Volume 44,
Issue 12,
2016
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扉・目次
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Source:
薬理と治療 44巻12号, 1697-1698 (2016);
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TOPICS
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Source:
薬理と治療 44巻12号, 1701-1709 (2016);
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SERIES 医療の現場から⑥
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Source:
薬理と治療 44巻12号, 1711-1715 (2016);
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REVIEW
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Source:
薬理と治療 44巻12号, 1717-1732 (2016);
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ORIGINAL ARTICLES
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薬理と治療 44巻12号, 1733-1739 (2016);
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Background/Aim Helicobacter pylori(H. pylori)is recognized as the major cause of gastritis and gastric ulcer diseases in patients. In the present study, we investigated whether OKUSA-ICHOYAKU, a gastroprotective drug which is a combination of the Phellodendron Bark and 7 powdered herbal medicines, protects the H. pylori-induced gastritis in Mongolian gerbils. Methods Mongolian gerbils were infected with H. pylori, and they were administered OKUSA-ICHOYAKU (1000 mg╱kg)or berberin(0.3 mg╱kg)twice daily for 4 weeks, starting from 1 day after H. pylori infection. Four weeks after H. pylori infection the gastric mucosa was evaluated both macro- and microscopically. Viable H. pylori counts and myeloperoxidase activity were also determined after the treatment with these drugs for 4 weeks. Results Mongolian gerbils exhibited various pathological changes in the gastric mucosa after H. pylori infection, including edema, bleeding and congestion. OKUSA-ICHOYAKU given for 4 weeks suppressed these pathological changes associated with H. pylori infection, in particular gastric bleeding. Similar effects were obtained by the repeated treatment with berberin, a major ingredient of obacunone. Viable H. pylori counts were significantly reduced by the repeated treatment with OKUSA-ICHOYAKU as well as berberin, although either of these drugs did not significantly affect the increase in myeloperoxidase activity in H. pylori-infected stomach. Conclusion OKUSA-ICHOYAKU shows the preventive effect against gastritis induced in Mongolian gerbils by H. pylori infection, and this effect may be partly accounted for by the effect of berberin. It is assumed that daily intake of this drug might be useful for the prophylactic treatment of H. pylori-associated gastric diseases in patients.
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Source:
薬理と治療 44巻12号, 1741-1756 (2016);
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Objectives To examine the safety and efficacy of mitiglinide╱voglibose fixed-dose combination tablets(mitiglinide calcium hydrate╱voglibose), a post-marketing surveillance was conducted in patients with type 2 diabetes. Methods This surveillance was conducted using a prospective central registration method. Patients were observed for 12 months or until discontinuation of the drug. Information including patient backgrounds, drug administration status, concomitant medications, adverse events, and laboratory values was collected. Results In total, 124 adverse drug reactions were observed in 101(5.55%)of 1819 patients. The most frequent adverse drug reaction was hypoglycemia; 26 events occurred in 22 patients (1.12%). Two severe hypoglycemia events were observed in 2 patients, both of whom recovered with appropriate treatment. There was no increase in the cumulative incidence of adverse drug reactions with long-term treatment. HbA1c was 7.48±1.23% at the baseline and 6.89±0.95% at 12 months after treatment, and was significantly decreased at all time points from 3 months after treatment, as compared with the start of treatment(P<0.0001). Conclusions No increase in adverse drug reactions or the incidence of hypoglycemia was observed with long-term administration of GLUBES® combination tablets, such that there were no new safety concerns. The therapeutic efficacy on diabetes persisted for up to 12 months.
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薬理と治療 44巻12号, 1757-1762 (2016);
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Objective The present study examined the effects of Kaempferia parviflora extract (KPE) supplementation on energy metabolism and fat utilization rate in healthy subjects. Methods A randomized double-blind crossover study was conducted to assess the effect of a single oral intake of KPE on 15 healthy volunteers. Respiratory quotient(RQ)and parameters of heart rate variability were determined during constant low-intensity exercise(30% of maximal oxygen consumption)after intake of the test food. Results After excluding outliers, the number of subjects analyzed was twelve. There were no significant differences in any of the parameters of heart rate variability between the placebo and KPE groups. Single oral intake of KPE significantly attenuated the increase of RQ by exercise compared to the placebo. Conclusion Our data suggest that a single oral intake of KPE increases the rate of fat utilization during exercise at a constant intensity, and is a potential tool for the prevention and improvement of obesity and metabolic syndrome.
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Source:
薬理と治療 44巻12号, 1763-1770 (2016);
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Objectives This study was performed to evaluate the safety of excessive consumption of alpha linolenic acid-enriched diacylglycerol(ALA-DAG). Methods A randomized, double-blind controlled, parallel-group trial was performed in 40 healthy subjects. The subjects were randomly allocated to either the control triacylglycerol (TAG)or ALA-DAG consumption groups. Daily consumption was set at 12.5 g╱d, which is five times the effective dose against visceral obesity. Safety parameters were assessed at the 0, 2, and 4 wk time-points. Results All subjects(n=20╱group)completed the study, and were included in the intention-to-treat samples. No adverse events associated with consumption of ALA-DAG occurred, based on blood biochemistry, hematology, or urinary analyses of the intention-to-treat samples. Conclusions The results suggest that excessive consumption of dietary ALA-DAG is safe in healthy subjects.
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薬理と治療 44巻12号, 1773-1783 (2016);
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Objective In recent years, the ingestion of bilberry extract has been reported to improve visual function. However, there are insufficient clinical studies on the efficacy of bilberry extract for the improvement of visual display terminals(VDT)-induced eye fatigue. Therefore, we examined the safety and efficacy of bilberry extrac(t BILBERON(R))on VDT-induced eye fatigue and eye dryness. Methods In this human trial, healthy adult subjects with subjective eyestrain who were exposed to VDT work for over 4h╱day were recruited. The subjects were randomly divided into 2 groups(n=11╱group)and ingested either 120 mg╱day BILBERON(R) or placebo capsule orally for 6 weeks. VDT was loaded at the examination days of the before and after 6-week ingestion. Schirmerʼs test was performed before VDT load to assess eye dryness, and the following investigations were performed before and after VDT load: miosis frequency, near point pupil diameter(NPD), and far point pupil diameter examination to determine accommodative function, critical flicker frequency(CFF)to assess eye fatigue, and a Likert scale questionnaire for subjective symptoms. Results Significant improvements were observed in amount of tears, NPD, and eye fatigue sensation in the test product group, as compared to those in the placebo group, after the 6-week ingestion period. Moreover, a measure of eye fatigue(CFF at red light)showed a significant decrease in the placebo group, as compared to those in the test product group, indicating a suppression of the accumulative eye fatigue in the test product group. Discussion Healthy subjects with subjective eyestrain showed improvements in VDT-induced eye dryness, accommodative function, eye fatigue and eye fatigue sensation following ingestion of 120 mg╱day bilberry extract(BILBERON(R))for 6 weeks. In addition, the test product appeared to be safe under the conditions employed in the present study.
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Source:
薬理と治療 44巻12号, 1785-1793 (2016);
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BARLEYmax 含有食品(ショートバー,クッキー形態で,BARLEYmax の摂取量として12,24,48g╱day に設計)の摂取が便通に及ぼす影響を確認するために,便秘傾向者15 名(42.9±9.8 歳)を対象として試験を行った。試験はランダム化二重盲検並行群間比較法にて実施した。対象者は,BARLEYmax含有食品(ショートバー,クッキー形態で,BARLEYmax の摂取量として12,24,48 g╱day に設計)を4 週間摂取し,その結果BARLEYmax 12g╱day 以上の摂取量で,排便回数・排便量の改善効果が確認された。本試験結果よりBARLEYmax含有食品の摂取は,便秘傾向者の便通改善に役立つことが示唆された。
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Source:
薬理と治療 44巻12号, 1795-1819 (2016);
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目的 本研究はにんにく卵黄含有サプリメント過剰摂取の安全性を非盲検試験にて評価した。方法 医師の判断により適格性を評価された日本人男女32 名を選抜した。試験参加者はにんにく卵黄含有サプリメントを1 日15 粒(通常の5 倍量),4週間摂取した。後観察期間を2 週間とした。摂取前,摂取2 週後,摂取4 週後,摂取終了2 週後に身体測定・理学検査,内科的検査,末梢血液検査,尿検査,自覚症状により安全性を評価した。試験参加者全体を解析したほか,サブグループとして試験食品摂取前のLDL-コレステロール値が正常域である健常者のグループ(正常域群)と,試験食品摂取前のLDL-コレステロール値が高め(120~139 mg╱dL)の者のグループ(境界域群)を構築し,層別解析を行った。結果 医師の判断のもと,介入期間を通じて重篤な疾病や有害事象は認められなかった。試験参加者全体およびサブグループにおける解析の結果,摂取前と比較して,身体測定・理学検査,末梢血液検査,自覚症状の検査では,有意な変動が散見されたが基準値の範囲内であった。尿検査でも摂取後に変動する傾向がみられたが,臨床的な問題はないと判断された。内科的検査の結果,軽微な有害事象が示されたが試験食品摂取との因果関係はなかった。結論ヒ トがにんにく卵黄含有サプリメントを通常の5 倍量である1 日15 粒を4 週間摂取した際の安全性が認められた。【利益相反】本試験食品は㈱てまひま堂により提供された。試験実施は㈱てまひま堂より㈱オルトメディコに委託され,㈱オルトメディコと医療法人社団盛心会タカラクリニックにて行われた。
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薬理と治療 44巻12号, 1821-1830 (2016);
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Objective We assessed safety and efficacy of heat-killed Enterococcus faecalis strain EC-12 (EC-12)regarding the molarity concentrations of organic acids in intestinal microflora in a randomized placebo controlled double-blind paralleled study. Methods A total of 48 Sub-optimal healthy Japanese adult women, 21-68 years old, were agreed to participate the study. 34 subjects were selected and 14 subjects were interviewed and excluded by a physician because of no Bifidobacterium levels. Subjects were randomly assigned to two groups(an EC-12 group and a placebo group). They consumed a capsule either 200 mg EC-12 or 200 mg dextrin in daily for 4 weeks. Intestinal microflora was assessed using terminal restriction fragment length polymorphism(T︱RFLP)analysis at baseline and 4 weeks after ingestion of EC-12 or placebo capsule. Fecal organic acids were also measured. Results A total of 25 subjects(EC-12 group, n=12; placebo group, n=13)completed the study. The primary endpoint of Bifidobacterium levels was significantly increased in the EC-12 group from the baseline to at 4 week after ingestion(P=0.002). Secondary endpoints of butyric acid and, propionic acid were also significantly increased in the EC-12 group(P=0.027, P=0.009, respectively). There are no adverse events, and safety parameters were no difference between two groups. Conclusion These results indicate that EC-12 was able to increase Bifidobacterium levels and fecal organic acids. In addition, the EC-12 are safe to ingest.
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薬理と治療 44巻12号, 1831-1839 (2016);
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Objectives In the present study, the dose response effect of soy peptide supplementation on cognitive function was examined. Methods A randomized, double-blind, placebo-controlled study was performed in 60 healthy male subjects aged between 20 and 22 years. The groups were as follows: soy peptide group receiving medium dose(4 g): n=20, soy peptide group receiving low dose(2g): n=20, placebo group: n=20. Psychological tests were performed at baseline and after two-weeks of supplementation with the test foods. Results The performance of subjects in the Uchida-Kraepelin test showed a dose-dependent effect of soy peptide supplementation. Subjects in the soy peptide groups showed significantly improved performance in the recognition memory test. Subjective evaluation using the visual analogue scale demonstrated that a medium dose of soy peptide reduced fatigue and stress after the psychological tests. Conclusions The present study suggests that daily supplementation with soy peptide, even at low doses, improves cognitive abilities, including memory recognition and sustained attention.
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INFORMATION
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Source:
薬理と治療 44巻12号, 1843-1845 (2016);
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薬理と治療 44巻12号, 1847-1857 (2016);
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Source:
薬理と治療 44巻12号, 1859-1862 (2016);
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