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Long-term efficacy of infliximab maintenance therapy for perianal Crohn’s disease

World Journal of Gastroenterology 2011年第9期17卷 1174-1179页

作者： Motoi Uchino Hiroki Ikeuchi Toshihiro Bando Hiroki Matsuoka Yoshio Takesue yoshiko takahashi Takayuki Matsumoto Naohiro Tomita Departments of Lower Gastroenterological Surgery Hyogo College of Medicine Infection Control and Prevention Hyogo College of Medicine Department of Internal Medicine Division of Lower GastroenterologyHyogo College of Medicine

AIM:To assess the long-term efficacy of seton drainage with infliximab maintenance therapy in treatment of stricture for perianal Crohn’s disease(CD). METHODS:Sixty-two patients with perianal CD who required surgical treatment with or without infliximab between September 2000 and April 2010 were identified from our clinic’s *** activities of the perianal lesions were evaluated using the modified perianal CD activity index(mPDAI)*** primary endpoint was a clinical response at 12-15 wk after surgery as a shortterm *** endpoints were recurrence as reflected in the mPDAI score,defined as increased points in every major *** clinical responses were classified as completely healed(mPDAI=0),partially improved(mPDAI score decreased more than 4 points),and failure or recurrence(mPDAI score increased or decreased less than 3 points). RESULTS:There were 43 males and 19 females,of whom 26 were consecutively treated with infliximab after surgery as maintenance *** healing was not *** was seen in 10/36(27.8%) patients without infliximab and 4/26(15.4%)patients with infliximab(P=0.25).Partial improvement was seen in 26/36(72.2%)patients without infliximab and 22/26(88.5%)patients with infliximab(P=0.25). Short-term improvement was achieved in 48/62(77.4%) *** the mPDAI score improved significantly with surgery regardless of infliximab,it decreased more from baseline in patients with infliximab(50.0%) than in those without infliximab(28.6%),(P=0.003). In the long-term,recurrence rates were low regardless of infliximab in patients without anorectal *** patients with anorectal stricture,cumulative recurrence incidences increased gradually and exceeded 40%at 5 years regardless of *** efficacy of infliximab treatment was found(P=0.97).Although the cumulative rate of ostomy creation was also low in patients without stricture and high in patients with stricture,no protective efficacy was found wit

关键词： Crohn’s disease Perianal fistula Infliximab Anorectal stricture Long-term efficacy

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Prediction of effects of punch shapes on tableting failure by using a multi-functional single-punch tablet press

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Asian Journal of Pharmaceutical Sciences 2017年第5期12卷 412-417页

作者： Takashi Osamura yoshiko Takeuchi Risako Onodera Masahiro Kitamura Yoshiteru takahashi Kohei Tahara Hirofumi Takeuchi Laboratory of Pharmaceutical Engineering Gifu Pharmaceutical University1-25-4Daigaku-NishiGifu501-1196Japan Pharmaceutical Technology Department Sawai Pharmaceutical Co.Ltd12-34HiroshibachoSuita-ShiOsaka564-0052Japan

We previously determined 'Tableting properties' by using a multi-functional single-punch tablet press(GTP-1). We proposed plotting 'Compactability' on the x-axis against'Manufacturability' on the y-axis to allow visual evaluation of 'Tableting properties'. Various types of tableting failure occur in commercial drug production and are influenced by the amount of lubricant used and the shape of the punch. We used the GTP-1 to measure'Tableting properties' with different amounts of lubricant and compared the results with those of tableting on a commercial rotary tableting machine. Tablets compressed with a small amount of lubricant showed bad 'Manufacturability', leading to sticking of powder on *** also tested various punch shapes. The GTP-1 correctly predicted the actual tableting results for all punch shapes. With punches that were more likely to cause tableting failure, our system predicted the effects of lubricant quantity in the tablet formulation and the occurrence of sticking in the rotary tableting machine.

关键词： Tableting Formulation design Lubricant Punch shape Single-punch tablet press Losartan potassium

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Formulation design of granules prepared by wet granulation method using a multi-functional single-punch tablet press to avoid tableting failures

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Asian Journal of Pharmaceutical Sciences 2018年第2期13卷 113-119页

作者： Takashi Osamura yoshiko Takeuchi Risako Onodera Masahiro Kitamura Yoshiteru takahashi Kohei Tahara Hirofumi Takeuchi Laboratory of Pharmaceutical Engineering Gifu Pharmaceutical University Pharmaceutical Technology Department Sawai Pharmaceutical Co.Ltd

We previously determined "Tableting properties" by using a multi-functional single-punch tablet press(GTP-1). We plotted "Compactability" on the x-axis against "Manufacturability"on the y-axis to allow visual evaluation of "Tableting properties". Here, we examined whether this evaluation method can be used in the formulation design of tablets prepared by wet granulation. We used the GTP-1 to measure "Tableting properties" with different amounts of binder, disintegrant, and lubricant, and compared the results with those of tableting on a commercial rotary tableting machine. Tableting failures(capping and binding in particular) occurred when samples that had been evaluated as having poor "Compactability" or"Manufacturability" on the GTP-1 were compressed on the rotary tableting machine. Thus,our evaluation method predicted tableting failure at the commercial scale. The method will prove useful for scaling up production.

关键词： tableting formulation design wet granulation capping binding single-punch tablet press

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Geriatric Nutritional Risk Index as a Simple Predictor of Mortality in Maintenance Hemodialysis Patients: A Single Center Study

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International Journal of Clinical Medicine 2015年第5期6卷 354-362页

作者： Sayaka takahashi Keiko Suzuki Fumiko Kojima yoshiko Tanaka Kosaku Nitta Department of Nephrology Shinjuku Ishikawa Clinic Department of Medicine Kidney Center Tokyo Women’s Medical University Tokyo Japan

Background: Malnutrition is associated with higher risk of mortality in maintenance hemodialysis (MHD) patients. The geriatric nutritional risk index (GNRI) has been developed as a tool to assess the nutritional risk. Objectives: The purpose of the present study was to examine the significance of the GNRI as a mortality predictor in MHD patients. Methods: We retrospectively examined the GNRI of 259 MHD patients aged 59.2 ± 12.8 years, and followed up for 36 months. The patients were divided into two groups according to GNRI values of 91.0. Predictors for all-cause mortality were examined using Kaplan-Meier and Cox proportional-hazards analyses. Results: During the follow-up period of 36 months, a total of 76 patients died. Kaplan-Meier survival analysis showed that the subjects with a GNRI 91 (n = 230) (Log-rank test,

关键词： Hemodialysis Malnutrition Geriatric Nutritional Risk Index Mortality

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Hemoglobin Level Stability after a Switch from Darbepoetin Alfa to Epoetin Beta Pegol for the Treatment of Renal Anemia in Hemodialysis Patients

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International Journal of Clinical Medicine 2015年第9期6卷 652-660页

作者： Sayaka takahashi yoshiko Tanaka Mari Takano Keiko Suzuki Mio Ueda Yukiko Shimamoto Kosaku Nitta Department of Nephrology Shinjuku Ishikawa Clinic Tokyo Japan Department of Medicine Kidney Center Tokyo Women’s Medical University Tokyo Japan

Background: New erythropoiesis-stimulating agents (ESAs) with a longer half-life have been developed for the treatment of anemia as a complication of patients with end-stage renal disease. Objectives: The objective of the present study was to assess the hemoglobin (Hb) stability of a Japanese cohort of hemodialysis (HD) patients who were simultaneously switched from darbepoetin alfa (DA) to epoetin beta pegol (CERA). Methods: This was an observational, prospective study of HD patients 20 years of age or more who were switched from intravenous (IV) DA to IV CERA and continued on HD for at least 3 months. The dose was adjusted to maintain the Hb level to within 1.0 g/dl of the baseline value. Results: A total of 68 HD patients (75.0% male, median age 63.0 years) were enrolled. The patients’ mean Hb levels were 10.8 ± (0.6) g/dl at Month 0, 10.9 ± 0.7 at Month 1, 10.8 ± 0.7 at Month 2, and 10.9 ± 0.8 at Month 3, and the differences from the level at Month 0 were not significant. After the switch, the ESA dose decreased significantly (P P < 0.0001). Conclusion: Switching from DA to CERA was associated with approximate 89% reduction of the required dose in Japanese HD patients being treated with an ESA and showed a favorable impact on the treatment of renal anemia, including the need for less frequent injections and a reduction of the ESA dose.

关键词： Darbepoetin Alfa Epoetin Beta Pegol Hemoglobin ESA Resistance Hemodialysis

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Prognostic value of KRAS and BRAF mutations in curatively resected colorectal cancer

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World Journal of Gastroenterology 2015年第4期21卷 1275-1283页

作者： Shigenori Kadowaki Miho Kakuta Shuhei takahashi Akemi takahashi yoshiko Arai Yoji Nishimura Toshimasa Yatsuoka Akira Ooki Kensei Yamaguchi Keitaro Matsuo Kei Muro Kiwamu Akagi Division of Gastroenterology Saitama Cancer CenterSaitama 362-0806Japan Department of Clinical Oncology Aichi Cancer Center HospitalAichi 464-8681Japan Division of Molecular Diagnosis and Cancer Prevention Saitama Cancer Center Saitama 362-0806Japan Division of Gastroenterological Surgery Saitama Cancer CenterSaitama 362-0806Japan Department of Preventive Medicine Kyushu University Faculty of Medical Sciences Fukuoka 812-8582Japan

AIM: To investigate the prognostic role of KRAS and BRAF mutations after adjustment for microsatellite instability(MSI) status in Japanese colorectal cancer(CRC) ***: We assessed KRAS and BRAF mutations and MSI status in 813 Japanese patients with curatively resected, stage Ⅰ-Ⅲ CRC and examined associations of these mutations with disease-free survival(DFS) and overall survival(OS) using uni- and multivariate Cox proportional hazards ***: KRAS and BRAF mutations were detected in 312(38%) of 812 and 40(5%) of 811 tumors, respectively. KRAS mutations occurred more frequently in females than in males(P = 0.02), while the presence of BRAF mutations was significantly associated with the female gender(P = 0.006), proximal tumor location(P < 0.001), mucinous or poorly differentiated histology(P < 0.001), and MSI-high tumors(P < 0.001). After adjusting for relevant variables, including MSI status, KRAS mutations were associated with poorer DFS(HR = 1.35; 95%CI: 1.03-1.75) and OS(HR = 1.46; 95%CI: 1.09-1.97). BRAF mutations were poor prognostic factors for DFS(HR = 2.20; 95%CI: 1.19-4.06) and OS(HR = 2.30; 95%CI: 1.15-4.71). Neither the BRAF by MSI interaction test nor the KRAS by MSI interaction test yielded statistically significant results for DFS and ***: KRAS and BRAF mutations are associated with inferior survival, independent of MSI status, inJapanese patients with curatively resected CRC.

关键词： Colorectal cancer KRAS BRAF Microsatellite instabi

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