[Questionnaire Survey on IVR Dose Management in Tokai Region].

PURPOSE: National diagnostic reference levels in Japan 2020 (DRLs 2020) have been published. In the field of angiography, in addition to the fluoroscopic dose rate, incident air kerma at the patient entrance reference point displayed on the equipment (Ka,r: mGy) and air kerma-area product displayed on the equipment (PKA: Gycm2) were set. A questionnaire survey was conducted at each facility in the Tokai region to confirm the status of medical radiation dose control in the region. METHOD: A questionnaire survey was conducted at each facility in the Tokai region. The items were fluoroscopic dose rate in each area (head and neck, cardiac, chest and abdomen, and limbs), DA and DSA dose rates, and dose area product meter (Ka,r, PKA) for the main procedures in each area. RESULT: The median values in this study were lower than those in the DRLs 2020, indicating that appropriate dose control is being implemented in the Tokai region. The trends of fluoroscopic and radiographic dose rates were different in each area, and there was some variation among the facilities. CONCLUSION: We believe that the incorporation of fluoroscopic and radiographic dose rates by area into the DRLs will facilitate more appropriate dose control at each facility in the future.

[Efficacy of L-shaped Shielding in Interventional Radiology by Transradial Approach and Consideration of Methods for Appropriate Use].

The present study investigated how effective an L-shaped shield was, depending on its position, in reducing a doctor's exposure to radiation during catheterization to access the transradial approach (TRA). The shield's effectiveness was evaluated by measuring the air kerma where the doctor stood under four conditions: with and without the shield, and with and without the shield in conjunction with conventional protection. To enable the shield to be positioned correctly in clinical practice, an illustrated instruction decal affixable to the shield's doctor-facing surface was produced, and the effectiveness of the decal was verified by means of a crossover test in which, as subjects of the study, different nurses set up the shield with and without the decal affixed to it. In the test, in which a human body phantom was used, the C-arm set at the PA angle, and the shield positioned 10 cm from the axilla of the phantom, the shield's effectiveness at 100 cm, 130 cm, and 160 cm above the floor where the doctor stood was 55%, 77%, and 47%, respectively. The effectiveness increased when the shield was positioned closer to the axilla. A significant difference in the positioning of the shield by the subjects was observed depending on whether or not the decal was affixed ( p<0.05, Wilcoxon signed-rank test), indicating that the use of the decal improved the positioning. It was concluded that, positioned correctly, the shield could effectively reduce the doctor's exposure to radiation during TRA.

EXAMINATION OF LENS EXPOSURE DOSES OF CARDIOLOGISTS, NEUROSURGEONS AND RADIOLOGISTS IN INTERVENTIONAL RADIOLOGY.

The International Commission on Radiological Protection (ICRP) 118th recommendation significantly reduced the threshold dose for cataract development from 8 to 0.5 Gy. Equivalent dose limits for the crystalline lenses of radiation workers are being reviewed for individual countries. Interventional radiology (IR) procedures are less invasive than surgery and have become widespread; however, there are concerns about exposure not only to patients but also to staff, including operators. Therefore, in this study, we used a human phantom to measure the near-lens dose of the operators (cardiologists, neurosurgeons and radiologists) and estimated the operator's lens dose for every major procedure in each clinical department; this was found to vary. Owing to the different imaging and fluoroscopy conditions of each department, and the varying ratio of fluoroscopy to radiography, it is necessary to measure the lens dose for each condition, as in this study. In addition, this study explains the differences between the protective effect of various safety equipment and the appropriate use of protective plates; it can contribute to the reduction of lens doses for operators.

A 3-year postmarketing study on the safety and effectiveness of once-monthly risedronate in Japanese patients with osteoporosis.

OBJECTIVES: This postmarketing study aims to evaluate the safety and effectiveness of oral administration of risedronate at 75 mg once monthly for 36 months in patients with osteoporosis in Japan. METHODS: Participants were ambulatory outpatients with osteoporosis who were ≥ 50 years old and had prevalent vertebral fractures. Outcomes were the incidence rate of adverse drug reaction (ADR), cumulative incidence of vertebral, nonvertebral, and hip fractures, the percent changes of lumbar spinal L2-4 bone mineral density (BMD), and low back pain. In addition, medication compliance was examined. RESULTS: Safety, vertebral fractures, and other outcomes were analyzed in 542, 328, and 535 patients, respectively. In the safety analysis set, 88.38% of the patients were women and the mean age was 75.9 years. The monthly medication compliance rate ranged from 83.24% to 95.38%. The incidence rate of ADRs, including 4 severe ADRs, was 10.52% (n = 57). The common ADRs were gastrointestinal disorders, musculoskeletal, and connective tissue disorders. No osteonecrosis of the jaw was reported. The cumulative incidences (95% CI) of vertebral, nonvertebral, and hip fractures at 36 months were 12.58% (8.61-18.18), 6.59% (4.31-10.01), and 1.58% (0.64-3.88), respectively. The L2-4 BMD increased by 10.59% compared with baseline value (P < 0.01), and the proportion of patients with low back pain decreased to 30.77%, at 36 months. CONCLUSIONS: Administering 75 mg of risedronate once a month remains a favorable compliance rate and may be useful for the treatment of patients, even the elderly, with osteoporosis in daily practice.

Efficacy on the risk of vertebral fracture with administration of once-weekly 17.5 mg risedronate in Japanese patients of established osteoporosis with prevalent vertebral fractures: a 156-week longitudinal observational study in daily practice.

Currently, the only available evidence for the efficacy of once-weekly 17.5 mg risedronate in preventing vertebral fractures was obtained in a 48-week study in Japan. We performed a 156-week prospective, longitudinal, observational study to determine the efficacy of the 17.5 mg risedronate in preventing vertebral fractures. We included Japanese patients with established osteoporosis who were older than 50 years and had radiographically confirmed vertebral fractures. The primary endpoint was the incidence of vertebral fractures every 24 weeks, with the final interval spanning 36 weeks. We also calculated the change in bone mineral density of the lumbar spine (L2-4 BMD) and urinary N-telopeptide of type I collagen (u-NTX), and assessed the incidence of adverse drug reactions and the drug adherence rate. Data from 241 patients were available for analysis of vertebral fracture prevention. The incidence rate of vertebral fractures decreased in a time-dependent manner (P = 0.0006; Poisson regression analysis). The risk ratio (fracture incidence per 100 person-years in the final 36 weeks versus that in the first 24 weeks) was 0.21 (95 % confidence interval 0.08-0.55). Compared to baseline values, L2-4 BMD increased by 6.41 % at 156 weeks, while u-NTX decreased by 36 % at 24 weeks and was maintained thereafter (P < 0.0001). The incidence rate of adverse drug reactions was 9.18 %. Drug adherence rates assessed every 4 weeks were over 90 %. Our results indicate that 156 weeks of treatment with once-weekly 17.5 mg risedronate effectively reduced the risk of vertebral fracture in Japanese patients with established osteoporosis older than 50 years.

The effect of risedronate (17.5 mg/week) treatment on quality of life in Japanese women with osteoporosis: a prospective observational study.

A prospective observational study to test the effects of risedronate 17.5 mg/week treatment on quality of life (QOL) of 1,363 Japanese female patients with osteoporosis showed QOL improvement after 12 weeks of administration. Comorbid factors such as ischemic heart disease, hip osteoarthritis, and higher values of FRAX blunted the effects of QOL of the treatment. Few studies have investigated the effect of osteoporosis treatment on QOL in relationship to comorbid factors other than osteoporosis and fracture. Efficacy was determined by changes over time in EQ-5D at baseline, at 12 and 24 weeks, and at the final assessment. Factors affecting changes in EQ-5D were evaluated with a multivariate analysis. Safety was determined by assessing the incident rate of adverse events. The improvement of EQ-5D compared to baseline was observed as significant after 12 weeks of treatment (p < 0.001). The greatest improvement was observed in the dimension of "pain/discomfort" by the multivariate analysis (p < 0.001). Factors affecting QOL improvement were FRAX value without BMD, age, glucocorticoid use, ischemic heart disease, hip osteoarthritis, and pain. The incidence rate of drug-related adverse events was 4.72 % (95 % confidence interval 3.63-6.02 %). Risedronate at 17.5 mg/week improved the QOL in patients with osteoporosis among Japanese women, and comorbidity factors decreased the effects.