A Phase III Multicenter, Open-Label, One-Arm Study to Evaluate the Efficacy and Safety of Remifentanil Hydrochloride for Pediatric Subjects under General Anesthesia

レミフェンタニル塩酸塩は4-アニリドピペリジン誘導体で選択的μ-オピオイド受容体作動薬として，国内では，成人における「全身麻酔の導入及び維持における鎮痛」の効能・効果で汎用されているが，小児の適応はない。今回，小児におけるレミフェンタニル塩酸塩の有効性，安全性及び薬物動態を評価するため，挿管による気道確保及びオピオイド鎮痛薬による鎮痛を必要とする全身麻酔下での手術を行った1～15歳の小児患者80例を対象に，第Ⅲ相多施設単群非盲検試験を実施した。主要評価項目の皮膚切開時の刺激への反応は11.3％で，年齢区分（1～6歳，7～15歳）による明らかな差は認められなかった。本剤の使用に関連する有害事象は30.0％で，主な事象は心拍数減少であった。レミフェンタニルのクリアランスと年齢に明らかな傾向は認められなかった。レミフェンタニル塩酸塩は全身麻酔下の小児患者において，十分な鎮痛効果を認め，安全に使用可能であった。Remifentanil is a potent, selective, 4-anilidopiperidine µ- opioid receptor agonist not licensed for analgesia in the maintenance of general anesthesia in pediatric subjects in Japan.　A phase III trial was conducted to evaluate remifentanil for pediatric subjects in Japan.　This multicenter, open-label, one-arm study in pediatric subjects between 1 and 15 years of age receiving general anesthesia included 80 subjects.　Nine subjects (11.3%) showed response to skin incision, which was the primary endpoint, and no apparent difference in response rate was found according to age (1–6, and 7–15 years old).　Drug-related treatment emergent adverse events were found in 24 subjects (30.0%) with the most common event being heart rate decreased (26.3%).　Remifentanil was found to be effective and safe for analgesia in maintenance of general anesthesia for pediatric subjects

視覚性運動錯覚が安静時脳機能結合に与える即時効果

東京都立大

Translocator protein imaging with 18F-FEDAC-positron emission tomography in rabbit atherosclerosis and its presence in human coronary vulnerable plaques

Background and aims: This study aimed to investigate whether N-benzyl-N-methyl-2-[7,8-dihydro-7-(2-[18F]fluoroethyl)-8-oxo-2-phenyl-9H-purin-9-yl]acetamide (18F-FEDAC), a probe for translocator protein (TSPO), can visualize atherosclerotic lesions in rabbits and whether TSPO is localized in human coronary plaques.Methods: 18F-FEDAC-PET of a rabbit model of atherosclerosis induced by a 0.5% cholesterol diet and ballooninjury of the left carotid artery (n = 7) was performed eight weeks after the injury. The autoradiography intensity of 18F-FEDAC in carotid artery tissue sections was measured, and TSPO expression was evaluated immunohistochemically.TSPO expression was examined in human coronary arteries obtained from autopsy cases (n = 16), and in human coronary plaques (n = 12) aspirated from patients with acute myocardial infarction (AMI).Results: 18F-FEDAC-PET visualized the atherosclerotic lesions in rabbits as high-uptake areas, and the standard uptake value was higher in injured arteries (0.574 ± 0.24) than in uninjured arteries (0.277 ± 0.13, p < 0.05) or myocardium (0.189 ± 0.07, p < 0.05). Immunostaining showed more macrophages and more TSPO expression in atherosclerotic lesions than in uninjured arteries. TSPO was localized in macrophages, and arterial autoradiography intensity was positively correlated with macrophage concentration (r = 0.64) and TSPO (r = 0.67). TSPO expression in human coronary arteries was higher in AMI cases than in non-cardiac death, or in the vulnerable plaques than in early or stable lesions, respectively. TSPO was localized in macrophages in all aspirated coronary plaques with thrombi.Conclusions: 18F-FEDAC-PET can visualize atherosclerotic lesions, and TSPO-expression may be a marker of highrisk coronary plaques

Fragmented Flying Geese (FFG) and Intra-Regional Agglomeration: Towards a Model Explaining Location Shifting of Japanese Multinational Corporations and the Electric Value Chains of ASEAN Economies

In this article, we study corporate behavior and develop a model for trends and factors in Japanese Multinational Corporations (MNCs) in the electrical and electronic industry that have played an important role in the economic development of East and Southeast Asia. We focus on Thailand, where Japanese MNCs are still increasing, and examine the practical applicability of the model. Basically, the model will be developed based on the existing flying geese model and regional agglomeration, but it will also be developed to explain new events such as progress in the division of labor by fragmentation and intra-regional agglomeration in East and Southeast Asia. Japanese MNCs in the electrical and electronic industry have shifted their production bases to developing countries one after another, as a variant of the third type of flying geese model. While the network of the international division of labor is forming with the development of fragmentation, the area around the eastern seaboard from Bangkok is playing an increasingly important role in the network of Japanese companies. In that sense, this study contributes to the body of literature on flying geese models with a modified model embodied with dynamic and systematic features of the ASEAN integrated economies

Fragmented Flying Geese (FFG) and Intra-Regional Agglomeration: Towards a Model Explaining Location Shifting of Japanese Multinational Corporations and the Electric Value Chains of ASEAN Economies

In this article, we study corporate behavior and develop a model for trends and factors in Japanese Multinational Corporations (MNCs) in the electrical and electronic industry that have played an important role in the economic development of East and Southeast Asia. We focus on Thailand, where Japanese MNCs are still increasing, and examine the practical applicability of the model. Basically, the model will be developed based on the existing flying geese model and regional agglomeration, but it will also be developed to explain new events such as progress in the division of labor by fragmentation and intra-regional agglomeration in East and Southeast Asia. Japanese MNCs in the electrical and electronic industry have shifted their production bases to developing countries one after another, as a variant of the third type of flying geese model. While the network of the international division of labor is forming with the development of fragmentation, the area around the eastern seaboard from Bangkok is playing an increasingly important role in the network of Japanese companies. In that sense, this study contributes to the body of literature on flying geese models with a modified model embodied with dynamic and systematic features of the ASEAN integrated economies

Knowledge and practices of preconception care among rural Japanese women: findings from a mixed methods investigation

Abstract Background Preconception care is not widespread in Japan and there is a pressing need to improve the practice. The present study assessed the knowledge and behavior of preconception care among women to seek effective intervention. Our research questions were: 1) How much do women know about preconception care? 2) How much are they practicing preconception care and what are the information sources of their behavior? 3) Do the women's preconception care behavior associated with accurate knowledge? Methods The research was conducted in a rural town in central Japan. Using an exploratory sequential mixed methods design, we undertook interviews, developed a survey based on the qualitative results, and then conducted a survey. The interviews explored how preconception care was perceived and practiced in women of childbearing age. The survey was designed to investigate the knowledge of preconception care among women with and without pregnancy experience, their practice behavior of preconception care, and whether the behavior is associated with knowledge. Results The participants were 13 for the interview and 232 for the survey. They had limited access to preconception care recommendations and advice for specific actions was given by obstetricians and gynecologists after pregnancy. There was a large gap in knowledge about preconception care between parous and nulliparous women, especially about the need for folic acid supplementation. Practices that were manageable in their daily lives, such as cessation of smoking and alcohol, diet, and weight management, were considered common sense. In contrast, recommended practices that require medical attention, such as screening for sexually transmitted diseases and cervical cancer, tended to be less accurately known and practiced. Participants' sources of information about preconception care were the Internet, family and friends and mass media. Conclusion In rural Japan, women of childbearing age lack knowledge about preconception care, especially before their first pregnancy. Primary care providers should try outreach to schools and women’s groups in the community, promote information sharing among family and close friends, and utilize information technology to enhance the knowledge and practice of preconception care