薬理と治療
Volume 41, Issue 6, 2013
Volumes & issues:
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扉・目次
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TOPICS:第12 回CRC と臨床試験のあり方を考える会議 2012 in 大宮
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【セッション4 /原資料マネジメントを再考する-質保証と効率の両立】 原資料マネジメントのあり方-海外のCRC の実践から
41巻6号(2013);View Description Hide Description私は, 平成23 年10 月~ 11 月にオーストラリア・クイーンズランド州に滞在し,現地のCRC 業務を視察する機会を得た。今回は,現地のCRC の原資料マネジメント業務を紹介するとともに,日本とオーストラリアの業務の違いから,日本でALCOACEEA の概念に沿った原資料マネジメントを実施するために必要な点について,私見を述べたい。 -
【セッション4 /原資料マネジメントを再考する-質保証と効率の両立】 原資料マネジメントのあり方- Global 監査の観点から
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【セッション6 /医療機器臨床試験における安全性データの収集と評価】 医療機器臨床試験における安全性データの収集と評価-依頼者の立場から
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【セッション6 /医療機器臨床試験における安全性データの収集と評価】 医療機器臨床試験における安全性データの収集と評価-実施医療機関の立場から
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【セッション6 /医療機器臨床試験における安全性データの収集と評価】 医療機器臨床試験における安全性データの収集と評価-規制当局の立場から
41巻6号(2013);View Description Hide Description
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DRUG PROFILE SERIES
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食事パターンにより用法・用量を調節できる選択的 DPP-4 阻害薬―2 型糖尿病治療薬―アナグリプチン(スイニー錠 100 mg)の基礎と臨床
41巻6号(2013);View Description Hide Description
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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一般市民の意識調査―Web を用いたアンケート結果による考察―
41巻6号(2013);View Description Hide DescriptionBackground In Japan, clinical trials of investigational new drugs must be conducted in accordance with GCP as enforced by law;however, there is still no legislation regulating other clinical researches. This study aimed to survey public awareness of clinical researches, including this double standard, and to discover the best way to conduct clinical research in Japan. Methods We administered an Internet-based questionnaire to the general public in March 2013. Results Only 20.0% of the respondents understood“Clinical Research,”which tended to be understood less than“Clinical Trial of Investigational Drug.”In addition, 86.6% of the respondents were not aware of the difference between“Clinical Research” and “Clinical Trial of Investigational New Drug.”On the other hand, 68.6% of the respondents were aware of the double-standard issue. Furthermore, people are not inclined to participate or cooperate in clinical research, and they appear to be more reluctant to participate in clinical research than in clinical trials of investigational new drugs. There were significant differences in the interest in participation or cooperation in clinical research between the experience and understanding in clinical research. Conclusion More public education on clinical research is needed. The result of this survey indicates that it is important for further growth of clinical research to improve people’s understanding of clinical research. There is also room for improvement in the implementation of clinical research to foster greater understanding and appreciation in general. -
臨床研究の歴史的背景・制度・実施体制に関する日米英の比較とわが国における改善策
41巻6号(2013);View Description Hide DescriptionBackground Finding stronger evidence in clinical research is important for improving the quality of medical care, and more importantly, for protecting national health. However, the clinical research system in Japan appears immature relative to those in the United States and Europe. To explore how clinical research in Japan can be improved, we conducted a comparative survey on the present status of clinical research in various locations. Methods We reviewed the existing literature on the historical background, systems, and frameworks of clinical research in Japan, the United States, and the United Kingdom. Results Commitments must be made to support and protect study participants, ethical committees, and researchers;to secure adequate government funds;and to establish an information sharing system among researchers, government, and the public. Conclusion It is important to establish a framework for the duties of the government and central organization toward supporting clinical research and training researchers to improve the quality of medical care. -
パクリタキセル注射液「NP」のマウス白血病L1210 細胞に対する抗腫瘍効果
41巻6号(2013);View Description Hide DescriptionAntitumor activity of generic drug Paclitaxel injection「NP」was examined in the system of murine L1210 leukemia, compared with that of original drug Taxol injection. Repeatedly intraperitoneal administrations of 6 and 12 mg/kg/day for 5 days of each paclitaxel increased significantly in life-span in mice with L1210 leukemia. No differences in the activity were observed between Paclitaxel injection「NP」and Taxol injection. Thus, it was concluded that both injections exert equivalent antitumor activity. -
Benifuuki Tea Suppresses Histamine Signaling and Matrix Metalloproteinase-9 Expression in TDI-Sensitized Nasal Allergy Model Rats
41巻6号(2013);View Description Hide DescriptionGreen tea has been reported to have various beneficial properties, including anti-influenza, anticancer, and anti-allergic effects. Benifuuki green tea(BGT), which contains O-methylated catechin, has been shown to significantly relieve the symptoms of perennial or seasonal allergic rhinitis. In this study, we investigated the effects of BGT in the nasal mucosa of toluene 2,4-diisocyanate(TDI)-sensitized nasal allergy model rats. Five-week-old male, brown Norway rats were sensitized for 2 weeks with 10 μL of 10% TDI. TDI-sensitized rats were fed a BGT-free diet or a 1% or 2% BGT diet immediately following TDI treatment. After a 10-day interval, provocation was initiated with the same amount of TDI. Nasal symptoms were scored for 10 min immediately after TDI provocation, and gene expression in the nasal mucosa was determined using real-time quantitative RT-PCR. The BGT diet suppressed TDI-induced nasal allergy-like symptoms, such as sneezing and watery rhinorrhea. TDI provocation caused a significant upregulation in the expression of histidine decarboxylase (HDC), histamine H1 receptor(H1R), and matrix metalloproteinase(MMP)-9, while consumption of the BGT diet significantly suppressed the mRNA levels of these targets. These results demonstrated that consumption of BGT alleviates nasal symptoms by the inhibition of histamine signaling through suppression of TDI-induced HDC and H1R gene expression. Moreover, BGT also suppressed the expression of MMP-9. Suppression of histamine signaling and MMP-9 gene expression may be a novel mechanism through which consumption of BGT prevents allergic diseases. Thus, O-methylated catechin may be useful as an anti-allergic drug for the treatment of Japanese cedar pollinosis. -
褥瘡モデルラットにおけるコラーゲンペプチド経口摂取の褥瘡治癒促進効果
41巻6号(2013);View Description Hide DescriptionObjective Effects of collagen peptide ingestion on healing of skin wound were examined in a rat model of pressure ulcer in comparison with effects of arginine known as a good ingredient. Methods SD rats aged 8 weeks were fed a low protein diet(AIN-93M;10% protein), and pressure ulcers were experimentally induced at 9 weeks of age. 0.2 g/kg/day collagen peptide, or 0.1 or 0.2 g/kg/day arginine was administered twice a day, half of a total daily dose each time. Healing process was compared among the control group and the experimental groups with regard to the daily wound area ratio, sum of daily wound area ratio, time and ratio of healing of pressure ulcer, and biochemical markers of blood. Results Wound area ratio was significantly smaller in the collagen peptide group and the arginine groups compared with the control group. Sum of daily wound area ratio was significantly smaller in the collagen peptide group but not in the arginine groups. Time and ratio of healing was significantly smaller in the collagen peptide group and the 0.2 g/kg/day arginine group. Collagen peptide-derived hydroxyprolylglycine that promotes wound healing of the skin in blood was significantly higher in the collagen peptide group. Conclusions The ingestion of collagen peptide promotes healing of pressure ulcers with effectiveness similar to the ingestion of arginine. The action mechanism of collagen peptide may differ from that of arginine. -
レボセチリジンの好酸球脱顆粒抑制作用
41巻6号(2013);View Description Hide DescriptionObjective Cetirigine hydrochloride(CT)and Levocetirizine hydrochloride(LCT)is well known to be non-sedative histamine H1 receptor antagonists and used for the treatment of the allergic diseases, such as pollinosis and atopic dermatitis with remarkable success. However, the influence of these agents on eosinophil degranulation is not fully understood. The present study, therefore, was undertaken to examine the influence of these agents on eosinophil degranulation, which was assessed by measuring eosinophil cationic protein(ECP)and major basic protein(MBP). Methods Mouse peritoneal exudate eosinophils obtained from BALB/c mice infected with Mesocestoides cortii were sensitized with M. cortii-specific mouse IgE. These sensitized eosinophils were stimulated with M. cortii-excreted antigens(1.0 ng/mL)in the presence of various concentrations with either CT or LCT for 24 hours. The levels of ECP and MBP in culture supernatants were examined by ELISA. We also examined the levels of ECP and MBP in nasal secretions obtained from pollinosis patients treated with LCT once a day for 4 weeks at a single dose of 5 mg by ELISA. Results Treatment of eosinophils with CT at more than 0.15 μM could significantly suppress the appearance of ECP and MBP after antigenic stimulation. The addition of LCT into eosinophil cultures at more than 0.05 μM also significantly inhibited the secretion of ECP and MBP from eosinophils induced by antigenic stimulation. Oral administration of LCT caused significant suppression of the appearance of ECP and MBP in nasal secretions along with attenuation of clinical symptoms. Conclusion These results strongly suggest that the suppressive activity of CT and LCT on eosinophil degranulation consists, in part, of a therapeutic mode of action of the agents on allergic diseases such as pollinosis.
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