Nihon Medi-Physics (Japan)

Abstract Background Individuals with hearing impairments face significant challenges during crises, particularly in accessing emergency alerts and maintaining communication, but little is known about the impact of prolonged crises on hearing aid usage. Objectives The aim of the study was to examine changes in hearing aid usage and concerns related to hearing emergency alerts among adults with hearing impairment during the October 7 war in Israel. Methods 847 hearing aid users (85.4% aged ≥ 60 years), 80% with at least moderate hearing difficulty participated in a survey. Results Changes in hearing aid use during the war were characterized with increased hearing aid usage and changes in usage patterns such as more frequent sleeping or showering with the devices. Fear of missing missile sirens was prevalent, with over 25% expressing concerns and 10% frequently failing to hear alarms. Despite regional differences in attack frequency, changes in hearing aid use were not correlated with place of residence, suggesting that psychological stress, rather than direct exposure, influenced behaviour. Notably, 75% of participants recognized remote hearing aid tuning as essential. Conclusions The study highlights the role of hearing aids in crisis situations, emphasizing the need for preparedness and integrating audiological support into emergency plans. In response, the HIMIC (Hearing Instruments Management in Crisis) guidelines for individual (HIMIC-I) and for public health (HIMIC-P) preparedness and hearing care, were developed to ensure device functionality, user preparedness and public services during major crisis, such as war times, pandemic, and environmental disasters. These recommendations address device selection, emergency planning, and usage in extreme conditions as well as preparedness of hearing clinics, human resources considerations, training, emergency inventory and establishing responsibilities. Ensuring access to remote audiological services and promoting proactive hearing aid preparedness can enhance safety and well-being for individuals with hearing impairment during prolonged crises.

BackgroundCognitive behavioral therapy for insomnia (CBT-I) has a high potential for improving insomnia and depressive symptoms; however, it is unclear whether the improvement of symptoms reaches the level of healthy people without these symptoms. We aimed to examine whether digital CBT-I can improve the insomnia and depression symptoms of workers to healthy levels.MethodsThe study included 752 workers who were divided into four groups by the use of the cutoff scores of insomnia and depression scales: insomnia alone, depression alone, combined insomnia with depression (COMB), and healthy. All groups were administered digital CBT-I for 2 weeks, and changes were compared post-treatment and at 1- and 3-month follow-ups.ResultsA significant decrease in insomnia symptoms from post-treatment to the 3-month follow-up was found in the insomnia alone (Hedges’ g: 1.07–1.52) and COMB groups (g: 1.17–1.41). The COMB group also showed a significant decrease in depressive symptoms (g: 0.38–0.70). Moreover, there were significant differences in insomnia symptoms between both of the insomnia groups and the healthy group and in depressive symptoms between the COMB group and the healthy group, post-treatment and at the 1- and 3-month follow-ups.ConclusionsDigital CBT-I effectively reduced insomnia and depressive symptoms but did not achieve the levels of healthy people within 3 months.Trial registration.UMIN, UMIN000050353. Registered 15 February 2023—Retrospectively registered, umin.ac.jp/ctr.Supplementary InformationThe online version contains supplementary material available at 10.1186/s13030-025-00334-y.

Abstract ObjectivesLong‐term disability in patients with multiple sclerosis (MS) results from axonal degeneration in the central nervous system, which might follow hypoperfusion in neurodegenerative diseases. This study aimed to clarify the distribution and clinical significance of brain hypoperfusion in patients with MS.MethodsWe measured brain hypoperfusion in eight patients with relapsing–remitting MS using N‐isopropyl‐p‐iodine‐123‐iodoamphetamine single‐photon emission computed tomography with three‐dimensional stereotactic surface projection and stereotactic extraction estimation; moreover, we examined its clinical relevance.ResultsWe detected marked hypoperfusion in the brainstem and cerebellum relative to that in the cerebrum. Each infratentorial segment, the midbrain, pons, and cerebellar anterior and posterior lobes, showed more severe hypoperfusion than the frontal and parietal lobes (n = 8). This was attributed mainly to oligoclonal band (OCB)‐negative patients (n = 3), even when OCB‐positive patients (n = 5) showed a similar trend. Consistently, OCB‐negative patients had lower blood flow at the pons, and cerebellar anterior and posterior lobes than OCB‐positive patients; however, both groups showed comparable hypoperfusion in the cerebral lobes. Hypoperfusion at the posterior cerebellar lobe and pons was correlated with poor performance in the Trail Making Test Part B (n = 6), indicating cognitive cerebellar dysfunction and cerebrocerebellar conductive disturbances.ConclusionsPatients with relapsing–remitting MS had lower infratentorial perfusion, which strongly links to OCB‐negativity. The distribution of brain hypoperfusion detected by N‐isopropyl‐p‐iodine‐123‐iodoamphetamine single‐photon emission computed tomography indicated pathological heterogeneity in relapsing–remitting MS. The infratentorial hypoperfusion is possibly associated with neurodegeneration.

Abstract 123I-FP-CIT (123I-Ioflupane) SPECT shows strong accumulation in the striatum, but morphological standardization is challenging due to low accumulation outside the striatum, particularly in subjects with marked striatal decline. In this study, morphological standardization without MRI was achieved using the adaptive template registration (ATR) method to create a subject-specific optimized template with weighted images of normal-type and egg-shape-type templates. The accuracy of a quantitative method for calculating the ratio with nonspecific accumulation in the occipital lobe was evaluated by placing voxels-of-interest (VOI) on standardized images, particularly targeting the striatum. Methods: The average images of eight subjects, demonstrating normal-type and egg-shape-type tracer accumulation in 123I-Ioflupane SPECT, were utilized as normal and disease templates, respectively. The study included 300 subjects that underwent both 123I-Ioflupane SPECT and MRI for the diagnosis of suspected Parkinson's disease or for exclusion diagnosis. Morphological standardization of SPECT images using structural MRI (MRI-based method) was considered the standard of truth (SOT). Three morphological standardizations without MRI were conducted. The first involved conventional morphological standardization using a normal template (fixed template method), the second employed the adaptive template registration (ATR) method, with a weighted template, and the third used the split-ATR method, processing the left and right striatum separately to address asymmetrical accumulation. VOIs were set on the striatum, caudate, putamen as regions of specific accumulation, and on the occipital lobe as a reference region for nonspecific accumulation. Results: Results showed significant and robust linearity in the striatal accumulation ratios for all templates when compared with the occipital lobe accumulation ratio when using the MRI-based method. Comparing intra-class correlations for different linearities, the ATR method and split-ATR method demonstrated higher linearity in the striatum, caudate, and putamen. Notably, in subjects with normal striatal (normal-type) or unclear striatal accumulation (burst striatum-type), no obvious improvement in accuracy was achieved when using the ATR or split-ATR methods. However, in subjects with striatal decline or lateral asymmetry, MRI-based methods accurately reflected striatal accumulation. Conclusion: The use of optimized templates, such as the ATR and split-ATR methods, improved reproducibility in fully automated processing and demonstrated superior linearity compared to that of MRI-based method, in the ratio to the occipital lobe. The ATR method, which enables morphological standardization when using SPECT images only, proved highly reproducible for clinical quantitative analysis of striatal accumulation, facilitating its clinical use.

Pharmacists play an important role not only in improving the safety and efficacy of drug therapy, but also in improving the efficiency of healthcare financing by prescription inquiries and provision of information to prescribing physicians. The purpose of this study was to survey prescription inquiries and provide information to physicians by pharmacists and to estimate the annual reduction in drug costs resulting from changes in prescriptions due to inquiries and information provision. The survey was conducted with the cooperation of the Japan Pharmaceutical Association and Nippon Pharmacy Association, requesting individual members of each organisation to respond to survey forms posted on the pharmacy website. The survey period was one week from December 2018 to March 2019. Responses were received from 2,783 pharmacies and 5,724 pharmacists, of which 2,117 (76％) and 5,024 (88％) were valid, respectively. The drug cost savings per prescription change due to prescription inquiries were –894 yen. The estimated annual drug cost savings due to prescription inquiries were –19,231,998,137 yen. The estimated drug cost savings per prescription change due to information provision were –1,103 yen. The estimated annual drug cost savings due to information provision were –944,257,363 yen. From these results, we conclude that prescription inquiries and the information provided by pharmacists contribute to community medicine through the efficiency of healthcare financing.

The package inserts of prescription drugs provide essential information for the proper administration of pharmacotherapy. The incidence of adverse reactions for several drugs is known to be higher in women than in men. However, no studies have examined whether information on gender differences is included in Japanese package inserts. Therefore, this study investigated information on gender differences in the package inserts of Japanese prescription drugs, using the drug information database JAMES provided by the Medical Information System Development Center and the Japan Pharmaceutical Information Center. Non-proprietary names of prescription drugs were yielded 1,679 in Japan. Of the 1,679 ingredients in package inserts of prescription drugs, 76 (4.5%) included information on gender differences. The number of inserts that contained information on gender differences in the "DOSAGE AND ADMINISTRATION," "ADVERSE REACTIONS," and "PHARMACOKINETICS" sections was 3, 16, and 62, respectively. Furthermore, in the "ADVERSE REACTIONS" section, 15 of the 16 inserts mentioned a higher frequency of adverse reactions in women compared with men. Importantly, most of the inserts with information on gender differences in the "PHARMACOKINETICS" section mentioned a higher area under the curve for women than for men. Most of the package inserts of prescription drugs with information on gender differences provide useful information aimed at preventing risks in women. However, there is an extreme lack of information on gender differences in the package inserts of prescription drugs in Japan, and we consider enhancing information on gender difference as an urgent issue.

This study compared the pharmacokinetic and safety profiles between a new generic and a branded reference product of 10-mg ezetimibe (EZE) tablets in 24 healthy Japanese male volunteers under fasting conditions, obtaining sufficient evidence for the marketing approval of the new generic product. The bioequivalence study was conducted with an open-label, 2 × 2, single-dose, crossover design in which the test and reference products were administered to volunteers after fasting for ≥10hours. Blood samples were collected 24 times before to 72hours after the administration of the investigational drug. We evaluated the peak drug concentration and the area under the plasma concentration-time curve up to the last measured concentration of EZE, EZEG, and total EZE (EZE + ezetimibe glucuronide [EZEG]). The 90% confidence intervals of the geometric mean ratios for peak drug concentration and area under the plasma concentration-time curve up to the last measured concentration of the test and reference products fell within the bioequivalence limits of 0.80 to 1.25 for EZE, EZEG, and total EZE. The test and reference products were well tolerated, and no adverse events occurred during the study. The test product was bioequivalent to the reference product.

Internal radiation therapy using Iodine-131 metaiodobenzylguanidine (131I-MIBG) for neuroblastoma has been discussed whether a special application scheme for off-labeled drugs called "Kouchi-Shinsei" could be applied to neuroblastoma or not by the Evaluation Committee on Unapproved or Off-labeled Drug with High Medical Needs (the Committee); if the Committee determines that Kouchi-Shinsei is applicable, neuroblastoma indication is expected to be regulatory approved within a year. Since a NHI medical technical fee is not yet set for neuroblastoma, the Japanese Society of Nuclear Medicine surveyed health resource use via a questionnaire survey of medical institution that has conducted a Japanese Advanced Medical Care B clinical study in neuroblastoma. Results showed that the necessary total cost per patient is 1,847,451 JPY when calculated based on the Draft Proposal for Medical Examination Value (Ver. 7.3) of the Japanese Health Insurance Federation for Surgery. Because follow-up is necessary for 3 months after administration, it was considered that an appropriate fee per patient is 1,847,451 JPY and an appropriate NHI medical technical fee per patient is 46,186 points which can be claimed up to once a month for 4 times including the initial month of the treatment.

Glioma is the most common type of central nervous system tumor reported worldwide. Current imaging technologies have limitations in the diagnosis and assessment of glioma. The present study aimed to confirm the diagnostic efficacy and safety of anti-1-amino-3-[18F]fluorocyclobutane carboxylic acid (18F-fluciclovine; anti-[18F]FACBC) as a radiotracer for patients undergoing combined positron emission tomography and computed tomography (PET/CT) for suspected glioma. Combined data from two multicenter, open-label phase III clinical trials were evaluated for this study. The two trials enrolled patients with suspected high- or low-grade glioma on the basis of clinical symptoms, clinical course, and magnetic resonance imaging findings, and who were scheduled for tumor resection surgery. Patients fasted for ≥ 4h and received 2mL of 18F-fluciclovine (radioactivity dose 78.3-297.0MBq), followed by a 10-min PET scan 10-50min after injection. The primary efficacy endpoint was the positive predictive value (PPV) of the gadolinium contrast-enhanced T1-weighted image negative [Gd (-)] and 18F-fluciclovine PET-positive [PET ( +)] area of the scans, using the histopathological diagnosis of the tissue sampled from that area as the standard of truth. All adverse events reported during the study were recorded for safety analysis. A total of 45 patients aged 23-89years underwent 18F-fluciclovine PET; 31/45 patients (68.9%) were male, and 30/45 patients (66.7%) were suspected to have high-grade glioma. The PPV of 18F-fluciclovine PET in the Gd (-) PET ( +) area was 88.0% (22/25 areas, 95% confidence interval: 70.0-95.8). The extent of planned tumor resection was modified in 47.2% (17/36 cases) after 18F-fluciclovine PET scan, with an extension of area in 30.6% (11/36 cases) and reduction in 16.7% (6/36 cases). Furthermore, tissue samples collected from PET ( +) areas tended to have a higher malignancy grade compared with those from PET (-) areas. Overall, 18F-fluciclovine was well tolerated. 18F-fluciclovine PET/CT is useful for determining the extent of tumor resection at surgical planning, and may serve as a safe and effective diagnostic tool for patients with suspected glioma. These trials were registered in the Japan Pharmaceutical Information Center Clinical Trials Information (JapicCTI-152986, JapicCTI-152985).