1.Rehabilitation Outcomes for Patients Receiving Intervention from a Palliative Care Team
Kyoko Sato ; Mitumasa Yoda ; Hitomi Higuchi ; Nobuyuki Kawate ; Masazumi Mizuma
Palliative Care Research 2016;11(2):906-909
Purpose: Approximately 30% of the patients who received intervention from a palliative care team for problematic symptoms (e.g., pain, nausea, depression) also underwent rehabilitation at our acute hospital. We investigated their changes in activities of daily living (ADLs) and outcomes (i.e., death, changing hospitals, or being discharged to their homes). Method: We retrospectively analyzed the patients’ medical records data to examine patient training content, Barthel Index (B.I.) scores, and outcomes. Results: For one year, 86 patients received rehabilitation and 42 (48%) underwent anticancer therapy. B.I. scores increased for 35% of the patients, were stable for 20%, and decreased for 45%; 95% of the patients with decreased B.I. scores could not be discharged home. Conclusion: Advanced cancer patients are likely to experience a decline in ADLs and require longer rehabilitation periods to improve. A team approach is important for preventing disuse syndromes within a palliative care setting.
2.Evaluation of Clinical Pharmacy Training for Adverse Drug Events Based on Japan Pharmaceutical Association Drug Information
Takanao Hashimoto ; Nobuyuki Takahashi ; Emiko Sato ; Noriyasu Hirasawa ; Yoshihisa Tomioka ; Katsuyuki Tochikubo ; Hiroshi Sato
Japanese Journal of Drug Informatics 2012;14(3):110-116
Objective: Collection of the latest information for appropriate and safe drug use is clinically essential, and the “Japan Pharmaceutical Association Drug Information” (JPADI) is a useful source. We prepared a text on the basis of JPADI for undergraduates to learn adverse drug events (ADEs). The objective of this study was to report the outcomes of our educational plan and student perspectives regarding the management of ADEs.
Methods: We provided 20 students with a self-study text for ADEs, including ADE reports, relief services by the Pharmaceuticals and Medical Devices Agency, and pharmacist medication errors. Case reports were categorized by disease discipline. Students were administered a questionnaire regarding their evaluation and interest regions of our text, the significance of relief services, and roles of drug information specialist.
Results: Fifteen students (75%) completed the questionnaire. Interest regions were pharmacist medication errors (n=9), systemic and multi-organ disorders (n=9), and cardiovascular disorders (n=5). We received comments such as “these errors are experiences creating cascades for the prevention of recurrence” (n=2). In terms of relief services, “expenses relief ” (n=4) as a merit and “vagueness of relief standards” (n=4) as a demerit were provided. Roles of drug information specialist included “provide easy-to-understand drug information to patients” (n=4) and “share with other medical staff ” (n=2). No specific improvements for the text were suggested.
Conclusion: Our educational plan using a self-study text based on drug information is useful for developing student responsibility and expertise for becoming pharmacist.
3.Dengue Hemorrhagic Fever in a Japanese Traveler with Pre-existing Japanese Encephalitis Virus Antibody
Rumi Sato ; Nobuyuki Hamada ; Takahito Kashiwagi ; Yoshihiro Imamura ; Koyu Hara ; Munetsugu Nishimura ; Tomoko Kamimura ; Tomohiko Takasaki ; Hiroshi Watanabe ; Takeharu Koga
Tropical Medicine and Health 2015;43(2):85-88
An adult Japanese man who had just returned from Thailand developed dengue hemorrhagic fever (DHF). A primary infection of dengue virus (DENV) was confirmed, specifically DENV serotype 2 (DENV-2), on the basis of the detection of the virus genome, a significant increase in the neutralizing antibody and the isolation of DENV-2. DHF is often observed following a secondary infection from another serotype of dengue virus, particularly in children, but this case was a primary infection of DENV. Japan is a non-endemic country for dengue disease. In fact, only Japanese encephalitis (JE) is known to be a member of the endemic flavivirus family. In this study, IgG antibody against Japanese encephalitis virus (JEV) was detected. JEV belongs to the family of dengue virus and prevails in Japan, particularly Kyushu. Among many risk factors for the occurrence of DHF, a plausible candidate could be a cross-reactive antibody-dependent enhancement (ADE) mechanism caused by JEV antibody. This indicates that most Japanese travelers who living in dengue non-endemic areas, particularly Kyushu, should be aware of the occurrence of DHF.
4.A Drug Utilization Study on Off-Label Uses
Nobuyuki GOTO ; Kazuo SATO ; Masaki SHIRAHASE ; Hisao HATTA ; Mikio MASADA ; Kazuhisa MATSUBA ; Yoshihiro KATAGIRI ; Masahiro NAKANO ; Keizo ISHIMOTO ; Takeo MINAMI ; Shikifumi KITAZAWA
Japanese Journal of Pharmacoepidemiology 1999;4(1):1-8
Objective : Heparin lock flush solution is diluctes and divided into vials before its use while it is used in quantity in Japan. Then, we carried out the research on use of heparin lock flush solution.
Methods : We executed the nationwide questionnaire investigation concerning making heparin lock flush solution.
Results : The recovery of the nationwide questionnaire investigation was as high as 78% (64/82) indicating general concern for the problem.
Heparin lock flush solution was made in 97% (246/253) of wards. 69% (174/253) of wards had a standard for preparation. Therebon, it is thought that the standardization of heparin lock flush solution is possible. The use concentration employed most frequently for the peripheral intravenous injection was 10 units/ml and that for the central vein injection was 100/ml units. In many wards the amount used at 1 time for the peripheral intravenous injection was 5 ml or 10 ml and that for the central vein injection, was 5 ml, 10 ml, or 20 ml.
84% of nurses requested marketing of heparin lock flush solution.
Conclusion : We investigated the use realities and the problem of heparin lock flush solution from a past report etc. Heparin lock flush solution is listed to the pharmacopeia in the United States and Britain. Heparin lock flush solution should be supplied as the goods on the market immediately even if it is seen from the profit, the safety, the medical economy.
5.A Drug Utilization Study on Off-Label Uses
Nobuyuki GOTO ; Kazuo SATO ; Masaki SHIRAHASE ; Hisao HATTA ; Mikio MASADA ; Kazuhisa MATSUBA ; Yoshihiro KATAGIRI ; Masahiro NAKANO ; Keizo ISHIMOTO ; Takeo MINAMI ; Shikifumi KITAZAWA
Japanese Journal of Pharmacoepidemiology 1999;4(1):9-19
Objective : Percutaneous ethanol injection (PEIT) for hepatocellular carcinoma is basic treatment of hepatocellular carcinoma. However, it is off-label uses to use ethanol for this treatment in the current state. Then, we executed the drug utilization study of Absolute ethanol injections at this time.
Methods : We executed the drug utilization study of Absolute ethanol injections at this time.
Results : The recovery of the questionnaire was high with 84.4% (151/179 medical institutions). The ethanol injections was made by 85% (129/151 facilities). Facilities where 100 or more ethanol injections was made annually were 76%. The raw material for making the ethanol injections was the reagent which was not the medicine in 44% of facilities. Information on safety and effectiveness concerning the ethanol injections was hardly offered from pharmacy. Finally, 96% (124/129 facilities) demanded marketing the ethanol injections.
Conclusion : We investigated the research report number by using “ICHUSHI” CD-ROM version (1988-1998) which was the medical literature data base. We were able to collect reports concerning PEIT of hepatocellular carcinoma of 636 reports. We were able to collect reports which used PEIT as a treatment method of hepatocellular carcinoma by as many as 636 reports. It has been understood that PEIT is enforced in Japan. Next, we reviewed the document and collected and evaluated information on effectiveness and safety concerning the ethanol injections used for PEIT. The treatment object, the usage, and the dosage have been decided at the relating academic meeting. Moreover, there was a report concerning a lot of effectiveness and safety in the PEIT treatment method of hepatocellular carcinoma. The ethanol injections used for PEIT is one of the medicines where information and scientific evidence concerning effectiveness and safety are accumulated. Moreover, a large amount of ethanol injections are nationally made in the pharmacy in the hospital. However, it has been proved that there are a lot of problems about the making. The ethanol injections is the medicine which should be supplied and made by the pharmaceutical company.
6.Dengue hemorrhagic fever in a Japanese traveler who had preexisting Japanese encephalitis virus antibody
Rumi Sato ; Nobuyuki Hamada ; Takahito Kashiwagi ; Yoshihiro Imamura ; Koyu Hara ; Yoshiko Naito ; Natsuko Koga ; Munetsugu Nishimura ; Tomoko Kamimura ; Tomohiko Takasaki ; Hiroshi Watanabe ; Takeharu Koga
Tropical Medicine and Health 2015;advpub(0):-
A patient, an adultJapanese traveler who had just returned from Thailand, had developed denguehemorrhagic fever (DHF). A primary infection of dengue virus (DENV) wasconfirmed, in particular, DENV serotype 2 (DENV-2) via the detection of the virusgenome, a significant increase in its specific neutralizing antibody and the isolationof DENV-2. DHF is often observed following a secondary infection from another serotypeof dengue virus, particularly in children, but this case was a primaryinfection of DENV. Japan is a non-endemic country of dengue disease. Instead,only Japanese encephalitis (JE) is known to be an endemic flavivirus family. Inthis study, IgG antibody against Japanese encephalitis virus (JEV) was detected.JEV belongs to the family of dengue virus and prevails in Japan, particularly inKyushu. Among many risk factors for the occurrence of DHF, a plausiblecandidate could be a cross-reactive antibody-dependent enhancement (ADE)mechanism by JEV antibody. This indicates that most Japanese travelers, wholive in non-endemic areas of dengue, particularly in Kyushu, should payattention to the occurrence of DHF.
7.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.
8.Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training: a prospective observational study conducted at a single center in Japan
Takahito TOBA ; Tsuyoshi ISHII ; Nobuyuki SATO ; Akira NOGAMI ; Aya HOJO ; Ryo SHIMIZU ; Ai FUJIMOTO ; Takahisa MATSUDA
Clinical Endoscopy 2025;58(1):94-101
Background/Aims:
The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance.
Methods:
Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method.
Results:
All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months.
Conclusions
Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.
9.Effectiveness of a novel ex vivo training model for gastric endoscopic submucosal dissection training: a prospective observational study conducted at a single center in Japan
Takahito TOBA ; Tsuyoshi ISHII ; Nobuyuki SATO ; Akira NOGAMI ; Aya HOJO ; Ryo SHIMIZU ; Ai FUJIMOTO ; Takahisa MATSUDA
Clinical Endoscopy 2025;58(1):94-101
Background/Aims:
The efficacy of endoscopic submucosal dissection (ESD) for early-stage gastric cancer is well established. However, its acquisition is challenging owing to its complexity. In Japan, G-Master is a novel ex vivo gastric ESD training model. The effectiveness of training using G-Master is unknown. This study evaluated the efficacy of gastric ESD training using the G-Master to evaluate trainees’ learning curves and performance.
Methods:
Four trainees completed 30 ESD training sessions using the G-Master, and procedure time, resection area, resection completion, en-bloc resection requirement, and perforation occurrence were measured. Resection speed was the primary endpoint, and learning curves were evaluated using the Cumulative Sum (CUSUM) method.
Results:
All trainees completed the resection and en-bloc resection of the lesion without any intraoperative perforations. The learning curves covered three phases: initial growth, plateau, and late growth. The transition from phase 1 to phase 2 required a median of 10 sessions. Each trainee completed 30 training sessions in approximately 4 months.
Conclusions
Gastric ESD training using the G-Master is a simple, fast, and effective method for pre-ESD training in clinical practice. It is recommended that at least 10 training sessions be conducted.
10.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.