薬理と治療
Volume 40, Issue 3, 2012
Volumes & issues:
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扉・目次
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TOPICS
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- 第11回CRCと臨床試験のあり方を考える会議 2011 in 岡山
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【シンポジウム3 /ファーマコゲノミクス解析をめぐる最近の現状/講演1】 ここまでわかってきたPGx-臨床応用の意義-
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【シンポジウム3 /ファーマコゲノミクス解析をめぐる最近の現状/講演2】 医薬品開発におけるPGx への規制(ICH トピック,製薬協,学会ガイドライン)
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【シンポジウム3 /ファーマコゲノミクス解析をめぐる最近の現状/講演3】 抗がん剤治験におけるファーマコゲノミクス(PGx)解析の現状-検体を提供する立場から-
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【シンポジウム3 /ファーマコゲノミクス解析をめぐる最近の現状/講演4】 生命倫理の立場から-審査のポイントと分かりやすい説明書-
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【シンポジウム4 /円滑な国際共同治験のために-グローバル治験が当たり前にできるヒント-/講演1】 国際共同治験における役割分担-治験依頼者の立場から-
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【シンポジウム4 /円滑な国際共同治験のために-グローバル治験が当たり前にできるヒント-/講演2】 国際共同治験におけるCRO,依頼者,医療機関の関係- CRO の立場から-
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【シンポジウム4 /円滑な国際共同治験のために-グローバル治験が当たり前にできるヒント-/講演3】 国際共同治験における医療機関としての課題と取り組み
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【シンポジウム4 /円滑な国際共同治験のために-グローバル治験が当たり前にできるヒント-/講演4】 CRC 業務の次のステップ- FDA 査察を経験して-
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ORIGINAL ARTICLES
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わが国における臨床研究に関する医師の意識調査―Web を用いたアンケート結果による考察―
40巻3号(2012);View Description Hide DescriptionBackground In Japan, clinical trials of investigational new drugs must be conducted in accordance with GCP enforced by law;however, there is still no legislation regulating other clinical researches. They are completely different from the standards in the Western countries, which have a legal framework for the conduct of human clinical research. It aims to ensure the health and safety of participants, ethical soundness, and the reliability of the data generated from clinical research. This study aimed to survey physicians’awareness of clinical researches, including this double standard, and to examine the best way to conduct and enhance clinical research in Japan. Methods We carried out an Internet-based questionnaire survey of Japanese physicians in September 2011. Results A total of 500 physicians were regarded object of the analysis. Only 34.2% of them understood the Ethical Guidelines for Clinical Studies, which tended to be understood better than GCP. There were significant differences in the understanding of the Ethical Guidelines for Clinical Studies between the number of physicians experienced in clinical research, the number of physicians experienced in clinical trials of investigational new drugs and the institutions the physicians were affiliated to. In addition, 79% of them were not aware of the difference between the Ethical Guidelines for Clinical Studies and GCP;significant differences were found in the understanding of it between the number of physicians experienced in clinical research and clinical trials of investigational new drugs. Therefore, more than 60% of the respondents were aware of the double-standard issue, which was related to the number of physicians experienced in clinical research and clinical trials of investigational new drugs. Furthermore, nearly all believed that it is important for physicians to promote and enhance clinical research, which tended to be more important than to promote and enhance clinical trials of investigational new drugs. There were significant differences in the promotion of clinical research between the number of physicians experienced in clinical research, the number of physicians experienced in clinical trials of investigational new drugs, the institutions the physicians were affiliated to, the understanding of Ethical Guidelines for Clinical Studies, and the understanding of GCP. Conclusion Additional education on the Ethical Guidelines for Clinical Studies is needed for physicians, particularly in general hospitals and clinics. The result of this survey indicates that there is room for improvement in the implementation structure of clinical research should be carefully considered. -
L-ornithine-L-aspartate Improves Alcohol-derived Fatigue Feeling in Flushers―A Questionnaire Study―
40巻3号(2012);View Description Hide DescriptionObjectives Residual alcohol effects on physiological and psychological symptoms are commonly experienced the next morning after alcohol consumption. The purpose of this study was to assess the efficacy of L-ornithine-L-aspartate(a stable salt of L-ornithine and Laspartate;LOLA)on alcohol-induced mood states observed the next morning. Methods This study was randomized, placebo-controlled, double-blind cross over design.Healthy adult Japanese, consisting of 20 non-flushers and 11 flushers, drank alcohol(0.4 g/kg body weight)between 2 and 2.5 hours before daily bedtime. Thirty minutes after finishing drinking, they ingested placebo or 800 mg of LOLA. At daily bedtime, they answered a drunkenness questionnaire. The next morning, they completed the Oguri-Shirakawa-Azumi sleep inventory, MA version(OSA-MA)and Visual Analog Scale(VAS)of mood when they woke up. Results There were no significant differences between LOLA and placebo in any of the typical feelings evoked at night after drinking or the subjective feelings when they woke up the next morning. However, when non-flushers and flushers were analyzed separately, ingestion of LOLA significantly improved“Initiation and maintenance of sleep”in the OSA-MA, and “Feeling of fatigue”and“Sleeping contentment”in the VAS in flushers, but not in nonflushers. Conclusions Taking 800 mg of LOLA after drinking alcohol may improve the quality of sleep and therefore produce a better mood state when awakened in the morning in flushers. -
柑橘由来フラボノイドの Hesperetin による血管内皮細胞の NADPH オキシダーゼ抑制作用
40巻3号(2012);View Description Hide DescriptionObjectives We have previously reported that glucosyl hesperidin(GHES), a water-soluble hesperidin derivative, improves endothelial dysfunction and reduces oxidative stress in spontaneously hypertensive rats(SHR). A detailed mechanism of GHES on vascular endothelial cells remains obscure. The aim of this work is to investigate the effects of hesperetin, a metabolite of GHES, on NADPH oxidase in endothelial cells isolated from SHR aorta.Methods Endothelial cells isolated from SHR aorta were incubated for 24 hours with hesperetin(10 and 50 μM). mRNA expression of NADPH oxidase subunits was measured byquantitative real-time polymerase chain reaction. NADPH oxidase activity was assessed by measuring O2・- production as lucigenin-enhanced chemiluminescence. Results In endothelial cells, hesperetin suppressed gene expression of p22phox, a membrane subunit of NADPH oxidase(50 μM, p<0.01 vs. control). Furthermore, NADPH oxidase activity was significantly inhibited by hesperetin treatment(50 μM, p<0.01 vs. control). Conclusions These results indicate that hesperetin acts directly on endothelial cells and reduces oxidative stress by repressing p22phox expression and NADPH oxidase activity,thereby ameliorating endothelial dysfunction. -
紅茶ポリフェノール高含有紅茶飲料の長期摂取が鉄代謝へ及ぼす影響について
40巻3号(2012);View Description Hide DescriptionObjectives It is shown that some of dietary polyphenols inhibit the absorption of dietary iron. A placebo-controlled, parallel-group trial was carried out to investigate whether iron deficit would be caused by the inhibition of iron absorption when healthy volunteers consume the newly developed black tea polyphenols(BTP)-enriched black tea beverage(BTP beverage)daily with meal for 12 weeks. Methods 80 healthy volunteers were divided into four groups who consumed either three bottles of BTP beverage, one bottle of BTP beverage, one bottle of regular black tea beverage or one bottle of placebo everyday for 12 weeks. Each bottle contained 350 mL of each beverage. The subjects who consumed three bottles of BTP beverage(BTP3 group)consumed a bottle of the beverage at every meal(three times per day)and the subjects in the other groups consumed a bottle of each beverage daily at dinner. Blood samples were collected every four weeks. Results Although serum ferritin increased 4 weeks after the termination of the consumption of the BTP beverage in the BTP3 group, blood hemoglobin concentration was increased and no adverse changes were observed in iron metabolism or in parameters for general health during the consumption period. These results indicated that possible inhibition of ironabsorption by the consumption of three bottles of BTP beverage does not cause iron deficit in a healthy population. Conclusion The long-term consumption of three bottles of BTP beverage per day with meals did not cause iron deficit in healthy volunteers.
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