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.Quality indicators for endometrial cancer care in Japan
Tamaki KAKUWA ; Yuichi ICHINOSE ; Ryoko RIKITAKE ; Taisuke ISHII ; Satoru NAGASE ; Yoichi KOBAYASHI ; Masanori KANEUCHI ; Hideki TOKUNAGA ; Manabu SEINO ; Hiroaki KAJIYAMA ; Munetaka TAKEKUMA ; Tsutomu TABATA ; Yoshito TERAI ; Yasuhisa TERAO ; Tohru MORISADA ; Hidemichi WATARI ; Yoko YAMAMOTO ; Akira KAWATA ; Takahiro HIGASHI
Journal of Gynecologic Oncology 2025;36(5):e77-
Objective:
The incidence and mortality rates of endometrial cancer are increasing globally, including in Japan. Quality of cancer care is promoted through guideline adherence. This study aimed to establish quality indicators (QIs) for endometrial cancer and explore the factors contributing to treatment nonadherence.
Methods:
QIs and pattern-of-care indicators (PCIs) were developed using the Research and Development/University of California Los Angeles modified Delphi method. QIs reflect desirable healthcare patterns, whereas PCIs address treatment areas with lacking evidence.Data from the Hospital-Based Cancer Registry and Diagnosis Procedure Combination Survey were used. Patients diagnosed or treated between January 1 and December 31, 2020 were included. The reasons for nonadherence were collected. Logistic regression was used to analyze the factors influencing adherence, including age, body mass index, comorbidities, facilities, and recurrence risk.
Results:
Of the 35 proposed QI candidates, 8 QIs and 9 PCIs were selected, predominantly focusing on surgical aspects. Adherence rates varied, with peritoneal lavage cytology being the highest (93.1%), and postoperative hormone replacement therapy (HRT) for patients aged <45 years being the lowest (30.9%), when focusing on process indicators. Reasons for nonadherence included patient preference and medical comorbidities as significant factors. Multivariate analysis highlighted age, clinical stage, and Barthel index as significant contributors to nonadherence.
Conclusion
We developed QIs to comprehensively assess endometrial cancer treatment.Adherence rates are favorable; however, HRT has a low adherence rate. Factors leading to nonadherence include advanced age and incomplete activities of daily living, particularly in advanced stages.
5.Two-stage mandibular setback employing modified Dingman’s mandibular body osteotomy with step for large antero-posterior dentofacial deformity correction: a report of two cases
Nithish SANKEPALLY ; Mrunalini RAMANATHAN ; Masako FUJIOKA-KOBAYASHI ; Rie SONOYAMA-OSAKO ; Elavenil PANNEERSELVAM ; Takahiro KANNO
Journal of the Korean Association of Oral and Maxillofacial Surgeons 2025;51(6):417-425
Mandibular prognathism is a well-known skeletal discrepancy with varying prevalence rates demographically. Patients with severe prognathism may experience difficulties speaking and chewing food as well as problems with psychosocial adjustment, indicating the need for surgical correction. In cases of single-stage larger mandibular setbacks, complications such as reduction in the pharyngeal airway and instability can be encountered. Therefore, two-stage orthognathic surgery could be recommended. Two patients (17-year-old female and 16-year-old female) reported with large mandibular antero-posterior discrepancies. Surgical correction was performed in two stages. In the first stage, a mandibular setback was performed with an anterior mandibular body osteotomy using Dingman’s technique with a modified step osteotomy, as it provides an increased surface area of contact between the osteotomized segments to achieve better stability. Osteofixation was done using locking titanium miniplates. A year after orthodontic decompensation at the second stage, maxillary advancement using Le Fort I osteotomy and bilateral sagittal split osteotomy for mandibular setback were performed and fixed with unsintered hydroxyapatite/poly-L-lactic acid plates and screws. The post-operative course was followed by post-surgical orthodontics. It can be concluded that a harmonized facial profile with good outcome in terms of skeletal stability, airway dimensions and occlusion were achieved with patient satisfaction.
6.Tele-education by an orthopedic specialist increased the confidence in orthopedics of a general practitioner at a rural solo-practice clinic
Takashi AKIMOTO ; Tadashi KOBAYASHI ; Hiroki MAITA ; Takahiro HIRANO
Journal of Rural Medicine 2024;19(1):40-43
Objective: General practitioners in rural clinics are required to deal with musculoskeletal problems, but they often lack the confidence. We aim to confirm changes in their confidence in orthopedic practices after using tele-education.Materials and Methods: We conducted tele-education in orthopedic practices from June 1, 2022, to November 30, 2022. Using a teleconference system, the first author, an orthopedic specialist, provided tele-education training to an independent general practitioner in a rural clinic. We adopted a 7-point Likert scale to assess the general practitioner’s confidence levels. In pre- and post-research, the counts and confidence levels in the scale were assessed for 18 types of orthopedic practices each month. Furthermore, we interviewed the general practitioner to examine the factors influencing their confidence.Results: The confidence levels increased for all measurement items. The most experienced orthopedic practice was “Advising on daily care for musculoskeletal problems”, with confidence levels increasing from 3 to 6. The least experienced orthopedic practice was “Manipulative reduction of radial head subluxation”, with confidence levels increasing from 4 to 5. The factors that influenced the change in confidence levels were regular feedback and unrestricted availability of consultations.Conclusion: Tele-education in orthopedics may enhance general practitioners’ confidence in orthopedic practices.
7.Utilization of the pericapsular nerve group block in preoperative rehabilitation of patients with femoral neck fractures -a case series-
Zhuan JIN ; Daisuke SUGIYAMA ; Fumiya HIGO ; Takahiro HIRATA ; Osamu KOBAYASHI ; Hiroshi MORIMATSU ; Kenichi UEDA
Korean Journal of Anesthesiology 2024;77(5):565-569
Background:
Elderly patients with femoral neck fractures, particularly those with severe comorbidities or living in regions with limited medical resources, may experience delays in surgical treatment. Although the benefits of preoperative rehabilitation (prehabilitation) in hip arthroplasty have been reported, pain management remains a challenge. The pericapsular nerve group (PENG) block, known for its exceptional analgesic effect and motor function preservation, may be a promising intervention during prehabilitation in these patients. Case: We enrolled ten patients with Garden classification 3–4 femoral neck fractures scheduled for hip arthroplasty. After receiving a PENG block with 20 ml of 0.375% ropivacaine, all patients underwent initial prehabilitation sessions comprising 9 mobility levels, ranging from bed-sitting to walking. One patient was excluded due to experiencing high blood pressure during prehabilitation. Six of the nine remaining patients (66.7%) were successfully transferred from bed to wheelchair.
Conclusions
The PENG block enhanced prehabilitation for patients with femoral neck fractures undergoing hip arthroplasty.
8.Utilization of and barriers to a telemedicine system at a rural general hospital in Japan: a mixed methods study
Takahiro HIRANO ; Tadashi KOBAYASHI ; Hiroki MAITA ; Takashi AKIMOTO ; Hiroyuki KATO
Journal of Rural Medicine 2023;18(4):226-232
Objective: The initial and operational costs of telemedicine are major barriers to its adoption. We aimed to investigate and identify the barriers to adopting a telemedicine system in a Japanese rural general hospital without incurring setup and operational costs.Materials and Methods: Our study was conducted between May and August 2018, and included six general practitioners working at a rural general hospital. We extracted data collected from messages (date and time, sender and recipient, and counts and contents of messages) and conducted semi-structured interviews, which were then analyzed using quantitative and qualitative methods.Results: We quantitatively analyzed the total counted of the 179 messages. The total counts recorded for each physician were 56 (A), 20 (B), 3 (C), 74 (D), 5 (E), and 21 (F). The mean monthly counts were 2.17 (May), 8.50 (June), 11.50 (July), and 7.67 (August). Interview data from the six physicians yielded 13 codes that included various points of dissatisfaction acting as barriers to using our system, which we grouped into mental and physical barriers. Mental barriers included suspicion of carrying, feelings of isolation, and loss, whereas physical barriers included portability, user authentication, internet speed, group chat system, notice, search image, typing, chat system, print facility, and limited function.Conclusion: The representative barriers to introducing a telemedicine system at a rural general hospital in Japan without initial and running costs could be classified as feelings of isolation and suspicion of carrying (mental barriers); and notice, portability, and user authentication (physical barriers). Continued investigation in this area is warranted, and solutions to these barriers could improve the shortage of medical staff in the context of declining birth rates and aging populations in Japan.
9.Long-term Observation of Gastric Adenocarcinoma of Fundic Gland Mucosa Type before and after Helicobacter pylori Eradication: a Case Report
Keitaro TAKAHASHI ; Nobuhiro UENO ; Takahiro SASAKI ; Yu KOBAYASHI ; Yuya SUGIYAMA ; Yuki MURAKAMI ; Takehito KUNOGI ; Katsuyoshi ANDO ; Shin KASHIMA ; Kentaro MORIICHI ; Hiroki TANABE ; Yuki KAMIKOKURA ; Sayaka YUZAWA ; Mishie TANINO ; Toshikatsu OKUMURA ; Mikihiro FUJIYA
Journal of Gastric Cancer 2021;21(1):103-109
Gastric adenocarcinoma of the fundic gland mucosa type (GA-FGM) was proposed as a new variant of gastric adenocarcinoma of the fundic gland type (GA-FG). However, at present, the influence of Helicobacter pylori and the speed of progression and degree of malignancy in GA-FGM remain unclear. Herein, we report the first case of intramucosal GA-FGM that was endoscopically observed before and after H. pylori eradication over 15 years. The lesion showed the same tumor size with no submucosal invasion and a low MIB-1 labeling index 15 years after its detection using endoscopy. The endoscopic morphology changed from 0-IIa before H. pylori eradication to 0-IIa+IIc and then 0-I after H. pylori eradication. These findings suggest that the unaltered tumor size reflects low-grade malignancy and slow growth, and that the endoscopic morphology is influenced by H. pylori eradication.
10.Initial treatment outcome and feasibility of low-dose cabazitaxel against docetaxel- and castration-resistant prostate cancer in a Japanese hospital
Ryosuke CHAYA ; Takehiko OKAMURA ; Takahiro YANASE ; Takashi NAGAI ; Yoshinobu MORITOKI ; Daichi KOBAYASHI ; Hidetoshi AKITA ; Takahiro YASUI
Journal of Rural Medicine 2020;15(1):25-28
Introduction: Cabazitaxel (CBZ) is used worldwide for castration-resistant prostate cancer after docetaxel treatment. In July 2014 the drug was approved in Japan with the same induction dose used for Caucasian patients. In this study, we examined and compared the results of an initial low-dose CBZ treatment in patients admitted to our hospital.Patients and Methods: Between July 2014 and August 2018, sixteen mCRPC patients were enrolled and underwent a low-dose CBZ treatment at our hospital. We compared the results with those of a Japanese metastatic docetaxel- and castration-resistant prostate cancer Phase I study.Results: The median patient age was 77 years (range, 53–84 years). Of the 16 patients, eight (50%) had a lymph node metastasis and 11 (68.8%) had a distant metastasis, 10 of whom had only a bone metastasis. The median dose of CBZ was 30 mg (range, 20–32 mg) and the median number of CBZ cycles was 2.5 (range, 1–18). The PSA level of 9 (56.3%) patients decreased after CBZ treatment, including 4 (25%) who showed a decrease to <50%. The median time interval in which the PSA level decreased was 2 months (range, 1–18 months). The observed adverse events (AE) were neutropenia (31.3%), febrile neutropenia (6.3%), fatigue (43.8%), nausea (18.8%), diarrhea (12.5%), decreased appetite (25%), dysgeusia (6.3%), white blood cell count decrease (43.8%), platelet count decrease (12.3%), and anemia (75%). However, no patient listed an AE as the reason for discontinuing the treatment.Conclusions: Even at a low dose, CBZ could improve the PSA value in patients with CRPC previously treated with docetaxel. Dose reduction and prophylactic administration of sustained G-CSF were also safe treatment options. Further studies involving an introduction period including a modulation of duration and dose are necessary, especially in Japanese patients.


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