Bulletin of National Institute of Health Sciences最新文献_第3页

[Topics from "Overseas Drug Safety Information" in the past five years]. [近五年“海外药物安全资讯”专题]。

Bulletin of National Institute of Health Sciences Pub Date : 2013-01-01

Kimiko Amanuma

{"title":"[Topics from \"Overseas Drug Safety Information\" in the past five years].","authors":"Kimiko Amanuma","doi":"","DOIUrl":"","url":null,"abstract":"The Drug Safety Information Section of the Division of Safety Information on Drug, Food and Chemicals has been providing bulletins titled \"Overseas Drug Safety Information\" in Japanese since 2003. These bulletins comprise summarized and translated reports of important post-marketing drug safety information that are published by foreign regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medical Agency. A new issue of the bulletin is posted every two weeks on the website of the National Institute of Health Sciences, Japan; to date (May 2013), a total of 280 issues have been posted, covering approximately 2400 foreign news items and articles since its inception. Recently, visits to the bulletin website have been increasing: the number of hits for each issue totaled 570,000 in fiscal 2012. Among the \"Overseas Drug Safety Information\" issued in the past five years, I briefly describe here several topics which interested me: erythropoietin-stimulating agents in chronic kidney disease and their cardiovascular risk; bisphosphonates and atypical femur fracture; effectiveness of oral liquid cough medicines containing codeine in children; bevacizumab for metastatic breast cancer; and congenital abnormality associated with the use of antiepileptic drugs by pregnant women. I also describe the potential safety signals identified by FDA using its Adverse Event Reporting System, and their importance in ensuring the safe use of drugs in the post-marketing phase.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 131","pages":"35-44"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31956983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Characterization of cases contravening of regulations regarding primary aromatic amines originating from azo dyes in commercial textile products and leather products in European Union]. [欧盟商业纺织品和皮革制品中源自偶氮染料的初级芳香胺违反法规的案例特征]。

Bulletin of National Institute of Health Sciences Pub Date : 2013-01-01

Tsuyoshi Kawakami, Kazuo Isama, Yoshiaki Ikarashi

{"title":"[Characterization of cases contravening of regulations regarding primary aromatic amines originating from azo dyes in commercial textile products and leather products in European Union].","authors":"Tsuyoshi Kawakami, Kazuo Isama, Yoshiaki Ikarashi","doi":"","DOIUrl":"","url":null,"abstract":"Contraventions of regulations regarding primary aromatic amines (PAAs) originating from azo dyes in commercial textile products and leather products in European Union (EU), notified in the period between 2006 and 2012 were collected from the Rapid Alert System for non-food consumer products (RAPEX), were characterized. Various types of products (clothes, footwear, bedding, etc.) and their raw materials (cotton, silk, viscose, leather, etc.) were reported to have contravened the regulations. The contravention frequencies for products made in China and India were higher than those for other countries. Ten percentage of the country in which the reported products were produced was unknown. The notification frequencies for benzidine and 4-aminoazobenzene were higher than those for other PAAs. Contravention of regulations regarding benzidine, 4-aminoazobenzene, and 3,3'-dimethoxybenzidine were notified every year. Contraventions of regulations regarding five PAAs--classified as IARC group 1--were notified one or several times. Since the scale of the survey conducted in Japan were small compared with RAPEX, it is necessary that many kinds and number of products should be surveyed in Japan. In addition, it is also necessary to pay attention to 4-aminoazobenzene, while it has not been detected in the previous studies conducted in Japan.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 131","pages":"66-74"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31956987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Special reports on advanced drugs and cellular and tissue-based products]. [关于先进药物、细胞和组织产品的特别报告]。

Bulletin of National Institute of Health Sciences Pub Date : 2013-01-01

引用次数: 0

[Ion-pair HPLC analysis of B vitamins in syrup products in Indonesia]. [印尼糖浆产品中维生素B的离子对高效液相色谱分析]。

Bulletin of National Institute of Health Sciences Pub Date : 2013-01-01

Tamaki Miyazaki, Tadafumi Horisaki, Yukio Aso, Haruhiro Okuda

引用次数: 0

[Evaluation of safety and functional effect of factors or molecules which are concerning cellular development, differentiation and signal transduction]. [与细胞发育、分化和信号转导有关的因子或分子的安全性和功能效应的评价]。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

引用次数: 0

[Study of purity tests for silicone resins]. 【有机硅树脂纯度检测的研究】。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

Kyoko Sato, Noriko Otsuki, Akio Ohori, Mitsuru Chinda, Noriko Furusho, Tsutomu Osako, Hiroshi Akiyama, Yoko Kawamura

{"title":"[Study of purity tests for silicone resins].","authors":"Kyoko Sato, Noriko Otsuki, Akio Ohori, Mitsuru Chinda, Noriko Furusho, Tsutomu Osako, Hiroshi Akiyama, Yoko Kawamura","doi":"","DOIUrl":"","url":null,"abstract":"In the 8th edition of Japan's Specifications and Standards for Food Additives, the purity test for silicone resins requires the determination of the refractive index and kinetic viscosity of the extracted silicone oil, and allows for only a limited amount of silicon dioxide. In the purity test, carbon tetrachloride is used to separate the silicone oil and silicon dioxide. To exclude carbon tetrachloride, methods were developed for separating the silicone oil and silicon dioxide from silicone resin, which use hexane and 10% n-dodecylbenzenesulfonic acid in hexane. For silicone oil, the measured refractive index and kinetic viscosity of the silicone oil obtained from the hexane extract were shown to be equivalent to those of the intact silicone oil. In regard to silicon dioxide, it was confirmed that, following the separation with 10% n-dodecylbenzenesulfonic acid in hexane, the level of silicon dioxide in silicone resin can be accurately determined. Therefore, in this study, we developed a method for testing the purity of silicone resins without the use of carbon tetrachloride, which is a harmful reagent.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"71-4"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31126014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Industry regulation and its relationship to the rapid marketing of medical devices]. [行业监管及其与医疗器械快速营销的关系]。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

Atsuko Matsuoka

引用次数: 0

[Toxicity effects of phthalate substitute plasticizers used in toys]. [玩具中邻苯二甲酸盐替代增塑剂的毒性效应]。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

Mutsuko Hirata-Koizumi, Mika Takahashi, Mariko Matsumoto, Tomoko Kawamura, Atsushi Ono, Akihiko Hirose

{"title":"[Toxicity effects of phthalate substitute plasticizers used in toys].","authors":"Mutsuko Hirata-Koizumi, Mika Takahashi, Mariko Matsumoto, Tomoko Kawamura, Atsushi Ono, Akihiko Hirose","doi":"","DOIUrl":"","url":null,"abstract":"Phthalate esters are widely used as plasticizers in polyvinyl chloride products. Because of human health concerns, regulatory authorities in Japan, US, Europe and other countries control the use of di(2-ethylhexyl) phthalate, diisononyl phthalate, di-n-butyl phthalate, butylbenzyl phthalate, diisodecyl phthalate and di-n-octyl phthalate for the toys that can be put directly in infants' mouths. While these regulatory actions will likely reduce the usage of phthalate esters, there is concern that other plasticizers that have not been sufficiently evaluated for safety will be used more frequently. We therefore collected and evaluated the toxicological information on di(2-ethylhexyl) terephthalate (DEHT), 1,2-cyclohexanedicarboxylic acid, diisononyl ester (DINCH), diisononyl adipate (DINA), 2,2,4-trimetyl-1,3-pentanediol diisobutyrate (TXIB), tri-n-butyl citrate (TBC) and acetyl tri-n-butyl citrate (ATBC) which were detected at a relatively high frequency in toys. The collected data have shown that chronic exposure to DEHT affects the eye and nasal turbinate, and DINCH exerts effects on the thyroid and kidney in rats. DINA and TXIB have been reported to have hepatic and renal effects in dogs or rats, and ATBC slightly affected the liver in rats. The NOAELs for repeated dose toxicity are relatively low for DINCH (40 mg/kg bw/day) and TXIB (30 mg/kg bw/day) compared with DEHT, DINA and ATBC. DEHT, TXIB and ATBC have been reported to have reproductive/developmental effects at relatively high doses in rats. For DINA and TBC, available data are insufficient for assessing the hazards, and therefore, adequate toxicity studies should be conducted. In the present review, the toxicity information on 6 alternatives to phthalate plasticizers is summarized, focusing on the effects after oral exposure, which is the route of most concern.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"31-42"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127735","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Study on recent status of development of genetically modified animals developed not for food purposes]. [非食用性转基因动物发展现状研究]。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

Osamu Nakajima, Hiroshi Akiyama, Reiko Teshima

{"title":"[Study on recent status of development of genetically modified animals developed not for food purposes].","authors":"Osamu Nakajima, Hiroshi Akiyama, Reiko Teshima","doi":"","DOIUrl":"","url":null,"abstract":"Genetically modified (GM) animals can be classified into two groups, those developed for food purposes and those developed not for food purposes. We investigated the recent status of development of GM animals developed not for food purposes. Among the GM animals developed not for food purposes, GM fish, chickens, and pigs were selected because many articles have been published on these organisms. Relevant articles published between 2008 and 2011 were surveyed using PubMed and transgenic fish, chicken, or pig as keywords. Then, studies on organisms that could potentially contaminate the food chain with products from these GM animals were selected and analyzed. Fifteen articles on GM fish were found. These articles were classified into four categories: bioreactor (n = 4), resistance to microorganisms (n = 6), resistance to environmental stresses (n = 1), and detection of chemicals (n = 4). Zebrafish were used in 8 of the articles. Six, three, and three articles were reported from Taiwan, Canada and China. Seven articles on GM chickens were found. These articles were classified into two categories: bioreactor (n = 5), and resistance to pathogens (n = 2). Two articles were reported from Japan and Korea, each. As for GM pigs, 43 articles were found. These articles were classified into three categories: xenotransplantation (n = 36), bioreactor (n = 6), and environmental cleanup (n = 1). Nineteen, seven, six, and five articles were reported from USA, Germany, Korea and Taiwan, respectively. Understanding the recent development of GM animals produced not for food purpose is important for assuring the safety of food.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"50-7"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31127738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

[Trends in drug-induced liver injury based on reports of adverse reactions to PMDA in Japan]. [基于日本PMDA不良反应报告的药物性肝损伤趋势]。

Bulletin of National Institute of Health Sciences Pub Date : 2012-01-01

Chie Sudo, Keiko Maekawa, Katsunori Segawa, Tadaaki Hanatani, Kimie Sai, Yoshiro Saito

{"title":"[Trends in drug-induced liver injury based on reports of adverse reactions to PMDA in Japan].","authors":"Chie Sudo, Keiko Maekawa, Katsunori Segawa, Tadaaki Hanatani, Kimie Sai, Yoshiro Saito","doi":"","DOIUrl":"","url":null,"abstract":"Reports on drug-related adverse reactions from manufacturing/distributing pharmaceutical companies or medical institutions/pharmacies are regulated under the Pharmaceutical Affairs Law of Japan, and this system is important for post-marketing safety measures. Although association between the medicine and the adverse event has not been clearly evaluated, and an incidence may be redundantly reported, this information would be useful to roughly grasp the current status of drug-related adverse reactions. In the present study, we analyzed the incidence of drug-induced liver injury by screening the open-source data publicized by the homepage of Pharmaceutical and Medical Devices Agency from 2005 to 2011 fiscal years. Major drug-classes suspected to cause general drug-induced liver injury were antineoplastics, anti-inflammatory agents/common cold drugs, chemotherapeutics including antituberculous drugs, antidiabetics, antiulcers and antiepileptics. In addition, reported cases for fulminant hepatitis were also summarized. We found that antituberculous isoniazid and antineoplastic tegafur-uracil were the top two suspected drugs. These results might deepen understanding of current situations for the drug-induced liver injury in Japan.","PeriodicalId":35462,"journal":{"name":"Bulletin of National Institute of Health Sciences","volume":" 130","pages":"66-70"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31126013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0