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Takekuma M.,Shizuoka Cancer Center Hospital | Hirashima Y.,Shizuoka Cancer Center Hospital | Ito K.,Kansai Rosai Hospital | Tsubamoto H.,Hyogo College of Medicine | And 6 more authors.
Gynecologic Oncology

Objective: A multicenter phase II trial was conducted to evaluate the activity and toxicity of paclitaxel and nedaplatin (cis- diammineglycolatoplatonum) in patients with advanced/recurrent uterine cervical cancer. Methods: Patients were required to have measurable disease. Histologic confirmation of the primary diagnosis as uterine cervical cancer was mandatory. The treatment consisted of paclitaxel 175 mg/m 2 over 3 hours and nedaplatin 80 mg/m 2 intravenously over 1 hour on day 1 every 28 days until progressive disease or adverse effects prohibited further therapy. Results: Fifty patients were enrolled into the study protocol from October 2007 to February 2010. 45 patients(90%) were eligible for assessment of response (RECIST version 1.0) to treatment; 31 patients (62%) received prior radiotherapy and 23 patients (46%) received prior chemotherapy. The overall response rate was 44.4% (11 complete responses and 8 partial responses) with 22.2% of patients having stable disease. Grades 3 or 4 adverse events (NCI-CTCAE ver 3) included neutropenia (n = 16, 32.7%), febrile neutropenia (n = 1, 2.0%), anemia (n = 9, 18.4%), but there was no significant thrombocytopenia. Non-hematologic toxicity was generally not serious and without a dominant pattern. The median progression-free survival was 7.5 months (95% C.I., 5.7, 9.4) and overall survival was 15.7 months (95% C.I., 9.4, 21.9). Conclusions: Paclitaxel 175 mg/m 2 and nedaplatin 80 mg/m 2 intravenously on day 1 every 28 days in patients with advanced/recurrence uterine cervical cancer demonstrated easy administration, favorable antitumor activity, and the toxicity profile of this regimen would be decreased compared with cisplatin-containing combinations. Evaluation of this regimen in phase III trials is warranted. © 2012 Elsevier Inc. All rights reserved. Source

Kuragano T.,Hyogo College of Medicine | Inoue T.,Osaka Medical College | Yoh K.,Hyogo College of Medicine | Shin J.,Motomachi HD Clinic | And 7 more authors.
Blood Purification

Background/Aims: The aim of this study was to determine whether treatment with β 2-microglobulin adsorption column (Lixelle) affects bone cysts and clinical symptoms in patients with dialysis-related amyloidosis (DRA). Methods: Radiographic changes in the number and area of bone cysts of the wrist and the hip joint were compared between 39 hemodialysis (HD) patients treated with Lixelle (Lixelle group) and 28 HD patients treated with conventional therapy as retrospective control (HD group). Clinical symptoms of DRA were also evaluated. Results: In the Lixelle group, the number of bone cysts and the cystic area in wrist joints were significantly decreased, although the changes in these parameters in hip joints were not significant. In the HD group, the corresponding parameters in the hip joints even significantly increased. Clinical symptoms notably improved after Lixelle treatment. Conclusion: Treatment with Lixelle reduces the radiolucency of bone cysts in the wrist joints, and improves clinical symptoms associated with DRA. © 2011 S. Karger AG, Basel. Source

Hirose S.,Chibune General Hospital | Iwahashi Y.,Chibune General Hospital | Seo A.,Chibune General Hospital | Sumiyoshi M.,Chibune General Hospital | And 3 more authors.
Internal Medicine

Reactive hypoglycemia induced by late dumping syndrome is often observed after gastrectomy. However, no effective therapy has yet been fully established. We herein describe a case in which concurrent therapy with a low-carbohydrate diet using low-glycemic-index food and an alpha-glucosidase inhibitor, miglitol, very effectively ameliorated the postprandial fluctuations in the blood glucose and plasma insulin levels in a patient with reactive hypoglycemia due to late dumping syndrome following total gastrectomy. The administration of miglitol under a low-carbohydrate diet using low-glycemic-index food may therefore be an ideal treatment for reactive hypoglycemia due to late dumping syndrome. © 2016 The Japanese Society of Internal Medicine. Source

Tanaka Y.,Chibune General Hospital | Takahashi T.,Chibune General Hospital | Tamori Y.,Chibune General Hospital | Tamori Y.,Kobe University
Endocrine Journal

Progranulin (PRGN) was recently identified as one of the adipokines involved in the development of insulin resistance. Thus, the aim of this study was to explore the importance of PRGN as a novel marker for metabolic diseases in Japanese. A total of 138 subjects were recruited by the Aijinkai Total Health Care Center. Physical examination, blood sample examination and total body CT scan were performed for all participants. Serum PRGN levels were examined in subjects with or without metabolic syndrome and with or without liver enzyme elevation. Association study of serum PRGN levels and regression analysis of the relationship of elevated liver enzymes to representative metabolic parameters were performed. The metabolic syndrome group exhibited older age, and higher BMI, blood pressure, fasting glucose, HbA1c, IRI, HOMA-R, TG, FFA, CRP, AST, ALT, LDH, and ALP, and larger visceral fat area, subcutaneous fat area and visceral fat area/subcutaneous fat area. Serum PRGN concentrations were significantly higher in the metabolic syndrome group than in the non-metabolic syndrome group. Bivariate correlation analysis revealed that serum PRGN concentrations correlated positively and significantly with AST, ALT, LDH, γGTP, ALP, waist circumference and visceral fat area. The group with elevated liver enzymes exhibited higher BMI, blood pressure, IRI, HOMA-R, and PRGN level and larger waist circumference and visceral fat area than the group without them. In logistic regression analysis, visceral fat area and PRGN were significantly predictive of elevated liver enzymes. These results suggest that serum PRGN level as well as visceral fat are associated closely with liver dysfunction. ©The Japan Endocrine Society. Source

Goto S.,University Graduate Center | Komaba H.,University Graduate Center | Komaba H.,Tokai University | Moriwaki K.,Niigata University of Health and Welfare | And 15 more authors.
Clinical Journal of the American Society of Nephrology

Background and objectives Lanthanum carbonate (LC) is a nonaluminum, noncalcium phosphate binder that is effective for hyperphosphatemia in dialysis patients. However, its efficacy and cost-effectiveness as second-line therapy have not been fully examined. Design, setting, participants, & measurements We first conducted a multicenter, open-label, 16-week clinical trial to examine the effect of additive LC in 116 hemodialysis patients who had uncontrolled hyperphosphatemia with conventional phosphorus-lowering therapy alone. Based on these clinical data, a state transition model was developed to evaluate the benefits and costs associated with LC as second-line therapy. Reduced risks for cardiovascular morbidity and mortality among patients treated with LC arise through more of the population achieving the target phosphorus levels. Uncertainty was explored through sensitivity analysis. Results After 16 weeks of additive LC treatment, mean serum phosphorus levels decreased from 7.30 _ 0.90 to 5.71 ± 1.32 mg/dl, without significant changes in serum calcium or intact parathyroid hormone levels. A subsequent cost-effectiveness analysis showed that compared with conventional treatment, additive LC incurred an average additional lifetime cost of $22,054 per person and conferred an additional 0.632 quality adjusted life years (QALYs). This resulted in an incremental cost-effectiveness ratio of $34,896 per QALY gained. Applying a cost-effectiveness threshold of $50,000 per QALY, a probabilistic sensitivity analysis showed that additive LC had a 97.4% probability of being cost-effective compared with conventional treatment. Conclusions Our results indicate that the use of LC as second-line therapy would be cost-effective among hemodialysis patients with uncontrolled hyperphosphatemia in Japan. ©2011 by the American Society of Nephrology. Source

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