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  1. Article: [Pharmacological property, mechanism of action and clinical study results of Pabinafusp Alfa (Genetical Recombination) (IZCARGO

    Yamamoto, Ryuji / Kawashima, Satoshi

    Nihon yakurigaku zasshi. Folia pharmacologica Japonica

    2022  Volume 157, Issue 1, Page(s) 62–75

    Abstract: Mucopolysaccharidosis type II (MPS II) is an X-linked recessive lysosomal storage disease with the accumulation of glycosaminoglycans in tissues and organs throughout the body caused by dysfunction or loss of iduronate-2-sulfatase (IDS), resulting in ... ...

    Abstract Mucopolysaccharidosis type II (MPS II) is an X-linked recessive lysosomal storage disease with the accumulation of glycosaminoglycans in tissues and organs throughout the body caused by dysfunction or loss of iduronate-2-sulfatase (IDS), resulting in somatic and central nervous system (CNS) disorders. Although enzyme replacement therapy (ERT) with recombinant human IDS is the current first-line therapy for MPS II, it is not effective for the CNS because intravenously administered enzyme cannot cross the blood-brain barrier (BBB) and thereby does not reach the brain parenchyma. Pabinafusp alfa, approved in March 2021 in Japan, is a recombinant fusion protein composed of human IDS and humanized anti-human transferrin receptor (hTfR) antibody, utilizing the BBB-penetrating technology "J-Brain Cargo
    MeSH term(s) Animals ; Disease Models, Animal ; Enzyme Replacement Therapy ; Humans ; Iduronate Sulfatase/genetics ; Iduronate Sulfatase/therapeutic use ; Mice ; Mucopolysaccharidosis II/drug therapy ; Mucopolysaccharidosis II/genetics ; Recombination, Genetic
    Chemical Substances Iduronate Sulfatase (EC 3.1.6.13)
    Language Japanese
    Publishing date 2022-01-01
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 1097532-9
    ISSN 1347-8397 ; 0015-5691
    ISSN (online) 1347-8397
    ISSN 0015-5691
    DOI 10.1254/fpj.21080
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: α-L-iduronidase fused with humanized anti-human transferrin receptor antibody (lepunafusp alfa) for mucopolysaccharidosis type I: A phase 1/2 trial.

    Harmatz, Paul / Giugliani, Roberto / Martins, Ana Maria / Hamazaki, Takashi / Kubo, Toru / Kira, Ryutaro / Minami, Kohtaro / Ikeda, Toshiaki / Moriuchi, Hiroaki / Kawashima, Satoshi / Takasao, Naoko / So, Sairei / Sonoda, Hiroyuki / Hirato, Tohru / Tanizawa, Kazunori / Schmidt, Mathias / Sato, Yuji

    Molecular therapy : the journal of the American Society of Gene Therapy

    2024  Volume 32, Issue 3, Page(s) 609–618

    Abstract: Mucopolysaccharidosis type I (MPS I) causes systemic accumulation of glycosaminoglycans due to a genetic deficiency of α-L-iduronidase (IDUA), which results in progressive systemic symptoms affecting multiple organs, including the central nervous system ( ...

    Abstract Mucopolysaccharidosis type I (MPS I) causes systemic accumulation of glycosaminoglycans due to a genetic deficiency of α-L-iduronidase (IDUA), which results in progressive systemic symptoms affecting multiple organs, including the central nervous system (CNS). Because the blood-brain barrier (BBB) prevents enzymes from reaching the brain, enzyme replacement therapy is effective only against the somatic symptoms. Hematopoietic stem cell transplantation can address the CNS symptoms, but the risk of complications limits its applicability. We have developed a novel genetically modified protein consisting of IDUA fused with humanized anti-human transferrin receptor antibody (lepunafusp alfa; JR-171), which has been shown in nonclinical studies to be distributed to major organs, including the brain, bringing about systemic reductions in heparan sulfate (HS) and dermatan sulfate concentrations. Subsequently, a first-in-human study was conducted to evaluate the safety, pharmacokinetics, and exploratory efficacy of JR-171 in 18 patients with MPS I. No notable safety issues were observed. Plasma drug concentration increased dose dependently and reached its maximum approximately 4 h after the end of drug administration. Decreased HS in the cerebrospinal fluid suggested successful delivery of JR-171 across the BBB, while suppressed urine and serum concentrations of the substrates indicated that its somatic efficacy was comparable to that of laronidase.
    MeSH term(s) Humans ; Mucopolysaccharidosis I/therapy ; Mucopolysaccharidosis I/drug therapy ; Iduronidase/adverse effects ; Iduronidase/genetics ; Iduronidase/metabolism ; Brain/metabolism ; Blood-Brain Barrier/metabolism ; Receptors, Transferrin/genetics ; Heparitin Sulfate/metabolism
    Chemical Substances Iduronidase (EC 3.2.1.76) ; Receptors, Transferrin ; Heparitin Sulfate (9050-30-0)
    Language English
    Publishing date 2024-01-10
    Publishing country United States
    Document type Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article
    ZDB-ID 2010592-7
    ISSN 1525-0024 ; 1525-0016
    ISSN (online) 1525-0024
    ISSN 1525-0016
    DOI 10.1016/j.ymthe.2024.01.009
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  3. Article ; Online: Spinal postural alignment measurements using markerless digital photography.

    Hida, Mitsumasa / Wada, Chikamune / Imai, Ryota / Kitagawa, Kodai / Okamatsu, Shogo / Ohnishi, Tadasuke / Kawashima, Satoshi

    Journal of orthopaedic surgery (Hong Kong)

    2020  Volume 28, Issue 3, Page(s) 2309499020960834

    Abstract: Background: A device that can measure posture alignment repeatedly is important for the prevention of hyperkyphosis.: Objective: We devised a markerless measurement method for hyperkyphosis using digital photography and investigated the correlation ... ...

    Abstract Background: A device that can measure posture alignment repeatedly is important for the prevention of hyperkyphosis.
    Objective: We devised a markerless measurement method for hyperkyphosis using digital photography and investigated the correlation with other noninvasive measurements and the validity and accuracy of this method.
    Methods: The study included 27 participants. The craniovertebral angle in supine (CVAS) and craniohorizontal angle in supine (CHAS) were calculated from digital photographs of the head and neck areas of the studied subjects with ImageJ. The correlations of CVAS and CHAS with the kyphosis index (KI) and block method (BM) were investigated. Intrarater correlation coefficient and Bland-Altman analyses were used to verify the reliability and accuracy of the measured results.
    Results: CHAS exhibited an excellent correlation with the KI and the BM. The intra- and interrater reliabilities of CHAS were almost perfect. Bland-Altman analysis revealed that CHAS was associated with minor addition errors.
    Conclusion: CHAS founded an excellent correlation and reliability with the conventional spinal postural alignment measurements. The addition error suggested that the manual was needed to confirm the landmark. The CHAS is a method used to measure the spinal postural alignment in a supine position without markers and without exposing the skin surface.
    MeSH term(s) Age Factors ; Aged ; Aged, 80 and over ; Cervical Vertebrae ; Female ; Humans ; Image Processing, Computer-Assisted ; Kyphosis/diagnosis ; Male ; Neck ; Observer Variation ; Photography ; Posture ; Reproducibility of Results
    Language English
    Publishing date 2020-11-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 1493368-8
    ISSN 2309-4990 ; 1022-5536
    ISSN (online) 2309-4990
    ISSN 1022-5536
    DOI 10.1177/2309499020960834
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  4. Article ; Online: Visceral fat area is a better indicator of surgical outcomes after laparoscopic gastrectomy for cancer than the body mass index: a propensity score-matched analysis.

    Imai, Yoshiro / Lee, Sang-Woong / Kawai, Masaru / Tashiro, Keitaro / Kawashima, Satoshi / Tanaka, Ryo / Honda, Kotaro / Matsuo, Kentaro / Uchiyama, Kazuhisa

    Surgical endoscopy

    2021  Volume 36, Issue 5, Page(s) 3285–3297

    Abstract: Background: The number of overweight gastric cancer patients who are undergoing laparoscopic gastrectomy (LG) has increased in Japan. However, the relationship between obesity and surgical outcomes of LG remains unclear. Therefore, this study aimed to ... ...

    Abstract Background: The number of overweight gastric cancer patients who are undergoing laparoscopic gastrectomy (LG) has increased in Japan. However, the relationship between obesity and surgical outcomes of LG remains unclear. Therefore, this study aimed to evaluate the effect of visceral fat area (VFA) on surgical outcomes of LG for gastric cancer compared to the body mass index (BMI).
    Methods: This study was a retrospective, cohort study that included 587 patients who underwent LG in our institution between January 2015 and December 2019. The patients were divided into two groups according to VFA (< 100 cm
    Results: After propensity score matching, 144 pairs of patients in the VFA group and 82 pairs of patients in the BMI group were extracted. Operative time (p = 0.003), intraoperative blood loss (p = 0.0006), and CRP levels on postoperative day 1 (p = 0.002) and on postoperative day 3 (p = 0.004) were significantly higher in the high-VFA group than in the low-VFA group. However, these surgical outcomes were not significantly different between the high-BMI and low-BMI groups. There was no strong correlation between VFA and BMI (R
    Conclusion: VFA is a better indicator of longer operative time than BMI. However, increased VFA did not affect postoperative complications.
    MeSH term(s) Body Mass Index ; Cohort Studies ; Gastrectomy/adverse effects ; Humans ; Intra-Abdominal Fat ; Laparoscopy/adverse effects ; Postoperative Complications/epidemiology ; Postoperative Complications/etiology ; Postoperative Complications/surgery ; Propensity Score ; Retrospective Studies ; Risk Factors ; Stomach Neoplasms/complications ; Stomach Neoplasms/surgery ; Treatment Outcome
    Language English
    Publishing date 2021-08-11
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 639039-0
    ISSN 1432-2218 ; 0930-2794
    ISSN (online) 1432-2218
    ISSN 0930-2794
    DOI 10.1007/s00464-021-08642-4
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  5. Article ; Online: Factors associated with hemoglobin glycation index in adults with type 1 diabetes mellitus: The FGM-Japan study.

    Sakane, Naoki / Hirota, Yushi / Yamamoto, Akane / Miura, Junnosuke / Takaike, Hiroko / Hoshina, Sari / Toyoda, Masao / Saito, Nobumichi / Hosoda, Kiminori / Matsubara, Masaki / Tone, Atsuhito / Kawashima, Satoshi / Sawaki, Hideaki / Matsuda, Tomokazu / Domichi, Masayuki / Suganuma, Akiko / Sakane, Seiko / Murata, Takashi

    Journal of diabetes investigation

    2023  Volume 14, Issue 4, Page(s) 582–590

    Abstract: Aims/introduction: The discrepancy between HbA1c and glucose exposure may have significant clinical implications; however, the association between the hemoglobin glycation index (HGI) and clinical parameters in type 1 diabetes remains controversial. ... ...

    Abstract Aims/introduction: The discrepancy between HbA1c and glucose exposure may have significant clinical implications; however, the association between the hemoglobin glycation index (HGI) and clinical parameters in type 1 diabetes remains controversial. This study aimed to find the factors associated with HGI (laboratory HbA1c - predicted HbA1c derived from the continuous glucose monitoring [CGM]).
    Materials and methods: We conducted a cross-sectional study of adults with type 1 diabetes (n = 211, age 50.9 ± 15.2 years old, female sex = 59.2%, duration of CGM use = 2.1 ± 1.0 years). All subjects wore the CGM for 90 days before HbA1c measurement. Data derived from the FreeStyle Libre sensor were used to calculate the glucose management indicator (GMI) and glycemic variability (GV) parameters. HGI was defined as the difference between the GMI and the laboratory HbA1c levels. The participants were divided into three groups according to the HGI tertile (low, moderate, and high). Multivariate regression analyses were performed.
    Results: The female sex ratio, HbA1c, and % coefficient of variation (%CV) significantly increased over the HGI tertile, while eGFR and Hb decreased over the HGI tertile. In multivariate analysis, the factors associated with HGI were %CV and eGFR, after adjusting for HbA1c level and sex (R
    Conclusions: This study demonstrated that HGI is associated with female sex, eGFR, and some glycemic variability indices, independently of HbA1c. Minimizing glycemic fluctuations might reduce HGI. This information provides diabetic health professionals and patients with personalized diabetes management for adults with type 1 diabetes.
    MeSH term(s) Humans ; Adult ; Female ; Middle Aged ; Aged ; Diabetes Mellitus, Type 1/complications ; Glycated Hemoglobin ; Diabetes Mellitus, Type 2/complications ; Blood Glucose/analysis ; Maillard Reaction ; Blood Glucose Self-Monitoring ; Japan/epidemiology ; Cross-Sectional Studies ; Hemoglobins/analysis
    Chemical Substances Glycated Hemoglobin ; Blood Glucose ; Hemoglobins
    Language English
    Publishing date 2023-02-14
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 2625840-7
    ISSN 2040-1124 ; 2040-1116
    ISSN (online) 2040-1124
    ISSN 2040-1116
    DOI 10.1111/jdi.13973
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  6. Article: Association of scan frequency with CGM-derived metrics and influential factors in adults with type 1 diabetes mellitus.

    Sakane, Naoki / Hirota, Yushi / Yamamoto, Akane / Miura, Junnosuke / Takaike, Hiroko / Hoshina, Sari / Toyoda, Masao / Saito, Nobumichi / Hosoda, Kiminori / Matsubara, Masaki / Tone, Atsuhito / Kawashima, Satoshi / Sawaki, Hideaki / Matsuda, Tomokazu / Domichi, Masayuki / Suganuma, Akiko / Sakane, Seiko / Murata, Takashi

    Diabetology international

    2023  Volume 15, Issue 1, Page(s) 109–116

    Abstract: Introduction: This study aimed to investigate the association between scan frequency and intermittently scanned continuous glucose monitoring (isCGM) metrics and to clarify the factors affecting scan frequency in adults with type 1 diabetes mellitus ( ... ...

    Abstract Introduction: This study aimed to investigate the association between scan frequency and intermittently scanned continuous glucose monitoring (isCGM) metrics and to clarify the factors affecting scan frequency in adults with type 1 diabetes mellitus (T1D).
    Methods: We enrolled adults with T1D who used FreeStyle® Libre. Scan and self-monitoring of blood glucose (SMBG) frequency and CGM metrics from the past 90-day glucose data were collected. The receiver operating characteristic curve was plotted to obtain the optimal cutoff values of scan frequency for the target values of time in range (TIR), time above range (TAR), and time below range (TBR).
    Results: The study was conducted on 211 adults with T1D (mean age, 50.9 ± 15.2 years; male, 40.8%; diabetes duration, 16.4 ± 11.9 years; duration of CGM use, 2.1 ± 1.0 years; and mean HbA1c, 7.6 ± 0.9%). The average scan frequency was 10.5 ± 3.3 scan/day. Scan frequency was positively correlated with TIR and negatively correlated with TAR, although it was not significantly correlated with TBR. Scan frequency was positively correlated with the hypoglycemia fear survey-behavior score, while it was negatively correlated with some glycemic variability metrics. Adult patients with T1D and good exercise habits had a higher scan frequency than those without exercise habits. The AUC for > 70% of the TIR was 0.653, with an optimal cutoff of 11 scan/day.
    Conclusions: In real-world conditions, frequent scans were linked to improved CGM metrics, including increased TIR, reduced TAR, and some glycemic variability metrics. Exercise habits and hypoglycemia fear-related behavior might affect scan frequency. Our findings could help healthcare professionals use isCGM to support adults with T1D.Clinical Trial Registry No. UMIN000039376.
    Language English
    Publishing date 2023-09-12
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 2574501-3
    ISSN 2190-1686 ; 2190-1678
    ISSN (online) 2190-1686
    ISSN 2190-1678
    DOI 10.1007/s13340-023-00655-9
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  7. Article ; Online: To Use or Not to Use a Self-monitoring of Blood Glucose System? Real-world Flash Glucose Monitoring Patterns Using a Cluster Analysis of the FGM-Japan Study.

    Sakane, Naoki / Hirota, Yushi / Yamamoto, Akane / Miura, Junnosuke / Takaike, Hiroko / Hoshina, Sari / Toyoda, Masao / Saito, Nobumichi / Hosoda, Kiminori / Matsubara, Masaki / Tone, Atsuhito / Kawashima, Satoshi / Sawaki, Hideaki / Matsuda, Tomokazu / Domichi, Masayuki / Suganuma, Akiko / Sakane, Seiko / Murata, Takashi

    Internal medicine (Tokyo, Japan)

    2023  Volume 62, Issue 18, Page(s) 2607–2615

    Abstract: Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM) ...

    Abstract Objective This study investigated self-monitoring of blood glucose (SMBG) adherence and flash glucose monitoring patterns using a cluster analysis in Japanese type 1 diabetes (T1D) patients with intermittently scanned continuous glucose monitoring (isCGM). Methods We measured SMBG adherence and performed a data-driven cluster analysis using a hierarchical clustering in T1D patients from Japan using the FreeStyle Libre system. Clusters were based on three variables (testing glucose frequency and referred Libre data for hyperglycemia or hypoglycemia). Patients We enrolled 209 participants. Inclusion criteria were patients with T1D, duration of isCGM use ≥3 months, age ≥20 years old, and regular attendance at the collaborating center. Results The rate of good adherence to SMBG recommended by a doctor was 85.0%. We identified three clusters: cluster 1 (low SMBG test frequency but high reference to Libre data, 17.7%), cluster 2 (high SMBG test frequency but low reference to Libre data, 34.0%), and cluster 3 (high SMBG test frequency and high reference to Libra data, 48.3%). Compared with other clusters, individuals in cluster 1 were younger, those in cluster 2 had a shorter Libre duration, and individuals in cluster 3 had lower time-in-range, higher severe diabetic distress, and high intake of snacks and sweetened beverages. There were no marked differences in the incidence of diabetic complications and rate of wearing the Libre sensor among the clusters. Conclusion We stratified the patients into three subgroups with varied clinical characteristics and CGM metrics. This new substratification might help tailor diabetes management of patients with T1D using isCGM.
    MeSH term(s) Humans ; Young Adult ; Adult ; Blood Glucose ; Diabetes Mellitus, Type 1/epidemiology ; Blood Glucose Self-Monitoring/methods ; Japan/epidemiology ; Cluster Analysis ; Hypoglycemic Agents
    Chemical Substances Blood Glucose ; Hypoglycemic Agents
    Language English
    Publishing date 2023-01-12
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 32371-8
    ISSN 1349-7235 ; 0021-5120 ; 0918-2918
    ISSN (online) 1349-7235
    ISSN 0021-5120 ; 0918-2918
    DOI 10.2169/internalmedicine.0639-22
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  8. Article ; Online: Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2-Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial.

    Nishikawa, Tadaaki / Hasegawa, Kosei / Matsumoto, Koji / Mori, Masahiko / Hirashima, Yasuyuki / Takehara, Kazuhiro / Ariyoshi, Kazuya / Kato, Tomoyasu / Yagishita, Shigehiro / Hamada, Akinobu / Kawasaki, Mamiko / Kawashima, Satoshi / Tomatsuri, Sawako / Nagasaka, Yukari / Yoshida, Hiroshi / Machida, Ryunosuke / Hirakawa, Akihiro / Nakamura, Kenichi / Yonemori, Kan

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2023  Volume 41, Issue 15, Page(s) 2789–2799

    Abstract: Purpose: To investigate the efficacy and safety of trastuzumab deruxtecan, an antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2) with a topoisomerase I inhibitor payload, in patients with uterine carcinosarcoma (UCS) ... ...

    Abstract Purpose: To investigate the efficacy and safety of trastuzumab deruxtecan, an antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2) with a topoisomerase I inhibitor payload, in patients with uterine carcinosarcoma (UCS) expressing HER2.
    Patients and methods: Patients with recurrent UCS with HER2 immunohistochemistry scores ≥1+ previously treated with chemotherapy were included. Patients were assigned to the HER2-high (immunohistochemistry score ≥2+; n = 22) or low (immunohistochemistry score of 1+; n = 10) groups for primary and exploratory analyses, respectively. Trastuzumab deruxtecan 6.4 or 5.4 mg/kg was administered intravenously once every 3 weeks until unacceptable toxicity or disease progression. Dose modification was based on the updated recommended phase II dose for breast cancer to be 5.4 mg/kg. The primary end point was the objective response rate by central review in the HER2-high group. Secondary end points included the overall response rate (ORR) in the HER2-high group by investigator assessment, ORR in the HER2-low group, progression-free survival (PFS), overall survival (OS), and safety.
    Results: The ORR by central review in the HER2-high and HER2-low groups were 54.5% (95% CI, 32.2 to 75.6) and 70.0% (95% CI, 34.8 to 93.3) and those by investigator assessments were 68.2% and 60.0%, respectively. The median PFS and OS in the HER2-high and HER2-low groups were 6.2 and 13.3 months and 6.7 months and not reached, respectively. Grade ≥ 3 adverse events occurred in 20 patients (61%). Grades 1-2 and 3 pneumonitis/interstitial lung disease occurred in eight (24%) and one (3%) patient, respectively.
    Conclusion: Trastuzumab deruxtecan has efficacy in patients with UCS, regardless of HER2 status. The safety profile was generally consistent with that previously reported. Toxicities were manageable with appropriate monitoring and treatment.
    MeSH term(s) Female ; Humans ; Antibodies, Monoclonal, Humanized/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Carcinosarcoma/genetics ; Carcinosarcoma/therapy ; Immunoconjugates/adverse effects ; Receptor, ErbB-2/metabolism ; Trastuzumab ; Uterine Neoplasms/genetics ; Uterine Neoplasms/therapy
    Chemical Substances Antibodies, Monoclonal, Humanized ; ERBB2 protein, human (EC 2.7.10.1) ; Immunoconjugates ; Receptor, ErbB-2 (EC 2.7.10.1) ; Trastuzumab (P188ANX8CK) ; trastuzumab deruxtecan (5384HK7574)
    Language English
    Publishing date 2023-03-28
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.22.02558
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  9. Article ; Online: Pharmacokinetics and pharmacodynamics of JR-051, a biosimilar of agalsidase beta, in healthy adults and patients with Fabry disease: Phase I and II/III clinical studies.

    Nakamura, Kimitoshi / Kawashima, Satoshi / Tozawa, Hirotaka / Yamaoka, Mariko / Yamamoto, Tatsuyoshi / Tanaka, Noboru / Yamamoto, Ryuji / Okuyama, Torayuki / Eto, Yoshikatsu

    Molecular genetics and metabolism

    2020  Volume 130, Issue 3, Page(s) 215–224

    Abstract: Fabry disease is a rare X-linked lysosomal disease, in which mutations in the gene encoding α-galactosidase A result in progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs including the skin, kidney, and heart, often ... ...

    Abstract Fabry disease is a rare X-linked lysosomal disease, in which mutations in the gene encoding α-galactosidase A result in progressive cellular accumulation of globotriaosylceramide (GL-3) in various organs including the skin, kidney, and heart, often leading to life-threatening conditions. Enzyme replacement therapy is currently the standard therapy for the disease, to which two α-galactosidase A formulations have been approved: agalsidase α (Replagal®, Shire) and agalsidase β (Fabrazyme®, Sanofi). We have recently developed a biosimilar of agalsidase β, JR-051, and investigated its pharmacokinetics and pharmacodynamics to assess its bioequivalence to agalsidase β. In a randomized phase I study, healthy adult male volunteers were treated with JR-051 or agalsidase β and the pharmacokinetics of the drugs were compared. The ratio of geometric means (90% confidence interval [CI]) of the AUC
    MeSH term(s) Adolescent ; Adult ; Aged ; Biomarkers/blood ; Biosimilar Pharmaceuticals/administration & dosage ; Biosimilar Pharmaceuticals/pharmacokinetics ; Biosimilar Pharmaceuticals/pharmacology ; Case-Control Studies ; Child ; Double-Blind Method ; Enzyme Replacement Therapy/methods ; Fabry Disease/enzymology ; Fabry Disease/therapy ; Female ; Glycolipids/blood ; Humans ; Male ; Middle Aged ; Sphingolipids/blood ; Tissue Distribution ; Young Adult ; beta-Galactosidase/administration & dosage
    Chemical Substances Biomarkers ; Biosimilar Pharmaceuticals ; Glycolipids ; Sphingolipids ; globotriaosyl lysosphingolipid (126550-86-5) ; beta-Galactosidase (EC 3.2.1.23)
    Language English
    Publishing date 2020-05-01
    Publishing country United States
    Document type Clinical Trial, Phase I ; Clinical Trial, Phase II ; Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 1418518-0
    ISSN 1096-7206 ; 1096-7192
    ISSN (online) 1096-7206
    ISSN 1096-7192
    DOI 10.1016/j.ymgme.2020.04.003
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  10. Article: [Game addiction].

    Mori, Akio / Iwadate, Masako / Minakawa, Nahoko T / Kawashima, Satoshi

    Nihon rinsho. Japanese journal of clinical medicine

    2015  Volume 73, Issue 9, Page(s) 1567–1573

    Abstract: The purpose of this article is to analyze the South Korea and China of computer game research, and the current state of research in Japan. Excessive game actions were analyzed by PET-MRI, MRI, fMRI, NIRS, EEG. These results showed that the prefrontal ... ...

    Abstract The purpose of this article is to analyze the South Korea and China of computer game research, and the current state of research in Japan. Excessive game actions were analyzed by PET-MRI, MRI, fMRI, NIRS, EEG. These results showed that the prefrontal cortical activity decreased during game play. Also, game addiction causes damage to the prefrontal cortex. The NIRS-EEG and simultaneous recording, during game play correspond well with the decrease of β band and oxygen-hemoglobin. The α band did not change with game play. However, oxygen-hemoglobin decreased during game play. South Korea, game addiction measures have been analyzed since 2002, but in Japan the research is recent.
    MeSH term(s) Behavior, Addictive/physiopathology ; Humans ; Image Processing, Computer-Assisted/methods ; Internet ; Magnetic Resonance Imaging/methods ; Prefrontal Cortex/physiopathology ; Video Games
    Language Japanese
    Publishing date 2015-09
    Publishing country Japan
    Document type English Abstract ; Journal Article ; Review
    ZDB-ID 390903-7
    ISSN 0047-1852
    ISSN 0047-1852
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