1.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
2.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
3.A phase II trial evaluating the efficacy and safety of repeated high dose medroxyprogesterone acetate (MPA) therapy for patients with recurrent early-stage endometrial cancer or atypical endometrial hyperplasia:Japanese Gynecologic Oncology Group study (JGOG2051/KGOG2031, REMPA trial)
Kensuke SAKAI ; Wataru YAMAGAMI ; Yasunori SATO ; Nobuyuki SUSUMU ; Yoshihito YOKOYAMA ; Kazuhiro TAKEHARA ; Masaki MANDAI ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2024;35(6):e106-
Background:
Fertility preserving therapy using medroxyprogesterone acetate (MPA) is an important option for young patients with endometrial cancer or atypical endometrial hyperplasia (AEH). However, the effectiveness and feasibility of repeated MPA therapy for patients with intrauterine recurrence following initial MPA therapy is controversial. Only a few single-institution retrospective studies have been conducted on repeated MPA therapy, therefore, multicenter prospective studies for repeated MPA therapy are highly needed.The aim of this study is to assess whether repeated MPA therapy is effective and feasible for patients with intrauterine recurrence following initial MPA therapy.
Methods
This is a prospective, single-arm, a multicenter phase II trial on repeated MPA therapy for intrauterine recurrence following fertility-preserving therapy for AEH or stage IA (the International Federation of Gynecology and Obstetrics [FIGO] 2008) non-myoinvasive endometrioid carcinoma grade 1. Patients are treated with oral MPA (500–600 mg/day).Pathologically assessment via dilation and curettage will be performed every 2 months until complete response. The major inclusion criteria are 1) intrauterine recurrence of AEH or stage IA (FIGO 2008) endometrioid carcinoma grade 1 without myometrial invasion or extrauterine spread confirmed by imaging tests after complete remission with the previous MPA therapy. 2) The number of recurrences should be up to twice. 3) histologically diagnosed as AEH or endometrioid carcinoma grade 1, 4) 20–42 years of age, and 5) strong desire and consent for fertility-sparing treatment. The primary endpoint is 2-year recurrence-free survival rate. A total of 115 patients will be enrolled from multiple institutions in Japan and Korea within 4 years and followed up for 2 years.
4.Investigation of the Appropriate Threshold for Warning Dosage and Development of a Predictive Logistic Regression Model to Detect Dose- Error of Prednisolone Tablets
Hiroyasu SATO ; Yoshinobu KIMURA ; Masahiro OHBA ; Yoshiaki ARA ; Susumu WAKABAYASHI ; Hiroko NOMURA ; Hiroaki WATANABE
Japanese Journal of Drug Informatics 2023;25(3):157-163
Objective: The wrong dose of high-risk drugs such as oral steroids is a serious issue that needs to be addressed. This study aims to determine the appropriate upper tolerable dose threshold and to develop a multi-variable logistic regression model to detect dose-errors in oral prednisolone tablets.Methods: Data on Prednisolone prescriptions were obtained from a single center. Out of the data collected, positive cases consisted of cases where dose-related modifications were made. A univariate logistic regression model was developed with the current daily dose. In the model, the Youden Index was used to determine the upper tolerable dose threshold. The investigation was done to determine whether the performance of the multivariate model was improved by adding clinical department and previous prescription information as variables.Results: Univariate models (AUC: 0.645) with only current daily doses and estimated optimal thresholds of 6 mg/day or 11 mg/day, respectively were determined to be appropriate. Including variables improved the performance of the predictive model; the best performing model (AUC: 0.840) was derived when the following variables were entered: “current daily dose,” “current prescription days,” “clinical department,” “daily dose of the previous prescription,” and “prescription days of the previous prescription”.Conclusion: A single upper tolerance limit is insufficient to determine dose adequacy for prednisolone tablets owing to their broad clinical dose range. Itmay be possible to develop a high-performance dose audit support model by adding information.
5.Efficacy of endoscopy under general anesthesia for the detection of synchronous lesions in oro-hypopharyngeal cancer
Yoichiro ONO ; Kenshi YAO ; Yasuhiro TAKAKI ; Satoshi ISHIKAWA ; Kentaro IMAMURA ; Akihiro KOGA ; Kensei OHTSU ; Takao KANEMITSU ; Masaki MIYAOKA ; Takashi HISABE ; Toshiharu UEKI ; Atsuko OTA ; Hiroshi TANABE ; Seiji HARAOKA ; Satoshi NIMURA ; Akinori IWASHITA ; Susumu SATO ; Rumie WAKASAKI
Clinical Endoscopy 2023;56(3):315-324
Background/Aims:
Image-enhanced endoscopy can detect superficial oro-hypopharyngeal squamous cell carcinoma; however, reliable endoscopy of the pharyngeal region is challenging. Endoscopy under general anesthesia during transoral surgery occasionally reveals multiple synchronous lesions that remained undetected on preoperative endoscopy. Therefore, we aimed to determine the lesion detection capability of endoscopy under general anesthesia for superficial oro-hypopharyngeal squamous cell carcinoma.
Methods:
This retrospective study included 63 patients who underwent transoral surgery for superficial oropharyngeal squamous cell carcinoma between April 2005 and December 2020. The primary endpoint was to compare the lesion detection capabilities of preoperative endoscopy and endoscopy under general anesthesia. Other endpoints included the comparison of clinicopathological findings between lesions detected using preoperative endoscopy and those newly detected using endoscopy under general anesthesia.
Results:
Fifty-eight patients (85 lesions) were analyzed. The mean number of lesions per patient detected was 1.17 for preoperative endoscopy and 1.47 for endoscopy under general anesthesia. Endoscopy under general anesthesia helped detect more lesions than preoperative endoscopy did (p<0.001). The lesions that were newly detected on endoscopy under general anesthesia were small and characterized by few changes in color and surface ruggedness.
Conclusions
Endoscopy under general anesthesia for superficial squamous cell carcinoma is helpful for detecting multiple synchronous lesions.
6.Perceptions of older adults and generativity among older citizens in Japan: a descriptive cross-sectional study
Yuho SHIMIZU ; Tomoya TAKAHASHI ; Kenichiro SATO ; Susumu OGAWA ; Daisuke CHO ; Yoshifumi TAKAHASHI ; Daichi YAMASHIRO ; Yan LI ; Keigo HINAKURA ; Ai IIZUKA ; Tomoki FURUYA ; Hiroyuki SUZUKI
Osong Public Health and Research Perspectives 2023;14(5):427-432
Objectives:
As the population ages worldwide, including in Japan, there is a growing expectation for older adults to remain active participants in society. The act of sharing one’s experiences and knowledge with younger generations through social engagement not onlyenriches the lives of older individuals, but also holds significant value for our society. In thisstudy, we examined both positive and negative perceptions of older adults and investigated the correlation between these perceptions and generativity among older citizens. Additionally, we evaluated the impact of life satisfaction on these factors.
Methods:
We conducted a survey of 100 older adults in Japan (mean age, 71.68 years) and utilized multiple regression analyses, using positive and negative perceptions of older adults, life satisfaction, and demographic factors as independent variables. The sub-categories of generativity—namely, generative action, concern, and accomplishment—were used as dependent variables.
Results:
Participants who held a more positive perception of older adults demonstrated a higher level of generative actions and concerns. Additionally, participants who reported higher levels of life satisfaction also exhibited more generative actions, concerns, and accomplishments. Conversely, those who held a more negative perception of older adults were found to have higher levels of generative actions.
Conclusion
Enhancing positive perceptions of older adults among them can boost the subcategories of generativity. This study, which was conducted from an exploratory perspective, has several limitations, including a potential sampling bias. A more comprehensive examination of the relationship between perceptions of older adults and generativity is anticipated in future research.
7.Empirical Study on Influencing Factors for Evaluation of Medical Service and Intention to Revisit of Patient Perspective in Community Pharmacies
Susumu Sashima ; Hidehiko Sakurai ; Yousuke Sato ; Takuya Wagatsuma ; Yukitoshi Hayase
Japanese Journal of Drug Informatics 2017;18(4):251-260
Objective: As a “family pharmacy and pharmacist,” high-quality medical service is demanded. Many patient satisfaction investigations are performed to evaluate community pharmacies, but it has been impossible until now to do so using an improvement index of the medical quality. Therefore, I investigated the influence and evaluation structure of two evaluation concepts regarding quality of medical service and patient satisfaction and intention to use again, which becomes the important key as a “family” pharmacy.
Methods: I used anonymous patient survey data gathered for the purpose of duties improvement in July 2009. I subjected the responses to factor and covariance structure analyses.
Results: Dates for four dimensions were obtained for factor analysis. As a whole, covariance structure analysis showed that, in terms of privacy and only for service quality, entertainment primarily influenced satisfaction. The ingestion instruction had a big effect on both sides. General satisfaction was also substantially influenced by service quality. The difference in influence degree was confirmed at each parameter.
Conclusion: It was found that not only satisfaction but also quality of service were equally demanded in community pharmacies. It is necessary to increase these because most are influenced by ingestion instruction as a factor in service quality. However, future investigation is necessary to clarify the detailed ingestion instruction contents.
8.Development of a new reagent for endoscopic ultrasound-guided celiac plexus neurolysis and tumor ablation therapy.
Kazuo HARA ; Kenji YAMAO ; Nobumasa MIZUNO ; Susumu HIJIOKA ; Hiroshi IMAOKA ; Masahiro TAJIKA ; Tutomu TANAKA ; Makoto ISHIHARA ; Takamitu SATO ; Nozomi OKUNO ; Nobuhiro HIEDA ; Tukasa YOSHIDA ; Niwa YASUMASA
Gastrointestinal Intervention 2016;5(3):216-220
BACKGROUND: Both endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) and tumor ablation using ethanol are very common procedures, and the utility of these therapies has already been reported in prominent journals. However, their effectiveness appears temporary and insufficient, especially EUS-CPN. We therefore have to consider new reagents for improving the results. The present study examined the best concentration of ethanol and povidone iodine mixed with atelocollagen for more effective therapies. METHODS: The effects of the new reagents were confirmed in three live pigs. At first, we injected three kinds of reagents (including indigo carmine) in three separate areas of para-aortic tissue under EUS guidance in one pig. At more than 4 hours after injection, we checked ethanol injection sites after dissection. In next study, we performed EUS-guided injection of a total of six kinds of reagents (two kinds of ethanol, three kinds of povidone iodine, and control atelocollagen) into the livers of two living pigs. After 2 weeks, we examined tissue damage to the liver in the two pigs. RESULTS: The 75% ethanol (absolute ethanol 3.75 mL + 1% atelocollagen 1.25 mL + a very small amount of indigo carmine) was seen like blue gel, and still remained in the para-aortic tissue. Brownish areas of povidone iodine mixed with 3% atelocollagen exhibited clear, regular borders with greatly reduced infiltration into surrounding tissue compared to others. CONCLUSION: We concluded that 75% ethanol mixed with 1% atelocollagen appears optimal for EUS-CPN. Povidone iodine mixed with 3% atelocollagen may be suitable for small tumor ablation therapy.
Celiac Plexus*
;
Endoscopic Ultrasound-Guided Fine Needle Aspiration
;
Endosonography
;
Ethanol
;
Indicators and Reagents
;
Indigo Carmine
;
Liver
;
Povidone-Iodine
;
Swine
9.An Investigation on Evaluation Structure of the Patient for Ingestion Instruction in Community Pharmacies
Susumu Sashima ; Hidehiko Sakurai ; Takuya Wagatsuma ; Yousuke Sato ; Yukitoshi Hayase
Japanese Journal of Drug Informatics 2015;17(3):118-124
Objective: Many studies on patient satisfaction are conducted in community pharmacies. In contrast, the present study assess the community pharmacy function and to the best of our knowledge, appears to be the first to evaluate the professional functions of pharmacists.
Methods: In September 2010, in 1 week, we conducted a survey that focused on pharmacists’ professional abilities. I subjected the responses to factor analysis and covariance structure analysis.
Results: We obtained 2,506 effective responses (appropriately completed and returned questionnaires) of the 4,633 questionnaires originally distributed. Data of seven dimensions were obtained for factor analysis. In all, the various information provision services rendered by a pharmacist were not significant. According to the covariance structure analysis, “safety” (a pharmaceutical management item) and “responsiveness” (a complimentary element) were significant factors. Differences in the degree of influence were confirmed for each parameter in the analysis, depending on the parameter. In addition, the information provision services were significant during the acute period.
Conclusion: Because the information provision services were not significant, the influence of “asymmetric information” warrant further analysis according to the specialty. I believe that it is necessary to examine asymmetric information in greater detail in the future. In addition, I think that an interventional study that is based on these results is also necessary.
10.Relationships between physical activity, ADL capability and fall risk in community-dwelling Japanese elderly population.
Tomohisa YOKOYA ; Shinichi DEMURA ; Susumu SATO
Environmental Health and Preventive Medicine 2007;12(1):25-32
OBJECTIVEThe purpose of this study was to clarify the relationships among fall risk, physical activity habits, and ADL capability in a community-dwelling Japanese elderly population.
METHODSThe subjects were 1,407 Japanese aged 65 or older (604 males, 803 females). Fall risk was evaluated using the Falling Assessment Chart of Suzuki et al. (2003). Physical activity habits such as the frequency of leaving the house, the use of transportation, the frequency of physical exercise, and interests were evaluated. ADL capability was evaluated using the Tokyo Metropolitan Institute of Gerontology Index of Competence.
RESULTSApproximately 25% of the subjects had a high fall risk (score of 5 or more). Fall risk increased with age and ADL capability decreased with age. The group with a low fall risk (score<5) had a significantly higher ADL capability than the group with a high fall risk (score≥5). From results of two-way ANCOVA (gender×physical activity habits) with age as the covariate, the fall risk of people who regularly go on leaving the house, exercise, and have interests tended to be low. Further more, the relationships between the scores and physical activity habits were examined by two-way ANCOVA with age and ADL capability as the covariates. There were significant differences in the frequency of leaving the house, and elderly persons who leaved regularly the house, had a low fall risk.
CONCLUSIONSThis study showed that fall risk is closely related to ADL capability, and that the frequency of leaving the house is very important for reducing fall risk.


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