2.Analysis of the Association between Neuraminidase Inhibitors and Neuropsychiatric Adverse Events Using Japanese Adverse Drug Event Report (JADER)
Natsumi Ueda ; Yamato Kato ; Junko Abe ; Yoko Nakayama ; Toshinobu Matsui ; Yuuki Hane ; Sayaka Sasaoka ; Yumi Motooka ; Haruna Hatahira ; Yasutomi Kinosada ; Zenichiro Kato ; Mitsuhiro Nakamura
Japanese Journal of Drug Informatics 2016;18(1):38-45
There have been concerns that neuraminidase inhibitors (oseltamivir, zanamivir, laninamivir, and peramivir) cause neuropsychiatric adverse events (NPAEs). We evaluated the number of relevant reports, reporting ratio, and reporting odds ratio (ROR) by using spontaneous reporting database, such as the Japanese Adverse Drug Event Report (JADER) (April 2004 to July 2014). The RORs of oseltamivir, zanamivir, laninamivir, and peramivir were 11.8 (95% confidence interval (CI), 10.8-13.0), 47.0 (95% CI, 40.0-55.3), 9.5 (95% CI, 6.8-13.2), and 3.3 (95% CI, 2.1-5.1), respectively. The lower limit of the ROR 95% CI of NPAEs of all neuraminidase inhibitors was ≥1. We analyzed the association of age and gender with NPAEs in patients treated with oseltamivir using a logistic regression model. The adjusted ROR of NPAEs was 66.9 (95% CI, 50.3-88.9) in male patients treated with osletamivir aged 10-19 years. The adjusted RORs of NPAEs were increased in male and female patients under the age of 20 years. Neuraminidase inhibitors including oseltamivir treatment could be associated with NPAEs. Therefore, these drugs should be used carefully in clinical practice.
3.Evaluation of Dermatological Disorders Caused by Anti-neoplastic Agents with an Adverse Event Spontaneous Reporting Database
Yuuki Hane ; Ryogo Umetsu ; Junko Abe ; Natsumi Ueda ; Yamato Kato ; Toshinobu Matsui ; Yumi Motooka ; Sayaka Sasaoka ; Haruna Hatahira ; Akiho Fukuda ; Misa Naganuma ; Siori Hasegawa ; Yasutomi Kinosada ; Mitsuhiro Nakamura
Japanese Journal of Drug Informatics 2016;18(3):201-208
Introduction: Dermatological disorders are one of the adverse events caused by cancer chemotherapy and are a dose-limiting factor for some anti-neoplastic agents. The severe symptoms associated with these disorders affect the patients’ quality of life (QOL). Early countermeasures for the onset of dermatological disorders associated with anti-neoplastic agent administration might be important.
Materials and Methods: We analyzed the occurrences of dermatological disorders after administration of an anti-neoplastic agent in the Food and Drug Administration Adverse Event Reporting System (FAERS), and compared the adverse event (AE) reporting ratio of the total reports. In addition, we studied the association between anti-neoplastic agents and dermatological disorders using cluster analysis. Reports for 15 anti-neoplastic agents (4 anti-neoplastic agents and 11 molecular target drugs) were analyzed.
Results: After excluding duplicate data in FAERS, 6,157,897 reports were analyzed. The number of reports that showed a dermatological disorder was 534,934. The reporting ratio of hand-foot syndrome with sorafenib and capecitabine was 11.20% and 7.05%, respectively.
Conclusions: We set the cluster number at six; cluster features obtained were as follows: (1) the reporting ratio of hand-foot syndrome was especially high, followed by the reporting ratio of rash, (2) the reporting ratio of rash and erythema was high. Similar anti-neoplastic agents may demonstrate similar occurrence tendencies of AEs and cluster features. Further studies are required to draw conclusions over these findings. Information services based on the feature of each cluster might be useful to improve patient QOL at the clinical site.
4.Survey of cattle fascioliasis in Tsuyama Abattoir.
Masahiko KATO ; Yasuyuki MURAKAMI ; Motota SHIMIZU ; Hideki YAMAMOTO ; Yumi YONEMOTO ; Ken-Ichi ISHII ; Shohei KIRA
Environmental Health and Preventive Medicine 2005;10(3):162-165
OBJECTIVESThe aim of this study was to survey the prevalence of fascioliasis in slaughtered cattle in order to provide breeders with feedback which may prevent cattle fascioliasis, as well as human fascioliasis.
METHODSThe results of meat inspection and the information extracted from the Discriminative Data Base on Individual Livestock in Japan were analyzed statistically in 6,224 cattle slaughtered at the Tsuyama Abattoir during the fiscal year 2002.
RESULTSThe age-adjusted fascioliasis and cholangitis rates of all cattle were 2.0% and 7.2%, respectively. When analyzed by cattle breed, both rates were significantly higher in Japanese native cattle than in Holstein or Jersey (Chi-square test, p<0.01). The cattle raised in Okayama Prefecture, Tochigi Prefecture and Shimane Prefecture were significantly different from cattle raised in other prefectures in the age-adjusted fascioliasis and cholangitis rates.
CONCLUSIONThe age-adjusted fascioliasis and cholangitis rates of all cattle can be considered as nationwide rates for slaughtered cattle. The results of the comparisons suggest that cattle fascioliasis is related to feeding with rice straw and that the measures to prevent cattle fascioliasis might differ a mong prefectural governments.
5.Introduction of Action Cards to Improve Readiness for Extremely Urgent Cesarean Sections
Ruriko ASAI ; Kana ONDA ; Yamato SAWADA ; Yumi KATO
Journal of the Japanese Association of Rural Medicine 2020;69(4):416-
Among the conditions that require a cesarean section, uterine rupture, premature separation of normally implanted placenta, umbilical cord prolapse, and sustained bradycardia require an extremely urgent cesarean section (grade A) for immediate delivery. Multidisciplinary collaboration involving multiple departments is essential to perform this operation, and prompt and precise preparation by nurses before the patient’s arrival is particularly important. To improve our hospital’s readiness for patients requiring extremely urgent cesarean section, we developed action cards, identified problems through repeated simulations, and revised action cards to address these problems. The resulting action cards was used in the clinical setting and appears to be a useful tool to support nurses in taking prompt effective action.
6.Increased Infiltration of CD8⁺ T Cells by Dacarbazine in a Patient with Mucosal Penile Melanoma Refractory to Nivolumab.
Masato FUNAZUMI ; Takeshi NAMIKI ; Yumi ARIMA ; Kohei KATO ; Kohei NOJIMA ; Kentaro TANAKA ; Keiko MIURA ; Hiroo YOKOZEKI
Annals of Dermatology 2016;28(4):486-490
Primary penile melanomas are rare tumors that represent less than 0.1% of all melanomas. We report a case of a 60-year-old Japanese male with a mucosal penile melanoma and describe an increased CD8⁺ T cell infiltration in brain after dacarbazine (DTIC) administration. After partial penectomy and left inguinal lymphadenectomy, he developed multiple lung, bone, spleen, brain and skin metastases. He was treated with interferon-β, DTIC and nivolumab. However, the metastases were not reduced in size. Immunohistochemistry showed an increase of CD8⁺ T cell infiltration and programmed death-ligand 1 (PD-L1) expression after the administration of DTIC, but the expression of programmed cell death protein 1 (PD-1) was negative. We speculate that DTIC exerted immunostimulatory effects, but nivolumab was ineffective due to the negative expression of PD-1 and/or an insufficient infiltration of CD8⁺ T cells. Although this is only one case, this case report could be the first step to discuss the development of effective therapies against melanoma to take advantage of the increased CD8⁺ T cell infiltration elicited by chemotherapeutic agents. It would be beneficial to pay more attention to the relationship between DTIC and immune checkpoint modulators.
Asian Continental Ancestry Group
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Brain
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Cell Death
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Dacarbazine*
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Humans
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Immunohistochemistry
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Lung
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Lymph Node Excision
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Male
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Melanoma*
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Middle Aged
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Neoplasm Metastasis
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Skin
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Spleen
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T-Lymphocytes*
7.How Study Time Outside of Class Affects Students' Motivation to Learn and Sense of Accomplishment: A Successful "Human Biology" Course Reform
Yumi KUROKAWA ; Yukari FURUSATO ; Yoshiko KATO ; Tsuyoshi TADA
Medical Education 2018;49(6):495-502
Purpose: Does longer study time motivate students to learn and make them feel a sense of accomplishment? Whilst “Human Biology,” one of the required courses in the first year of the medical school, was in need of a total course design reformation to make a shift from teaching to learning, it was necessary to examine whether longer study time is effective for better learning outcomes. Methods: To get students to learn outside of class, we flipped the course. Since the scores from weekly quizzes, which are held at the beginning of every class, and mid-term and final exams were returned to the students, fully calculated and strictly applied to their grades, students became motivated to study before class. During class time, lessons were taught in the active learning style. We used covariance structure analysis to examine the relationship between the out of class learning design, the syllabus reformation, students’ learning attitudes in the class, and their sense of accomplishment. Results: Study time outside of class increased from 4 hours per week in 2013 to 10 hours per week in 2016, and the students became more satisfied with the course. Our analysis shows that this well-structured syllabus and designing of lessons made the students study more both inside and outside of class, and allowed students to achieve the higher goals of the course. Conclusion: Designing out of class learning and incorporating it well with assessment resulted in longer study time and a stronger sense of accomplishment.
8.Experiential Training in Elementary and Junior High School Education through the Creation of Health Guidance Videos
Yumi YONEOKA ; Satomi SHIBAZAKI ; Yuka SHIBAZAKI ; Hisashi KATO ; Keiichiro ISHIBASHI ; Kensuke NAKAHIRA ; Shigehisa MORI
Medical Education 2021;52(3):209-214
At Saitama Medical University, elementary and junior high school experiential training was conducted to give students experience with health promotion, health guidance, and communication with different generations. In the 2020 FY, each small group was in charge of different grades and themes. They created a 10-minute health guidance video remotely. By doing the video project remotely, students could take time to do group work and deepen their understanding of the theme and children of the target grade. It also became easier to teach students how to use the PC tools needed for the task. The students learned not only the knowledge necessary for health guidance, but also how to concretely assess the target person and convey information as consciously as possible. It is important to nurture within students an attitude of seriously engaging in the training despite not physically going to school. For this reason, communication with the school is important.
9.A Survey Regarding the Price Calculation Method for New Drugs Based on the Chuikyo-Document about the NHI Drug Price List
Shiori HASEGAWA ; Yamato KATO ; Toshinobu MATSUI ; Haruna HATAHIRA ; Sayaka SASAOKA ; Yumi MOTOOKA ; Satoshi NAKAO ; Ririka MUKAI ; Kazuyo SHIMADA ; Natsumi UEDA ; Mitsuhiro NAKAMURA
Japanese Journal of Drug Informatics 2018;20(2):120-128
In Japan, the National Health Insurance (NHI) prices of new drugs are set according to the NHI Drug Price Standard (NHI Price Standard). The NHI Price Standard was notified by the Ministry of Health, Labour, and Welfare based on the ”Drug Price Calculation Criteria” proposed by the Central Social Insurance Medical Council (Chuikyo) in Japan. The NHI Price Standard affects the research and development strategy of pharmaceutical companies. In order to discover undetected relationships, the factors influencing the ”drug price” were evaluated through the association rule mining technique. We surveyed the Chuikyo‐documents about NHI price listing over the period October 27, 2006 to February 8, 2007. The number of approved new drugs was 874, while that of drugs completed (”drug price per day”) was 314. The numbers of new compounds corresponding to a drug price per day of ”below 200 yen,” ”between 200 yen and 1,000 yen,” ”between 1,000 and 10,000 yen,” and ”above or equal to 10,000 yen” were 87 (27.7%), 91 (29.0%), 79 (25.2%), and 57 (18.2%), respectively. In the association rule mining method, we observed high lift values of the combined items ”above or equal to 30,000 patients expected to be administrated” and ”drugs affecting sensory organs” in the group of drug price per day below 200 yen. The lift values of the combinations of ”biological preparations” and ”similar efficacy comparison‐based price setting (Ⅱ)” or ”below 30,000 patients expected to be administrated” and ”antineoplastic drug” in the group of ”above or equal to 10,000 yen of drug price per day” were high. These results provide a basis for the development and application of new drugs in Japan.