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Safety, Tolerability, and Pharmacokinetics of E3030, a Novel Peroxisome Proliferator-Activated Receptor <i>α/γ</i>Dual Agonist, in Healthy Japanese Male Subjects

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Pharmacology & Pharmacy 2014年第2期5卷 139-148页

作者： Yutaka Takeuchi Yuki Nishioka Yasumi Kitahara Setsuo Hasegawa Akihiro ohnishi Clinical Development Japan/Asia Clinical Research PCU Eisai Co. Ltd. Tokyo Japan Department of Laboratory Medicine Daisan Hospital Jikei University School of Medicine Tokyo Japan Japan Regulatory Affairs Global Regulatory CFU Eisai Co. Ltd. Tokyo Japan Sekino Clinical Pharmacology Clinic Tokyo Japan Present address: Pharmaspur Inc. Tokyo Japan

Objective: The objectives of the present study were to evaluate the safety of single oral dose E3030 in healthy Japanese male subjects, and to evaluate pharmacokinetics after single oral dose E3030 and food effect on pharmacokinetic profiles. Methods: This study was conducted in a randomized, double-blind, placebo-controlled, ascending single-dose study in 56 healthy Japanese male subjects. Subjects were orally administered E3030 (0.5-40 mg) or placebo. Results: Six of 42 (14%) subjects’ administered E3030 experienced adverse events;however, all adverse events were mild and transient, and there was no dose-dependent increase in any adverse event. Plasma samples were collected over 96 hours after dosing. After administration in the fasted state, Cmax of E3030 was achieved between 1.00 and 1.75 hours, indicating rapid absorption. Both Cmax and AUC were dose-proportional in the range of 0.5 to 40 mg. The average range of elimination half-life was 18.4-23.8 hr. CL/F and Vz/F also remained nearly constant regardless of dose levels. In addition, food effect was exploratorily evaluated in five subjects of administered E3030 (10 mg) in both fasted and fed states. The fed/fasted ratios for the geometric mean of the Cmax and AUC were 0.803 and 0.913, respectively. Conclusion: E3030 was safe and well tolerated at single doses up to 40 mg. The pharmacokinetic profile showed good linearity, and food effect on pharmacokinetics of E3030 was not significant.

关键词： PPAR Agonist Phase 1 Pharmacokinetics Healthy Subjects

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Inhibitory effect of fluvastatin on ileal ulcer formation in rats induced by nonsteroidal antiinflammatory drug

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World Journal of Gastroenterology 2005年第7期11卷 1040-1043页

作者： Mari Hagiwara Keiko Kataoka Hideki Arimochi Tomomi Kuwahara Haruyuki Nakayama Yoshinari ohnishi Department of Molecular Bacteriology

AIM: Nonsteroidal anti-inflammatory drugs (NSAIDs)cause gastrointestinal damage as one of their side effects in humans and experimental animals. Lipid peroxidation plays an important role in NSAID-induced ulceration. The aim of this study was to investigate the inhibitory effect of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)reductase inhibitors on the ulceration in small intestines of ***: The effects of three HMG-CoA reductase inhibitors, fluvastatin, pravastatin and atorvastatin on ileal ulcer formation in 5-bromo-2-(4-fluorophenyl)-3-(4-methylsulfonylphenyl) thiophene (BFMeT)-treated rats were examined. Antioxidative activity of the inhibitors was measured by a redox-linked colorimetric ***: Fluvastatin, which was reported to have antioxidative activity, repressed the ileal ulcer formation in rats treated with BFMeT an NSAIDs. However, the other HMG-CoA reductase inhibitors (pravastatin and atorvastatin)did not repress the ileal ulcer formation. Among these HMG-CoA reductase inhibitors, fluvastatin showed a significantly stronger reducing power than the others(pravastatin, atorvastatin).CONCLUSION: Fluvastatin having the antioxidaitive activity suppresses ulcer formation in rats induced by NSAIDs.

关键词：回肠溃疡小鼠动物实验非甾体激素消炎药药物治疗

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Remain Aggressive Behavior in Children with Temporal Lobe Epilepsy after Surgery

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Journal of Behavioral and Brain Science 2015年第3期5卷 81-87页

作者： sayuri Sukigara Eiji Nakagawa Masanori Ishikawa Kenji Sugai Masayuki Sasaki Takanobu Kaido Akio Takahashi Taisuke Otsuki Department of Child Neurology National Center Hospital National Center of Neurology and Psychiatry (NCNP) Tokyo Japan Department of Psychiatry NCNP Tokyo Japan Department of Neurosurgery NCNP Tokyo Japan

Behavioral problems have a high rate in patients with temporal lobe epilepsy but there have been few detailed reports about pediatric patients. We report two children with temporal lobe epilepsy who manifest behavior abnormality remaining after surgery. One child developed complex partial seizures at 10 years and 3 months of age caused by a left temporal ganglioglioma and manifested behavioral problems of lability, aggression, impulsivity and disinhibition. Seizures were relieved after temporal lobe resection at 10 years and 8 months of age but behavioral symptoms had been remained. The second child developed epilepsy at 3 years of age. He manifested similar behavioral problems at 7 years old. Seizures were relieved after temporal lobe resection at 13 years old but behavioral symptoms had been remained. Their courses suggested that aggressive behavior might be associated with not only temporal lesion but also other lesions such as frontal lobe or neural circuitry between both lobes. It is important to inform families of patients that behavioral disorders may not improve after epileptic surgery.

关键词： Temporal Lobe Epilepsy Behavioral Disorder Aggression Epileptic Surgery

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Observation of Cell-Size Variation under Environmental Stress by Fluorescence Correlation Spectroscopy without Objective Image Magnification

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Journal of Environmental Science and Engineering(A) 2012年第3期1卷 364-370页

作者： Kitao Fujiwara Keishiro Horiuchi sayuri Goryoda Yasuhiro Hashidume Naoko Horiguchi Takeshi Miyakawa Masako Takasu Motohide Aoki School of Life Sciences Tokyo University of Pharmacy and Life Sciences Tokyo 192-0392 Japan

Fluorescence correlation spectroscopy (FCS) without objective image magnification (without using con-focal microscope) was applied to observe the variation in cell size of Escherichia coli (E. coli) induced by the anti-cancer agent MitomycinC (MMC). In the system without image magnification followed in this study, the suspension of E. coli cells was stirred, and the difference in movement due to the different cell sizes induced by the compulsive solution flow was detected. The addition of 0.1-0.4 μg/L of MMC elongated the E. coli cell length from about 3.6 to 7.8 μm. The flow cell (i. d. = about 1 mm) also produced a size-dependent correlation curve. The present system is not based on single molecular FCS but is inexpensive and effective at observing the variation in cell size induced by environmental changes.

关键词：大肠杆菌细胞图像放大环境胁迫光谱荧光抗癌药物使用浓度悬架系统

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Liposome fullerene as a novel antioxidant for skin treatment

Liposome fullerene as a novel antioxidant for skin treatment

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The Second Eastern Asia Dermatology Congress(EADC2012)

作者： Takahiro Fujimoto sayuri Hyodo Masayuki Ito Mio Murakami Yuuki Fujikawa Kazuhisa Maeda Clinic F Department of physics School of ScienceTokai University

＜正＞Oxidative stress is strongly related with serious skin problems and topical application of antioxidants is efficacious therapeutic *** developed a fullerene-incorporated liposome（LpsmF） that does not have a significant biological toxic effect and investigated the effectiveness of LpsmF in reducing oxidative stress,thereby helping to sustain healthy

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Fulminant phlegmonitis of the esophagus, stomach,and duodenum due to Bacillus thuringiensis

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World Journal of Gastroenterology 2015年第12期21卷 3741-3745页

作者： Hisatake Matsumoto Hiroshi Ogura Masafumi Seki Mitsuo ohnishi Takeshi Shimazu Department of Traumatology and Acute Critical Medicine Osaka University Graduate School of Medicine Division of Infection Control and Prevention Osaka University Graduate School of Medicine

We report a case of phlegmonitis of the esophagus, stomach, and duodenum in patient in an immunocompromised state. Culture of gastric juice and blood yielded Bacillus thuringiensis. This case showed that even low-viru... 详细信息

关键词： Phlegmonous gastritis Esophagus Duodenum Bacillus

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Normalization of Serum Alkaline Phosphatase in Primary Sclerosing Cholangitis Associated with Ulcerative Colitis

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Health 2014年第10期6卷 969-974页

作者： Mitsuro Chiba Hidehiko Tsuda Satoko Tsuda Masafumi Komatsu Yasuo Horie Hirohide ohnishi Depatment of Gastroenterology Akita University School of Medicine Akita Japan Division of Gastroenterology Akita City Hospital Akita Japan Division of Gastroenterology Akita Kumiai General Hospital Akita Japan

Primary sclerosing cholangitis (PSC) is commonly associated with ulcerative colitis (UC). PSC progresses independently of UC ultimately resulting in liver failure. There is no established medical treatment to improve the natural course of PSC. Normalization of serum alkaline phosphatase (ALP) in early stage might delay the progress of PSC. A 20-year-old female, had a sudden attack of right hypochondralgia with high fever and abnormal liver function tests without elevation of bilirubin: ALP 478 IU/L, aspartate aminotransferase 360 IU/L, alanine aminotransferase 174 IU/L. Abnormal liver function tests returned to normal after the attacks. Morphological examinations initially indicated then confirmed a diagnosis of PSC. One month after displaying PSC symptoms administration of ursodeoxycholic acid was initiated. Similar attacks of cholangitis were repeated several times over the following two years. Even in the absence of these attacks, she always suffered postprandial hypochondralgia. There was no acute cholangitis in the year prior to the last hospitalization due to abdominal pain and bloody diarrhea. Findings were consistent with UC in the form of entire colitis. Sulfasalazine, metronidazole and semi-vegetarian diet (SVD) were initiated. Metronidazole is routinely used in inflammatory bowel disease (IBD) in our practice with the expectation of elimination of any potentially pathogenic bacteria. SVD was designed for IBD hoping to increase beneficial bacteria. A remission of UC was ascertained during hospitalization. Elevated ALP, in the absence of clinical cholangitis, was decreased to normal after the therapy for UC.

关键词： Primary Sclerosing Cholangitis Ulcerative Colitis Alkaline Phosphatase Metronidazole Vegetarian Diet

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A Computation Model of Echo Avoidance in Human Audition

A Computation Model of Echo Avoidance in Human Audition

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1998 International Conference on Neural Networks and Brain(ICNN&B’98)

作者： Jie Huang Noboru ohnishi Xiaolan Guo Noboru Sugie Bio-Mimetic Control Research Center The Institute of Physical and Chemical Research(RIKEN)2271-130 AnagahoraShimoshidamiMoriyama-kuNagoya 463Japan Department of Information Engineering Graduate School of EngineeringNagoya UniversityFuro-choChikusa-kuNagoya464-01 Japan

＜正＞The precedence effect being a topic of continuous theoretical interest in hearing research,however,cannot be predicted explicitly by a model until so *** this paper,an acho-avoidance mechanism is proposed by assuming that the precedence effect is caused by the inhibition of sound localization which depends on the estimated soundto -echo *** assume there is a neural echo estimation mechanism in the human auditory *** is found that a temporal pattern of aftereffect with delay and decay features,which is adopted from the previous psychological tests on the increase of the perceptual threshold of interaural time difference following a preceding impulsive sound, can be used for echo *** results of psychological experiments,***-level and unequal-level paired click tests,Haas’s tests,Franssen’s tests and others,can be interpreted consistently.

关键词： precedence effect sound localization echo estimation echo avoidance reverberant environment

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Advantageous tactics with certain probiotics for the treatment of graft-versus-host-disease after hematopoietic stem cell transplantation

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World Journal of Hematology 2023年第2期10卷 15-24页

作者： sayuri Yoshikawa Kurumi Taniguchi Haruka Sawamura Yuka Ikeda Ai Tsuji Satoru Matsuda Food Science and Nutrition Nara Women's UniversityNara 630-8506Japan

Hematopoietic stem cell transplantation(HSCT)becomes a standard form of cellular therapy for patients with malignant *** is the first-choice of immunotherapy,although HSCT can be associated with many complications such as graft-versus-host disease(GVHD)which is a major cause of morbidity and mortality after allogeneic *** has been shown that certain gut microbiota could exert protective and/or regenerative immunomodulatory effects by the production of short-chain fatty acids(SCFAs)such as butyrate in the experimental models of GVHD after allogeneic *** of gut commensal bacteria which can produce SCFAs may worsen dysbiosis,increasing the risk of *** of G-protein coupled receptors such as GPR41 seems to be upre-gulated in the presence of commensal bacteria,which might be associated with the biology of regulatory T cells(Tregs).Treg cells are a suppressive subset of CD4 positive T lymphocytes implicated in the prevention of GVHD after allogeneic ***,we discuss the current findings of the relationship between the modification of gut microbiota and the GVHD-related immunity,which suggested that tactics with certain probiotics for the beneficial symbiosis in gut-immune axis might lead to the elevation of safety in the allogeneic HSCT.

关键词： Gut microbiota Hematopoietic stem cell Reactive oxygen species Allogeneic hematopoietic stem cell transplantation Graft vs host disease Gut-immune axis©The Author(s)2023.Published by Baishideng Publishing Group Inc.All rights reserved.

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Crystallization of Cellobiohydrolase in the Presence of Cellulose-Degraded Cellobiose: Analysis of Intermolecular Interactions and Association Dynamics

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Journal of Crystallization Process and Technology 2014年第1期4卷 1-13页

作者： Kazuo Onuma Naoki Furubayashi Fujiko Shibata Yoshiko Kobayashi Sachiko Kaito Yuki ohnishi Koji Inaka Maruwa Foods and Biosciences Inc. Tsutsui-cho Yamatokoriyama Nara Japan National Institute of Advanced Industrial Science and Technology (AIST) Tsukuba Ibaraki Japan

Crystallization of enzymes in presence of impurities is important for clarifying the role of enzymes in natural world. Although it is proposed that impurities inhibit nucleation of enzyme crystallization, details are unclear. In this study, crystallization of cellobiohydrolase from Aspergillus niger was investigated by dynamic and time-resolved static light scattering using cellobiose as an impurity. We aimed to clarify how cellobiose inhibits cellobiohydrolase crystallization and to crystallize cellobiohydrolase in concentrated cellobiose without using seeds. The contribution of attractive forces to total intermolecular interactions of cellobiohydrolase monomers increased with the molar ratio of cellobiose/cellobiohydrolase (R(cb/ce)). Association dynamics of cellobiohydrolase using lithium sulfate, however, showed that the initial aggregation rate decreased with an increase in R(cb/ce). Because binding sites of cellobioses to cellobiohydrolase molecules differed from those for the growth of protein crystals, the binding of cellobioses would increase the chemical potential of the cellobiohydrolase monomers, which gradually reduced supersaturation for growth as the aggregate size increased. This result was in contrast with the conventional idea that cellobiose inhibits the nucleation of cellobiohydrolase crystals. Gentle agitation of cellobiose-containing cellobiohydrolase solutions during sitting-drop vapor-diffusion growth resulted in the growth of cellobiohydrolase single crystals for all R(cb/ce) conditions without using seeds.

关键词： Enzyme Crystallization Inhibitor Hamaker Constant Light Scattering

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