1.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
2.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
3.Early resolution of bowel urgency by budesonide foam enema results in improved quality of life in patients with ulcerative colitis: a multicenter prospective observational study
Taku KOBAYASHI ; Kei MORIYA ; Toshimitsu FUJII ; Shigeki BAMBA ; Shinichiro SHINZAKI ; Akihiro YAMADA ; Takashi HISABE ; Shintaro SAGAMI ; Shuji HIBIYA ; Takahiro AMANO ; Noritaka TAKATSU ; Katsutoshi INAGAKI ; Ken-ichi IWAYAMA ; Toshifumi HIBI
Intestinal Research 2025;23(2):157-169
Background/Aims:
Bowel urgency is an important symptom for quality of life determination in patients with ulcerative colitis (UC). Few clinical studies have focused on bowel urgency as an efficacy endpoint. Budesonide foam enema has shown efficacy for clinical and endoscopic improvement in mild-to-moderate UC. We evaluated the improvement of clinical symptoms (bowel urgency), safety, and treatment impact of twice-daily budesonide foam enema on the quality of life in patients with UC.
Methods:
This open-label, multicenter, prospective observational study comprised a 4-week observation period assessing the effectiveness and safety of twice-daily budesonide foam enema. Mild-to-moderate UC patients who had bowel urgency were included. Patients collected data daily in an electronic patient-reported outcome system or logbooks. The primary endpoint was the rate of resolution of bowel urgency at the end of the 4-week observation period. The rate of bowel incontinence was also assessed.
Results:
Sixty-one patients were enrolled. Of patients with a final evaluation, the rate of resolution of bowel urgency was 58.5% (31/53; 95% confidence interval, 44.1%–71.9%). Bowel urgency decreased over time, with a significant difference observed on day 7 versus day 0. Bowel incontinence showed a decreasing trend from day 5, with a significant difference confirmed on day 12 versus day 0. The clinical remission rate was 64.4% (38/59; 95% confidence interval, 50.9%–76.4%). One adverse event not related to budesonide rectal foam occurred.
Conclusions
The findings suggest that bowel urgency can be improved early with twice-daily budesonide foam enema. No new safety signals were observed.
4.Endocuff-Assisted versus Cap-Assisted Colonoscopy Performed by Trainees: A Retrospective Study
Yutaka OKAGAWA ; Tetsuya SUMIYOSHI ; Yusuke TOMITA ; Shutaro OIWA ; Fumihiro OGATA ; Takashi JIN ; Masahiro YOSHIDA ; Ryoji FUJII ; Takeyoshi MINAGAWA ; Kohtaro MORITA ; Hideyuki IHARA ; Michiaki HIRAYAMA ; Hitoshi KONDO
Clinical Endoscopy 2020;53(3):339-345
Background/Aims:
The adenoma detection rate (ADR) of screening colonoscopies performed by trainees is often lower than that of colonoscopies performed by experts. The effcacy of cap-assisted colonoscopy (CAC) in adenoma detection is well documented, especially that of CACs performed by trainees. Endocuff, a new endoscopic cap, is reportedly useful for adenoma detection; however, no trials have compared the effcacy of Endocuff-assisted colonoscopy (EAC) and CAC conducted by trainees. Therefore, the present study retrospectively compared the effcacy between EAC and CAC in trainees.
Methods:
This was a single-center, retrospective study involving 305 patients who underwent either EAC or CAC performed by three trainees between January and December 2018. We evaluated the ADR, mean number of adenomas detected per patient (MAP), cecal intubation rate, cecal intubation time, and occurrence of complications between the EAC and CAC groups.
Results:
The ADR was significantly higher in the EAC group than in the CAC group (54.3% vs. 37.3%, p=0.019), as was the MAP (1.36 vs. 0.74, p=0.003). No significant differences were found between the groups with respect to the cecal intubation rate or cecal intubation time. No major complications occurred in either group.
Conclusions
Our results suggest that EAC exhibits increased ADR and MAP compared to CAC when performed by trainees.
5.Effects of a Group Exercise Activity Managed by Elderly Volunteers on the Physical Function of Community-dwelling Older Women who Had Recently Completed an Exercise Program Led by Fitness Experts
Ayane Sato ; Takashi Jindo ; Keisuke Fujii ; Taishi Tsuji ; Naruki Kitano ; Kazushi Hotta ; Tomohiro Okura
An Official Journal of the Japan Primary Care Association 2017;40(1):9-15
Introduction: The purpose of this study was to investigate the effects that a group exercise activity managed by elderly volunteers would have on the physical function of older women after they participated in a formal exercise program taught by fitness experts.
Methods: Subjects were 47 community-dwelling older women who had completed a 3-month exercise program led by expert instructors in Kasama City, Ibaraki. After completing this exercise program, 28 subjects continued to participate in a group exercise activity led by elderly volunteers for approximately 11 months. The remaining 19 subjects did not join the group activities after the formal program. In both the initial, expert-led exercise program and the subsequent, volunteer-led group activity, subjects mainly engaged in the square-stepping exercise, which is a novel exercise for improving lower extremity physical function. In order to assess participants' physical function, we conducted five physical performance tests at both the baseline and follow-up; the former is the last day of the exercise program and the latter is approximately a year after the baseline.
Results: Two-way ANOVA demonstrated a significant interaction in the timed up and go test (P=0.003). The performance of subjects who had participated in the volunteer-managed group activity improved between the baseline and follow-up tests (P=0.007).
Conclusion: Participating in a group exercise activity managed by elderly volunteers can improve mobility skills of older women who had previously completed a formal exercise program led by expert instructors.
6.Dosimetric advantages and clinical outcomes of simultaneous integrated boost intensity-modulated radiotherapy for anal squamous cell carcinoma.
Katsuyuki SAKANAKA ; Satoshi ITASAKA ; Yuichi ISHIDA ; Kota FUJII ; Takahiro HORIMATSU ; Takashi MIZOWAKI ; Yoshiharu SAKAI ; Masahiro HIRAOKA
Radiation Oncology Journal 2017;35(4):368-379
PURPOSE: The purpose of this study was to explore the dosimetric difference between simultaneous integrated boost intensity-modulated radiotherapy (SIB-IMRT) and three-dimensional conformal radiotherapy (3DCRT), and the clinical outcomes of anal squamous cell carcinoma (ASCC) chemoradiotherapy featuring SIB-IMRT. MATERIALS AND METHODS: This study included ten patients with ASCC who underwent chemoradiotherapy using SIB-IMRT with 5-fluorouracil and mitomycin C. SIB-IMRT delivered 54 Gy to each primary tumor plus metastatic lymph nodes and 45 Gy to regional lymph nodes, in 30 fractions. Four patients received additional boosts to the primary tumors and metastatic lymph nodes; the median total dose was 54 Gy (range, 54 to 60 Gy). We additionally created 3DCRT plans following the Radiation Therapy Oncology Group 9811 protocol to allow dosimetric comparisons with SIB-IMRT. Locoregional control, overall survival, and toxicity were calculated for the clinical outcome evaluation. RESULTS: Compared to 3DCRT, SIB-IMRT significantly reduced doses to the external genitalia, bladder, and intestine, delivering the doses to target and elective nodal region. At a median follow-up time of 46 months, 3-year locoregional control and overall survival rates were 88.9% and 100%, respectively. Acute toxicities were treated conservatively. All patients completed radiotherapy with brief interruptions (range, 0 to 2 days). No patient experienced ≥grade 3 late toxicity during the follow-up period. CONCLUSION: The dosimetric advantages of SIB-IMRT appeared to reduce the toxicity of chemoradiotherapy for ASCC achieving high locoregional control in the extended period.
Anus Neoplasms
;
Carcinoma, Squamous Cell*
;
Chemoradiotherapy
;
Epithelial Cells*
;
Fluorouracil
;
Follow-Up Studies
;
Genitalia
;
Humans
;
Intestines
;
Lymph Nodes
;
Mitomycin
;
Radiotherapy
;
Radiotherapy Planning, Computer-Assisted
;
Radiotherapy, Conformal
;
Radiotherapy, Intensity-Modulated*
;
Survival Rate
;
Treatment Outcome
;
Urinary Bladder
7.A Case of Dry Eye and Eye Strain Successfully Treated with Shimbuto, Kihito, and Electrothermo-Acupuncture
Shohaku YAMAMOTO ; Masaki SONODA ; Atuko TAKATA ; Daisuke TAMIYA ; Rie FUJII ; Ryoji ENDO ; Takashi ITO
Kampo Medicine 2017;68(3):212-217
We treated dry eyes and eyestrains successfully with electrothermo-acupuncture and Kampo medicine. The case was a 41-year-old woman who was treated with a few eye drops. She came to our hospital to receive Kampo medicine because her photophobia and eye pain got worse. After taking shimbuto, her complaint got better with improving physical fatigue. Electrothermo-acupuncture was effective for photophobia and eye pain promptly and remarkably. After we added kihito to her, she did not need to use eye drops with improving bloody urine and sleeplessness. Photophobia and eye-ache are thought to be related to the trigeminal nerve system. In this case, we consider that the point of application of electrothermo-acupuncture is the trigeminal nerve system. At the same time, “rikan” and “hikyo” might be involved in this case with the general malaise of eye.
8.Magnetic resonance enterography for the evaluation of the deep small intestine in Crohn's disease.
Kazuo OHTSUKA ; Kento TAKENAKA ; Yoshio KITAZUME ; Toshimitsu FUJII ; Katsuyoshi MATSUOKA ; Maiko KIMURA ; Takashi NAGAISHI ; Mamoru WATANABE
Intestinal Research 2016;14(2):120-126
For the control of Crohn's disease (CD) a thorough assessment of the small intestine is essential; several modalities may be utilized, with cross-sectional imaging being important. Magnetic resonance (MR) enterography, i.e., MRE is recommended as a modality with the highest accuracy for CD lesions. MRE and MR enteroclysis are the two methods performed following distension of the small intestine. MRE has sensitivity and specificity comparable to computed tomography enterography (CTE); although images obtained using MRE are less clear compared with CTE, MRE does not expose the patient to radiation and is superior for soft-tissue contrast. Furthermore, it can assess not only static but also dynamic and functional imaging and reveals signs of CD, such as abscess, comb sign, fat edema, fistula, lymph node enhancement, less motility, mucosal lesions, stricture, and wall enhancement. Several indices of inflammatory changes and intestinal damage have been proposed for objective evaluation. Recently, diffusion-weighted imaging has been proposed, which does not need bowel preparation and contrast enhancement. Comprehension of the characteristics of MRE and other modalities is important for better management of CD.
Abscess
;
Animals
;
Capsule Endoscopy
;
Comb and Wattles
;
Comprehension
;
Constriction, Pathologic
;
Crohn Disease*
;
Diffusion Magnetic Resonance Imaging
;
Edema
;
Fistula
;
Humans
;
Intestine, Small*
;
Lymph Nodes
;
Sensitivity and Specificity
9.Invasiveness Reduction of Recent Total En Bloc Spondylectomy: Assessment of the Learning Curve.
Takayoshi ISHII ; Hideki MURAKAMI ; Satoru DEMURA ; Satoshi KATO ; Katsuhito YOSHIOKA ; Moriyuki FUJII ; Takashi IGARASHI ; Hiroyuki TSUCHIYA
Asian Spine Journal 2016;10(3):522-527
STUDY DESIGN: Case-control study. PURPOSE: To evaluate the surgical magnitude and learning curve of "second-generation" total en bloc spondylectomy (TES). OVERVIEW OF LITERATURE: In June 2010, we developed second-generation TES combined with tumor-induced cryoimmunology, which does not require autograft harvesting. METHODS: TES was performed in 63 patients between June 2010 and September 2013. Three groups of patients were evaluated: 20 undergoing surgery in the first year of development of second-generation TES (group I), 20 in the second year (group II), and 23 in the third year (group III). Patient backgrounds showed no remarkable differences. Operating time, intraoperative blood loss, blood transfusion, and postoperative C-reactive protein and creatine phosphokinase were compared among the groups. RESULTS: Mean±standard deviation operating time was 486±130 minutes in group I, 441±85 minutes in group II, and 396±75 minutes in group III. The time was significantly shorter in group III than in group I (p<0.05). Intraoperative blood loss was 901±646 mL in group I, 433±177 mL in group II, and 411±167 mL in group III. Blood loss was significantly lower in groups II and III than in group I (p<0.01). Transfusion was not required in 20 of 23 patients in group III, and mean C-reactive protein levels on postoperative day 3 were significantly lower in this group than in group I (6.12 mg/L vs. 10.07 mg/L; p<0.05). Postoperative creatine phosphokinase levels did not differ among the groups. CONCLUSIONS: TES is associated with a significant learning curve. Thus, second-generation TES can no longer be considered highly invasive.
Autografts
;
Blood Transfusion
;
C-Reactive Protein
;
Case-Control Studies
;
Creatine Kinase
;
Humans
;
Learning Curve*
;
Learning*
10.Invasiveness Reduction of Recent Total En Bloc Spondylectomy: Assessment of the Learning Curve.
Takayoshi ISHII ; Hideki MURAKAMI ; Satoru DEMURA ; Satoshi KATO ; Katsuhito YOSHIOKA ; Moriyuki FUJII ; Takashi IGARASHI ; Hiroyuki TSUCHIYA
Asian Spine Journal 2016;10(3):522-527
STUDY DESIGN: Case-control study. PURPOSE: To evaluate the surgical magnitude and learning curve of "second-generation" total en bloc spondylectomy (TES). OVERVIEW OF LITERATURE: In June 2010, we developed second-generation TES combined with tumor-induced cryoimmunology, which does not require autograft harvesting. METHODS: TES was performed in 63 patients between June 2010 and September 2013. Three groups of patients were evaluated: 20 undergoing surgery in the first year of development of second-generation TES (group I), 20 in the second year (group II), and 23 in the third year (group III). Patient backgrounds showed no remarkable differences. Operating time, intraoperative blood loss, blood transfusion, and postoperative C-reactive protein and creatine phosphokinase were compared among the groups. RESULTS: Mean±standard deviation operating time was 486±130 minutes in group I, 441±85 minutes in group II, and 396±75 minutes in group III. The time was significantly shorter in group III than in group I (p<0.05). Intraoperative blood loss was 901±646 mL in group I, 433±177 mL in group II, and 411±167 mL in group III. Blood loss was significantly lower in groups II and III than in group I (p<0.01). Transfusion was not required in 20 of 23 patients in group III, and mean C-reactive protein levels on postoperative day 3 were significantly lower in this group than in group I (6.12 mg/L vs. 10.07 mg/L; p<0.05). Postoperative creatine phosphokinase levels did not differ among the groups. CONCLUSIONS: TES is associated with a significant learning curve. Thus, second-generation TES can no longer be considered highly invasive.
Autografts
;
Blood Transfusion
;
C-Reactive Protein
;
Case-Control Studies
;
Creatine Kinase
;
Humans
;
Learning Curve*
;
Learning*


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