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( Toshifumi Hibi ),( Makoto Naganuma ),( Eisei Oda ),( Yoji Yamada ),( Yoshitomo Chujoh ),( Ryoichi Yoshihara ),( Mamoru Watanabe ) 대한장연구학회 2020 Intestinal Research Vol.18 No.1
Background/Aims: Mucosal healing (MH) of distal lesions in ulcerative colitis (UC) has recently been confirmed with budesonide 2-mg foam (BF) treatment in 2 clinical trials; however, few studies have investigated the predictive factors for complete MH. Methods: We conducted a post hoc analysis using pooled data from phase II and III clinical trials evaluating the efficacy and safety of BF for UC. Additionally, we analyzed the relationships between complete MH and baseline factors and clinical symptoms from baseline to week 6. Results: Among the 291 Japanese patients from the 2 pooled clinical studies, 119 patients in the BF twice a day group and 117 in the placebo group were included in the full analysis set. The proportion of patients with a rectal bleeding (RB) subscore of 0 was significantly higher in the BF group than in the placebo group after a 5-day treatment (P<0.05). After a 2-day treatment, significantly more patients in the BF group had a stool frequency (SF) subscore of 0 than patients in the placebo group (P<0.05). Multivariate analysis showed that complete MH at week 6 was influenced by baseline SF subscore and 5-aminosalicylic acid (5-ASA) enema or suppository use (P=0.0086 and P=0.0015, respectively). The relationship between complete MH at week 6 and RB subscore after week 2 was also confirmed. Conclusions: Normal SF at baseline, history of 5-ASA topical product use, and elimination of RB after week 2 are suggested predictors of complete MH at week 6 with twice-daily BF treatment. (Intest Res 2020;18:56-68)
( Nagamu Inoue ),( Kiyonori Kobayashi ),( Makoto Naganuma ),( Fumihito Hirai ),( Morio Ozawa ),( Dilek Arikan ),( Bidan Huang ),( Anne M. Robinson ),( Roopal B. Thakkar ),( Toshifumi Hibi ) 대한장연구학회 2017 Intestinal Research Vol.15 No.3
Background/Aims: Intestinal Behcet`s disease (BD) is an immune-mediated inflammatory disorder. We followed up the patients and evaluated safety profile and effectiveness of adalimumab for the treatment of intestinal BD through 100 weeks rolled over from the 52 week clinical trial (NCT01243671). Methods: Patients initiated adalimumab therapy at 160 mg at week 0, followed by 80 mg at week 2, followed by 40 mg every other week until the end of the study. Long-term safety and all adverse events (AEs) were examined. The efficacy was assessed on the basis of marked improvement (MI) and complete remission (CR) using a composite efficacy index, which combined global gastrointestinal symptoms and endoscopic assessments. Re-sults: Twenty patients were enrolled in this study; 15 patients received adalimumab treatment until study completion. The incidence of AEs through week 100 was 544.4 events/100 person-years, which was comparable to the incidence through week 52 (560.4 events/100 person-years). No unexpected trend was observed and adalimumab was well tolerated. At weeks 52 and 100, 60.0% and 40.0% of patients showed MI, respectively, and 20.0% and 15.0% of patients showed CR, respectively. Conclusions: This report demonstrates 2 years safety and effectiveness of adalimumab in intestinal BD patients. Patients with intestinal BD refractory to conventional treatment receiving up to 2 years of adalimumab treatment demonstrated safety outcomes consistent with the known profile of adalimumab, and the treatment led to sustained reduction of clinical and endoscopic disease activity. (Intest Res 2017;15:395-401)
Effects of the Oral Administration of Mosapride Citrate on Capsule Endoscopy Completion Rate
( Yosuke Ida ),( Naoki Hosoe ),( Hiroyuki Imaeda ),( Rieko Bessho ),( Riko Ichikawa ),( Makoto Naganuma ),( Takanori Kanai ),( Toshifumi Hibi ),( Haruhiko Ogata ) 대한소화기학회 2012 Gut and Liver Vol.6 No.3
Background/Aims: In capsule endoscopy (CE), the capsule does not always reach the cecum within its battery life, which may reduce its diagnostic yield. We evaluated the effect of mosapride citrate, a 5-hydroxytryptamine-4 agonist that increases gastrointestinal motility, on CE completion. Meth-ods: In a retrospective study, we performed univariate and multivariate analyses for 232 CE procedures performed at our hospital. To identify factors that affect CE completion, the following data were systematically collected: gender, age, gastric transit time (GTT), nonsteroidal anti-inflammatory drug administration, previous abdominal surgery, hospitaliza-tion, use of a polyethylene glycol solution, use of mosapride citrate (10 mg), body mass index (BMI), and total recording time. Results: The univariate analysis showed that oral mo-sapride citrate, GTT, and BMI were associated with improved CE completion. Multivariate analyses showed that oral mo-sapride citrate (odds ratio [OR], 1.99; 95% confidence inter-val [CI], 1.01 to 3.91) and GTT (OR, 2.34; 95% CI, 1.13 to 4.87) were significant factors for improving the CE completion. Oral mosapride citrate significantly shortened the GTT and small bowel transit time (SBTT). Conclusions: Oral mosapride ci-trate reduced the GTT and SBTT during CE and improved the CE completion rate. (Gut Liver 2012;6:339-343)