著者
Takashi Matsumoto Shunsuke Kubo Masaki Izumo Shingo Mizuno Shinichi Shirai on behalf of the MitraClip Japan PMS Investigators
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-21-0309, (Released:2021-10-29)
参考文献数
16
被引用文献数
10

Background:The MitraClip NT System was approved for marketing in Japan on October 31, 2017, and a prospective, multi-center, single-arm Post-Marketing use Surveillance (PMS) study was launched in 2018. This is the first report of the Japan PMS study with 1-year subject outcomes.Methods and Results:A total of 500 patients were registered between April 2018 and January 2019. Patients with symptomatic chronic moderate-to-severe (3+) or severe mitral regurgitation (MR; 4+), MR with a Society of Thoracic Surgery (STS) replacement score of ≥8%, or presence of 1 pre-defined risk factor were enrolled. Primary outcome measures included acute procedural success (APS), and rate of Single Leaflet Device Attachment (SLDA) at 30 days. The overall cohort was elderly (77.9±9.48 years) with functional MR etiology in 71.6% of the subjects. The majority of subjects were New York Heart Association (NYHA) class III/IV (68.9%), with mean STS replacement score of 11.95±9.66%. The APS rate was 91.13% and the 30-day SLDA rate was 1.21%. Durable MR reduction was achieved with 88.1% of subjects at MR ≤2+ at 1 year. Significant improvement in the functional capacity was observed, with 93% of subjects at NYHA class I/II at 1 year.Conclusions:In the Japan PMS experience, the MitraClip procedure resulted in improvements in MR severity, with significantly improved functional outcomes. These results demonstrate safety and efficacy of MitraClip therapy in the eligible Japanese population.
著者
Tamio Teramoto Makiko Usami Yoshiharu Takagi Marie T. Baccara-Dinet for the ODYSSEY Japan Investigators
出版者
Japan Atherosclerosis Society
雑誌
Journal of Atherosclerosis and Thrombosis (ISSN:13403478)
巻号頁・発行日
pp.45070, (Released:2018-08-01)
参考文献数
39
被引用文献数
9

Aim: To examine the efficacy and safety of alirocumab in Japanese patients with dyslipidemia with or without diabetes mellitus (DM).Methods: Patients (n=216) with heterozygous familial hypercholesterolemia (heFH), non-FH at high cardiovascular risk with coronary artery disease (CAD), or category III (primary prevention) were enrolled; 148 (68.5%) patients had a diagnosis of DM at baseline. Patients were randomized (2:1), with stratification factor (heFH, non-FH), to alirocumab (75 mg every 2 weeks [Q2W] with increase to 150 mg if week 8 LDL-C was above predefined limits) or placebo subcutaneously for 52 weeks on top of stable statin therapy.Results: At Week 24, least square (LS) mean±standard error changes in low-density lipoprotein cholesterol (LDL-C) concentration from baseline in alirocumab-treated patients were -63.1±1.6% and -60.8±2.7% in those with and without DM. These LDL-C reductions were maintained to Week 52: -63.0±1.6% (LS mean difference vs placebo -62.4±3.0%; P<0.0001) with DM and -61.3±2.8% (LS mean difference vs placebo -53.4±4.0%; P<0.0001) without DM. The most common adverse events in the alirocumab group were nasopharyngitis, back pain, injection site reaction, and fall. No particular safety signals or concerns were noted between DM and non-DM groups at 52 weeks. A dose-increase in alirocumab from 75 to 150 mg Q2W was necessary in two heFH patients, neither of whom had DM.Conclusions: In high-cardiovascular-risk Japanese patients with hypercholesterolemia on stable statin therapy, alirocumab produced substantial and sustained LDL-C reductions throughout the 52-week study regardless of DM status at baseline, with a similar safety profile to placebo.
著者
Atsushi Hirayama Norio Tanahashi Hiroyuki Daida Naoki Ishiguro Motohiko Chachin Toshihiko Sugioka Shinichi Kawai on behalf of all ACCEPT study investigators in Japan
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-12-1573, (Released:2013-10-22)
参考文献数
35
被引用文献数
4 23

Background: A prospective, 3-year comparative observational study compared the risk of cardiovascular events in patients with osteoarthritis or rheumatoid arthritis prescribed celecoxib or a nonsteroidal antiinflammatory drug (NSAID). Methods and Results: Patients prescribed celecoxib (n=5,470) or NSAIDs (n=5,059) between November 1, 2007, and July 31, 2008 in 1,084 hospitals and clinics in Japan were eligible for safety analysis. Mean (standard deviation) observation for the celecoxib group was 716 (420) days and 692 (426) days for the NSAID group (P=0.004). Composite I (adjudicated cardiovascular adverse events of myocardial infarction, angina pectoris, heart failure, cerebral infarction, cerebral hemorrhage) number of events (percentage) and rate/1,000 person years was 66 (1.2%) and 6.2 (10,745 person years), respectively, for the celecoxib and 65 (1.3%) and 6.8 (9,601 person years) for the NSAID (P=0.58) groups. Composite II (all cardiovascular events) number of events (percentage) and rate/1,000 person years was 79 (1.4%) and 7.4, respectively, for the celecoxib and 84 (1.7%) and 8.8 for the NSAID (P=0.26) group. Adjusted Cox hazards ratio (95% confidence interval) was 0.89 (0.63–1.27; P=0.52) for Composite I, 0.87 (0.63–1.19; P=0.39) for Composite II and 1.03 (0.75–1.41; P=0.87) for death from all causes. Conclusions: After adjustment for confounding variables, celecoxib was not associated with an increase of cardiovascular risk in comparison with nonselective NSAID in Japanese patients with rheumatoid arthritis or osteoarthritis in an observational setting.
著者
Hajime Yoshifuji Yoshikazu Nakaoka Haruhito A. Uchida Takahiko Sugihara Yoshiko Watanabe Sohei Funakoshi Mitsuaki Isobe Masayoshi Harigai Japan Research Committee of the Ministry of Health Labour and Welfare for Intractable Vasculitis (JPVAS)
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0656, (Released:2023-12-19)
参考文献数
34
被引用文献数
1

Background: Takayasu arteritis, affecting primarily young women, damages large arteries and organs. We examined the impact of disease duration and sex on organ damage and quality of life using Japan’s Intractable Disease Registry.Methods and Results: After refining data, 2,013 of 2,795 patients were included in the study. Longer disease duration was related to a lower prevalence of disease activity symptoms, a higher prevalence of organ damage, and a higher proportion of patients requiring nursing care. Compared with men, women tended to have an earlier onset age, exhibiting longer disease duration. A higher proportion of women had aortic regurgitation and required nursing care. The proportion of female patients in employment was lower than that of the general female population, whereas no difference was observed between male patients and the general male population. Logistic regression analysis revealed that age at surveillance, brain ischemia, visual impairment/loss, and ischemic heart disease were significant factors associated with high nursing care needs (Level ≥2, with daily activity limitations).Conclusions: Early diagnosis and effective treatment, particularly to prevent brain ischemia, visual impairment, and ischemic heart disease, may improve the quality of life of patients with Takayasu arteritis, especially women.
著者
Masayuki Shima Narumi Tokuda Hideki Hasunuma Yoshiko Kobayashi Hiroyuki Tanaka Hideaki Sawai Hiroaki Shibahara Yasuhiro Takeshima Munetaka Hirose the Japan Environment and Children’s Study (JECS) Group
出版者
The Japanese Society for Hygiene
雑誌
Environmental Health and Preventive Medicine (ISSN:1342078X)
巻号頁・発行日
vol.27, pp.37, 2022 (Released:2022-09-28)
参考文献数
47
被引用文献数
4

Background: Epidural analgesia relives pain during labor. However, the long-term effects on neurodevelopment in children remain unclear. We explored associations between exposure to epidural analgesia during labor and childhood neurodevelopment during the first 3 years of life, in the Japan Environment and Children’s Study (JECS), a large-scale birth cohort study.Methods: Pregnant women were recruited between January 2011 and March 2014, and 100,304 live births of singleton children born at full-term by vaginal delivery, and without congenital diseases were analyzed. Data on mothers and children were collected using a self-administered questionnaires and medical record transcripts. The children’s neurodevelopment was repeatedly assessed for five domains (communication, gross motor, fine motor, problem solving, and personal-social), using the Ages and Stages Questionnaires, Third Edition, at six time points from age 6 to 36 months. After adjusting for potential confounders, the associations between exposure to epidural analgesia during labor and children’s neurodevelopment at each time point were assessed.Results: Of the 42,172 children with valid data at all six time points, 938 (2.4%) were born to mothers who received epidural analgesia during labor. Maternal exposure to epidural analgesia was associated with neurodevelopmental delays during the first 3 years after birth. Delay risks in gross and fine motor domains were the greatest at 18 months (adjusted odds ratio (aOR) [95% confidence interval (CI)]: 1.40 [1.06, 1.84] and 1.54 [1.17, 2.03], respectively), subsequently decreasing. Delay risks in communication and problem-solving domains were significantly high at 6 and 24 months, and remained significant at 36 months (aOR [95% CI]: 1.40 [1.04, 1.90] and 1.28 [1.01, 1.61], respectively). Exposure to epidural analgesia was also associated with the incidence of problem solving and personal-social delays from 18 to 24 months old. Neurodevelopmental delay risks, except for communication, were dominant in children born to mothers aged ≥30 years at delivery.Conclusions: This study showed that maternal exposure to epidural analgesia during labor was associated with neurodevelopmental delays in children during the first 3 years after birth.
著者
宇宙開発事業団 National Space Development Agency of Japan
出版者
宇宙開発事業団
雑誌
宇宙開発事業団特別報告 = NASDA Special Publication (ISSN:13457918)
巻号頁・発行日
pp.1冊, 1995-08-31

本用語集は1993年10月に発行した宇宙開発事業団特別報告「航空宇宙関連日英対訳技術用語集(NASDA-SPP-930002)」に、NASAのシソーラスの中から特に航空宇宙に関連の深い用語(英語)を抽出し、それに和訳をつけた新たな技術分野の用語を加えてより広範囲な航空宇宙関連用語集として改訂したものである。この用語集に収録している用語は主として次の9つの技術分野からのものである。(1)空気力学・航空力学、(2)航空機、(3)流体力学、(4)バイオテクノロジー・生物工学、(5)通信、(6)コンピュータ・電子計算機、(7)数学、(8)推進システム、(9)宇宙飛行体。この用語集は和英編と英和編の2部からなっており、収録用語数は(NASDA-SPP-930002)「航空宇宙関連日英対訳技術用語集」1993年度版が2,282語、(NASDA-SPP-950003)「航空宇宙関連日英対訳技術用語集」1995年度版が7,115語である。
著者
Ichiro TSUDA Edgar KOERNER Hiroshi SHIMIZU Bioholonics Research Project Research Development Corporation of Japan Bioholonics Research Project Research Development Corporation of Japan Faculty of Pharmaceutical Sciences Department of Biophysics University of Tokyo
雑誌
Progress of theoretical physics = Progress of theoretical physics (ISSN:0033068X)
巻号頁・発行日
vol.78, no.1, pp.51-71, 1987-07-25

A model which can perform learning, formation of memory without teacher for successive memory recalls is presented. The philosophical background of the study is summarized. The investigated network consists of two sets both composed of asynchronously firing model neurons. One set of neurons is responsible for the field effect, and the other is introduced as an input/output module. The field effect is given in the form of the system's self-response. It is shown that positive end negative global feedbacks by the field effect play an essential role in the successive recall of stored patterns. The possibility that these proposed mechanisms are implemented in the brain is discussed. We obtained a quasi-deterministic law on the level of a macrovariable concerning a random successive recall of memory representations by taking a Lorenz-plot of this macrovariable. We show that this macroscopic order is deterministic chaos steming from collapse of tori and this type of chaos can be an effective gadget of memory traces.
著者
Ken Okumura Kazuo Matsumoto Yoshinori Kobayashi Akihiko Nogami Robert B Hokanson Fred Kueffer for the CRYO-Japan PMS Study Investigators
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-16-0285, (Released:2016-06-30)
参考文献数
17
被引用文献数
2 31

Background:Outcomes of cryoballoon ablation for paroxysmal atrial fibrillation (PAF) have been reported in the Western countries but not in Japan. The CRYO-Japan PMS study was a single-arm, observational, multicenter, prospective study of the 2nd-generation cryoballoon Arctic Front AdvanceTM. We evaluated device- and procedure-related complications and clinical outcomes at 6 months.Methods and Results:The 616 patients (male, 72%; mean age, 63±11 years) were enrolled from 33 Japanese hospitals. Of all patients, 610 had PAF, and procedural data were analyzed in 607. A subset of 328 patients was followed for 6 months for the primary efficacy analysis. AF recurrence outside the 3-month blanking period or repeat ablation was considered treatment failure. Pulmonary vein isolation was achieved in 606/607 patients (99.8%); 1 patient (0.3%) had a repeat ablation during the blanking period. Freedom from AF at 6 months was 88.4% (95% CI: 84.1–91.6%). Device- and/or procedure-related adverse events included phrenic nerve injury unresolved at hospital discharge in 9/616 patients (1.5%), which resolved within 6 months in 7, pericardial effusion in 5/616 (0.8%), and tamponade in 4/616 (0.6%). One non-device-related death from pneumonia was reported 6 days post-procedure.Conclusions:Cryoballoon ablation is safe and effective for Japanese PAF patients, with 88.4% AF freedom at 6 months post-ablation.
著者
Atsushi Hirayama Norio Tanahashi Hiroyuki Daida Naoki Ishiguro Motohiko Chachin Toshihiko Sugioka Shinichi Kawai on behalf of all ACCEPT study investigators in Japan
出版者
日本循環器学会
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.78, no.1, pp.194-205, 2014 (Released:2013-12-25)
参考文献数
35
被引用文献数
4 23

Background: A prospective, 3-year comparative observational study compared the risk of cardiovascular events in patients with osteoarthritis or rheumatoid arthritis prescribed celecoxib or a nonsteroidal antiinflammatory drug (NSAID). Methods and Results: Patients prescribed celecoxib (n=5,470) or NSAIDs (n=5,059) between November 1, 2007, and July 31, 2008 in 1,084 hospitals and clinics in Japan were eligible for safety analysis. Mean (standard deviation) observation for the celecoxib group was 716 (420) days and 692 (426) days for the NSAID group (P=0.004). Composite I (adjudicated cardiovascular adverse events of myocardial infarction, angina pectoris, heart failure, cerebral infarction, cerebral hemorrhage) number of events (percentage) and rate/1,000 person years was 66 (1.2%) and 6.2 (10,745 person years), respectively, for the celecoxib and 65 (1.3%) and 6.8 (9,601 person years) for the NSAID (P=0.58) groups. Composite II (all cardiovascular events) number of events (percentage) and rate/1,000 person years was 79 (1.4%) and 7.4, respectively, for the celecoxib and 84 (1.7%) and 8.8 for the NSAID (P=0.26) group. Adjusted Cox hazards ratio (95% confidence interval) was 0.89 (0.63–1.27; P=0.52) for Composite I, 0.87 (0.63–1.19; P=0.39) for Composite II and 1.03 (0.75–1.41; P=0.87) for death from all causes. Conclusions: After adjustment for confounding variables, celecoxib was not associated with an increase of cardiovascular risk in comparison with nonselective NSAID in Japanese patients with rheumatoid arthritis or osteoarthritis in an observational setting.  (Circ J 2014; 78: 194–205)
著者
Fumio Terasaki Hiroshi Okamoto Katsuya Onishi Akira Sato Hiroaki Shimomura Bin Tsukada Kyoko Imanaka-Yoshida Michiaki Hiroe Toshimichi Yoshida Yasushi Kitaura Akira Kitabatake Study Group for Intractable Diseases by a Grant from the Ministry of Health Labor and Welfare of Japan
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.71, no.3, pp.327-330, 2007 (Released:2007-02-25)
参考文献数
29
被引用文献数
60 72

Background Tenascin-C (TN-C), an extracellular matrix glycoprotein, is specifically expressed at high levels during embryonic development, but not in the adult heart. TN-C reappears at sites of inflammatory tissue remodeling or wound healing under various pathologic conditions, such as acute myocardial infarction, acute myocarditis, and some cases of cardiomyopathy. Therefore, the expression of TN-C might be useful for detecting the clinical characteristics of, and ventricular remodeling in, dilated cardiomyopathy (DCM). Methods and Results Circulating serum TN-C levels in 107 patients with DCM were measured using an ELISA kit. Clinical data were also assessed by Pearson's or Spearman's correlation analysis to estimate correlations between variables. Serum TN-C levels in DCM patients were higher than those in normal controls (p<0.001). TNC levels showed a significantly positive correlation with New York Heart Association functional class (p<0.001), B-type natriuretic peptide level (p<0.001), cardiothoracic ratio on chest X-ray (p<0.01), left ventricular end-diastolic diameter (p<0.05) and left ventricular end-systolic diameter (p<0.01), and a significantly negative correlation with left ventricular ejection fraction (p<0.01). Conclusions The findings suggest that increased serum TN-C levels indicate the severity of heart failure, left ventricular dysfunction and remodeling in patients with DCM. (Circ J 2007; 71: 327 - 330)
著者
Yoshiko Watanabe Yuuki Shimizu Takuya Hashimoto Toru Iwahashi Kunihiro Shigematsu Yoshikazu Nakaoka Masayoshi Harigai Japan Research Committee of the Ministry of Health Labour and Welfare for Intractable Vasculitis (JPVAS)
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-23-0211, (Released:2023-07-07)
参考文献数
37
被引用文献数
1

Background: The latest demographics, clinical and living conditions, and comorbidities of patients with thromboangiitis obliterans (TAO) in Japan are unknown.Methods and Results: We conducted a retrospective cross-sectional survey using the annual database of the Japanese Ministry of Health, Labour and Welfare medical support system for patients with TAO between April 2013 and March 2014. This study included 3,220 patients (87.6% male), with current age ≥60 years in 2,155 patients (66.9%), including 306 (9.5%) patients aged ≥80 years. Overall, 546 (17.0%) had undergone extremity amputation. The median interval from onset to amputation was 3 years. Compared with never smokers (n=400), 2,715 patients with a smoking history had a higher amputation rate (17.7% vs. 13.0%, P=0.02, odds ratio [OR]=1.437, 95% confidence interval [CI]=1.058–1.953). A lower proportion of workers and students was seen among patients after amputation than among amputation-free patients (37.9% vs. 53.0%, P<0.0001, OR=0.542, 95% CI=0.449–0.654). Comorbidities, including arteriosclerosis-related diseases, were found even in patients in their 20–30 s.Conclusions: This large survey confirmed that TAO is not a life-threatening but an extremity-threatening disease that threatens patients’ professional lives. Smoking history worsens patients’ condition and extremity prognosis. Long-term total health support is required, including care of extremities and arteriosclerosis-related diseases, social life support, and smoking cessation.
著者
Naho Morisaki Aurélie Piedvache Seiichi Morokuma Kazushige Nakahara Masanobu Ogawa Kiyoko Kato Masafumi Sanefuji Eiji Shibata Mayumi Tsuji Masayuki Shimono Toshihiro Kawamoto Shouichi Ohga Koichi Kusuhara the Japan Environment and Children’s Study Group
出版者
Japan Epidemiological Association
雑誌
Journal of Epidemiology (ISSN:09175040)
巻号頁・発行日
pp.JE20210049, (Released:2021-08-28)
参考文献数
16
被引用文献数
15

Background: Tracking gestational weight gain (GWG) during pregnancy makes it possible to optimize pregnancy outcomes, and GWG growth curves are well suitable for this purpose. The GWG guidelines for Japanese were revised in 2021. However, currently, there are no GWG growth curves to guide women on how to gain weight to meet these guidelines.Methods: Using data on 96,631 live births from the Japan Environment and Children’s Study (JECS), we created descriptive GWG percentile curves estimating the trajectory of GWG required to meet the GWG guidelines stratified by pre-pregnancy body mass index (BMI). For both analyses, Bayesian mixed models with restricted cubic splines adjusted for maternal characteristics were used.Results: GWG curves substantially differed by pre-pregnancy BMI and were higher among multiparas and those with lower maternal age and with no previous disease. We estimated that underweight, normal weight, overweight, and obese women who gain 8.4 to 11.1 kg, 6.4 to 9.1 kg, 3.8 to 6.5 kg, and <1.9 kg at 30 weeks of gestation are on the trajectory to reach the new guidelines at 40 weeks of gestation.Conclusions: We provide GWG percentiles curves for Japanese women, as well as GWG trajectory curves to meet the new GWG recommendations. These results may help pregnant women monitor weight during pregnancy.