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( Yasuo Suzuki ),( Takashi Hagiwara ),( Mariko Kobayashi ),( Kazuo Morita ),( Tomoyo Shimamoto ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.3
Background/Aims: The safety and effectiveness of adalimumab was demonstrated in a phase 3 trial in Japanese patients with intestinal Behçet’s disease. The aim of this study was to evaluate the long-term safety and effectiveness of adalimumab in Japanese patients with intestinal Behçet’s disease. Methods: This prospective, all-case, post-marketing study was conducted at 254 centers in Japanese patients with intestinal Behçet’s disease receiving adalimumab. The primary endpoint was incidence of adverse drug reactions. Effectiveness endpoints included global improvement rating and change in C-reactive protein levels. Results: Of the 473 registered patients, 462 and 383 included in the safety and effectiveness populations were administered adalimumab for a mean of 515.3 and 579.5 days, respectively. Overall, 395 patients (85.5%) received adalimumab at the recommended dose. Adverse drug reactions and serious adverse drug reactions were reported in 120 (25.97%) and 51 (11.04%) patients, respectively. The incidence of adverse drug reactions was significantly higher in patients with comorbidities (P<0.0001), patients taking concomitant oral corticosteroids (P<0.0001), and those not self-administering adalimumab (P=0.0257). At study end, global improvement rating was “effective” (n=156, 40.7%) or “markedly effective” (n=168, 43.9%) in 324 patients (overall effective, 84.6%). Mean C-reactive protein levels (mg/dL) decreased from 1.96 at baseline (n=324) to 0.58 at week 24 (n=208) and 0.25 at week 156 (n=37). Conclusions: This large real-world study confirmed the long-term safety and effectiveness of adalimumab in patients with intestinal Behçet’s disease. No new safety concerns were identified. (Clinical trial registration number: NCT01960790) (Intest Res 2021;19:301-312)
( Yasuo Suzuki ),( Mitsuo Iida ),( Hiroaki Ito ),( Isamu Saida ),( Toshifumi Hibi ) 대한장연구학회 2016 Intestinal Research Vol.14 No.1
The therapeutic effect of mesalamine is considered to be dose-dependent; however, no consensus has been reached regarding the optimal doses for individual patients. This study aimed to provide new insight for dose optimization using two doses of pH-dependent release mesalamine for induction of remission of moderately active ulcerative colitis (UC). Methods: In a multicenter, double-blind, randomized study, 110 patients with moderately active UC were assigned to two groups after treatment with a constant dose of mesalamine. Fifty-five patients were treated with a pH-dependent release formulation of 3.6 or 4.8 g/day for 8 weeks. The primary endpoint was a decrease in the UC disease activity index (UCDAI) adjusted by covariates. Results: In the full analysis set (n=110), the mean decrease in UCDAI was 3.1 in the 3.6 g/day group and 3.4 in the 4.8 g/day group (P >0.05). In a subgroup analysis, the effectiveness of the 4.8 g/day dose was greater in particular populations, such as those who had been previously treated with a lower dose of mesalamine and those with more severe disease. The safety was comparable between the two groups. Conclusions: The results suggest that treatment with pH-dependent release mesalamine at either 3.6 or 4.8 g/day was effective and safe for the induction of remission in patients with moderately active UC. However, the patients receiving mesalamine at 2.4 g/day but in whom the therapeutic effect is not sufficient and having more severe symptoms (UCDAI 9.10), benefit from higher doses of mesalamine compared to others. (Intest Res 2016;14:50-59)
( Tadakazu Hisamatsu ),( Yasuo Suzuki ),( Mariko Kobayashi ),( Takashi Hagiwara ),( Takeshi Kawaberi ),( Haruhiko Ogata ),( Toshiyuki Matsui ),( Mamoru Watanabe ),( Toshifumi Hibi ) 대한장연구학회 2021 Intestinal Research Vol.19 No.4
Background/Aims: Crohn’s disease is a chronic disorder; therefore, it is essential to investigate long-term safety and efficacy of treatments. This study assessed the safety and effectiveness of adalimumab for up to 3 years in Japanese patients with Crohn’s disease in real-world settings. Methods: This was a multicenter, single-cohort, observational study of patients with Crohn’s disease. Safety assessments included incidence of adverse drug reactions. Effectiveness assessments included clinical remis-sion, mucosal healing, and Work Productivity and Activity Impairment (WPAI). Results: The safety and effectiveness analysis populations comprised 389 and 310 patients, respectively. Mean (standard deviation) exposure to adalimumab in the safety analysis population was 793.4 (402.8) days, with a 58.1% retention rate. A total of 105 patients (27.0%) and 43 patients (11.1%) experienced adverse drug reactions and serious adverse drug reactions, respectively, with no patient reporting tuberculosis or hepatitis B. Infections and serious infections were reported in 37 patients (9.5%) and 17 patients (4.4%), respectively. Malig-nancy was reported as an adverse drug reaction in 2 patients (0.5%). Remission rate increased from 37.8% (98/259) at baseline to 73.9% (167/226) at week 4 and remained >70% over 3 years. Proportion of patients without mucosal ulcerations increased from 2.7% (2/73) at baseline to 42.3% (11/26) between years >2 to ≤3. WPAI improvement started at 4 weeks, with the overall work impairment score improving from 42.7 (n=102) at baseline to 26.9 (n=84) at 4 weeks. Conclusions: Results from this study confirm the long-term safety and effectiveness of adalimumab treatment in Japanese patients with Crohn’s disease in the real-world setting. (Intest Res 2021;19:408-418)
Real-Time, in Situ Monitoring of the Oxidation of Graphite: Lessons Learned
Morimoto, Naoki,Suzuki, Hideyuki,Takeuchi, Yasuo,Kawaguchi, Shogo,Kunisu, Masahiro,Bielawski, Christopher W.,Nishina, Yuta American Chemical Society 2017 Chemistry of materials Vol.29 No.5
<P>Graphite oxide (GO) and its constituent layers (i.e., graphene oxide) display a broad range of functional groups and, as such, have attracted significant attention for use in numerous applications. GO is commonly prepared using the 'Hummers method' or a variant thereof in which graphite is treated with KMnO4 and various additives in H2SO4. Despite its omnipresence, the underlying chemistry of such oxidation reactions is not well understood and typically affords results that are irreproducible and, in some cases, unsafe. To overcome these limitations, the oxidation of graphite under Hummers-type conditions was monitored over time using in situ X-ray diffraction and in situ X-ray absorption near edge structure analyses with synchrotron radiation. In conjunction with other atomic absorption spectroscopy, UV vis spectroscopy and elemental analysis measurements, the underlying mechanism of the oxidation reaction was elucidated, and the reaction conditions were optimized. Ultimately, the methodology for reproducibly preparing GO on large scales using only graphite, H2SO4 and KMnO4 was developed and successfully adapted for use in continuous flow systems.</P>
( Seongjin Oh ),( Yasuyuki Suzuki ),( Shusuke Hayashi ),( Yutaka Suzuki ),( Satoshi Koike ),( Yasuo Kobayashi ) 한국축산학회(구 한국동물자원과학회) 2017 한국축산학회지 Vol.59 No.11
Background: Cashew nut shell liquid (CNSL) is an agricultural byproduct containing alkylphenols that has been shown to favorably change the rumen fermentation pattern only under experimentally fixed feeding conditions. Investigation of CNSL potency in rumen modulation under a variety of feeding regimens, and evidence leading to the understanding of CNSL action are obviously necessary for further CNSL applications. The objective of this study was to evaluate the potency of CNSL for rumen modulation under different dietary conditions, and to visually demonstrate its surfactant action against selected rumen bacteria. Methods: Batch culture studies were carried out using various diets with 5 different forage to concentrate (F:C) ratios (9:1, 7:3, 5:5. 3:7 and 1:9). Strained rumen fluid was diluted with a buffer and incubated with each diet. Gas and short chain fatty acid (SCFA) profiles were characterized after 18 h incubation at 39 °C. Monensin was also evaluated as a reference additive under the same conditions. Four species of rumen bacteria were grown in pure culture and exposed to CNSL to determine their morphological sensitivity to the surfactant action of CNSL. Results: CNSL supplementation decreased total gas production in diets with 5:5 and 3:7 F:C ratios, whereas the F:C ratio alone did not affect any gas production. Methane decrease by CNSL addition was more apparent in diets with 5:5, 3:7, and 1:9 F:C ratios. An interactive effect of CNSL and the F:C ratio was also observed for methane production. CNSL supplementation enhanced propionate production, while total SCFA production was not affected. Monensin decreased methane production but only in a diet with a 1:9 F:C ratio with increased propionate. Studies of pure cultures indicated that CNSL damaged the cell surface of hydrogen- and formate-producing bacteria, but did not change that of propionate-producing bacteria. Conclusion: CNSL can selectively inhibit rumen bacteria through its surfactant action to lead fermentation toward less methane and more propionate production. As CNSL is effective over a wider range of dietary conditions for such modulation of rumen fermentation in comparison with monensin, this new additive candidate might be applied to ruminant animals for various production purposes and at various stages.