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Iwaki, Japan

Mori J.,Tokyo Medical University | Tanimoto T.,Jyoban Hospital | Tanimoto T.,Tokyo Medical University | Miura Y.,Teikyo University | Kami M.,Tokyo Medical University
Japanese Journal of Clinical Oncology

Objective: All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. Methods: We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Results: Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. Conclusion: All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. Source

Akiyama J.,Jyoban Hospital | Kato S.,Jyoban Hospital | Tsubokura M.,Soma Central Hospital | Tsubokura M.,Tokyo Medical University | And 7 more authors.

Following the Fukushima nuclear power plant disaster, assessment of internal radiation exposure was indispensable to predict radiation-related health threats to residents of neighboring areas. Although many evaluations of internal radiation in residents living north and west of the crippled Fukushima nuclear power plant are available, there is little information on residents living in areas south of the plant, which were similarly affected by radio-contamination from the disaster. To assess the internal radio-contamination in residents living in affected areas to the south of the plant or who were evacuated into Iwaki city, a whole body counter (WBC) screening program of internal radio-contamination was performed on visitors to the Jyoban hospital in Iwaki city, which experienced less contamination than southern areas adjacent to the nuclear plant. The study included 9,206 volunteer subjects, of whom 6,446 were schoolchildren aged 415 years. Measurements began one year after the incident and were carried out over the course of two years. Early in the screening period only two schoolchildren showed Cs-137 levels that were over the detection limit (250 Bq/body), although their Cs-134 levels were below the detection limit (220 Bq/body). Among the 2,760 adults tested, 35 (1.3%) had detectable internal radio-contamination, but only for Cs-137 (range: 250 Bq/body to 859 Bq/body), and not Cs-134. Of these 35 subjects, nearly all (34/35) showed elevated Cs-137 levels only during the first year of the screening. With the exception of potassium 40, no other radionuclides were detected during the screening period. The maximum annual effective dose calculated from the detected Cs-137 levels was 0.029 and 0.028 mSv/year for the schoolchildren and adults, respectively, which is far below the 1 mSv/year limit set by the government of Japan. Although the data for radiation exposure during the most critical first year after the incident are unavailable due to a lack of systemic measurements, the present results suggest that internal radio-contamination levels more than one year after the incident were minimal for residents living south of the crippled Fukushima nuclear plant, and that the annual additional effective doses derived from internal Cs contamination were negligible. Thus, internal radio-contamination of residents living in southern radio-contaminated areas appears to be generally well controlled. © 2015 Akiyama et al.This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Source

Mori J.,Jyoban Hospital | Tsubokura M.,Minamisoma Municipal General Hospital | Sugimoto A.,University of Tokyo | Tanimoto T.,Jyoban Hospital | And 3 more authors.
Preventive Medicine

Objective: The objective of this study is to assess the localized incidence of dog bites following the nuclear accident related to the Great East Japan Earthquake in March 2011. Methods: We identified the patients with dog bites in our hospital in Minamisoma City, Fukushima, during the period from 1. year prior to the earthquake to 3.5. months following it, and calculated the monthly and weekly incidence proportions by dividing the patient number by the total emergency room visits. We also analyzed the data by the characteristics of the patients. Results: We identified 27 dog-bite cases during the post-disaster period. The median monthly incidence proportion during the pre-disaster period and the highest monthly incidence proportion during the post-disaster period were 0.21 and 6.50 per 100 visits, respectively. The weekly incidence proportion peaked at 3. weeks after the earthquake and thereafter decreased to the baseline level. Conclusion: The Fukushima nuclear accident may be associated with an increased incidence of dog bites, and the prolonged evacuation in response to the radiation contamination may have prolonged the increased incidence after the disaster. Physicians and local residents should recognize this potential hazard. Countermeasures to contend with this risk should be a mandatory aspect of disaster preparedness, including for nuclear accidents. © 2013 Elsevier Inc. Source

Okazaki M.,Jyoban Hospital | Komatsu M.,Jyoban Hospital | Kawaguchi H.,Jyoban Hospital | Tsuchiya K.,Tokyo Womens Medical University | Nitta K.,Tokyo Womens Medical University
Blood Purification

Background: Evidence suggests hemodialysis (HD) patients with resistance to erythropoiesis-stimulating agents (ESA) have a higher mortality rate. We investigated the association between ESA responsiveness and mortality in our HD population. Methods: A prospective cohort study of chronic HD patients was conducted at Jyoban Hospital in Fukushima, Japan. We collected data on patient demographic factors, comorbidities, dialysis vintage, body weight, ESA dose and hemoglobin concentration, as well as data on known risk factors for ESA hyporesponsiveness. The erythropoietin resistance index (ERI) was calculated by dividing the weekly body-weight-adjusted epoetin dose by the hemoglobin concentration. The association between ESA hyporesponsiveness estimated by the highest tertile of ERI and mortality was investigated by using the Cox proportional hazards model with adjustments for demographic factors, comorbidities, dialysis adequacy and serum biochemical data. Results: A total of 248 patients were included as subjects in the cohort, and their overall 2-year mortality rate was 13.3%. According to the results of the Kaplan-Meier analysis, patients with an ERI in the highest tertile had significantly higher mortality than patients with an ERI in the lower two tertiles (p = 0.0121). The highest ERI tertile was associated with higher all-cause mortality in both the unadjusted hazards model (hazard ratio, HR: 4.429; 95% CI: 1.249-15.704) and the adjusted hazards model (HR: 4.204; 95% CI: 1.173-15.065). Conclusions: A higher degree of resistance to ESA in chronic HD patients is associated with increased mortality. © 2014 S. Karger AG, Basel. Source

Komatsu M.,Jyoban Hospital | Okazaki M.,Jyoban Hospital | Tsuchiya K.,Tokyo Womens Medical University | Kawaguchi H.,Jyoban Hospital | Nitta K.,Tokyo Womens Medical University
Blood Purification

Background: Malnutrition is common in hemodialysis (HD) patients, and it is associated with increasing risk of mortality. The geriatric nutritional risk index (GNRI) has been developed as a tool to assess the nutritional risk. The aim of this study was to examine the reliability of the GNRI as a mortality predictor in a Japanese HD cohort. Methods: We prospectively examined the GNRI of 332 maintenance HD patients aged 65.4 ± 13.2, 213 males, and followed up on them for 36 months. The patients were divided into quartiles (Q) according to GNRI values (Q1: <91.6, Q2: 91.7-97.0, Q3: 97.1-102.2, Q4: >102.3). Predictors for all-cause mortality were examined using Kaplan-Meier and Cox proportional-hazards analyses. Results: The GNRI presented a normal distribution. During the follow-up period of 36 months, 76 patients died. The overall mortality at the end of the 3-year observational period was 22.3%. At the 3-year follow-up period, Kaplan-Meier survival rates for all-cause mortality were 72.3, 79.3, 84.9 and 92.6% in Q1, Q2, Q3, and Q4, respectively (p = 0.0067). Multivariate Cox proportional-hazards analysis demonstrated that the GNRI was a significant predictor of adjusted all-cause mortality (HR 0.958; 95% CI 0.929-0.989, p = 0.0073). Conclusions: The results of the present study demonstrate that the GNRI is a strong predictor of overall mortality in HD patients. However, cardiovascular mortality was not associated with GNRI values, and did not differ among the GNRI quartiles. The GNRI score can be considered a simple and reliable marker of predictor for mortality risk in Japanese HD patients. © 2015 S. Karger AG, Basel. Source

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