1.Continuous Sterile Compounding and Infusion Warming Methods for Children Requiring Medical Care by Community Pharmacists: A Case Report
Takashi DOUMEKI ; Yoshitaka HASEGAWA ; Hitoshi ITO ; Mitsuo KOBAYASHI ; Ryota TSUKIOKA ; Miya OISHI
An Official Journal of the Japan Primary Care Association 2025;48(1):30-33
2.Leucine-rich alpha-2 glycoprotein is useful in predicting clinical relapse in patients with Crohn’s disease during biological remission
Naohiro NAKAMURA ; Yusuke HONZAWA ; Yuka ITO ; Yasuki SANO ; Naoto YAGI ; Sanshiro KOBAYASHI ; Mamiko AOI ; Takashi TOMIYAMA ; Tomomitsu TAHARA ; Norimasa FUKATA ; Toshiro FUKUI ; Makoto NAGANUMA
Intestinal Research 2025;23(2):170-181
Background/Aims:
Serum leucine-rich alpha-2 glycoprotein (LRG) is a potential biomarker of Crohn’s disease (CD). This study aimed to evaluate the usefulness of LRG in predicting clinical relapse in patients in remission with CD.
Methods:
This retrospective observational study assessed the relationships among patient-reported outcome (PRO2), LRG, and other blood markers. The influence of LRG on clinical relapse was assessed in patients in remission with CD.
Results:
Data of 94 patients tested for LRG between January 2021 and May 2023 were collected. LRG level did not correlate with PRO2 score (ρ = 0.06); however, it strongly correlated with C-reactive protein (CRP) level (r=0.79) and serum albumin level (r=–0.70). Among 69 patients in clinical remission, relapse occurred in 22 patients (31.9%). In the context of predicting relapse, LRG showed the highest area under the curve, followed by CRP level, platelet count, and albumin level. Multivariate analysis revealed that only LRG (P= 0.02) was an independent factor for predicting clinical remission. The cumulative non-relapse rate was significantly higher in patients with LRG < 13.8 μg/mL than in patients in remission with LRG ≥ 13.8 μg/mL and normal CRP level (P= 0.002) or normal albumin level (P= 0.001). Cumulative non-relapse rate was also higher in patients with LRG < 13.8 μg/mL compared to those with LRG ≥ 13.8 μg/mL in patients with L3 or B2+B3 of Montreal calcification.
Conclusions
LRG is useful in predicting clinical relapse in patients with CD during biological remission. LRG is a useful biomarker for predicting prognosis, even in patients with intestinal stenosis, or previous/present fistulas.
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.Leucine-rich alpha-2 glycoprotein is useful in predicting clinical relapse in patients with Crohn’s disease during biological remission
Naohiro NAKAMURA ; Yusuke HONZAWA ; Yuka ITO ; Yasuki SANO ; Naoto YAGI ; Sanshiro KOBAYASHI ; Mamiko AOI ; Takashi TOMIYAMA ; Tomomitsu TAHARA ; Norimasa FUKATA ; Toshiro FUKUI ; Makoto NAGANUMA
Intestinal Research 2025;23(2):170-181
Background/Aims:
Serum leucine-rich alpha-2 glycoprotein (LRG) is a potential biomarker of Crohn’s disease (CD). This study aimed to evaluate the usefulness of LRG in predicting clinical relapse in patients in remission with CD.
Methods:
This retrospective observational study assessed the relationships among patient-reported outcome (PRO2), LRG, and other blood markers. The influence of LRG on clinical relapse was assessed in patients in remission with CD.
Results:
Data of 94 patients tested for LRG between January 2021 and May 2023 were collected. LRG level did not correlate with PRO2 score (ρ = 0.06); however, it strongly correlated with C-reactive protein (CRP) level (r=0.79) and serum albumin level (r=–0.70). Among 69 patients in clinical remission, relapse occurred in 22 patients (31.9%). In the context of predicting relapse, LRG showed the highest area under the curve, followed by CRP level, platelet count, and albumin level. Multivariate analysis revealed that only LRG (P= 0.02) was an independent factor for predicting clinical remission. The cumulative non-relapse rate was significantly higher in patients with LRG < 13.8 μg/mL than in patients in remission with LRG ≥ 13.8 μg/mL and normal CRP level (P= 0.002) or normal albumin level (P= 0.001). Cumulative non-relapse rate was also higher in patients with LRG < 13.8 μg/mL compared to those with LRG ≥ 13.8 μg/mL in patients with L3 or B2+B3 of Montreal calcification.
Conclusions
LRG is useful in predicting clinical relapse in patients with CD during biological remission. LRG is a useful biomarker for predicting prognosis, even in patients with intestinal stenosis, or previous/present fistulas.
5.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.
6.Leucine-rich alpha-2 glycoprotein is useful in predicting clinical relapse in patients with Crohn’s disease during biological remission
Naohiro NAKAMURA ; Yusuke HONZAWA ; Yuka ITO ; Yasuki SANO ; Naoto YAGI ; Sanshiro KOBAYASHI ; Mamiko AOI ; Takashi TOMIYAMA ; Tomomitsu TAHARA ; Norimasa FUKATA ; Toshiro FUKUI ; Makoto NAGANUMA
Intestinal Research 2025;23(2):170-181
Background/Aims:
Serum leucine-rich alpha-2 glycoprotein (LRG) is a potential biomarker of Crohn’s disease (CD). This study aimed to evaluate the usefulness of LRG in predicting clinical relapse in patients in remission with CD.
Methods:
This retrospective observational study assessed the relationships among patient-reported outcome (PRO2), LRG, and other blood markers. The influence of LRG on clinical relapse was assessed in patients in remission with CD.
Results:
Data of 94 patients tested for LRG between January 2021 and May 2023 were collected. LRG level did not correlate with PRO2 score (ρ = 0.06); however, it strongly correlated with C-reactive protein (CRP) level (r=0.79) and serum albumin level (r=–0.70). Among 69 patients in clinical remission, relapse occurred in 22 patients (31.9%). In the context of predicting relapse, LRG showed the highest area under the curve, followed by CRP level, platelet count, and albumin level. Multivariate analysis revealed that only LRG (P= 0.02) was an independent factor for predicting clinical remission. The cumulative non-relapse rate was significantly higher in patients with LRG < 13.8 μg/mL than in patients in remission with LRG ≥ 13.8 μg/mL and normal CRP level (P= 0.002) or normal albumin level (P= 0.001). Cumulative non-relapse rate was also higher in patients with LRG < 13.8 μg/mL compared to those with LRG ≥ 13.8 μg/mL in patients with L3 or B2+B3 of Montreal calcification.
Conclusions
LRG is useful in predicting clinical relapse in patients with CD during biological remission. LRG is a useful biomarker for predicting prognosis, even in patients with intestinal stenosis, or previous/present fistulas.
7.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.
8.Disaster Relief Activities of a Pharmacist Team That Accompanied the Kansai Intensive Area Care Unit for SARS-CoV-2 at an Intensive Care Home for the Elderly Affected by the 2024 Noto Peninsula Earthquake
Takashi IMANISHI ; Shota IMAHORI ; Masanori KOBAYASHI ; Shigemi MURAKAMI ; Tomomi YOSHIMURA ; Takeyuki KOHNO ; Eiji KAWAKAMI
An Official Journal of the Japan Primary Care Association 2025;48(4):118-122
Following the Great East Japan Earthquake, the role of pharmacists in disaster areas has grown in importance and responsibilities have become increasingly diverse. During the 2024 Noto Peninsula Earthquake, we participated in disaster relief activities as a pharmacist team. In these efforts, we worked alongside the Kansai Intensive Area Care Unit for SARS-CoV-2 "KISA2-tai". We encountered a situation that highlights the critical role of pharmacist teams in disaster relief efforts at an intensive care home for the elderly. Herein, we report the results and problems encountered during these activities.
9.Comparative advantages of activities with lumbosacral preservation for adult spinal deformity surgery: a retrospective Japanese cohort study
Yoshinori ISHIKAWA ; Takashi KOBAYASHI ; Eiji ABE ; Ryo SHOJI ; Naohisa MIYAKOSHI
Asian Spine Journal 2024;18(5):699-705
Methods:
Among 399 patients who underwent ASD surgery, 62 (≥5 levels fused, >2-year follow-up) underwent fusion from T9–10 to L5 (group L, n=21) or to S2–alar–iliac (group S, n=41). Spinal alignments, Scoliosis Research Society (SRS)-22 scores, performance of activities (clipping toenail, wiping buttock, and wearing socks), proximal and distal junctional failure (PJF+DJF), rod fractures (RFs), and overall revision rates (RRs) were compared between the groups.
Results:
Group L included younger patients and had longer follow-ups when compared with group S. Although the preoperative pelvic incidence and SRS sagittal modifiers were better in group L, postoperative spinal restorations were nonpathological in both groups. Both groups showed similar deformity progression at the 2-year follow-up; however, group L had lower SRS-22 pain scores. Although “wiping buttocks” did not differ between the groups, the performance of “clipping toenails” and “wearing socks” was poorer in group S at 2 years (possible, group S; 40% vs. group L; 85%–90%). The RRs did not differ between the groups; however, the PJF+DJF rate was higher in group L. DJF was not observed in group S, but occurrence of RFs was noted.
Conclusions
Although poorer SRS-22 pain scores might be related to lumbosacral mobility, sufficient restoration, equivalent deformity progression, and similar RRs with better activity imply that lumbosacral preservation should be considered in younger patients with moderate deformities.
10.A novel fully covered metal stent for unresectable malignant distal biliary obstruction: results of a multicenter prospective study
Arata SAKAI ; Atsuhiro MASUDA ; Takaaki EGUCHI ; Keisuke FURUMATSU ; Takao IEMOTO ; Shiei YOSHIDA ; Yoshihiro OKABE ; Kodai YAMANAKA ; Ikuya MIKI ; Saori KAKUYAMA ; Yosuke YAGI ; Daisuke SHIRASAKA ; Shinya KOHASHI ; Takashi KOBAYASHI ; Hideyuki SHIOMI ; Yuzo KODAMA
Clinical Endoscopy 2024;57(3):375-383
Background/Aims:
Endoscopic self-expandable metal stent (SEMS) placement is currently the standard technique for treating unresectable malignant distal biliary obstructions (MDBO). Therefore, covered SEMS with longer stent patency and fewer migrations are required. This study aimed to assess the clinical performance of a novel, fully covered SEMS for unresectable MDBO.
Methods:
This was a multicenter single-arm prospective study. The primary outcome was a non-obstruction rate at 6 months. The secondary outcomes were overall survival (OS), recurrent biliary obstruction (RBO), time to RBO (TRBO), technical and clinical success, and adverse events.
Results:
A total of 73 patients were enrolled in this study. The non-obstruction rate at 6 months was 61%. The median OS and TRBO were 233 and 216 days, respectively. The technical and clinical success rates were 100% and 97%, respectively. Furthermore, the rate of occurrence of RBO and adverse events was 49% and 21%, respectively. The length of bile duct stenosis (<2.2 cm) was the only significant risk factor for stent migration.
Conclusions
The non-obstruction rate of a novel fully covered SEMS for MDBO is comparable to that reported earlier but shorter than expected. Short bile duct stenosis is a significant risk factor for stent migration.


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