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Mahlangu J.,Comprehensive Care | Powell J.S.,University of California at Davis | Ragni M.V.,University of Pittsburgh | Chowdary P.,Royal Free Hospital | And 24 more authors.
Blood | Year: 2014

This phase 3 pivotal study evaluated the safety, efficacy, and pharmacokinetics of a recombinant FVIII Fc fusion protein (rFVIIIFc) for prophylaxis, treatment of acute bleeding, and perioperative hemostatic control in 165 previously treated males aged ≥12 years with severe hemophilia A. The study had 3 treatment arms: arm 1, individualized prophylaxis (25-65 IU/kg every 3-5 days, n = 118); arm 2, weekly prophylaxis (65 IU/kg, n = 24); and arm 3, episodic treatment (10-50 IU/kg, n = 23). a subgroup compared recombinant FVIII (rFVIII) and rFVIIIFc pharmacokinetics. End points included annualized bleeding rate (ABR), inhibitor development, and adverse events. The terminal half-life of rFVIIIFc (19.0 hours) was extended 1.5-foldvsrFVIII (12.4 hours; P <.001). Median ABRs observed in arms 1, 2, and 3 were 1.6, 3.6, and 33.6, respectively. In arm 1, the median weekly dose was 77.9 IU/kg; approximately 30% of subjects achieved a 5-day dosing interval (last 3 months on study). Across arms, 87.3% of bleeding episodes resolved with 1 injection. Adverse events were consistent with those expected in this population; no subjects developed inhibitors. rFVIIIFc was well-tolerated, had a prolonged half-life compared with rFVIII, and resulted in low ABRs when dosed prophylactically 1 to 2 times per week. This trial was registered at www.clinicaltrials.gov as #NCT01181128. © 2014 by The American Society of Hematology.


Nishiwaki M.,Ogikubo Hospital | Tazaki K.,Ogikubo Hospital | Shimizu H.,Ogikubo Hospital | Ilyas A.M.,Thomas Jefferson University
Journal of Bone and Joint Surgery - Series A | Year: 2011

Background: Intramedullary nailing for the treatment of unstable distal radial fractures is reported to provide stable fixation with minimal soft-tissue complications, but there is a paucity of data documenting the results of this technique. The purpose of this study was to prospectively determine the functional outcomes of treatment of unstable distal radial fractures with an intramedullary nail. Methods: Patients aged fifty years and older with a dorsally displaced unstable distal radial fracture - an extra-articular or simple intra-articular fracture - that was amenable to closed or percutaneous reduction were offered treatment with intramedullary nail fixation (MICRONAIL). Thirty-one patients were enrolled in the study, and twenty-nine patients with a mean age of sixty-seven years (range, fifty-one to eighty-five years) were available for one-year follow-up. According to the AO classification, there was one type-A2, twenty-four type-A3, and four type-C2 distal radial fractures. The patients were evaluated at six weeks, three months, six months, and one year after surgery. Outcome measures included standard radiographic parameters, active wrist range of motion, grip strength, a modified Mayo wrist score, and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Results: At the final one-year follow-up evaluation, the active range of motion of the injured wrist relative to that on the uninjured side averaged 95% of flexion, 95% of extension, 93% of ulnar deviation, 91% of radial deviation, 99% of pronation, and 99% of supination. The mean grip strength was 96% of that on the uninjured side. According to the modified Mayo wrist score, there were twenty excellent and nine good results. The mean DASH score was 4.8 points. The final radiographic measurements demonstrated, on average, 25° of radial inclination, 11° of volar tilt, 10 mm of radial length, and +1 mm of ulnar variance. Loss of reduction occurred in two patients. One patient developed transient superficial radial sensory neuritis, which resolved within two months. Conclusions: Intramedullary nailing can be a safe and effective treatment with minimal complications for dorsally displaced unstable extra-articular or simple intra-articular distal radial fractures. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence. Copyright © 2011 by The Journal of Bone and Joint Surgery, Incorporated.


Yoshikawa T.,Ogikubo Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2013

Several technological advances have been made in laparoscopic surgery, and the use of reduced port surgery (RPS)has gradually become widespread. To assess the safety and usefulness of RPS, we compared the short -term outcomes of conventional laparoscopy-assisted total gastrectomy(LATG)and LATG with the RPS approach. From April 2009 to February 2012, 16 cases with gastric cancer underwent conventional LATG with 5 ports as well as minilaparotomy for anastomosis(Conventional group). From February 2012 to November 2012, 12 cases underwent RPS LATG(RPS group). In the RPS group, a multi-instrument port at the umbilicus was used during surgery. This port held 3 trocars and 2 5-mm trocars that were inserted under the right lumbocostal arch. The mean operation time was 333 minutes in the Conventional group, and 370 minutes in the RPS group. The mean postoperative hospital stay was 23 days in the Conventional group, and 17 days in the RPS group. Postoperative mortality was 0% in both groups. Anastomotic leakage occurred in 2 cases in the Conventional group, whereas pancreatic fistula occurred in 2 cases in the RPS group. Due to postoperative bleeding, 1 case in the RPS group underwent redo laparoscopic operation. Anastomotic stenosis was noted in 4 cases in each group. The patients with stenosis required endoscopic balloon dilation several times and the symptom eventually resolved in all cases. By comparing the short-term outcomes for conventional LATG and RPS LATG, we noted that reduced port laparoscopy-assisted total gastrectomy is a feasible procedure.


Yabe N.,Ogikubo Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2013

A 78-year-old man was admitted to Ogikubo Hospital for pancreatic tumors detected by computed tomography (CT). The patient had undergone right nephrectomy for renal cell carcinoma (RCC) 27 years previously. Dynamic CT revealed a hypervascular mass in the pancreatic head and a cystic mass in the pancreatic body that were approximately 35 mm and 20 mm in size, respectively. Total pancreatectomy and splenectomy were performed. Histological examination of the resected specimens revealed metastatic tumors from RCC and they were diagnosed as clear cell type. Metastatic carcinoma of the pancreas is uncommon. Pancreatic metastasis from RCC is rare; however, it could occur many years after the initial diagnosis and treatment of the primary tumor. A long and careful follow-up that includes examination of the pancreas is mandatory after nephrectomy for RCC. In this paper, we discuss a case of RCC metastasis to the pancreas and report it in the literature.


A 60-year-old woman receiving treatment for diabetes underwent laparoscopic-assisted low anterior resection and was diagnosed as having rectosigmoid cancer in January 2010( pSS, n2[ +], sM0 fStage IIIb, mutant-type K-ras). She refused adjuvant chemotherapy. In July, after surgery, chest-abdominal-pelvic computed tomography( CT) scans showed bilateral lobe multiple liver metastases and right lobe lung metastases. We recommended oxaliplatin and capecitabine (CapeOX) plus bevacizumab( BV) chemotherapy or surgery. The CapeOX plus BV regimen was initiated at the patient's request. After 8 cycles of chemotherapy, a partial response was observed in the metastatic liver tumors and stable disease was observed in the lung metastases. As hypertension appeared after 16 cycles of chemotherapy, we switched the treatment to CapeOX. After 10 cycles of CapeOX, the chemotherapy was changed to capecitabine at the patient's request owing to the development of grade 2 chronic peripheral neuropathy. Chest-abdominal-pelvic CT scans after 32 cycles of this regimen revealed shrinkage of the multiple liver metastases. The patient has been receiving treatment as an outpatient. Surgical resection should be considered for patients with initially unresectable colon cancer with liver and/or lung metastases if systemic chemotherapy is effective.


A 71-year-old postmenopausal woman was undergoing treatment for depression. She visited the hospital with a chief complaint of fibrosclerosis of the entire left breast 8 years previously. She was diagnosed as having stage IV( T3N1M1b) left breast cancer (papillotubular>scirrhous carcinoma, g+, f+, estrogen receptor [ER]-negative, progesterone receptor [PgR]-negative, and human epidermal growth factor receptor 2[ HER2/neu]-positive[ 3+]). Synchronous bone metastases were detected in the left tenth rib, the eleventh dorsal vertebra, and in the area spanning the lower lumbar to sacral vertebrae. First-line treatment was systemic therapy with 4 cycles of Adriamycin and cyclophosphamide (AC) followed by 4 cycles of trastuzumab and paclitaxel. The breast mass initially observed on clinical imaging disappeared and only calcifications were observed. Bone metastases were detected only in the left tenth rib. As an additional therapy, 3-dimensional radiotherapy( 50 Gy/25 fractions), which irradiated the left mammary gland, axilla, and supraclavicular fossa, was administered. The tumor was well controlled for approximately 3 years. However, a gradual increase in the level of carcinoembryonic antigen( CEA) was accompanied by an increase in the left breast mass and enlargement of left axillary lymph nodes. Modified radical mastectomy (Bt+Ax [level I]) was performed for this condition 3 years ago. Papillotubular-type invasive ductal carcinoma (INF β, ly3, v0, g+, f+, s+, nuclear grade 3 [atypia 3+mitosis 3]) was diagnosed histopathologically. Lymph node metastases were also detected. As histopathological examination of the bone metastatic lesion showed no progression, administration of lapatinib and capecitabine was initiated. After 15 cycles of treatment, enlarged right axillary lymph nodes were observed and local excision was performed. Histopathological examination revealed recurrence of the breast cancer. The patient was diagnosed as having grade 3( atypia 3, mitosis 2) breast cancer( ER-negative, PgR-negative, HER2/neu positive[ 3+], and MIB-1 index 50%). The response to treatment with lapatinib and capecitabine was progressive disease( PD), and therefore, trastuzumab and gemcitabine therapy was selected. Currently, the patient has undergone 30 cycles of this regimen and the tumor is well controlled. This regimen was considered effective for the treatment of patients with HER2-positive metastatic breast cancer.


Nagao A.,Ogikubo Hospital | Nakazawa S.,Ogikubo Hospital | Hanabusa H.,Ogikubo Hospital
Journal of Hematology and Oncology | Year: 2014

Multicentric Castleman disease (MCD) is a lymphoproliferative disorder caused by human herpesvirus 8 (HHV8) infection HIV associated MCD (HIV-MCD) presents with various clinical symptoms. Many HIV-negative MCD patients are often treated with anti-human interleukin-6 (IL6) receptor monoclonal antibodies (tocilizumab), and successful results have been reported. IL-6 plays an important role in the development of both HIV-positive and HIV-negative MCD; however, the efficacy of tocilizumab in HIV-MCD patients is unknown. We herein report the clinical and biologic courses of two HIV-MCD patients treated with tocilizumab. In both cases, a significant and rapid clinical improvement was observed after the first infusion. However, the treatment efficacy was not maintained for a long period, and relapse occurred at 15 and 22 weeks, respectively. Both patients received rituximab and subsequently achieved complete clinical remission. Our report, in addition to data presented in the literature, suggests that tocilizumab could be an initial treatment option in patients with HIV-MCD. © 2014 Nagao et al.; licensee BioMed Central Ltd.


Nakamura S.,Ogikubo Hospital
Hand surgery : an international journal devoted to hand and upper limb surgery and related research : journal of the Asia-Pacific Federation of Societies for Surgery of the Hand | Year: 2014

To the best of our knowledge, there are no previous reports on anterior interosseous nerve palsy (AINP) caused by a soft tissue tumor after fracture of the distal radius. We treated a case of giant forearm lipoma that caused AINP one day after internal fixation of a distal radius fracture.


Goto M.,University of Tokyo | Goto M.,Tokyo Metroplitan University | Takedani H.,Tokyo Medical University | Haga N.,University of Tokyo | And 4 more authors.
Haemophilia | Year: 2014

Haemophiliacs who have had to keep a physically inactive lifestyle due to bleeding during childhood are likely to have little motivation for exercise. The purpose of this study is to clarify the effectiveness of the self-monitoring of home exercise for haemophiliacs. A randomized controlled trial was conducted with intervention over 8 weeks at four hospitals in Japan. Subjects included 32 male outpatients aged 26-64 years without an inhibitor who were randomly allocated to a self-monitoring group and a control group. Individual exercise guidance with physical activity for improvement of their knee functions was given to both groups. The self-monitoring materials included an activity monitor and a feedback system so that the self-monitoring group could send feedback via the Internet and cellular phone. The self-monitoring was performed by checking exercise adherence and physical activity levels, bleeding history and injection of a coagulation factor. Both groups showed significant improvements in exercise adherence (P < 0.001) and physical function such as the strength of knee extension (P < 0.001), range of knee extension (P < 0.001), range of ankle dorsiflexion (P < 0.01), a modified Functional Reach (P < 0.05) and 10 metre gait time (P < 0.01). In particular, improvements in exercise adherence (P < 0.05), self-efficacy (P < 0.05), and strength of knee extension (P < 0.05) were significant in the self-monitoring group compared with those in the control group. No increase in bleeding frequency and pain scale was noted. The self-monitoring of home exercise for haemophilic patients is useful for the improvement of exercise adherence, self-efficacy and knee extension strength. © 2014 John Wiley & Sons Ltd.


Shima M.,Nara Medical University | Hanabusa H.,Ogikubo Hospital | Taki M.,Nagoya University | Matsushita T.,St. Marianna University School of Medicine | And 6 more authors.
New England Journal of Medicine | Year: 2016

BACKGROUND: In patients with severe hemophilia A, standard treatment is regular prophylactic and episodic intravenous infusions of factor VIII. However, these treatments are burdensome, especially for children, and may lead to the formation of anti-factor VIII alloantibodies (factor VIII inhibitors). Emicizumab (ACE910), a humanized bispecific antibody mimicking the cofactor function of factor VIII, was developed to abate these problems. METHODS We enrolled 18 Japanese patients with severe hemophilia A (with or without factor VIII inhibitors) in an open-label, nonrandomized, interindividual dose-escalation study of emicizumab. The patients received subcutaneous emicizumab weekly for 12 weeks at a dose of 0.3, 1.0, or 3.0 mg per kilogram of body weight (cohorts 1, 2, and 3, respectively). The end points were safety and pharmacokinetic and pharmacodynamic profiles. An additional, exploratory end point was the annualized bleeding rate, calculated as 365.25 times the number of bleeding episodes, divided by the number of days in the treatment period as compared with the 6 months before enrollment. RESULTS Emicizumab was associated with neither serious adverse events nor clinically relevant coagulation abnormalities. Plasma concentrations of emicizumab increased in a dose-dependent manner. Activated partial-thromboplastin times remained short throughout the study. The median annualized bleeding rates in cohorts 1, 2, and 3 decreased from 32.5 to 4.4, 18.3 to 0.0, and 15.2 to 0.0, respectively. There was no bleeding in 8 of 11 patients with factor VIII inhibitors (73%) and in 5 of 7 patients without factor VIII inhibitors (71%). Episodic use of clotting factors to control bleeding was reduced. Antibodies to emicizumab did not develop. CONCLUSIONS Once-weekly subcutaneous administration of emicizumab markedly decreased the bleeding rate in patients who had hemophilia A with or without factor VIII inhibitors. Copyright © 2016 Massachusetts Medical Society. All rights reserved.

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