2.The changes of Silent Period before and after training of standing on balance-mat
Sakiko Ito ; Hiroki Funasaki ; Hiroteru Hayashi ; Kentaro Kawai ; Yasuhide Nakayama
Japanese Journal of Physical Fitness and Sports Medicine 2012;61(4):415-419
The purpose of this study was to evaluate the changes of pre-motion time (PMT), pre-motion silent period (PMSP), and switching silent period (SSP) before and after the training using balance-mat. Twenty healthy people aged 21-36 years old (average 26.5 years old) were subjected to a series of experiment. These were randomly divided into two groups (10 subjects each), control and balance-mat group. Activities of M. Soleus and M. Tibialis anterior were recorded by electromyogram (EMG) for the duration subjects were tried to raise their both heels as quick respond to a flashing lamp. Intervention consisted of 3minutes standing on the floor in control group, and 3 minutes standing on the balance-mat in balance-mat group. Then EMG was recorded as the same manner after the intervention in each group. There was no statistical difference of duration of PMSP and SSP between the two groups before intervention. On the other hand, those in balance-mat group were significantly shorter than those in control group after intervention. In addition, in balance-mat group, duration of PMSP and SSP after intervention were significantly shorter than that before intervention. There was no statistical difference of PMT between before and after the intervention. These results suggested balance-mat training was effective for shorten the duration of SSP and PMSP, that lead to control the posture function.
3.Risk Communication Regarding Drugs:The FDA Strategic Plan for Risk Communication
Michiko YAMAMOTO ; Wakako HORIKI ; Hiroki SUGIMORI ; Takeo NAKAYAMA
Japanese Journal of Pharmacoepidemiology 2010;15(1):11-21
In enabling consumers to make thetr own judgments regarding the risks of drugs, it is essntial to share information regarding the risks of drugs among stakeholders (governmental agencies, pharmaceutical companies, healthcare professionals and consumers or patients) and to have communication (risk communication).In particular, the communication between governmental agencies and consumers or patients is given a high priority. Hence, its provisions and strategies should be considered thoroughly.
FDA's risk communication efforts are part of a larger drug safety initiative that began in November 2004. In fact, FDA is engaged in verification and strategies aiming at strengthening drug safety. As a part of these efforts, FDA has published the "Guidance Drug Safety Information-FDA's Communication to the Public" and "FDA Strategic Plan for Risk Communication".
In this article, we present the "FDA Strategic Plan for Risk Communication" translated into Japanese and explain the situation of risk communication for drugs from the FDA perspective. We also examine the future of risk communication in Japan.
4.Challenges in the conduct of clinical research
Yasuji ARIMURA ; Toshihiko NISHIDA ; Maya MINAMI ; Yoko YOKOYAMA ; Hiroki MISHINA ; Shin YAMAZAKI ; Tatsuro ISHIZAKI ; Koji KAWAKAMI ; Takeo NAKAYAMA ; Yuichi IMANAKA ; Takashi KAWAMURA ; Shunichi FUKUHARA
Medical Education 2010;41(4):259-265
The promotion of clinical research in Japan requires the establishment of a formal and systematic education and training program for clinicians to ensure they become effective clinician investigators. The first of its kind in Japan, a formal 1-year masters-degree-level training program (MCR course) was started at Kyoto University School of Medicine and Public Health. The first 28 students graduated in 2008, with most returning to their original clinical institutions.
1) As follow-up, we conducted a self-administered questionnaire survey of all 28 graduates (response rate, 86%) concerning the current status of clinical research and problems encountered at their institutions.
2) Almost 40% of respondents (n=24) reported "no time" or "no research collaborators" for clinical research.
3) Twenty respondents (83%) have attempted to promote clinical research at their hospital or workplace, but only 1 has received institutional support.
4) Over half of the respondents (54%) would like to be working in both clinical research and clinical practice at their hospital in the future (10-year timescale). Forty-two percent of respondents had a concrete image of the clinical researcher's career path.
5) Although open to improvement, the MCR program presents a concrete model for the education of clinical researchers. These findings suggest that promoting the conduct of clinical research requires the implementation of a support system and adjustment of personal and physical infrastructure.
5.1.How Can We Promote Work Style Reforms of Cardiovascular Surgeons ?
Hiromi WADA ; Hiroki ARASE ; Yoshinori INOUE ; Koki ETO ; Yuichiro KISHIMOTO ; Yusuke KINUGASA ; Hiroshi KURAZUMI ; Hiroshi KODAMA ; Sayako NAKAGAWA ; Taisuke NAKAYAMA ; Kenji NAMIGUCHI ; Akira FUJITA ; Hiromu HORIE
Japanese Journal of Cardiovascular Surgery 2020;49(1):1-U1-1-U4
The work style of doctors gets attention within the Work Style Reforms that have been fully implemented since 2019. Now, we conducted a questionnaire survey at 10 institutions in Chugoku and Shikoku region and reviewed the latest work style of cardiovascular surgeons in comparison with other departments.
6.Efficacy and Safety of Trastuzumab Deruxtecan and Nivolumab as Third- or Later-Line Treatment for HER2-Positive Advanced Gastric Cancer: A SingleInstitution Retrospective Study
Keitaro SHIMOZAKI ; Izuma NAKAYAMA ; Daisuke TAKAHARI ; Kengo NAGASHIMA ; Koichiro YOSHINO ; Koshiro FUKUDA ; Shota FUKUOKA ; Hiroki OSUMI ; Mariko OGURA ; Takeru WAKATSUKI ; Akira OOKI ; Eiji SHINOZAKI ; Keisho CHIN ; Kensei YAMAGUCHI
Journal of Gastric Cancer 2023;23(4):609-621
Purpose:
Determination of optimal treatment strategies for HER2-positive advanced gastric cancer (AGC) in randomized trials is necessary despite difficulties in direct comparison between trastuzumab deruxtecan (T-DXd) and nivolumab as third or later-line treatments.
Materials and Methods:
This single-institution, retrospective study aimed to describe the real-world efficacy and safety of T-DXd and nivolumab as ≥ third line treatments for HER2-positive AGC between March 2016 and May 2022. Overall, 58 patients (median age, 64 years;69% male) were eligible for the study (T-DXd group, n=20; nivolumab group, n=38).
Results:
Most patients exhibited a HER2 3+ status (72%) and presented metastatic disease at diagnosis (66%). The response rates of 41 patients with measurable lesions in the T-DXd and nivolumab groups were 50% and 15%, respectively. The T-DXd and nivolumab groups had a median progression-free survival of 4.8 months (95% confidence interval [CI], 3.3, 7.0) and 2.3 months (95% CI, 1.5, 3.5), median overall survival (OS) of 10.8 months (95% CI, 6.9, 23.8) and 11.7 months (95% CI, 7.6, 17.1), and grade 3 or greater adverse event rates of 50% and 2%, respectively. Overall, 64% patients received subsequent treatment. Among 23 patients who received both regimens, the T-DXd–nivolumab and nivolumab–T-DXd groups had a median OS of 14.0 months (95% CI, 5.0, not reached) and 19.3 months (95% CI, 9.5, 25.1), respectively.
Conclusions
T-DXd and nivolumab showed distinct efficacy and toxicity profiles as ≥ third line treatments for HER2-positive AGC. Considering the distinct features of each regimen, they may help clinicians personalize optimal treatment approaches for these patients.
7.Pranlukast reduces asthma exacerbations during autumn especially in 1- to 5-year-old boys
Yoshinori MORITA ; Eduardo CAMPOS ALBERTO ; Shuichi SUZUKI ; Yoshinori SATO ; Akira HOSHIOKA ; Hiroki ABE ; Kimiyuki SAITO ; Toshikazu TSUBAKI ; Mana HARAKI ; Akiko SAWA ; Yoshio NAKAYAMA ; Hiroyuki KOJIMA ; Midori SHIGETA ; Fumiya YAMAIDE ; Yoichi KOHNO ; Naoki SHIMOJO
Asia Pacific Allergy 2017;7(1):10-18
BACKGROUND: Leukotriene receptor antagonists have been used to prevent virus-induced asthma exacerbations in autumn. Its efficacy, however, might differ with age and sex. OBJECTIVE: This study aimed to investigate whether pranlukast added to usual asthma therapy in Japanese children during autumn, season associated with the peak of asthma, reduces asthma exacerbations. It was also evaluated the effect of age and sex on pranlukast's efficacy. METHODS: A total of 121 asthmatic children aged 1 to 14 years were randomly assigned to receive regular pranlukast or not according to sex, and were divided in 2 age groups, 1–5 years and 6–14 years. The primary outcome was total asthma score calculated during 8 weeks by using a sticker calendar related to the days in which a child experienced a worsening of asthma symptoms. This open study lasted 60 days from September 15 to November 14, 2007. RESULTS: Significant differences in pranlukast efficacy were observed between sex and age groups. Boys aged 1 to 5 years had the lower total asthma score at 8 weeks (p = 0.002), and experienced fewer cold episodes (p = 0.007). There were no significant differences between pranlukast and control group in total asthma score at 8 weeks (p = 0.35), and in the days in which a child experienced a worsening of asthma symptoms (p = 0.67). CONCLUSION: There was a substantial benefit of adding pranlukast to usual therapy in asthmatic children, especially in boys aged 1 to 5 years, during autumn season.
Asian Continental Ancestry Group
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Asthma
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Child
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Child, Preschool
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Humans
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Leukotriene Antagonists
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Seasons
8.A novel method for determining dose distribution on panoramic reconstruction computed tomography images from radiotherapy computed tomography
Hiroyuki OKAMOTO ; Madoka SAKURAMACHI ; Wakako YATSUOKA ; Takao UENO ; Kouji KATSURA ; Naoya MURAKAMI ; Satoshi NAKAMURA ; Kotaro IIJIMA ; Takahito CHIBA ; Hiroki NAKAYAMA ; Yasunori SHUTO ; Yuki TAKANO ; Yuta KOBAYASHI ; Hironori KISHIDA ; Yuka URAGO ; Masato NISHITANI ; Shuka NISHINA ; Koushin ARAI ; Hiroshi IGAKI
Imaging Science in Dentistry 2024;54(2):129-137
Purpose:
Patients with head and neck cancer (HNC) who undergo dental procedures during radiotherapy (RT) face an increased risk of developing osteoradionecrosis (ORN). Accordingly, new tools must be developed to extract critical information regarding the dose delivered to the teeth and mandible. This article proposes a novel approach for visualizing 3-dimensional planned dose distributions on panoramic reconstruction computed tomography (pCT) images.
Materials and Methods:
Four patients with HNC who underwent volumetric modulated arc therapy were included. One patient experienced ORN and required the extraction of teeth after RT. In the study approach, the dental arch curve (DAC) was defined using an open-source platform. Subsequently, pCT images and dose distributions were generated based on the new coordinate system. All teeth and mandibles were delineated on both the original CT and pCT images. To evaluate the consistency of dose metrics, the Mann-Whitney U test and Student t-test were employed.
Results:
A total of 61 teeth and 4 mandibles were evaluated. The correlation coefficient between the 2 methods was 0.999, and no statistically significant difference was observed (P>0.05). This method facilitated a straightforward and intuitive understanding of the delivered dose. In 1 patient, ORN corresponded to the region of the root and the gum receiving a high dosage (approximately 70 Gy).
Conclusion
The proposed method particularly benefits dentists involved in the management of patients with HNC. It enables the visualization of a 3-dimensional dose distribution in the teeth and mandible on pCT, enhancing the understanding of the dose delivered during RT.