Higashimurayama-shi, Japan
Higashimurayama-shi, Japan

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Morita J.,Meiji Seika Pharma Co. | Tanaka M.,Meiji Seika Pharma Co. | Nomoto M.,Meiji Seika Pharma Co. | Matsuki S.,Sugioka Memorial Hospital | And 3 more authors.
BioDrugs | Year: 2016

Background: DMB-3111 is a biosimilar trastuzumab drug being jointly developed by Meiji Seika Pharma (Japan) and Dong-A Socio Holdings (Korea). We investigated the bioequivalence of DMB-3111 relative to trastuzumab. Objectives: The aim of this study was to investigate the bioequivalence between DMB-3111 and trastuzumab and the pharmacokinetic, safety, and immunogenicity of both drugs in healthy Japanese adult males. Methods: Seventy healthy Japanese adult males were randomized 1:1 to receive either DMB-3111 or trastuzumab as a single intravenous infusion (6 mg/kg) over 90 min. Bioequivalence was assessed in terms of the pharmacokinetic parameters of both drugs. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Immunogenicity was tested using anti-drug antibody (ADA) assays. Results: The 90 % confidence intervals of the treatment differences (DMB-3111 versus trastuzumab) in the mean log-transformed maximum concentration, the area under the concentration-time curves (from 0 min to the last measured value or from 0 min to infinity), mean residence time, and the terminal half-life were within the accepted range for bioequivalence [log(0.80) to log(1.25)]. The frequencies of AEs and adverse drug reactions were similar with both drugs. No ADA reactivity to DMB-3111 or trastuzumab was observed in any subject. Conclusions: DMB-3111, a trastuzumab biosimilar, was bioequivalent to trastuzumab in terms of its pharmacokinetics and showed similar safety after a single intravenous infusion at 6 mg/kg over 90 min in healthy Japanese adult males. DMB-3111 is likely to show similar efficacy and safety profiles to trastuzumab in cancer patients (ClinicalTrials.gov #NCT02100917). © 2015 The Author(s).


PubMed | Meiji Seika Pharma Co., PS Clinic and Sugioka Memorial Hospital
Type: Comparative Study | Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy | Year: 2016

DMB-3111 is a biosimilar trastuzumab drug being jointly developed by Meiji Seika Pharma (Japan) and Dong-A Socio Holdings (Korea). We investigated the bioequivalence of DMB-3111 relative to trastuzumab.The aim of this study was to investigate the bioequivalence between DMB-3111 and trastuzumab and the pharmacokinetic, safety, and immunogenicity of both drugs in healthy Japanese adult males.Seventy healthy Japanese adult males were randomized 1:1 to receive either DMB-3111 or trastuzumab as a single intravenous infusion (6 mg/kg) over 90 min. Bioequivalence was assessed in terms of the pharmacokinetic parameters of both drugs. Adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Immunogenicity was tested using anti-drug antibody (ADA) assays.The 90% confidence intervals of the treatment differences (DMB-3111 versus trastuzumab) in the mean log-transformed maximum concentration, the area under the concentration-time curves (from 0 min to the last measured value or from 0 min to infinity), mean residence time, and the terminal half-life were within the accepted range for bioequivalence [log(0.80) to log(1.25)]. The frequencies of AEs and adverse drug reactions were similar with both drugs. No ADA reactivity to DMB-3111 or trastuzumab was observed in any subject.DMB-3111, a trastuzumab biosimilar, was bioequivalent to trastuzumab in terms of its pharmacokinetics and showed similar safety after a single intravenous infusion at 6 mg/kg over 90 min in healthy Japanese adult males. DMB-3111 is likely to show similar efficacy and safety profiles to trastuzumab in cancer patients (ClinicalTrials.gov #NCT02100917).


PubMed | Osaka City General Hospital, Sugioka Memorial Hospital and Okinawa Prefectural Nanbu Medical Center and Childrens Medical Center
Type: Case Reports | Journal: Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery | Year: 2016

The purpose of this study was to report transumbilical arterial embolization of a large dural arteriovenous fistula (AVF) in a low-birth-weight neonate with congestive heart failure (CHF).A female neonate was delivered by cesarean section at 31 weeks of gestation. Her birth weight was 1538 g and Apgar scores were 6 at both 1 and 5 min. Because of dyspnea and retracted respiration immediately after birth, she required mechanical ventilation. Ultrasound revealed right cardiac overload and a large cystic mass at the posterior brain. Magnetic resonance imaging on day 1 showed a large dural AVF (dural sinus malformation with arteriovenous (AV) shunts) at the torcular herophili. Umbilical artery and vein catheterization were performed on the same day for neurointervention. CHF prompted emergency embolization on day 8. The transfemoral arterial route could not be used because of its small size and compromised femoral artery blood flow. Transumbilical arterial embolization shrank the AV shunts markedly, resulting in clinical improvement, thus requiring no further intervention. Follow-up angiography at 4 months confirmed no residual AVF. Her growth and development were normal at the last follow-up at age 4 years.This patient apparently was the lowest birth weight neonate with a large AVF successfully treated by embolization, which is usually performed through the transfemoral arterial route. The transumbilical arterial route is an alternative for neonates with birth weight <2000 g and very small femoral arteries.


Osano K.,Sugioka Memorial Hospital | Nagamine R.,Sugioka Memorial Hospital | Todo M.,Kyushu University | Kawasaki M.,University of Occupational and Environmental Health Japan
Scientific World Journal | Year: 2014

One of the most common errors of total knee arthroplasty procedure is a malrotation of tibial component. The stress on tibial insert is closely related to polyethylene failure. The objective of this study is to analyze the effect of malrotation of tibial component for the stress on tibial insert during high flexion using a finite element analysis. We used Stryker NRG PS for analysis. Three different initial conditions of tibial component including normal, 15° internal malrotation, and 15° external malrotation were analyzed. The tibial insert made from ultra-high-molecular-weight polyethylene was assumed to be elastic-plastic while femoral and tibial metal components were assumed to be rigid. Four nonlinear springs attached to tibial component represented soft tissues around the knee. Vertical load was applied to femoral component which rotated from 0° to 135° while horizontal load along the anterior posterior axis was applied to tibial component during flexion. Maximum equivalent stresses on the surface were analyzed. Internal malrotation caused the highest stress which arose up to 160% of normal position. External malrotation also caused higher stress. Implanting prosthesis in correct position is important for reducing the risk of abnormal wear and failure. © 2014 Kei Osano et al.


Anuar M.A.,Kyushu University | Todo M.,Kyushu University | Nagamine R.,Sugioka Memorial Hospital | Hirokawa S.,Kyushu University
TheScientificWorldJournal | Year: 2014

The primary objective of this study is to distinguish between mobile bearing and fixed bearing posterior stabilized knee prostheses in the mechanics performance using the finite element simulation. Quantifying the relative mechanics attributes and survivorship between the mobile bearing and the fixed bearing prosthesis remains in investigation among researchers. In the present study, 3-dimensional computational model of a clinically used mobile bearing PS type knee prosthesis was utilized to develop a finite element and dynamic simulation model. Combination of displacement and force driven knee motion was adapted to simulate a flexion motion from 0° to 135° with neutral, 10°, and 20° internal tibial rotation to represent deep knee bending. Introduction of the secondary moving articulation in the mobile bearing knee prosthesis has been found to maintain relatively low shear stress during deep knee motion with tibial rotation.


Mohd Anuar M.A.,Kyushu University | Mohd Anuar M.A.,University Technology of MARA | Todo M.,Kyushu University | Nagamine R.,Sugioka Memorial Hospital | Hirokawa S.,Kyushu University
Scientific World Journal | Year: 2014

The primary objective of this study is to distinguish between mobile bearing and fixed bearing posterior stabilized knee prostheses in the mechanics performance using the finite element simulation. Quantifying the relative mechanics attributes and survivorship between the mobile bearing and the fixed bearing prosthesis remains in investigation among researchers. In the present study, 3-dimensional computational model of a clinically used mobile bearing PS type knee prosthesis was utilized to develop a finite element and dynamic simulation model. Combination of displacement and force driven knee motion was adapted to simulate a flexion motion from 0° to 135° with neutral, 10°, and 20° internal tibial rotation to represent deep knee bending. Introduction of the secondary moving articulation in the mobile bearing knee prosthesis has been found to maintain relatively low shear stress during deep knee motion with tibial rotation. © 2014 Mohd Afzan Mohd Anuar et al.


PubMed | Sugioka Memorial Hospital, Kyushu University and University Technology of MARA
Type: | Journal: TheScientificWorldJournal | Year: 2014

The primary objective of this study is to distinguish between mobile bearing and fixed bearing posterior stabilized knee prostheses in the mechanics performance using the finite element simulation. Quantifying the relative mechanics attributes and survivorship between the mobile bearing and the fixed bearing prosthesis remains in investigation among researchers. In the present study, 3-dimensional computational model of a clinically used mobile bearing PS type knee prosthesis was utilized to develop a finite element and dynamic simulation model. Combination of displacement and force driven knee motion was adapted to simulate a flexion motion from 0 to 135 with neutral, 10, and 20 internal tibial rotation to represent deep knee bending. Introduction of the secondary moving articulation in the mobile bearing knee prosthesis has been found to maintain relatively low shear stress during deep knee motion with tibial rotation.


Kawasaki T.,University of Occupational and Environmental Health Japan | Kawasaki C.,Sugioka Memorial Hospital | Ueki M.,University of Occupational and Environmental Health Japan | Hamada K.,University of Occupational and Environmental Health Japan | And 2 more authors.
Journal of Trauma and Acute Care Surgery | Year: 2013

Background: It has been demonstrated that proinflammatory mediators increase in patients with sepsis, trauma, and burns. These mediators are associated with the development of septic shock and organ dysfunction. Dexmedetomidine (DEX), a selective agonist of the α2-adrenergic receptors, is used in intensive care units for sedation. However, it still remains unclear whether DEX administration has any effects on the production of proinflammatory mediators. In this study, we investigated the effects of DEX on lipopolysaccharide (LPS)-induced production of tumor necrosis factor α, interleukin 6 (IL-6), IL-8, and high-mobility group box 1 protein in human whole blood. Methods: Human whole blood was cultured with LPS for up to 24 hours, and LPS-induced proinflammatory mediator production was measured. Next, we tested the effect of DEX on whole blood proinflammatory mediator production. Human whole blood was cultured with LPS and various concentrations of DEX for 12 hours. Then, we investigated the influence of yohimbine, an antagonist of the α2-adrenergic receptors, on the effects of DEX. The effect of DEX on necrosis factor κB (NFκB) activation was also investigated. Results: DEX suppressed tumor necrosis factor α, IL-6, IL-8, and high-mobility group box 1 protein production in human whole blood. The suppressing effects of DEX on proinflammatory mediator production were reversed by yohimbine. The Results suggested that the mechanism for the suppressive effects of DEX on proinflammatory mediator production is meditated via α2-adrenergic receptors. These effects of DEX also include an inhibitory effect on NFκB activation. Conclusion: We demonstrate the suppressing effect of DEX on inflammatory mediator production in human whole blood after LPS stimulation. The mechanism for the suppressive effect of DEX on proinflammatory mediator production may be through the α2-adrenergic receptors and NFκB inhibition. © 2013 Lippincott Williams and Wilkins.


PubMed | Sugioka Memorial Hospital
Type: Journal Article | Journal: Journal of orthopaedic surgery (Hong Kong) | Year: 2011

To assess the effect of each step of medial soft-tissue releases on the joint gap angle during posterior-stabilised total knee arthroplasty (TKA).82 women and 9 men (mean age, 72 years) with medial osteoarthritic knees underwent 100 posterior-stabilised TKAs, in which release of superficial fibres of the medial collateral ligament (MCL) were required using the gap control technique. The order of releases was the superficial MCL, the pes anserinus, and then the semi-membranosus. The superficial MCL was released selectively. The effect of each step of medial soft-tissue releases in full extension and in 90 flexion was compared.After all medial soft-tissue releases, the mean joint gap angles decreased from 8.7 to 3.8 varus in flexion and from 4.4 to 1.4 varus in extension. The total effect of medial soft-tissue releases was significantly larger in flexion than in extension (4.93.2 vs. 3.02.0, p<0.0001), except for the release of posterior fibres of the superficial MCL. The effect of release of the semi-membranosus in flexion was largest.The release effect was significantly greater in flexion than in extension during posterior-stabilised TKA; the joint gap technique may be more reliable in medial osteoarthritic knees with moderate and severe varus instability.


Chen W.,Sugioka Memorial Hospital
Journal of orthopaedic surgery (Hong Kong) | Year: 2011

To assess the effect of each step of medial soft-tissue releases on the joint gap angle during posterior-stabilised total knee arthroplasty (TKA). 82 women and 9 men (mean age, 72 years) with medial osteoarthritic knees underwent 100 posterior-stabilised TKAs, in which release of superficial fibres of the medial collateral ligament (MCL) were required using the gap control technique. The order of releases was the superficial MCL, the pes anserinus, and then the semi-membranosus. The superficial MCL was released selectively. The effect of each step of medial soft-tissue releases in full extension and in 90 o flexion was compared. After all medial soft-tissue releases, the mean joint gap angles decreased from 8.7 o to 3.8 o varus in flexion and from 4.4 o to 1.4 o varus in extension. The total effect of medial soft-tissue releases was significantly larger in flexion than in extension (4.9 o±3.2 o vs. 3.0 o±2.0 o, p<0.0001), except for the release of posterior fibres of the superficial MCL. The effect of release of the semi-membranosus in flexion was largest. The release effect was significantly greater in flexion than in extension during posterior-stabilised TKA; the joint gap technique may be more reliable in medial osteoarthritic knees with moderate and severe varus instability.

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