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Toyota, Japan

Kimura T.,Kyoto University | Morimoto T.,Kinki University | Natsuaki M.,Kyoto University | Shiomi H.,Kyoto University | And 17 more authors.
Circulation | Year: 2012

Background-Several recent randomized trials comparing everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) reported similar outcomes. However, only 1 trial was powered for a clinical end point, and no trial was powered for evaluating target-lesion revascularization. Methods and Results-Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial is a prospective multicenter randomized open-label trial comparing EES with SES in Japan. The trial was powered for evaluating noninferiority of EES relative to SES in terms of target-lesion revascularization. From February and July 2010, 3197 patients were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group, demonstrating noninferiority of EES to SES (Pnoninferiority<0.0001, and Psuperiority=0.34). Cumulative incidence of definite stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P=0.77). An angiographic substudy enrolling 571 patients (EES, 285 patients and SES, 286 patients) demonstrated noninferiority of EES relative to SES regarding the primary angiographic end point of in-segment late loss (0.06±0.37 mm versus 0.02±0.46 mm, Pnoninferiority<0.0001, and Psuperiority=0.24) at 278±63 days after index stent implantation. Conclusions-One-year clinical and angiographic outcome after EES implantation was noninferior to and not different from that after SES implantation in a stable coronary artery disease population with relatively less complex coronary anatomy. One-year clinical outcome after both EES and SES use was excellent with a low rate of target-lesion revascularization and a very low rate of stent thrombosis. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035450. © 2012 American Heart Association, Inc. Source

Kimura M.,Aichi Gakuin University | Nagao T.,Okazaki City Hospital | Nagao T.,Kings College | Machida J.,Toyota Memorial Hospital | Warnakulasuriya S.,Kings College
International Journal of Oral and Maxillofacial Surgery | Year: 2013

White sponge nevus (WSN) is a rare autosomal dominant disorder characterized by white plaques of oral mucosa; it is benign condition with no effective treatment. The disorder usually manifests during early childhood or adolescence. Mutations of keratin 4 or 13 gene have been identified as causing WSN. The aim of this study is to determine whether keratin 4 or 13 gene mutation was the molecular basis of WSN in a Japanese family. The proband in this family was an 11-year-old boy, with three other people affected by WSN. Genomic DNA was extracted from two affected members and an unaffected member. Segments of keratin 4 and 13 genes were amplified by PCR, and direct DNA sequencing was carried out. Sequence analysis revealed a heterozygous 3 bp deletion (N160Del) localized in the helix-initiation motif at the beginning of alpha-helical domain 1A of keratin 4 gene from affected members. One member lacking the phenotype was genetically tested normal. The authors identified a mutation of the keratin 4 gene recurrent in a family affected by WSN. Further investigation of the multifunctional role of keratin genes is warranted in the group of inherited epithelial disorders that may result in identification of effective treatment for this genetic disease. © 2012 International Association of Oral and Maxillofacial Surgeons. Source

Kobayashi T.,Gunma University | Saji T.,Toho University | Otani T.,National Center for Child Health and Development | Takeuchi K.,Saitama University | And 18 more authors.
The Lancet | Year: 2012

Background Evidence indicates that corticosteroid therapy might be beneficial for the primary treatment of severe Kawasaki disease. We assessed whether addition of prednisolone to intravenous immunoglobulin with aspirin would reduce the incidence of coronary artery abnormalities in patients with severe Kawasaki disease. Methods We did a multicentre, prospective, randomised, open-label, blinded-endpoints trial at 74 hospitals in Japan between Sept 29, 2008, and Dec 2, 2010. Patients with severe Kawasaki disease were randomly assigned by a minimisation method to receive either intravenous immunoglobulin (2 g/kg for 24 h and aspirin 30 mg/kg per day) or intravenous immunoglobulin plus prednisolone (the same intravenous immunoglobulin regimen as the intravenous immunoglobulin group plus prednisolone 2 mg/kg per day given over 15 days after concentrations of C-reactive protein normalised). Patients and treating physicians were unmasked to group allocation. The primary endpoint was incidence of coronary artery abnormalities during the study period. Analysis was by intention to treat. This trial is registered with the University Hospital Medical Information Network clinical trials registry, number UMIN000000940. Findings We randomly assigned 125 patients to the intravenous immunoglobulin plus prednisolone group and 123 to the intravenous immunoglobulin group. Incidence of coronary artery abnormalities was significantly lower in the intravenous immunoglobulin plus prednisolone group than in the intravenous immunoglobulin group during the study period (four patients [3%] vs 28 patients [23%]; risk difference 0 20, 95% CI 0 12-0 28, p<0 0001). Serious adverse events were similar between both groups: two patients had high total cholesterol and one neutropenia in the intravenous immunoglobulin plus prednisolone group, and one had high total cholesterol and another non-occlusive thrombus in the intravenous immunoglobulin group. Interpretation Addition of prednisolone to the standard regimen of intravenous immunoglobulin improves coronary artery outcomes in patients with severe Kawasaki disease in Japan. Further study of intensified primary treatment for this disease in a mixed ethnic population is warranted. Funding Japanese Ministry of Health, Labour and Welfare. Source

Yamamoto H.,Toyota Memorial Hospital
Nihon Kokyūki Gakkai zasshi = the journal of the Japanese Respiratory Society | Year: 2011

We report a case of myeloid sarcoma in the anterior mediastinum. The patient was a 33-year-old man with a chief complaint of right shoulder pain, right upper limb edema, and cough. Chest contrast-enhanced computed tomography (CT) revealed a partially enhanced anterior mediastinal tumor. A CT-guided biopsy was then performed, and a Hematoxylin-eosin (HE) stain revealed mitosis of tumor cells and other cells, including eosinophils. Immunohistochemical stains with myeloperoxidase, CD34, CD43, CD68 and c-Kit tests were positive for tumor cells. Due to a pathological diagnosis of myeloid sarcoma, he was treated with chemotherapy based on a diagnosis of acute myelogenous leukemia. After complete remission was obtained, the patient visited another hospital to receive an unrelated bone marrow transplantation. Although it rarely occurs as a mediastinal tumor, the prognosis of myeloid sarcoma is unfavorable, and thus should be taken into consideration as a differential diagnosis. Source

Tanaka K.,Toyota Memorial Hospital | Tanaka K.,Wakayama Medical University | Umesaki N.,Wakayama Medical University
European Journal of Gynaecological Oncology | Year: 2010

Purpose: To evaluate the potential role of three-dimensional (3D) ultrasound, and to assess its diagnostic performance and ability to predict therapeutic efficacy in cervical cancer. Methods: Thirty patients with cervical cancer and 35 normal controls were studied by transvaginal 3D power Doppler ultrasound before treatment. Eleven patients who received neoadjuvant chemotherapy (n = 6), radiation (n = 3), or chemoradiation (n = 2), had further measurements taken one month and two months after treatment. Results: From the receiving operating characteristics curve analysis, the best vascularization index (VI) cutoff value of 5.24 distinguished cervical cancer from the normal cervix, with a sensitivity of 73.3% and a specificity of 94.3%. Cervical tumor volume measured by magnetic resonance imaging was positively correlated with the tumor volume measured by 3D ultrasonography (r = 0.91, p < 0.0001). In six patients who received neoadjuvant chemotherapy, the percent change in tumor volume during the second month of treatment was positively correlated with the percent change in flow index (FI) during the first month of treatment (r = 0.83, p < 0.05). Conclusions: VI may be a diagnostic marker and FI may be a predictive marker of treatment response in cervical cancer. Source

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