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        Randomized, crossover questionnaire survey of acceptabilities of controlled-release mesalazine tablets and granules in ulcerative colitis patients

        Keiji Yagisawa,Taku Kobayashi,Ryo Ozaki,Shinji Okabayashi,Takahiko Toyonaga,Miki Miura,Mari Hayashida,Eiko Saito,Masaru Nakano,Hajime Matsubara,Tadakazu Hisamatsu,Toshifumi Hibi 대한장연구학회 2019 Intestinal Research Vol.17 No.1

        Background/Aims: Oral mesalazine is an important treatment for ulcerative colitis (UC), and non-adherence to mesalazineincreases the risk of relapse. Controlled-release (CR) mesalazine has 2 formulations: tablets and granules. The relative acceptabilitiesof these formulations may influence patient adherence; however, they have not been compared to date. This studyaimed to evaluate the acceptabilities of the 2 formulations of CR mesalazine in relation to patient adherence using a crossoverquestionnaire survey. Methods: UC patients were randomly assigned to 2 groups in a 1:1 ratio. Patients in each group tookeither 4 g of CR mesalazine tablets or granules for 6 to 9 weeks, and then switched to 4 g of the other formulation for a further 6to 9 weeks. The acceptability and efficacy were evaluated by questionnaires, and adherence was assessed using a visual analogscale. The difference in acceptabilities between the 2 formulations and its impact on adherence were assessed. Results: A totalof 49 patients were prospectively enrolled and 33 patients were included in the analysis. Significantly more patients found thetablets to be less acceptable than the granules (76% vs. 33%, P=0.0005). The granules were preferable to the tablets when the 2formulations were compared directly (73% vs. 21%, P=0.004), for their portability, size, and numbers of pills. The adherence ratewas slightly better among patients taking the granules (94% vs. 91%) during the observation period, but the difference was notsignificant (P=0.139). Conclusion: CR mesalazine granules are more acceptable than tablets, and may therefore be a better optionfor long-term medication. (Intest Res 2019;17:87-93)

      • KCI등재

        Individualized treatment based on CYP3A5 single-nucleotide polymorphisms with tacrolimus in ulcerative colitis

        Shinji Okabayashi,Taku Kobayashi,Eiko Saito,Takahiko Toyonaga,Ryo Ozaki,Shintaro Sagami,Masaru Nakano,Junichi Tanaka,Keiji Yagisawa,Satoshi Kuronuma,Osamu Takeuchi,Toshifumi Hibi 대한장연구학회 2019 Intestinal Research Vol.17 No.2

        Background/Aims: The pharmacokinetics of tacrolimus (TAC) is known to be largely influenced by single-nucleotide polymorphisms (SNPs) in CYP3A5. Patients starting TAC require careful dose adjustment, owing to the wide range of optimal dosages, depending on their CYP3A5 expression status. Here, we evaluated whether individualization of TAC dosages based on CYP3A5 SNPs would improve its therapeutic efficacy in ulcerative colitis. Methods: Twenty-one patients were prospectively treated, with their initial dosage adjusted according to their CYP3A5 status (0.1, 0.15, and 0.2 mg/kg/day for CYP3A5*3/*3, CYP3A5*1/*3, and CYP3A5*1/*1, respectively). Their clinical outcomes were compared with those of patients treated with a fixed dose (0.1 mg/kg/day). Results: The first blood trough level of CYP3A5 expressors, CYP3A5*1/*3 or CYP3A5*1/*1, and the overall rate in achieving the target blood trough level within a week in the individualized-dose group were significantly higher than those in the fixed-dose group (5.15±2.33 ng/mL vs. 9.63±0.79 ng/mL, P=0.035 and 12.5% vs. 66.7%, P=0.01). The remission rate at 2 weeks in the expressors was as high as that in the nonexpressors, CYP3A5*3/*3, in the individualized-dose group. Conclusions: Individualized TAC treatment is effective against ulcerative colitis regardless of the CYP3A5 genotype. (Intest Res 2019;17:218-226)

      • SCOPUSKCI등재

        Effectiveness of administering zinc acetate hydrate to patients with inflammatory bowel disease and zinc deficiency: a retrospective observational two-center study

        ( Kensuke Sakurai ),( Shigeru Furukawa ),( Takehiko Katsurada ),( Shinsuke Otagiri ),( Kana Yamanashi ),( Kazunori Nagashima ),( Reizo Onishi ),( Keiji Yagisawa ),( Haruto Nishimura ),( Takahiro Ito ) 대한장연구학회 2022 Intestinal Research Vol.20 No.1

        Background/Aims: Inflammatory bowel disease (IBD) patients frequently have zinc deficiency. IBD patients with zinc deficiency have higher risks of IBD-related hospitalization, complications, and requiring surgery. This study aimed to examine the effectiveness of zinc acetate hydrate (ZAH; Nobelzin) in IBD patients with zinc deficiency. Methods: IBD patients with zinc deficiency who received ZAH from March 2017 to April 2020 were registered in this 2-center, retrospective, observational study. Changes in serum zinc levels and disease activity (Crohn’s Disease Activity Index [CDAI]) before and after ZAH administration were analyzed. Results: Fifty-one patients with Crohn’s disease (CD, n=40) or ulcerative colitis (UC, n=11) were registered. Median serum zinc level and median CDAI scores significantly improved (55.5-91.0 μg/dL, P<0.001; 171.5-129, P<0.001, respectively) in CD patients 4 weeks after starting ZAH administration. Similarly, median serum zinc levels and CDAI scores significantly improved (57.0-81.0 μg/dL, P<0.001; 177-148, P=0.012, respectively) 20 weeks after starting ZAH administration. Similar investigations were conducted in groups where no treatment change, other than ZAH administration, was implemented; significant improvements were observed in both serum zinc level and CDAI scores. Median serum zinc levels in UC patients 4 weeks after starting ZAH administration significantly improved from 63.0 to 94.0 μg/dL (P=0.002), but no significant changes in disease activity were observed. One patient experienced side effects of abdominal discomfort and nausea. Conclusions: ZAH administration is effective in improving zinc deficiency and may contribute to improving disease activity in IBD. (Intest Res 2022;20:78-89)

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