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- 저자 : ( Tetsuharu Hori ) (검색결과 3 건)
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( Tetsuharu Moriya ),( Kaoru Horie ) 한국언어정보학회 2002 국제 워크샵 Vol.2002 No.-
This paper discusses constraints on grammaticalization, a primarily diachronic process through which lexical elements take on grammatical functions. In particular, it will argue that two constraints on this process, namely Persistence and Layering, explain the different distributional patterns of time-relationship adverbs in Japanese, Korean, English and German. Furthermore, it will suggest that the distributional difference between Japanese and Korean time-relationship adverbs is not an isolated phenomenon but is a reflection of the overall semantic typological differences between the two languages in the sense of Hawkins (1986).
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( Hiroyuki Okamoto ),( Nathanael L. Dirks ),( Maria Rosario ),( Tetsuharu Hori ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.1
Background/Aims: Vedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn’s disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinet ics in Asian and non-Asian UC and CD patients. Methods: Population pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharma cokinetic analysis of vedolizumab. Results: Vedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CLL) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (Vc) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CLL and 19% for Vc; interoccasion variability on CLL was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CLL. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CLL was negligible and likely not of clinical importance. Conclusions: Pharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920) (Intest Res 2021;19:95-105)
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( Taku Kobayashi ),( Hiroaki Ito ),( Toshifumi Ashida ),( Tadashi Yokoyama ),( Masakazu Nagahori ),( Tomoki Inaba ),( Mitsuhiro Shikamura ),( Takayoshi Yamaguchi ),( Tetsuharu Hori ),( Philippe Pinton 대한장연구학회 2021 Intestinal Research Vol.19 No.4
Background/Aims: A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) for-mulation. Methods: Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤2 points; no individual subscore >1 point) at week 52. Results: Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n=10), placebo (n=10), or vedolizumab 300 mg IV (n=2). At week 52, 4 out of 10 pa-tients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (dif-ference: 20% [95% confidence interval, ±27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo. Conclusions: Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14) (Intest Res 2021;19:448-460)
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