1.An Integrated High School-University Lecture Program in Basic Medical Science
Yoji NAGASHIMA ; Yukio KATOUNO ; Takamasa SAITO ; Hideki KANEKO ; Ichiro AOKI ; Hitoshi KITAMURA ; Rieko IJIRI ; Eiji GOTO
Medical Education 2005;36(2):101-106
Integrated lecture programs for high school students involving university teaching staff have recently become popular. Here, we report on such a program involving lectures on tumor pathology attended by 110 high school students at the Yokohama City University School of Medicine. Two weeks before the lectures at our university, the students were given a 45-minute introductory lecture by a teacher at their school. The 1-day course at our university comprised an overview lecture by the author (40 minutes), light-microscopic observation of histologic specimens of normal and tumor tissues (50 minutes), and a summary with an introduction to diagnostic pathology (20 minutes). During light-microscopic observation, medical students served as teaching assistants. The high school students were given handouts of microscopic
2.A Study on Continuous Risk Management Plan Utilization after Drug Approval:
Yuki KOBAYASHI ; Rieko SAITO ; Seiko MIYAZAKI
Japanese Journal of Drug Informatics 2024;26(1):45-50
Objective: In Japan, pharmaceutical manufacturers have been required to develop a Risk Management Plan (RMP) since April 2013. Publication of the RMP is expected to enable the wide content-sharing of post-marketing risk management and its utilization among medical professionals to further enhance and strengthen post-marketing safety measures. In this study, we examined what points should be focused on for continuous utilization of RMPs after drug approvals by investigating the numbers of safety concerns addition of antineoplastic and immunomodulating agents, and where safety concerns added after approval are listed in package inserts. Furthermore, we investigated the reasons why these safety concerns were considered as such. Methods: Antineoplastics and immunomodulating agents, which account for more than half of all drugs containing new active ingredients approved in recent years, among drugs containing new active ingredients approved from fiscal year (FY) 2013 to FY 2019 were included in the study. The safety concerns (excluding important missing information) in RMPs as of April 1, 2021 for the subject drugs were compared with those at the time of approval. Safety concerns added after approval were investigated where they were listed in package inserts as of April 1, 2021. Furthermore, risks that were added as important potential risks were investigated as to why they were considered as such. Results: There were 117 risks added after approval. Those added to the important identified risks were listed in one of the sections of the package insert, whereas 11 risks were added to the important potential risks that could not be confirmed in the package inserts. Some important potential risks added after approval are suspected to have a causal relationship with the drug, but were not listed in the package inserts. Conclusion: It is important to utilize RMPs continuously to further understand risks of taking the drug.
3.The Murakami Cohort Study of vitamin D for the prevention of musculoskeletal and other age-related diseases: a study protocol.
Kazutoshi NAKAMURA ; Ribeka TAKACHI ; Kaori KITAMURA ; Toshiko SAITO ; Ryosaku KOBAYASHI ; Rieko OSHIKI ; Yumi WATANABE ; Keiko KABASAWA ; Akemi TAKAHASHI ; Shoichiro TSUGANE ; Masayuki IKI ; Ayako SASAKI ; Osamu YAMAZAKI
Environmental Health and Preventive Medicine 2018;23(1):28-28
BACKGROUND:
Age-related musculoskeletal diseases are becoming increasingly burdensome in terms of both individual quality of life and medical cost. We intended to establish a large population-based cohort study to determine environmental, lifestyle, and genetic risk factors of musculoskeletal and other age-related diseases, and to clarify the association between vitamin D status and such diseases.
METHODS:
We targeted 34,802 residents aged 40-74 years living in areas of northern Niigata Prefecture, including Sekikawa Village, Awashimaura Village, and Murakami City (Murakami region). The baseline questionnaire survey, conducted between 2011 and 2013, queried respondents on their lifestyle and environmental factors (predictors), and self-reported outcomes. Plasma 25-hydroxyvitamin D (25[OH]D) concentration, an indicator of vitamin D status, was determined with the Liaison® 25OH Vitamin D Total Assay. The primary outcome of this study was osteoporotic fracture; other outcomes included age-related diseases including knee osteoarthritis, perception of chronic pain, dementia, and long-term care insurance use. Mean ages of men and women were 59.2 (SD = 9.3, N = 6907) and 59.0 (SD = 9.3, N = 7457) years, respectively. From the blood samples provided by 3710 men and 4787 women, mean 25(OH)D concentrations were 56.5 (SD = 18.4) nmol/L (22.6 ng/mL) and 45.4 (SD = 16.5) nmol/L (18.2 ng/mL), respectively.
DISCUSSION
Follow-up surveys are planned every 5 years for 15 years, and incident cases of our targeted diseases will be followed at hospitals and clinics in and nearby the cohort area. We anticipate that we will be able to clarify the association between vitamin D status and multiple disease outcomes in a Japanese population.
Aged
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Aging
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Cohort Studies
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Epidemiologic Research Design
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Female
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Humans
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Incidence
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Japan
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epidemiology
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Male
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Middle Aged
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Musculoskeletal Diseases
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epidemiology
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prevention & control
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Predictive Value of Tests
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Quality of Life
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Risk Factors
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Vitamin D
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analogs & derivatives
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blood