To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes: A Prospective, Open-Label, Single-Arm, Single-Center Clinical Study

This study was designed to evaluate the effect of Nesinaact on non-alcoholic steatohepatitis through magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) and liver fibroscan in patients with type 2 diabetes. This is a prospective, open-label, single-arm, single-center clinical Study. After 24 weeks of Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment, the improvement of parameters estimated by MRI and liver fibroscan will be estimated.

开始日期2020-05-29

申办/合作机构

Yonsei University

NCT03499704 / Active, not recruiting临床4期

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.

开始日期2020-02-11

申办/合作机构

Celltrion Pharm Inc.

NCT03501277 / Completed临床1期

A Randomized, Open-Label, Single-Dose, 4-Period Crossover Study to Determine the Bioequivalence of Alogliptin (25 mg) and Pioglitazone (15 and 30 mg) When Administered as Individual Tablets and as Fixed-Dose Combination Tablets to Healthy Russian Subjects

The purpose of this study is to assess the relative bioavailability and bioequivalence of 2 strengths of the FDC tablet product SYR-322-4833 BL compared to the individual alogliptin and pioglitazone tablets in healthy Russian participants.

开始日期2018-05-26

申办/合作机构

Takeda Pharmaceutical Co., Ltd.

100 项与苯甲酸阿格列汀/盐酸吡格列酮相关的临床结果

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100 项与苯甲酸阿格列汀/盐酸吡格列酮相关的转化医学

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100 项与苯甲酸阿格列汀/盐酸吡格列酮相关的专利（医药）

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项与苯甲酸阿格列汀/盐酸吡格列酮相关的文献（医药）

2023-07-26·Journal of affective disorders

Low-dose lithium adjunct to quetiapine improves cognitive task performance in mice with MK801-induced long-term cognitive impairment: Evidence from a pilot study.

Article

作者: Chuanjun Zhuo ; Hongjun Tian ; Jingjing Zhu ; Tao Fang ; Jing Ping ; Lina Wang ; Yun Sun ; Langlang Cheng ; Chunmian Chen ; Guangdong Chen

BACKGROUND:

Low-dose lithium (LD-Li) has been shown to rescue cognitive impairment in mouse models of short-term mild cognitive impairment, dementia, and schizophrenia. However, few studies have characterized the effects of LD-Li, alone or in conjunction with anti-psychotics, in the mouse model of MK801-induced long term cognitive impairment.

METHODS:

The present study used in vivo Ca²⁺ imaging and a battery of cognitive function assessments to investigate the long-term effects of LD-Li on cognition in mice exposed to repeated injections of MK801. Prefrontal Ca²⁺ activity was visualized to estimate alterations in neural activity in the model mice. Pre-pulse inhibition (PPI), novel object recognition (NOR), Morris water maze (MWM), and fear conditioning (FC) tasks were used to characterize cognitive performance; open field activity (OFA) testing was used to observe psychotic symptoms. Two treatment strategies were tested: LD-Li [250 mg/d human equivalent dose (HED)] adjunct to quetiapine (QTP; 600 mg/d HED); and QTP-monotherapy (mt; 600 mg/d HED).

RESULTS:

Compared to the QTP-mt group, the LD-Li + QTP group showed greatly improved cognitive performance on all measures between experimental days 29 and 85. QTP-mt improved behavioral measures compared to untreated controls, but the effects persisted only from day 29 to day 43. These data suggest that LD-Li + QTP is superior to QTP-mt for improving long-term cognitive impairments in the MK801 mouse model.

LIMITATIONS:

There is no medical consensus regarding lithium use in patients with schizophrenia.

CONCLUSION:

More pre-clinical and clinical studies are needed to further investigate effective treatment strategies for patients with long-term cognitive impairments, such as chronic schizophrenia.

2023-06-09·Poultry science

Peroxisome proliferator-activated receptor gamma (PPARγ) activation: a potential treatment for ascites syndrome in broiler chickens.

Article

作者: Mahin Rahimi ; Shaban Rahimi ; Mohammad Amir Karimi Torshizi ; Mohsen Sharafi ; Ali Akbar Masoudi ; Jesse L Grimes

Ascites (serous fluid accumulation in the abdominal cavity) has been observed worldwide in fast growing broilers. Pulmonary vascular remodeling is an important pathological feature of broiler ascites syndrome. Peroxisome proliferators-activated receptor gamma (PPARγ) and peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) are expressed in pulmonary vascular endothelial cells and vascular smooth muscle cells (VSMC) where they participate in the regulation of normal pulmonary vascular function. The objective of the present study was to investigate the effects of omega-3 fatty acids (found in fish oil) and pioglitazone (PIO) as natural and synthetic PPARγ ligands supplementation on PPARγ and PGC-1α expression in the prevention of pulmonary arterial hypertension (PAH) syndrome in broiler chickens. The experiment was conducted with 4 treatment groups: 1) negative control, normal temperature conditions with basal diet; 2) positive control, low-temperature conditions with basal diet; 3) positive control + 10 mg PIO/kg of weight/d and 4) positive control + 1% FO. Each treatment had 5 replicates. Ascites heart index (RV/TV) was significantly (P < 0.05) reduced in chickens receiving FO (0.20) and PIO (0.21) compared to the positive control group (0.26). The addition of PIO in broilers under cold-induced ascites significantly increased the expression of PPARγ (9.44) and PGC-1α (5.81) genes in lung tissue compared to the negative control group (1.03, P < 0.05). Proliferative indexes of VSMC in pulmonary arteries such as PMT, PIT, and percentage wall thickness were significantly elevated in positive control group, indicating that pulmonary vascular remodeling occurred following VSMC proliferation in ascites. The vessel internal diameter was increased in FO and PIO groups. Based on these results, activation and expression of PPARγ and PGC-1α genes as a critical regulator of pulmonary artery smooth muscle cell using ligands, especially PIO, can be effective in reducing the incidence of PAH in broiler chickens.

2023-01-01·Frontiers in neuroscience

Pioglitazone enhances brain mitochondrial biogenesis and phase II detoxification capacity in neonatal rats with 6-OHDA-induced unilateral striatal lesions.

Article

作者: Daniela Vázquez-González ; Juan Carlos Corona

The psychostimulant methylphenidate (MPH) is the first-line pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), but has numerous adverse side effects. The PPARγ receptor agonist pioglitazone (PIO) is known to improve mitochondrial bioenergetics and antioxidant capacity, both of which may be deficient in ADHD, suggesting utility as an adjunct therapy. Here, we assessed the effects of PIO on ADHD-like symptoms, mitochondrial biogenesis and antioxidant pathways in multiple brain regions of neonate rats with unilateral striatal lesions induced by 6-hydroxydopamine (6-OHDA) as an experimental ADHD model. Unilateral striatal injection of 6-OHDA reduced ipsilateral dopaminergic innervation by 33% and increased locomotor activity. This locomotor hyperactivity was not altered by PIO treatment for 14 days. However, PIO increased the expression of proteins contributing to mitochondrial biogenesis in the striatum, hippocampus, cerebellum and prefrontal cortex of 6-OHDA-lesioned rats. In addition, PIO treatment enhanced the expression of the phase II transcription factor Nrf2 in the striatum, prefrontal cortex and cerebellum. In contrast, no change in the antioxidant enzyme catalase was observed in any of the brain regions analyzed. Thus, PIO may improve mitochondrial biogenesis and phase 2 detoxification in the ADHD brain. Further studies are required to determine if different dose regimens can exert more comprehensive therapeutic effects against ADHD neuropathology and behavior.

项与苯甲酸阿格列汀/盐酸吡格列酮相关的新闻（医药）

2022-09-29

·生物制品圈

新研究发现接种流感疫苗可降低罹患阿尔茨海默病、抑郁症等多种疾病风险

▍摘要流行性感冒，简称流感，是由流感病毒引起的急性呼吸道传染病，通过空气飞沫传播，是传播速度最快的传染病之一。流感在全球每年可导致300万~ 500万的重症和29万~ 65万呼吸道疾病相关死亡。每年流感流行季节，儿童流感罹患率约为20% ~ 30%，在某些高流行季节，甚至高达50%。接种流感疫苗仍然是预防流感的最有效方式，然而我国流感疫苗接种率不足3%，与欧美相差甚远。近日，国际顶级期刊《Nature》发文，一项对卡塔尔3万多名卫生保健工作者的研究发现，接种流感疫苗可降低新冠感染风险，其对重症防护效力高达90%。新的研究表明，接种流感疫苗还可以有效降低罹患阿尔茨海默病（AD）、抑郁症等神经系统疾病的风险，降低慢性阻塞性肺病、心血管等疾病的影响。▍最新研究表明接种流感疫苗可预防阿尔茨海默病阿尔茨海默病（Alzheimer Disease，AD），俗称老年痴呆。据WHO估计，目前全球有超过5500万人患有痴呆症，超过25%来自中国。在中国，每100个60岁以上的老人中就有5个痴呆症患者。阿尔茨海默病每年所致的社会总经济负担高达11406亿元，是癌症经济负担的5倍。近期，一项发表在《阿尔茨海默病杂志》（Journal of Alzheimer's Disease）的研究指出，与未接种流感疫苗的同龄人相比，接种至少一种流感疫苗的人在四年内患阿尔茨海默病的可能性降低40%[1]。为了探讨接种流感疫苗对罹患阿尔茨海默病风险的影响，来自德克萨斯大学休斯顿健康科学中心（UT Health）的研究人员从数据库中纳入了935887名、平均年龄为73.7岁且接种了流感疫苗的老年人与935887名未接种流感疫苗的65岁以上老年人进行队列分析[1]。结果显示，接种过流感疫苗的老年人中，有5.1%（n =47889）的人发展为了AD；在没接种流感疫苗的老年人中共有8.5%（n =79630）的人发展为了AD，见图1。与未接种过流感疫苗的老年人相比，接种流感疫苗后老年人发生AD的风险降低40%（RR=0.6，95% CI：0.59–0.61）[1][2]。图1. 接种流感疫苗或未接种流感疫苗患AD人数该研究发现，每年坚持接种流感疫苗的人患阿尔茨海默病的比率最低。然而，这一保护机制需要进一步研究[2]。图2. 按流感疫苗接种次数估算的偶发性AD的CIF曲线AD的两个核心病理特征是淀粉样斑块和神经纤维缠结[3][4]。淀粉样蛋白级联假说表明，淀粉样蛋白β（Aβ）的沉积触发了大脑中的神经元功能障碍和死亡。越来越多的证据表明，系统性免疫反应可以对大脑产生持久的影响，并影响AD的风险和/或进展。老年人感染各种病原微生物都会增加其认知能力下降的风险和/或比率，包括流感呼吸道感染、肺炎、疱疹感染、慢性牙周炎、尿道感染、胃肠道感染、败血症，以及最近的COVID-19。因此，预防或减少病原微生物感染可能是延迟或降低神经退行性疾病风险的合理策略[4][1]。该研究进一步分析了接种流感疫苗对降低罹患AD风险的相关机制：❶流感特异性免疫机制，包括减轻继发于流感感染引起的损害和/或流感与AD病理学之间的相似性；❷接种流感疫苗引发的固有免疫系统反应，可对其它病原微生物产生非特异性保护作用,即免疫训练；❸通过适应性免疫系统的淋巴细胞介导的交叉反应，接种流感疫苗产生的特异性免疫对其他病原微生物的非特异性保护作用[1]。无论确切机制如何，越来越多的文献支持先天免疫训练的相关性，即疫苗与降低AD风险有关。▍接种流感疫苗可降低罹患抑郁症风险与流感疫苗显著降低阿尔茨海默病的患病风险类似的机理，流感疫苗还能降低罹患其它神经系统疾病的风险。来自英国的一项研究[5]。纳入了103307名在2000年至2013年期间诊断为抑郁症的80岁以下患者，分析了与以往流感感染相关的抑郁症的相对风险估计，按此类事件的数量、时间和严重程度分级，并根据各种共病、吸烟状况、酒精摄入、体重指数、口服皮质类固醇和苯二氮卓类药物进行了对比分析。与未接种流感疫苗的患者相比，接种流感疫苗患抑郁症风险降低了6.6%（OR 1.29，95%CI 1.19–1.39）。表1. 接种流感疫苗与抑郁症风险之间的关系类型Cases(n=103307)n(%)Controls(n=103307)n(%)Crude OR(95%CI)Adjusted a OR(95%CI)未接种流感疫苗8566（8.3）6746（6.5）1.33(1.28-1.37)1.30(1.25-1.35)接种流感疫苗1742（1.7）1345（1.3）1.39(1.29-1.49)1.29(1.19-1.39)▍接种流感疫苗能有效减少慢性阻塞性肺病、心血管疾病等影响与同龄健康成年人相比，慢性基础疾病患者感染流感病毒后，更易出现严重疾病或死亡，其流感相关住院率和超额死亡率更高。我国成都开展的一项队列研究表明，接种三价流感疫苗（IIV3）可以减少慢性阻塞性肺病（COPD）和慢性支气管炎的急性感染和住院[6][7]。研究发现，与未接种疫苗的对照组相比，IIV3接种3个月、6个月后COPD急性加重的住院天数分别减少3.3天、7.1天[6]。此外，还有研究发现流感疫苗对儿童和成人哮喘患者有较好免疫原性[8]；哮喘患者接种流感疫苗能够有效减少流感感染和哮喘发作[9]。英国的一项研究表明：流感疫苗在心血管疾病患者中免疫原性良好，能够保护心血管病患减少流感感染。冠心病患者接种流感疫苗后，可以减少急性冠脉综合征（ACS）患者的心血管不良事件发生率，降低其住院风险和与心脏病相关的死亡率[10]。流感疫苗还可降低心衰患者的死亡风险。丹麦的一项队列研究提示，在随访期间（中位随访时间为3.7年），接种≥1剂次流感疫苗可使心力衰竭（HeartFailure,HF）患者的全因死亡风险降低18%（风险比（HR）=0.82,95％CI:0.81-0.84），心血管死亡风险降低18%(风险比=0.82,95％CI:0.81-0.84）。此外，一些研究显示，接种流感疫苗可减少糖尿病患者、免疫功能受损患者的住院时间，降低住院率及死亡率[11]。18-64岁的糖尿病患者接种流感疫苗对住院的保护效果是58%；老年人糖尿病患者接种流感疫苗，对住院的保护效果为23%，对全死因死亡的保护效果为38-56%[12]。另外，研究提示接种流感疫苗可以减少免疫功能受损的流感住院儿童并发症的发生风险，缩短住院时间[11]。▍鼻喷流感减毒活疫苗可产生更全面的免疫反应灭活流感疫苗主要以体液免疫发挥作用，鼻喷流感减毒活疫苗可诱导更为全面的三重免疫，即：粘膜免疫、细胞免疫、体液免疫。一项对儿童的试验表明，疫苗株亚型与流行株不匹配的流行季，接种1剂鼻喷流感减毒活疫苗的保护效力为86%（交叉免疫，即：可预防所含流感病毒流行株之外的其他亚型流感病毒）。据《中国流感疫苗预防接种技术指南》指出，除对实验室确诊流感有保护效果外，有试验表明，鼻喷流感减毒活疫苗可减少21%的发热性疾病，也可减少30%的中耳炎，对6-8月龄儿童实验室确诊流感合并急性中耳炎的保护效果为85%[13]。流感减毒活疫苗经鼻腔注射后可诱导体液和鼻粘膜均产生抗体，同时也可诱导细胞介导的免疫反应，且当疫苗株亚型与循环株不匹配的流行季，也有很高的保护率。▍小结接种流感疫苗可以有效预防阿尔茨海默病（AD）等神经系统疾病，预防慢性阻塞性肺病、心血管等疾病，减少感染新型冠状病毒风险，降低罹患抑郁症风险。这可能一方面与流感疫苗激发了人体先天免疫训练有关，另一方面与接种流感疫苗降低了流感并发症有关。与灭活流感疫苗相比，鼻喷流感减毒活疫苗可更加全面的激发人体免疫，产生更为持久的抗体保护，对疫苗株之外的流感病毒具有更为广泛的预防效果，可有效降低多种疾病以及并发症的罹患风险。参考文献：[1]Bukhbinder AS, Ling Y, Hasan O, et al. Risk of Alzheimer's Disease Following Influenza Vaccination: A Claims-Based Cohort Study Using Propensity Score Matching. J Alzheimers Dis. 2022;10.3233/JAD-220361. doi:10.3233/JAD-220361[2]Avram S. Bukhbinder, Yaobin Ling, Omar Hasan, Xiaoqian Jiang, Yejin Kim, Kamal N. Phelps, Rosemarie E. Schmandt, Albert Amran, Ryan Coburn, Srivathsan Ramesh, Qian Xiao, Paul E. Schulz. Risk of Alzheimer’s Disease Following Influenza Vaccination: A Claims-Based Cohort Study Using Propensity Score Matching. Journal of Alzheimer's Disease, 2022; 1 DOI: 10.3233/JAD-220361[3]Bondi MW, Edmonds EC, Salmon DP. Alzheimer's Disease: Past, Present, and Future. J Int Neuropsychol Soc. 2017;23(9-10):818-831. doi:10.1017/S135561771700100X[4]Webers A, Heneka MT, Gleeson PA. The role of innate immune responses and neuroinflammation in amyloid accumulation and progression of Alzheimer's disease. Immunol Cell Biol. 2020;98(1):28-41. doi:10.1111/imcb.12301[5]Bornand D, Toovey S, Jick S S, et al. The risk of new onset depression in association with influenza–A population-based observational study[J]. Brain, behavior, and immunity, 2016, 53: 131-137. https://doi.org/10.1016/j.bbi.2015.12.005[6]黄远东, 赵晓平, 万涛, 等. 慢性阻塞性肺病人群流感疫苗接种的效果观察[J]. 海南医学, 2011, (04): 29-31. doi: 10.3969/j.issn.1003-6350.2011.04.011.[7]高忠翠,李江涛,展胜.卡舒宁联合流感疫苗对老年性慢性支气管炎合并急性感染的防治效果[J].中国生物制品学杂志,2011,24(10):1214-1216. doi: CNKI:SUN:SWZP.0.2011-10-030.[8]Schwarze J, Openshaw P, Jha A, et al. Influenza burden, prevention, and treatment in asthma-A scoping review by the EAACI Influenza in asthma task force. Allergy. 2018;73(6):1151-1181. doi:10.1111/all.13333[9]Vasileiou E, Sheikh A, Butler C, et al. Effectiveness of Influenza Vaccines in Asthma: A Systematic Review and Meta-Analysis. Clin Infect Dis. 2017;65(8):1388-1395. doi:10.1093/cid/cix524.[10]Clar C, Oseni Z, Flowers N, Keshtkar-Jahromi M, et al. Influenza vaccines for preventing cardiovascular disease. Cochrane Database Syst Rev. 2015;2015(5):CD005050. Published 2015 May 5. doi:10.1002/14651858.CD005050.pub3.[11]Collins JP, Campbell AP, Openo K, et al. Clinical Features and Outcomes of Immunocompromised Children Hospitalized With Laboratory-Confirmed Influenza in the United States, 2011-2015. J Pediatric Infect Dis Soc. 2019;8(6):539-549. doi:10.1093/jpids/piy101.[12] Remschmidt C, Wichmann O, Harder T. Vaccines for the prevention of seasonal influenza in patients with diabetes: systematic review and meta-analysis. BMC Med. 2015 Mar 17;13:53. doi: 10.1186/s12916-015-0295-6. PMID: 25857236; PMCID: PMC4373029.[13]国家免疫规划技术工作组流感疫苗工作组.中国流感疫苗预防接种技术指南(2021—2022)[J].中华医学杂志,2021,101(40):3287-3312. doi: 10.3760/cma.j.issn.0253-9624.2020.01.007.识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗抗体信使RNA免疫疗法

2022-09-23

·Healthcare IT News

South Korea's Myongji Hospital to develop robots that support dementia patients

Myongji Hospital, a tertiary healthcare institution in South Korea's Gyeonggi Province, is developing an AI-driven care robot to assist patients with dementia. The AI robot called "PIO" will be developed as part of a recently-signed technology development agreement with Whydots, a local robot maker. WHAT IT'S ABOUT The PIO robot, which resembles a parrot, aims to stimulate attachment and emotions in early dementia patients. It has a camera that recognises its user's face and facial expressions and is able to express emotions through its LED eyes and body movements. In its development, Myongji will contribute its experience and clinical data of dementia patients accumulated from the Baekse-chongmyung School, which runs the hospital's community-based dementia management programme. The hospital will also craft cognitive intervention content. WHY IT MATTERS According to a press statement, PIO can help relieve depression and improve users' emotional stability and cognitive ability. An initial trial of the technology early this year found that it helped improve the emotional condition and mental ability of patients at the Baekse-chongmyung School. It also received high satisfaction from users. PIO is also expected to reduce the workload for nursing personnel by interacting with patients while supporting the management of their condition. THE LARGER TREND Local governments in South Korea have provided companion robots to single persons and those who are living with mental health issues to support their well-being. The government of Chungnam Province , for one, is currently trying out AI-based care robots, which have been deployed to help communicate with single residents and people living with mental health issues as part of its suicide prevention efforts. The Gwanak district in Seoul followed suit by deploying the AI robot called Channy to serve as a personal companion for single adults in their community. ON THE RECORD South Korea's senior population is fast growing, making up about 16% of the total population or 8.53 million last year. According to Statistics Korea, this rising trend could continue, possibly reaching around 13 million in 2030 and 17 million in 2040. By 2050, people aged 65 and older will potentially account for over 40% of the entire population. "As the number of dementia patients is expected to increase due to the rapid ageing of the population, proper and effective treatment and management of dementia is urgently needed," said Myongji Hospital Director Kim Jin-gu. He added that the Myongji Hospital will continue to develop technology and produce content for dementia-friendly AI care robots with its know-how and expertise acquired from operating the Baekse-chongmyung School.

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01395797 (CTgov)	临床1/2期	尼古丁依赖 \| 海洛因依赖	82	Placebo (Placebo - Heroin)	膚顧壓觸衊築築範廠選(製網顧構膚餘繭觸醖膚) = 蓋蓋鬱壓衊網簾齋簾鹹餘製蓋築網築構獵鏇獵 (顧構膚築製觸獵願衊築, 積餘鏇觸願壓淵衊鬱顧 ~ 鬱積網衊襯夢獵築觸遞) 更多	-	2017-07-13
				PIO (Pio High Dose - Heroin)	膚顧壓觸衊築築範廠選(製網顧構膚餘繭觸醖膚) = 鹹簾餘憲餘窪蓋憲膚觸餘製蓋築網築構獵鏇獵 (顧構膚築製觸獵願衊築, 齋餘壓衊壓憲顧鏇齋積 ~ 鏇繭衊製艱範簾襯繭繭) 更多
NCT03501277 (CTgov)	临床1期	-	72	alogliptin+pioglitazone+SYR-322-4833 BL (Regimen A)	(築鹽糧鏇蓋蓋艱範顧廠): Least Square Mean (LSM) difference = 1.0706 (90% CI, 1.0230 ~ 1.1204); LSM diiference = 0.9594 (90% CI, 0.8837 ~ 1.0415) 更多	-	2019-08-08
				Alogliptin+pioglitazone (Regimen B)