As the Japanese health insurance system is reimbursed on a fee-for-service basis, the claims data are useful sources for quantitative analysis on practice and prescription patterns as well as the health care resource use. However, the claims database has limitations such as incomplete description of the patients' condition and severity, and the lack of prescription data for low-priced drugs.
For use in pharmacoepidemiologic studies, patient information from medical charts, prescription forms, and/or hospital information systems may need to be included to compensate for the limitations of the claims data.

Studies have shown that postoperative disseminated intravascular coagulopathy (DIC) occurs in some patients with cardiac disease, acute aortic dissection, and ruptured abdominal aortic aneurysm. The specific pathophysiology of DIC in these settings are related to low cardiac function, shock, infection and sepsis as well as activation of coagulation cascade in the aneurysm sac or dissected aorta. A soluble form of recombinant human thrombomodulin (rhsTM) was approved in 2008 for the treatment of DIC. This report describes the safety and efficacy of rhsTM for the treatment of DIC in patients with cardiovascular disease operated in our department. Between October 2010 and March 2012, 35 patients with postoperative DIC were treated with rhsTM. Diagnosis of DIC was based on the diagnostic criteria for DIC of the Japanese Association for Acute Medicine (JAAM). During the first 6 months of the study period, after a diagnosis of DIC was made, the patients were treated with gabexate mesilate and antithrombin III, and if patients showed no improvement with conventional treatment, they received rhsTM for 6 days. During the last 10 months of the study period, patients received rhsTM soon after a diagnosis of DIC was made. Twenty seven patients survived for 28 days after rhsTM treatment, and the mortality rate was 22.9% (8/35). Patients who survived showed improvement in acute phase DIC scores, FDP levels, D-Dimer, fibrinogen and platelet counts during rhsTM treatment, but no improvement was observed in patients who died. No serious adverse events were found up to 28 days after the start of rhsTM administration. In conclusion, this study showed no adverse events of rhsTM, and further studies are needed to confirm that rhsTM administration is an effective therapeutic modality in the management of DIC after cardiovascular surgery.

Object: A multicenter survey was conducted to investigate the status of use of supplements and related problems in patients with diabetes mellitus.
Methods: A questionnaire was mailed to institutions where members of the Drug Information Section, Tokyo Hospital Pharmacists Association, worked, and hospitalized patients with diabetes mellitus were surveyed with a questionnaire.
Results: The response rate of the questionnaire was 85%, and 22 patients reported taking supplements.  The most common motivation to purchase supplements was a recommendation from an acquaintance, followed by a recommendation from a family member and TV. Only 9.1% of the patients consulted healthcare professionals when purchasing supplements.  The patients who did not follow the dosage and administration instructions and those who were not aware of precautions regarding proper use accounted for 31.8% and 63.6%, respectively.  The proportion of patients who did not inform their physicians about the use of supplements was 65.2%, and 4.5% reported some health damage (rash).
Conclusion: Our results revealed that supplements were used without careful consideration and were not administered properly, suggesting that scientific evaluation of efficacy and safety was warranted in future studies.  It is important for pharmacists to actively collect information on patient use of supplements and share the information within the medical team.

Effects of 20km running uppn taking a low-carbohydrate, high-fat and protein diet on the changes in blood pressure, heart rate, body weight, skinf old thickness, blood components and urinary recordings in five healthy young men were investigated and the changes in these items which occured by taurine inducement were studied by double blind test method. The results were as follows:
1) As to the degree of decrease in body weight in 20km running, the case in taurine administration (T. A.) was more than in placebo administration (P. A.) .
2) As to the degree of increase in systolic pressure upon 20km running, T. A. was less than P. A. 3) The rate of creatine kinase isozyme (CK-MB) against creatine kinase (CK), which increased after 20km running in P. A., was possible to reduce by T. A.
4) T. A. was less than P.A. in the rate of increase in lactate dehydrogenase (LDH) on 20km running.
5) In P. A., triglyceride increased after 20km running, but in T. A., it decreased.
6) T. A, much influenced the rate of individual fatty acid composition on 20km running
7) T. A, was more than P. A. in the secretion of adrenaline on 20km running.
8) No changes were observed in other blood components and urinary kallikrein.

OBJECTIVE: Directional leads are used for deep brain stimulation (DBS). Two of the four contacts of the leads are divided into three parts, enabling controlled stimulation in a circumferential direction. The direction of adverse effects evoked by DBS in the subthalamic nucleus (STN) and stimulation strategies using directional leads were evaluated. METHODS: Directional leads were implanted into the bilateral STN of six parkinsonian patients (1 man, 5 women; mean age 66.2 years). The contact centers were located within the upper border of the STN, and the locations were identified electrically using microrecordings. Adverse effects were evaluated with electrical stimulation (30 μs, 130 Hz, limit 11 mA) using the directional part of each lead after surgery, and the final stimulation direction was investigated. Unified Parkinson's disease rating scale (UPDRS) scores were evaluated before and after DBS. RESULTS: Fifty-six motor and four sensory symptoms were evoked by stimulation; no adverse effect was evoked in 14 contacts. Motor and sensory symptoms were evoked by stimulation in the anterolateral direction and medial to posterolateral direction, respectively. Stimulation in the posteromedial direction produced adverse effects less frequently. The most frequently used contacts were located above the STN (63%), followed by the upper part of the STN (32%). The mean UPDRS part III and dyskinesia scores decreased after DBS from 30.2 ± 11.7 to 7.2 ± 2.9 and 3.3 ± 2.4 to 0.5 ± 0.8, respectively. CONCLUSION: The incidence of adverse effects was low for the posteromedial stimulation of the STN. Placing the directional part of the lead above the STN may facilitate the control of dyskinesia.
Deep Brain Stimulation ; Dyskinesias ; Electric Stimulation ; Female ; Humans ; Incidence ; Parkinson Disease ; Pilot Projects ; Subthalamic Nucleus

The present study was performed to investigate the effect of long distance walking upon physical functions for healthy male subjects. The first experiment was carried out in 1977, the second, in 1978, and the third, in 1979 in each autum season. At the first experiment, subjects began walking upon having breakfast, then ate and drank noting during first 30km, and took some foods during another 26km. Twelve hours and fifty minutes of time was spent for 56km walking including 15, 60, and 30 minutes rest periods in between. In the second experiment, subjects ate nothing after dinner of the previous evening and 35km walking took 6 hours during which some rest periods were taken for blood sampling. The third was 80km walking for two days. Subjects walked 40km in 8 hours in the first day and on the following day they walked 40km in ten hours and twenty minutes. They took foods and rest freely.
From the view points of the changes in blood and urinary recordings obtained from those three experiments, the influences of long distance walking on the body indicate as follows ;
1) In case of long distance walking while nothing to eat and drink, the rate of serum saturated fatty acids composition decreased and unsaturated fatty acids increased.
2) In a fasting state, blood glucose gradually decreased, LDH activity increased and blood lactate, GOT and GPT activity presented no significant changes on long distance walking.
3) It was shown that the longer distance to walk, the lesser tendency in blood triglyceride even though subjects take a carbohydrate rich diet while walking.
4) In fasting state, less than 35km walking without foods, the stress to the body seemed not to be critical.
5) More than 40km walking in a day, even though taking meals, would result a significantly severe stress for body.
6) As long as usual meals are taken, 80km walking for two days continuously, 40km in each day, would not result in such a physical stress over the following days.

An oral examination using a simulated case conference format was conducted for fourth year medical students who took a practical course on clinical reasoning prior to their clinical clerkship. Although there were many disadvantages such as fewer cases and shorter testing time to use such examinations for summative purposes, we found that we could assess students' knowledge and presentation skills based on their logical reasoning. We could also comprehensively evaluate students' readiness for clerkship by applying the RIME assessment framework. We discovered the practical value of using the examination as a means of supporting learners who are facing difficulty in learning after we successfully used it to detect such learners and address their concerns. We hope that some elements of this simulated case conference can be used not only as a job preview but also as an assessment tool for pre-clinical clerkship education in other medical schools.

Objective: To evaluate the usefulness of virtual monochromatic images (VMIs) obtained using dual-layer dual-energy CT (DL-DECT) for evaluating brain tumors. Materials and Methods: This retrospective study included 32 patients with brain tumors who had undergone non-contrast head CT using DL-DECT. Among them, 15 had glioblastoma (GBM), 7 had malignant lymphoma, 5 had high-grade glioma other than GBM, 3 had low-grade glioma, and 2 had metastatic tumors. Conventional polychromatic images and VMIs (40–200 keV at 10 keV intervals) were generated. We compared CT attenuation, image noise, contrast, and contrast-to-noise ratio (CNR) between tumor and white matter (WM) or grey matter (GM) between VMIs showing the highest CNR (optimized VMI) and conventional CT images using the paired t test. Two radiologists subjectively assessed the contrast, margin, noise, artifact, and diagnostic confidence of optimized VMIs and conventional images on a 4-point scale. Results: The image noise of VMIs at all energy levels tested was significantly lower than that of conventional CT images (p < 0.05). The 40-keV VMIs yielded the best CNR. Furthermore, both contrast and CNR between the tumor and WM were significantly higher in the 40 keV images than in the conventional CT images (p < 0.001); however, the contrast and CNR between tumor and GM were not significantly different (p = 0.47 and p = 0.31, respectively). The subjective scores assigned to contrast, margin, and diagnostic confidence were significantly higher for 40 keV images than for conventional CT images (p < 0.01). Conclusion In head CT for patients with brain tumors, compared with conventional CT images, 40 keV VMIs from DL-DECT yielded superior tumor contrast and diagnostic confidence, especially for brain tumors located in the WM.

Objective: To evaluate the usefulness of virtual monochromatic images (VMIs) obtained using dual-layer dual-energy CT (DL-DECT) for evaluating brain tumors. Materials and Methods: This retrospective study included 32 patients with brain tumors who had undergone non-contrast head CT using DL-DECT. Among them, 15 had glioblastoma (GBM), 7 had malignant lymphoma, 5 had high-grade glioma other than GBM, 3 had low-grade glioma, and 2 had metastatic tumors. Conventional polychromatic images and VMIs (40–200 keV at 10 keV intervals) were generated. We compared CT attenuation, image noise, contrast, and contrast-to-noise ratio (CNR) between tumor and white matter (WM) or grey matter (GM) between VMIs showing the highest CNR (optimized VMI) and conventional CT images using the paired t test. Two radiologists subjectively assessed the contrast, margin, noise, artifact, and diagnostic confidence of optimized VMIs and conventional images on a 4-point scale. Results: The image noise of VMIs at all energy levels tested was significantly lower than that of conventional CT images (p < 0.05). The 40-keV VMIs yielded the best CNR. Furthermore, both contrast and CNR between the tumor and WM were significantly higher in the 40 keV images than in the conventional CT images (p < 0.001); however, the contrast and CNR between tumor and GM were not significantly different (p = 0.47 and p = 0.31, respectively). The subjective scores assigned to contrast, margin, and diagnostic confidence were significantly higher for 40 keV images than for conventional CT images (p < 0.01). Conclusion In head CT for patients with brain tumors, compared with conventional CT images, 40 keV VMIs from DL-DECT yielded superior tumor contrast and diagnostic confidence, especially for brain tumors located in the WM.

Epidemic of SARS-CoV-2 affected the human society, with multidimensional impact. COVID-19 vaccine was developed as an important tool for public health which can change epidemic situation. In early 2021, products got an approved and become available in Japan also. Several difficulty from development to approval which was overcame by collaborative work of several stakeholders, have been already known. As same as this, in post-marketing phase, there were several challenging situation. MR visit to health care institute was quite restricted. The duration from product approval to product use, was quite short. Vaccine distribution was controlled by government to keep nationwide optimization, and vaccination was done based on prioritization. To expand vaccination site, large scale vaccination sites and occupational vaccination sites which differed from usual health care institute, was opened. Under these situation, we made various effort to do several actions aligned with several related rules like pharmaceutical and Medical Device acts. For timely information delivery and information collection, internet technology was utilized. Post-marketing survey plan was revised from usual survey to database survey, because product used basically at occupational vaccination site. In this material, we would like to report what we did as Early Post-marketing Phase Vigilance (EPPV), safety monitoring and post-marketing survey under COVID-19 situation. We hope this report can be utilized to discuss what we should do under resemble situation.