Volume 44,
Issue 10,
2016
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扉・目次
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Source:
薬理と治療 44巻10号, 1397-1398 (2016);
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報告
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Source:
薬理と治療 44巻10号, 1413-1416 (2016);
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2016 年9 月1 日現在,厚生労働省は101 種類の先進医療制度を設けている。将来の保険適用に向けて品質のよいデータ収集を効率的に行う必要がある。とくに,データレビューは被験者の人権保護や安全性保持の重要な役割を果たす。2015 年6 月11 日にStep 2 として発表されたHCH‒E6(R2)では,リスクに基づくアプローチが記載されており,RBM に基づいたデータレビューも注目されている。データレビューツールの候補として,本学内にて学術や研究,教育支援活動で利用可能であったJMP(R) Pro 12のGUI の仕様調査と動作確認を行った。確認結果は,GUI 操作のみで変数名やラベル名に関係なくキーを指定してデータ結合が可能,かつ可視化された図表が動的にデータにリンクできることを確認した。さらに,統計学の基本的な手法やスクリプトも利用できた。ただし,SAS データのユーザー指定フォーマット値は通常のデータの読み込みであると表示にフォーマット値が反映されなく,SAS(R) 環境なしではJMP(R) Pro 12 でSAS プログラムを実行することはできなかった。まとめにあたり,JMP(R) Pro 12 は,解析実施結果の検収試験やデータレビューに有効な手段の一つであると判断した。【利益相反】東京大学医学部附属病院がSAS(R) 9.4とJMP(R)Pro 12 のライセンス費用を支払っており,公開すべき利益相反に該当する事項はない。
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ORIGINAL ARTICLES
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Source:
薬理と治療 44巻10号, 1417-1434 (2016);
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Background Several clinical trials have investigated the impact of coffee-derived mannooligosaccharides on the reduction of abdominal and visceral fat in various kinds of food products, but no systematic review was conducted. Objective The objective was to perform a systematic review with meta-analysis of randomized controlled trials of coffee-derived mannooligosaccharides to better understand its impact on visceral fat reduction in the healthy overweight adults. Design A systematic literature search of scientific databases and register databases for clinical trials and systematic review was conducted. The main outcome measures were abdominal fat area and visceral fat area measured by computed tomography scan. A random-effects model was used to calculate the standardized mean difference and 95% CIs as the difference between the mean for the treatment and placebo groups. Standard methods for assessing statistical heterogeneity and publication bias were used. Results Five studies met the inclusion criteria. The use of coffee-derived mannooligosaccharides reduced the abdominal fat area [standardized mean difference(SMD): -0.99; 95% CI:-1.26, -0.72]and visceral fat area[SMD: -0.66; 95% CI: -0.92, -0.40] No heterogeneity or publication bias was observed in the meta-analysis. Conclusion Coffee-derived mannooligosaccharides might beneficially affect visceral fat in the healthy overweight adults.
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Source:
薬理と治療 44巻10号, 1435-1443 (2016);
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Background Constipation is a common complaint, especially in the elderly. For severe constipation, proactive treatment with medicines is necessary to improve quality of life. Several types of medicines, including Kampo medicines, are used for its therapy. Mashiningan(MNG) is empirically prescribed for constipation in Japan; however, its precise pharmacological effects are not completely understood. In this study, we investigated the effect of MNG on defecation in constipation model rats. Methods MNG(100 and 200 mg╱kg)was orally administered to fiber-free diet-induced constipation model rats. The defecation response was evaluated using the number, weight, and water content of feces. Excretory function was evaluated using carmine red transit rate. Results A fiber-free diet for 3 days reduced the number and dry weight of feces. The dry weight per feces was also significantly lower in the fiber-free diet group than in the normal diet group. Miniaturization and dry surface of feces were macroscopically observed. MNG dose-dependently increased the number, size, and water content of feces in the constipation model rats. Rats on fiber-free diet exhibited slower carmine red transit, which was accelerated by MNG administration. Conclusions The main effect of MNG included softening and swelling of feces, thereby ameliorating defecation dysfunction caused by fiber-free diet. Thus, MNG may be a potentially useful treatment for constipation.
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Source:
薬理と治療 44巻10号, 1445-1454 (2016);
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Objective This study aims to evaluate the improvement effects of orally administrated γ-aminobutyric acid(GABA)on mood status, sleep quality and fatigue in worker. Methods A total of 62 subjects were randomly divided into either the GABA(100 mg╱day) or placebo group. They orally consumed the respective test substance every day for 12 weeks. Perceived mood and quality of sleep were measured by the Profile of Mood States second edition(POMS 2), Pittsburgh Sleep Quality Index(PSQI), Athens Insomnia Scale(AIS), and Visual Analogue Scale for Fatigue(VAS-F). This study was registered in UMIN-CTR (UMIN000019308). Results Compared with the placebo group, the GABA group showed a significant increase the vigor-activity scale measured by POMS 2 at week 6 relative to the baseline(P=0.045). Conclusion Oral administration of GABA could enhance positive feelings such as vigor and energy, in subjects who were aware of fatigue and sleep disorders in their daily life.
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Source:
薬理と治療 44巻10号, 1455-1462 (2016);
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Objectives We developed resistant glucan(RG), a form of purified water-soluble dietary fiber, through the activated carbon-catalyzed poly-condensation of glucose syrup followed by the removal of digestible saccharides. The beneficial physiological functions of RG as a dietary fiber, regarding the postprandial elevation of plasma glucose levels in human subjects, are not yet known. In the present study, we aimed to determine the inhibitory effects of RG on the absorption of sugars in the small intestine of rats, and on its postprandial plasma glucose level in human subjects with mainly borderline diabetes. Methods 1)The inhibitory effect of RG on the absorption of sugars in the small intestine was assessed by measuring the perfusion of glucose, sucrose and maltose in 8-week old male Sprague Dawley rats. 2)The randomized, double-blind, cross-over testing using 62 human subjects examined the inhibitory effects of RG on elevating the postprandial plasma glucose level. The plasma glucose and insulin levels were measured after ingesting 5 g of RG or a placebo(maltodextrin)in the loading meals. Results 1)RG significantly inhibited the absorption of glucose produced by the degradation of maltose. 2)Compared with the placebo, RG significantly inhibited the elevation of plasma glucose levels 60 and 90 min after intake, and lowered the plasma glucose area under the curve. Conclusions These results indicate that RG is a soluble dietary fiber which inhibits the elevation of postprandial plasma glucose levels in humans.
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Source:
薬理と治療 44巻10号, 1463-1469 (2016);
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Objective A randomized, double-blind, placebo-controlled crossover study with non-diabetic individuals was conducted to investigate the suppressive effect of acacia polyphenol (AP)supplement on postprandial blood glucose elevation. Methods The changes in the blood glucose and insulin levels in thirteen individuals were monitored over a period of 120 min after taking either 120 mg of proanthocyanidins(250 mg of AP) or a placebo before consuming 200 g of cooked rice. Results The results showed a significant difference between those who had taken the AP and the placebo with respect to the change in blood glucose level over the time period from 0 min to 60 min after the rice consumption. Both the blood glucose IAUC and insulin IAUC were significantly lower in the group who had been given AP. These results demonstrated that the AP supplement reduced the absorption of carbohydrates and limited the rise of the blood glucose in humans after eating and hence AP may be able to be used in the control of blood glucose in humans suffering from diabetes. Conclusions This study demonstrates that the AP supplement decreases glucose absorption and limits the blood glucose elevation in humans after eating; it also prevents the rapid secretion of insulin. These effects of an AP supplement are beneficial for blood glucose control.
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Source:
薬理と治療 44巻10号, 1471-1479 (2016);
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Background The common cold is widespread and affects all ages and both genders. In many cases, it decreases the quality of life and work productivity. It has been reported that the intake of certain food materials can reduce the incidence or symptoms of the common cold, but the results are conflicting. One reason could be the differences in evaluation methods between studies. We reported that the intake of Lactobacillus pentosus strain b240(B240)decreased the incidence rate of the common cold with dose dependency. We excluded allergic patients from our study as their symptoms were similar to that of patients with common cold. However, several subjects took an anti-allergic drug during the study period. Therefore, we reanalyzed the data after excluding these subjects from the per protocol set and assessed whether their exclusion led to accurate estimation of the incidence of the common cold. Methods Data analyzed in this study were obtained from a previously reported, randomized, double-blind, placebo-controlled study of 300 healthy elderly adults, to estimate the reduction in common cold incidence by taking B240. We conducted subgroup analysis by excluding subjects who took an anti-allergy drug during the study period and reviewed the results. Results By excluding data for anti-allergy drug users, we confirmed that the intake of both 20 billion B240(P=0.018)as well as the intake of 2 billion B240(P=0.040)reduced the incidence of the common cold. This effect was dose-dependent. Conclusions Our results suggest that we can precisely evaluate the effect of food materials on the common cold by excluding data for those who took an anti-allergy drug during the study.
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Source:
薬理と治療 44巻10号, 1483-1494 (2016);
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目的本研究は,うなぎコラーゲンペプチドの摂取がヒトの肌環境に及ぼす影響を,ランダム化プラセボ対照二重盲検並行群間比較試験にて評価した。方法健康で肌に悩みを感じる日本人女性14 名を選抜した。参加者はうなぎコラーゲンペプチド入りおにぎり群(EC 群,コラーゲンタンパク量として1日摂取量:5.25 g,ヒドロキシプロリン量として1 日摂取量:294 mg)とデキストリン入りおにぎり群(プラセボ,P 群)にランダムに割り付けられ,各群ともに1 個20 g のおにぎりに配合して1 日3 個,8週間摂取した。摂取前と摂取8 週後に肌の水分値,色素沈着数,色素沈着総面積の測定および安全性を評価した。結果EC 群6 名(平均年齢42.5±9.5 歳),P 群7 名(平均年齢41.7±7.1 歳)を分析対象者とした。摂取前後の変化量では,P 群と比較してEC 群の肌における水分値が有意に高値を示し(P=0.0013),色素沈着数と色素沈着総面積が有意に低値を示した(P=0.045,0.049)。結論本研究においてうなぎコラーゲンペプチドの継続摂取は,肌に悩みを感じる健常な日本人女性において,肌の水分量を増加し,色素沈着を抑制した。【利益相反】本研究は経済産業省の地域資源活用事業(平成24 年5 月23 日,関東第70 号)より助成金を得た。本研究食品は㈲勝美により提供された。また試験実施は㈲健康評価センターの出資により行われた。【謝辞】本研究にご協力いただきました試験参加者,測定スタッフに感謝の意を表します。また,試験食品を提供してくださった㈲勝美に深く感謝申し上げます。
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Source:
薬理と治療 44巻10号, 1495-1504 (2016);
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Objective A randomized double-blind placebo-controlled study for 12 weeks was conducted on 46 subjects to evaluate the safety of the food containing olive and grape seed polyphenols in the case of long︱term intake in healthy adults. Methods The subjects(23 males and 23 females; mean age, 39.9±9.3 years old)were randomly divided into two groups, one is test group and the other is placebo group. The test group ingested daily 4 capsules of test food including 50 mg of olive extract containing 6 mg of hydroxytyrosol and 75 mg of grape seed oligomeric proanthocyanidins for 12 weeks. On the other hand, the placebo group ingested the same amount of placebo food for the same duration. The incidence and severity of side effects or adverse events were monitored during the study period. Results No adverse event attributed to the test food was found in the study. The incidence of adverse events were 29.2% or 20.8% in the placebo or test food group respectively, which was no statistically significant difference. No clinically significant changes in the vital signs, blood parameters and urine parameters were observed during the study period. Conclusions Thus, these results indicated the safety of the food containing olive and grape seed polyphenols in the case of long-term intake.
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CASE REPORT
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Source:
薬理と治療 44巻10号, 1507-1511 (2016);
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Daptomycin はMethicillin-resistant Staphylococcusaureus に抗菌活性を有する薬剤である。適応疾患として感染性心内膜炎があるが,海外第Ⅲ相臨床試験の結果より右心系のみ適応があり,左心系には適応がない。また,左心系感染性心内膜炎に対してDAPを使用した報告例は本邦ではまれである。今回,左心系感染性心内膜炎患者にDAP を投与し感染症のコントロールが図れた1例を経験したので報告する。症例は87 歳,男性で,高度腎機能障害(CCr 23.1mL╱分)のため,DAP を1 回300 mg(7 mg╱kg)で隔日投与した。その結果,DAP 投与開始後7 日目の血液でMRSA の陰性化が確認された。DAP 投与開始時のWBC,CRP は,それぞれ11,900╱μL,15.3mg╱dL であったのが,投与19 日目(転院時)には38 度以上の発熱がなく,WBC 5500╱μL,CRP 6.97 mg╱dLとなった。これらのことから,DAP はMRSAによる左心系感染性心内膜炎の治療選択肢になる可能性があると考えられる。【利益相反】著者全員において,本論文に関する利益相反はない。
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INFORMATION
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Source:
薬理と治療 44巻10号, 1517-1521 (2016);
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Source:
薬理と治療 44巻10号, 1523-1533 (2016);
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Source:
薬理と治療 44巻10号, 1534-1537 (2016);
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