AD模型中改善动物认知能力，提高淀粉样蛋白的清除（图片来源：参考资料[2]） ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Cognito Therapeutics Announces Spectris™ Treatment Demonstrates 56.4% Reduction in Alzheimer’s Disease Dependence Score with Strong Safety Profile. Retrieved October 29, 2024, from https://www.businesswire.com/news/home/20241029125390/en [2] Martorell et al, (2019). Multi-sensory Gamma Stimulation Ameliorates Alzheimer’s-Associated Pathology and Improves Cognition. Cell, https://doi.org/10.1016/j.cell.2019.02.014. 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果突破性疗法临床2期

100 项与氨丁三醇相关的药物交易

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