KEIO JOURNAL OF MEDICINE最新文献

Injury Prevalence and Associated Factors in Japanese Competitive Kendo Collegiate Athletes. 日本竞技剑道运动员损伤发生率及相关因素分析。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2026-03-25 Epub Date: 2025-09-10 DOI: 10.2302/kjm.2024-0008-OA

Takeshi Kimura, Aleksandra Mącznik, Akira Kinoda, Yuichi Yamada, Yuki Muramoto, Yoshinori Katsumata, Kazuki Sato

{"title":"Injury Prevalence and Associated Factors in Japanese Competitive Kendo Collegiate Athletes.","authors":"Takeshi Kimura, Aleksandra Mącznik, Akira Kinoda, Yuichi Yamada, Yuki Muramoto, Yoshinori Katsumata, Kazuki Sato","doi":"10.2302/kjm.2024-0008-OA","DOIUrl":"10.2302/kjm.2024-0008-OA","url":null,"abstract":"In Japan, many schools include kendo as part of the school physical education program. Farther afield, kendo also serves as a life-long method to improve and retain physical fitness and mental skills for adults of all ages around the world. Therefore, kendo has the potential to be an inexpensive public health modality if proven safe. This study aimed to investigate the 1-year prevalence of kendo-related injuries in Japanese collegiate athletes. The factors associated with kendo injuries were explored in a retrospective observational study using an online survey between June 2022 and August 2023. Athlete characteristics and injury occurrence, location, type, and circumstances were recorded. The survey was completed by 143 athletes (average age 19.9 years) with an average of 12.9 years of experience in kendo. We found that the 1-year prevalence of injuries in Japanese kendo collegiate athletes was 43%. The only factors associated with injury were sex and body mass index (BMI) status. Female athletes were 4.9 time more likely to report an injury than male athletes, whereas athletes with overweight or obese status (BMI ≥ 25) were 3.7 times more likely to report an injury than athletes with underweight or normal BMI status (BMI < 25). Special attention should be given to injury prevention and long-term development in female kendo athletes, especially in strength training.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"1-8"},"PeriodicalIF":1.5,"publicationDate":"2026-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Acceptability and Preliminary Effects of Online Evidence-based Practice Education Program for Undergraduate Nursing Students: A Pre- and Post-intervention Study. 护理本科学生在线循证实践教育计划的可接受性及初步效果：干预前后研究。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2026-03-25 Epub Date: 2025-09-18 DOI: 10.2302/kjm.2024-0013-OA

Sotaro Shimada, Ai Tomotaki, Ardith Z Doorenbos, Hiroki Fukahori

{"title":"Acceptability and Preliminary Effects of Online Evidence-based Practice Education Program for Undergraduate Nursing Students: A Pre- and Post-intervention Study.","authors":"Sotaro Shimada, Ai Tomotaki, Ardith Z Doorenbos, Hiroki Fukahori","doi":"10.2302/kjm.2024-0013-OA","DOIUrl":"10.2302/kjm.2024-0013-OA","url":null,"abstract":"Evidence-based practice (EBP) plays a crucial role in improving healthcare quality; however, there is still a lack of insight into EBP education for nursing in Japan. We aimed to evaluate the acceptability and preliminary effects of an online EBP education program on undergraduate nursing students in Japan. A pilot, single-armed, pre- and post-intervention design study using mixed methods was conducted with 11 nursing students. Participants completed an 8-h EBP education program over a 2-day period, which provided introductory knowledge and skills based on the five steps of EBP. The total score of the Student-Evidence-Based Practice Questionnaire showed a trend toward improvement with a medium effect size (P = 0.06, d =0.51). The following subscales displayed improvement with small to medium effect sizes: \"frequency of practice\" (P = 0.14, d =0.34), \"retrieving/reviewing evidence\" (P = 0.04, d = 0.59), and \"sharing and applying EBP\" (P = 0.13, d = 0.36). The focus group interviews revealed an enhanced understanding of EBP, improved skills for reading articles, and highlighted the importance of interactive teaching and access to on-demand learning materials. Our results suggested that the online EBP education program was acceptable and demonstrated preliminary effects in enhancing the skills of undergraduate nursing students in retrieving and reviewing evidence and results in thematic analysis. Further research such as a controlled trial including a more diverse sample with longer follow-up should be conducted to validate our findings and examine the program's long-term effects on clinical practice.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"9-19"},"PeriodicalIF":1.5,"publicationDate":"2026-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145087703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Ligustilide Attenuates Neuroinflammation and Fibrosis in an Aluminum Chloride-induced Rat Model of Alzheimer's Disease via mTOR/STAT3 Signaling Inhibition. 川芎内酯通过抑制mTOR/STAT3信号通路减轻氯化铝诱导的阿尔茨海默病大鼠模型的神经炎症和纤维化

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2026-03-06 DOI: 10.2302/kjm.2025-0017-OA

Nizar Sirag, Hassabelrasoul Elfadil, Abduallh J Ghabban, Abdulmajeed M Alasiri, Ibtisam R Alnasser, Hibah S Bedaiwi, Sadeem F Alharbi, Maha J Almarwani, Omar M Aljohani, Hanan M Hassan, Mohammed M H Al-Gayyar, Ayman Salama

{"title":"Ligustilide Attenuates Neuroinflammation and Fibrosis in an Aluminum Chloride-induced Rat Model of Alzheimer's Disease via mTOR/STAT3 Signaling Inhibition.","authors":"Nizar Sirag, Hassabelrasoul Elfadil, Abduallh J Ghabban, Abdulmajeed M Alasiri, Ibtisam R Alnasser, Hibah S Bedaiwi, Sadeem F Alharbi, Maha J Almarwani, Omar M Aljohani, Hanan M Hassan, Mohammed M H Al-Gayyar, Ayman Salama","doi":"10.2302/kjm.2025-0017-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0017-OA","url":null,"abstract":"Alzheimer's disease (AD) affects approximately 50 million individuals worldwide and is projected to triple by 2050. Ligustilide is a naturally occurring compound with varied pharmacological actions. Ligustilide has been reported to ameliorate AD by inhibiting PKA/AKAP1 or inducing α-secretase, but no prior research has examined its ability to activate the inflammasome in AD. We aimed to investigate the potential therapeutic effects of ligustilide in rats with AD by assessing the inflammatory and fibrotic pathways. AD was induced in rats by aluminum chloride. Subsequently, some rats were orally administered 20 mg/kg of ligustilide. For structural assessment, hippocampal brain tissue sections were stained with hematoxylin/eosin and subjected to anti-mTOR and anti-phospho-tau antibody staining. The collected samples were then analyzed for gene expression and protein levels of mTOR, STAT3, TGF-β, β-catenin, NFκB, TNF-α, TLR4, and NLRP3. We found that rats treated with ligustilide displayed marked improvements in their behavior. Furthermore, microscopic analysis of hematoxylin/eosin-stained images revealed that ligustilide reduced inflamed tissues and partially dilated blood vessels, without gliosis or vacuolated neuropil. Additionally, ligustilide decreased the expression of mTOR, STAT3, TGF-β, β-catenin, NFκB, TNF-α, TLR4, and NLRP3. In conclusion, ligustilide improved AD in rats and reduced inflammation and fibrosis. This effect is attributed to ligustilide's ability to reduce mTOR and STAT3 activity, thereby suppressing NFκB, TNF-α, TLR4, and NLRP3, and inhibiting the inflammasome pathway. Consequently, this cascade results in decreased STAT3 and TGF-β levels, thereby reducing fibrosis.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147379095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Community Pharmacists' Attitudes and Experiences Regarding the Promotion of Vaccinations in Japan. 日本社区药师对推广疫苗接种的态度与经验。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2026-02-13 DOI: 10.2302/kjm.2025-0007-OA

Hiroki Iwata, Taiki Kirihara, Noriko Kobayashi, Yuki Nakamura, Tomoko Koike, Katsunori Yamaura

{"title":"Community Pharmacists' Attitudes and Experiences Regarding the Promotion of Vaccinations in Japan.","authors":"Hiroki Iwata, Taiki Kirihara, Noriko Kobayashi, Yuki Nakamura, Tomoko Koike, Katsunori Yamaura","doi":"10.2302/kjm.2025-0007-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0007-OA","url":null,"abstract":"Japan has the lowest vaccine confidence worldwide. Although community pharmacists are expected to support public health, it remains unclear whether Japanese community pharmacists-who cannot administer vaccines-engage in vaccine consultation and promotion. This cross-sectional study used a paper-based, self-administered, anonymous questionnaire distributed to randomly selected community pharmacists in Japan to investigate their attitudes and experiences regarding vaccination, exploring issues related to the prevalence of the vaccine-related roles of community pharmacists. One thousand pharmacies were chosen, and the valid response rate was 44.6%. While 86.5% of respondents had experience with vaccine consultation, only 59.2% had experience with vaccine promotion. The rate of vaccine promotion was significantly higher among community pharmacists who recognized Japan's low vaccine confidence and held positive attitudes toward vaccine promotion (P < 0.001). Most respondents (76.9%) desired training to expand pharmacists' roles in vaccination. Additionally, 62.1% supported pharmacist-administered vaccines, though many were concerned about technical skills (83.3%) and potential anaphylaxis (63.6%). These findings suggest that promoting awareness of vaccine hesitancy and strengthening attitudes toward vaccine promotion could increase the number of community pharmacists involved in such activities. Japanese pharmacists may also need appropriate vaccine administration knowledge and skills to prepare for potential future responsibilities in vaccine administration.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146203231","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Identifying High-Cost RSV Hospitalizations at a Secondary Hospital in Japan. 确定日本二级医院RSV住院的高成本。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2026-01-23 DOI: 10.2302/kjm.2025-0020-LE

Tomomi Matsuda, Yoshiko Seki, Masayuki Akashi, Kazushige Ikeda

{"title":"Identifying High-Cost RSV Hospitalizations at a Secondary Hospital in Japan.","authors":"Tomomi Matsuda, Yoshiko Seki, Masayuki Akashi, Kazushige Ikeda","doi":"10.2302/kjm.2025-0020-LE","DOIUrl":"https://doi.org/10.2302/kjm.2025-0020-LE","url":null,"abstract":"Respiratory syncytial virus (RSV) is a leading cause of hospitalization in infants and young children worldwide. Although most RSV hospitalizations occur at secondary hospitals, information on RSV-related healthcare costs in these settings is limited. A retrospective analysis of RSV-related hospitalizations was conducted at Saitama City Hospital, a secondary hospital, between April 2018 and May 2024. Patients with laboratory-confirmed RSV infection were included. The study period was divided into three phases based on revisions of the national medical reimbursement schedule. Hospitalization costs were calculated, and high-cost outliers were identified using the interquartile range (IQR) method. A total of 345 patients were hospitalized for RSV, with a marked reduction in Phase II admissions corresponding to the early COVID-19 pandemic. Median hospitalization costs per episode increased in all three phases, from JPY 318,930 to JPY 393,930. Eighteen admissions were identified as cost outliers and classified into three subgroups: (1) children with airway or neurologic disorders, often older than 24 months; (2) otherwise healthy infants under 12 months; and (3) children eligible for palivizumab who contracted RSV before or after the recommended prophylaxis period. Our findings emphasize the existence of high-cost RSV cases outside the currently recognized high-risk groups, including older children with chronic airway disease and healthy young infants. Clinical burden and healthcare costs may be reduced by refining prophylaxis strategies and early intervention in Japan.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2026-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pemphigus: An Autoimmune Disease Model for Understanding the Role of Autoreactive T Cells. 天疱疮：了解自身反应性T细胞作用的自身免疫性疾病模型。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2025-12-25 Epub Date: 2025-05-28 DOI: 10.2302/kjm.2025-0002-IR

Hayato Takahashi

{"title":"Pemphigus: An Autoimmune Disease Model for Understanding the Role of Autoreactive T Cells.","authors":"Hayato Takahashi","doi":"10.2302/kjm.2025-0002-IR","DOIUrl":"10.2302/kjm.2025-0002-IR","url":null,"abstract":"Finding cures is the ultimate goal of research on autoimmune diseases. Pemphigus is an autoantibody-mediated autoimmune skin disease in which specific autoantibodies target desmogleins 1 and 3 as autoantigens. The condition leads to painful blisters and erosions in the skin and oral mucosa, impacting patients' ability to eat and other daily activities, significantly affecting quality of life. The molecular mechanisms by which these pathogenic autoantibodies induce blisters have been extensively studied and understanding has advanced considerably. However, many critical questions remain, such as the exact cause of the disease, the mechanisms that normally prevent autoimmunity, and the pathogenic cells involved, other than autoantibodies. This article focuses on the role of autoreactive T cells in pemphigus and uses the pemphigus model to answer some of these questions. Research into pemphigus has enhanced our understanding of both the pathogenic and regulatory mechanisms involved, not only in pemphigus but also in other skin diseases caused by cellular autoimmunity. The growing body of scientific evidence on pemphigus has made it a model disease, paving the way for the development of novel therapeutic approaches, including antigen-specific immunotherapy for autoimmune diseases and chronic inflammatory disorders.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"177-188"},"PeriodicalIF":1.5,"publicationDate":"2025-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prognosis Prediction by ¹⁸F-fluorodeoxyglucose Positron Emission Tomography Parameters in Patients Undergoing Chemoradiation Therapy for Esophageal Cancer. 18f -氟脱氧葡萄糖正电子发射断层扫描参数对食管癌放化疗患者预后的预测

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2025-12-25 Epub Date: 2025-09-23 DOI: 10.2302/kjm.2023-0018-OA

Yusuke Motomura, Junichi Fukada, Tadaki Nakahara, Hirofumi Toyama, Takayuki Abe, Masahiro Jinzaki, Naoyuki Shigematsu

{"title":"Prognosis Prediction by 18F-fluorodeoxyglucose Positron Emission Tomography Parameters in Patients Undergoing Chemoradiation Therapy for Esophageal Cancer.","authors":"Yusuke Motomura, Junichi Fukada, Tadaki Nakahara, Hirofumi Toyama, Takayuki Abe, Masahiro Jinzaki, Naoyuki Shigematsu","doi":"10.2302/kjm.2023-0018-OA","DOIUrl":"10.2302/kjm.2023-0018-OA","url":null,"abstract":"The aim of this study was to identify 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) parameters that could predict the prognosis of patients with esophageal cancer before and after undergoing chemoradiation therapy. We retrospectively reconstructed images under the same conditions for patients who underwent pre- and post-treatment 18F-FDG-PET for chemoradiation therapy for esophageal cancer. Correlations between 2-year survival rates and pre-treatment values, differences between pre- and post-treatment quotients, and their ratios were examined for various standardized uptake values (SUV), metabolic tumor volumes (MTV), and each SUVmean (Mean SUV)*MTV (Vol.mean). We enrolled 29 patients who underwent pre-and post-treatment 18F-FDG-PET. The median overall survival was 21.4 months (range, 3.6-100.9 months). Pre-treatment MTV had the most favorable hazard ratio (HR) for survival. However, the MTV product (Vol.meanQ), SUV corrected for basal metabolic rate using Mifflin-St Jeor estimation (BMR.ms), Vol.mean (SUVmeanQ) using the qPET method, SUVmean, and HR using Vol.meanQ corrected for body weight were nearly equivalent. No significant results were obtained for the pre- and post-treatment quotients. The pre- and post-treatment Vol.meanQ is a useful prognostic parameter that considers the effect of age-related loss of lean body mass. The use of parameters, including metabolism, will facilitate more appropriate use of 18F-FDG-PET before and after chemoradiation therapy.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"189-204"},"PeriodicalIF":1.5,"publicationDate":"2025-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144121096","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Community Pharmacists' Perceptions and Needs Regarding Oral Healthcare Advice in Japan. 日本社区药剂师对口腔保健建议的看法和需求。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2025-12-25 Epub Date: 2025-05-27 DOI: 10.2302/kjm.2024-0022-OA

Hiroki Iwata, Rintaro Yoshida, Naoko Hayashi, Noriko Kobayashi, Kazuko Fujimoto, Katsunori Yamaura

{"title":"Community Pharmacists' Perceptions and Needs Regarding Oral Healthcare Advice in Japan.","authors":"Hiroki Iwata, Rintaro Yoshida, Naoko Hayashi, Noriko Kobayashi, Kazuko Fujimoto, Katsunori Yamaura","doi":"10.2302/kjm.2024-0022-OA","DOIUrl":"10.2302/kjm.2024-0022-OA","url":null,"abstract":"It is desirable for community pharmacists to be involved in promoting and maintaining the oral health of local residents. In this study, we conducted a questionnaire survey of Japanese community pharmacists to understand the actual conditions and the attitudes of these pharmacists regarding oral healthcare advice. A web-based anonymous self-administered questionnaire survey was completed by community pharmacists from March 26 to 29, 2021. We received responses from 324 pharmacists. A majority of respondents (66.0%) regarded dealing with \"daily oral health issues and oral care\" as a role of community pharmacists. Respondents also reported being consulted by patients or customers about mouth ulcers (70.1%) and xerostomia (54.6%). However, the frequency of consumer inquiries about these oral conditions was less than once per week. Just over half of the respondents (52.2%) said they were confident about dealing with mouth ulcers, whereas less than 40% were confident about handling other oral problems. The most common anxiety was a \"lack of knowledge about appropriate responses to oral symptoms\" (60.2%). The respondents desired education and training (75.6%) to better promote oral health-related activities. Japanese community pharmacists believe that they have a role to play in oral health issues and oral care, but their level of confidence in their ability to respond to oral health issues is low. Pharmacists are concerned about their lack of knowledge about oral healthcare and they desire more opportunities for education and training so that they can perform pharmacy-based maintenance and promotion of oral healthcare for local residents.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"205-213"},"PeriodicalIF":1.5,"publicationDate":"2025-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analysis of the Stability of 0.04% Mitomycin C Ophthalmic Solution under Various Storage Conditions. 0.04%丝裂霉素C眼用液不同贮存条件下的稳定性分析。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2025-12-25 Epub Date: 2025-06-28 DOI: 10.2302/kjm.2025-0003-OA

Yuma Nonomiya, Koki Yamaguchi, Yuta Yokoyama, Isana Nakajima, Ryusei Hara, Daigo Shoji, Tomomi Takiguchi, Kazumi Takehana, Aya Jibiki, Sayo Suzuki, Tomonori Nakamura, Hideki Tsuji, Masakazu Yamaguchi

{"title":"Analysis of the Stability of 0.04% Mitomycin C Ophthalmic Solution under Various Storage Conditions.","authors":"Yuma Nonomiya, Koki Yamaguchi, Yuta Yokoyama, Isana Nakajima, Ryusei Hara, Daigo Shoji, Tomomi Takiguchi, Kazumi Takehana, Aya Jibiki, Sayo Suzuki, Tomonori Nakamura, Hideki Tsuji, Masakazu Yamaguchi","doi":"10.2302/kjm.2025-0003-OA","DOIUrl":"10.2302/kjm.2025-0003-OA","url":null,"abstract":"A 0.04% mitomycin C (MMC) ophthalmic solution is not commercially available and is prepared in hospitals as required. The physical properties and stability of the MMC ophthalmic solution have not been clarified because of a lack of data. This study aimed to assess the stability of the MMC ophthalmic solution under various storage conditions. The MMC ophthalmic solution was prepared by dissolving 2 mg of MMC in 5 mL of saline solution. Each batch of ophthalmic solution was stored under three conditions [cold/shaded light, room temperature/shaded light, and room temperature/scattered light (approximately 4000 lx)], and MMC concentration was determined using high-performance liquid chromatography on days 0, 1, 3, 5, 7, 14, and 21. The expiry date was calculated based on the results of the degradation analysis. pH measurements and bacterial culture tests were conducted for each storage condition. The MMC concentrations on day 21 under cold/shaded light, room temperature/shaded light, and room temperature/scattered light were 340, 287, and 227 µg/mL, respectively. MMC concentrations decreased over time, and the decrease was highest when the samples were stored at room temperature and exposed to light, and lowest under cold conditions and protected from light. The pH of MMC solutions was 5.8 after preparation, which increased to 6.9 with time under all storage conditions. Culture tests did not detect any bacteria under any storage conditions. The MMC ophthalmic solution was most stable under cold/shaded conditions, and our study clarifies its expiry date for clinical use.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":"214-220"},"PeriodicalIF":1.5,"publicationDate":"2025-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144530316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparison of Clinical Development of Digital Therapeutics among Japan, the Unites States, and Germany. 日本、美国和德国数字治疗临床发展的比较。

IF 1.5

KEIO JOURNAL OF MEDICINE Pub Date : 2025-11-21 DOI: 10.2302/kjm.2025-0006-OA

Toshiyoshi Tominaga, Tomonobu Hasegawa, Eiji Harada

{"title":"Comparison of Clinical Development of Digital Therapeutics among Japan, the Unites States, and Germany.","authors":"Toshiyoshi Tominaga, Tomonobu Hasegawa, Eiji Harada","doi":"10.2302/kjm.2025-0006-OA","DOIUrl":"https://doi.org/10.2302/kjm.2025-0006-OA","url":null,"abstract":"Digital therapeutics (DTx) have demonstrated promising potential as a novel therapeutic approach, with their clinical development gaining momentum. Comparison of DTx development between Japan, a relative newcomer, and Germany and the U.S., known for favorable circumstances, is a topic of interest. DTx developed in Japan as of November 2023 were identified on the Pharmaceuticals and Medical Devices Agency (PMDA) website and in the literature. Similar DTx available in the U.S. and Germany were identified in the databases maintained by the U.S. Food and Drug Administration (USFDA) and Federal Institute for Drugs and Medical Devices (BfArM). Data on their clinical trials and regulatory status were obtained from these databases and their respective national clinical trial registries. The data obtained were compared and analyzed. By November 2023, Japan had developed DTx, encompassing 11 therapeutic areas. Seven DTx had reached or completed the confirmatory study stage, whereas five DTx were in the exploratory phase. Twenty DTx in the therapeutic areas were selected from the U.S. and Germany. A total of 27 DTx were reviewed regarding the designs of confirmatory studies and regulatory actions taken. Trial designs demonstrated more similarities than differences across the countries and therapeutic areas. Placebo trial design-associated difficulties were conspicuous. Although regulatory actions to place DTx in the market differed across countries, they effectively ensured the efficacy and safety of DTx that were suitable for marketing considering the most current science. The regulatory measures in the three countries seem to have positively impacted DTx development.","PeriodicalId":46245,"journal":{"name":"KEIO JOURNAL OF MEDICINE","volume":" ","pages":""},"PeriodicalIF":1.5,"publicationDate":"2025-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145596914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0