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.

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.

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

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.

Aged ; Aged, 80 and over ; Carotid Artery Diseases ; physiopathology ; surgery ; Cerebrovascular Circulation ; physiology ; Female ; Humans ; Iofetamine ; Male ; Perioperative Period ; Radiopharmaceuticals ; Stents ; Tomography, Emission-Computed, Single-Photon ; methods

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.