Osaka Koseinenkin Hospital

Ōsaka, Japan

Osaka Koseinenkin Hospital

Ōsaka, Japan
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Fuji T.,Osaka Koseinenkin Hospital | Fujita S.,Takarazuka Daiichi Hospital | Tachibana S.,Mishuku Hospital | Kawai Y.,Sanno Hospital
Journal of Thrombosis and Haemostasis | Year: 2010

Edoxaban (the free base of DU-176b) is an oral, direct factor (F)Xa inhibitor in clinical development for the prevention and treatment of thromboembolic events. Objectives: The aim of the present study was to evaluate the efficacy and safety of edoxaban for the prevention of venous thromboembolism (VTE) in patients undergoing total knee arthroplasty (TKA). Patients/methods: This was a randomized, double-blind, placebo-controlled, multicenter study conducted in Japan. A total of 523 Japanese patients were assigned to receive edoxaban 5, 15, 30 or 60 mg once daily or placebo for 11-14 days. A placebo control was used as neither low-molecular-weight heparin (LMWH) nor fondaparinux had been approved for thromboprophylaxis at the time of the study in Japan. The primary efficacy outcome was the incidence of VTE (lower-extremity deep vein thrombosis, symptomatic pulmonary embolism or symptomatic deep vein thrombosis). The primary safety outcome was the incidence of major and clinically relevant non-major bleeding. Results: Edoxaban produced a significant dose-related reduction in VTE: the incidence of VTE was 29.5%, 26.1%, 12.5% and 9.1% in the edoxaban 5-, 15-, 30- and 60-mg treatment groups vs. 48.3% in the placebo group. The incidence of major and clinically relevant non-major bleeding was similar across all groups without any significant differences among edoxaban doses or between edoxaban and placebo. Conclusions: Edoxaban demonstrated significant dose-dependent reductions in VTE in patients undergoing TKA with a bleeding incidence similar to placebo. [This trial is registered with JAPIC, JapicCTI-060283 (ja).] © 2010 International Society on Thrombosis and Haemostasis.


Fuji T.,Osaka Koseinenkin Hospital | Fuijita S.,Takarazuka Daiichi Hospital | Ujihira T.,Red Cross | Sato T.,National Hospital Organization
Journal of Arthroplasty | Year: 2010

We assessed the efficacy, safety, and dose-response of dabigatran etexilate (DAB) in preventing venous thromboembolism (VTE) in Japanese patients undergoing total knee arthroplasty (TKA). Five hundred twelve patients received DAB (110, 150, or 220 mg) or placebo once daily for 11 to 14 days, starting the day after surgery. The primary efficacy end point was the incidence of total VTE and all-cause mortality; the primary safety end point was incidence of major, clinically relevant, and minor bleeding events. Total VTE and all-cause mortality were lower in patients receiving DAB (39.6%, 32.7%, and 24.0%) than placebo (56.4%). There was no difference in the incidence of major bleeding between the DAB and placebo groups. Overall, DAB reduced the incidence of VTE in Japanese patients undergoing TKA, with a comparable safety profile vs placebo. © Elsevier Inc.


Fuji T.,Osaka Koseinenkin Hospital | Fujita S.,Takarazuka Daiichi Hospital | Kawai Y.,International University of Health and Welfare | Nakamura M.,Mie University | And 4 more authors.
Thrombosis Research | Year: 2014

Introduction Edoxaban is an oral, direct, once-daily factor Xa inhibitor. This study evaluated the safety and efficacy of edoxaban compared to subcutaneous enoxaparin in Japanese patients undergoing hip fracture surgery. Materials and methods In this multicenter, randomized, open-label, active-comparator, phase 3 trial, 92 patients were randomized 2:1 to receive edoxaban 30 mg once daily (n = 62) or enoxaparin sodium (enoxaparin) 2000 IU (equivalent to 20 mg) twice daily (n = 30) for 11 to 14 days. The primary endpoints were the incidence of major or clinically relevant non-major (CRNM) bleeding and incidence of any bleeding events (major, CRNM, or minor bleeding). Secondary efficacy endpoints included the incidence of thromboembolic events, venous thromboembolism-related deaths, and all-cause deaths. Additional adverse events were recorded throughout the study. Results In the edoxaban and enoxaparin treatment groups, the incidence of major or CRNM bleeding was 3.4% and 6.9%, respectively, while any bleeding event occurred in 25.4% and 17.2% of patients, respectively. The incidence of thromboembolic events was 6.5% in the edoxaban group and 3.7% in the enoxaparin group. All events were asymptomatic deep vein thrombosis. The incidence of adverse events was 72.9% and 82.8% in the edoxaban and enoxaparin groups, respectively. Conclusions Compared to subcutaneous enoxaparin 2000 IU twice daily, oral edoxaban 30 mg once daily demonstrated similar safety and efficacy in the prevention of thromboembolic events in Japanese patients undergoing hip fracture surgery. Clinical trials registration number: NCT01181141. © 2014 Elsevier Ltd. All rights reserved.


Yamashita S.,Osaka Koseinenkin Hospital
Clinical calcium | Year: 2010

Osteogenesis imperfecta (OI) is a genetic disorder characterized by fragile bone and reduced bone mineral density. Cyclic intravenous pamidronate is now the most widely used treatment for moderate to severe forms of OI. Oral bisphosphonates provide clinical benefit and convenience to the patients with mild form of OI. Recently, some studies demonstrated that intravenous zolendronate in children with OI is safe in short-term and similarly effective to parmidronate. Optimal dose, duration of treatment and long-term safety of newer bisphosphonates require further investigations.


PURPOSE: To compare the efficacy and safety of 0.0015% tafluprost ophthalmic solution (Tafluprost) with Placebo ophthalmic solution (Placebo) in normal tension glaucoma (NTG). SETTING: Total of 94 patients enrolled in a randomized, double-blind, parallel-group and multicenter study. METHOD: Patients with NTG were randomly assigned to either Tafluprost or Placebo. Both ophthalmic solutions were instilled once a day in the morning for 4 weeks. RESULTS: Mean intraocular pressure (IOP) changes from baseline were -4.0 +/- 1.7 mmHg in Tafluprost administered patients and -1.4 +/- 1.8 mmHg in Placebo administered patients at 4 weeks, with a statistically significant difference (p<0.001). IOP change at 4 weeks, % IOP reduction at 2 and 4 weeks were also significantly greater in Tafluprost than in Placebo. A total of 51.0% in Tafluprost treated group and 8.9% in Placebo treated group reported adverse drug reactions. CONCLUSION: These results indicate that Tafluprost is clinically useful in the treatment of NTG.


Yamamoto T.,Gifu University | Kuwayama Y.,Osaka Koseinenkin Hospital
Ophthalmology | Year: 2011

Purpose To introduce the Collaborative Bleb-related Infection Incidence and Treatment Study and to provide an interim, 2.5-year follow-up report of the findings. This prospective study sought to determine the incidence, severity, and prognosis of bleb-related infection and to investigate the efficacy of the antibacterial therapy in preventing it. Design Prospective cohort study. Participants A total of 908 eyes of 908 glaucoma patients who had undergone mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation performed at 34 clinical centers. Methods Outcomes were measured at 6-month intervals, with special attention to bleb-related infections, and data for 2.5 years of follow-up result were summarized. Main Outcome Measures The incidence and severity of bleb-related infection. Results Of the 908 eyes, 9 eyes developed a bleb-related infection. The Kaplan-Meier survival analysis revealed that the probability of development of bleb-related infection was 1.5±0.6% (cumulative probability ± standard error) at the 2.5-year follow in the trabeculectomy cases and 1.4±1.0% in the combined surgery cases. It was 1.5% in both cases with a limbal-based flap and in those with a fornix-based flap. It was significantly different between cases with bleb leakage and those without it (P = 0.037; log-rank test). Conclusions The cumulative probability of bleb-related infection was prospectively determined to be 1.5±0.6% in eyes treated with mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation at the 2.5-year follow-up in the Collaborative Bleb-related Infection Incidence and Treatment Study. Financial Disclosure(s) The authors have no proprietary or commercial interest in any materials discussed in this article. © 2011 American Academy of Ophthalmology.


Fujimori T.,Osaka University | Iwasaki M.,Osaka University | Okuda S.,Osaka Rosai Hospital | Takenaka S.,Osaka Koseinenkin Hospital | And 3 more authors.
Spine | Year: 2014

STUDY DESIGN.: Retrospective study. OBJECTIVE.: We sought to determine the long-term outcomes of laminoplasty versus anterior decompression and fusion in the treatment of cervical myelopathy caused by ossification of the posterior longitudinal ligament (OPLL) and to ascertain what factors should be considered in selecting appropriate surgical procedure. SUMMARY OF BACKGROUND DATA.: There are little data about long-term results of cervical myelopathy due to OPLL with an occupying ratio 60% or more. METHODS.: We retrospectively studied 27 patients having OPLL with an occupying ratio 60% or more and a follow-up period of at least 2 years. Clinical outcome was evaluated using Japanese Orthopaedic Association scores and recovery rates (≥75%, excellent; 50%-74%, good; 25%-50%, fair; and <25%, poor). RESULTS.: The mean age and the mean duration of follow-up were 57 years and 10.2 years. The mean Japanese Orthopaedic Association score was 9.3 before surgery and 12.4 at the final follow-up examination. There were 15 patients in the laminoplasty group (LAM group) and 12 patients in the anterior decompression and fusion group (ADF group). The ADF group had a significantly better recovery rate at final evaluation (53% vs. 30%; P = 0.04), a longer duration of surgery (314 vs. 128 min; P < 0.01), and greater blood loss (600 vs. 240 mL; P < 0.01) than did the LAM group. In the LAM group, 4 patients with excellent or good results had a significantly larger degree of cervical lordosis (30 vs. 10 ; P = 0.002) than others. CONCLUSION.: The ADF group had a significantly better recovery rate than the LAM group, although the degree of surgical invasiveness was high. ADF is generally recommended for OPLL with an occupying ratio 60% or more. © 2013, Lippincott Williams & Wilkins.


Shimada K.,Osaka Koseinenkin Hospital | Tanaka H.,Osaka Koseinenkin Hospital | Matsumoto T.,Kurashiki Central Hospital | Miyake J.,Osaka University | And 3 more authors.
Journal of Bone and Joint Surgery - Series A | Year: 2012

Background: There is a need to clarify the usefulness of and problems associated with cylindrical costal osteochondral autograft for reconstruction of large defects of the capitellum due to osteochondritis dissecans. Methods: Twenty-six patients with advanced osteochondritis dissecans of the humeral capitellum were treated with use of cylindrical costal osteochondral autograft. All were males with elbow pain and full-thickness articular cartilage lesions of ≥15 mm in diameter. Clinical, radiographic, and magnetic resonance imaging outcomes were evaluated at a mean follow-up of thirty-six months (range, twenty-four to fifty-one months). Results: All patients had rapid functional improvement after treatment with costal osteochondral autograft and returned to their former activities, including sports. Five patients needed additional minor surgical procedures, including screw removal, loose body removal, and shaving of protruded articular cartilage. Mean elbow function, assessed with use of the clinical rating system of Timmerman and Andrews, was 111 points preoperatively and improved to 180 points at the time of follow-up and to 190 points after the five patients underwent the additional operations. Mean elbow motion was 126° of flexion with 16° of extension loss preoperatively and improved to 133° of flexion with 3° of extension loss at the time of follow-up. Osseous union of the graft on radiographs was obtained within three months in all patients. Revascularization of the graft depicted on T1-weighted magnetic resonance imaging and congruity of the reconstructed articular surface depicted on T2-weighted or short tau inversion recovery imaging were assessed at twelve and twenty-four months postoperatively. Functional recovery was good, and all patients were satisfied with the final outcomes. Conclusions: Cylindrical costal osteochondral autograft was useful for the treatment of advanced osteochondritis dissecans of the humeral capitellum. Functional recovery was rapid after surgery. Additional operations were performed for five of the twenty-six patients, whereas the remaining patients showed essentially full recovery within a year. All patients were satisfied with the results at the time of short-term follow-up. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2012 by The Journal of Bone and Joint Surgery, Incorporated.


Yamamoto T.,Gifu University | Sawada A.,Gifu University | Mayama C.,University of Tokyo | Araie M.,University of Tokyo | And 3 more authors.
Ophthalmology | Year: 2014

Purpose To report the 5-year incidence of bleb-related infection after mitomycin C-augmented glaucoma filtering surgery and to investigate the risk factors for infections. Design Prospective, observational cohort study. Participants A total of 1098 eyes of 1098 glaucoma patients who had undergone mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation performed at 34 clinical centers. Methods Patients were followed up at 6-month intervals for 5 years, with special attention given to bleb-related infections. The follow-up data were analyzed via Kaplan-Meier survival analysis and the Cox proportional hazards model. Main Outcome Measures Incidence of bleb-related infection over 5 years and risk factors for infections. Results Of the 1098 eyes, a bleb-related infection developed in 21 eyes. Kaplan-Meier survival analysis revealed that the incidence of bleb-related infection was 2.2±0.5% (cumulative incidence ± standard error) at the 5-year follow-up for all cases, whereas it was 7.9±3.1% and 1.7±0.4% for cases with and without a history of bleb leakage, respectively (P = 0.000, log-rank test). When only eyes with a well-functioning bleb were counted, it was 3.9±1.0%. No differences were found between the trabeculectomy cases and the combined surgery cases (P = 0.398, log-rank test) or between cases with a fornix-based flap and those with a limbal-based flap (P = 0.651, log-rank test). The Cox model revealed that a history of bleb leakage and younger age were risk factors for infections. Conclusions The 5-year cumulative incidence of bleb-related infection was 2.2±0.5% in eyes treated with mitomycin C-augmented trabeculectomy or trabeculectomy combined with phacoemulsification and intraocular lens implantation in our prospective, multicenter study. Bleb leakage and younger age were the main risk factors for infections. © 2014 by the American Academy of Ophthalmology.


Fuji T.,Osaka Koseinenkin Hospital | Nakamura M.,Mie University | Takeuchi M.,Kitasato University
Clinical and Applied Thrombosis/Hemostasis | Year: 2014

Objective: To evaluate the efficacy and safety of darexaban (YM150) in Asian patients undergoing total hip or total knee arthroplasty. Methods: In 2 phase II/III multicenter, randomized, double-blind, placebo-controlled, parallel-group studies, patients were randomized to oral darexaban 15 mg twice daily (bid), darexaban 30 mg bid, oral placebo bid, or subcutaneous enoxaparin 20 mg bid. Primary efficacy outcome for both studies was total venous thromboembolism (VTE) incidence. Results: Both darexaban doses were statistically significantly superior to placebo for total VTE incidence (hip study: darexaban 15 mg bid [2.9%] vs placebo [17.1%], P < .001; darexaban 30 mg bid [5.2%] vs placebo [17.1%], P .003; and knee study: darexaban 15 mg bid [27.2%] vs placebo [52.8%], P .002; darexaban 30 mg bid [15.5%] vs placebo [52.8%], P < .001). In both studies, the incidence of bleeding events was low across all treatment groups. Conclusion: Darexaban is effective and well tolerated as VTE prophylaxis in Asian patients undergoing elective major orthopedic surgery. © The Author(s) 2013.

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