薬理と治療
Volume 43, Issue 8, 2015
Volumes & issues:
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扉・目次
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TOPICS:第14 回CRC と臨床試験のあり方を考える会議2014 in 浜松
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- 2.シンポジウム/「臨床研究・治験の普及・啓発」を問いなおす-この10 年とこれから
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【講演3】 一般国民・患者にとって利用しやすい「臨床試験情報検索ポータルサイト」とは?- 2 年間の研究活動から見えてきたもの
43巻8号(2015);View Description Hide Description -
- 5.シンポジウム/研究者主導臨床試験の質の向上へのアプローチ-臨床研究の信頼性確保の取り組み
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REVIEWS
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長時間作用性β2刺激薬・オロダテロールのCOPD に対する臨床的有用性
43巻8号(2015);View Description Hide DescriptionOlodaterol, a once︱daily, long︱acting beta2︱agonist(LABA), has recently been regulatory approved overseas with indication of chronic obstructive pulmonary disease(COPD). It has the pharmacological features of high intrinsic activity in addition to selectivity and affinity for the beta2-adrenergic receptor. Various phaseⅢ clinical trials have shown the high effectiveness of olodaterol in patients with COPD, as well as its excellent clinical benefits including safety comparable to that of placebo. Olodaterol was developed as an inhalation medication to be administered by Respimat. In Japan, future therapeutic contribution of olodaterol is expected mostly in combination with tiotropium, whose clinical benefit has already been established in the treatment of COPD.
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ORIGINAL ARTICLES
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無作為化二重盲検比較法によるヒハツ抽出物含有粉末緑茶の正常高値血圧者ならびにⅠ度高血圧者に対する長期摂取時の血圧降下作用および安全性の検証試験
43巻8号(2015);View Description Hide DescriptionThe efficacy and safety of powdered green tea containing long pepper extract for long term intake as a hypotensive agent was analyzed. The study, designed as a randomized double-blind placebo-controlled parallel-group study, was conducted in individuals with blood pressure in the high normal range and patients with first-degree hypertension. The subjects[60 subjects╱group, 120 subjects in total (male╱female=93╱27, age=26︱64 years old)]took either the test tea[powdered green tea containing 150 mg of long pepper extract(including 90μg of piperine)]or control tea(placebo; powdered green tea free of long pepper extract)once daily for 12 weeks. We observed systolic and diastolic blood pressures, side effect, adverse event, laboratory test data, body weight, and heart rate. The test tea group showed a significant reduction of both the systolic and diastolic blood pressures compared to the placebo group at each time-point of evaluation from Week 1 onward. The results from the stratified analysis by baseline blood pressure classification showed similar to all subjects. No adverse reactions were seen in any of the groups during the study period. These results confirmed that powdered green tea containing long pepper extract exerts a sufficient reduction of both the systolic and diastolic blood pressures, beginning from early as 1 week after the start of intake. Also no safety problems were observed. So, powdered green tea containing long pepper extract is expected to contribute greatly to primary prevention of hypertension. -
ヒハツ抽出物含有粉末緑茶の過剰摂取時の安全性の検討
43巻8号(2015);View Description Hide DescriptionThe safety of excess intake of powdered green tea containing long pepper extract, which was taken at dosage three times the standard amount, was analyzed. The study was conducted in individuals with blood pressure in the normal range, high normal range and patients with first-degree hypertension. The subjects[10 subjects╱group, 30 subjects in tota(l male╱female=24╱6, age=22-63 years old)]took three packs of the test tea[powdered green tea containing 150 mg of long pepper extract(including 90μg of piperine)]once daily for 4 weeks. We observed systolic and diastolic blood pressures, side effect, adverse event, laboratory test data, body weight, and heart rate. Although both of systolic and diastolic blood pressures were a significant reduction compared to the baseline at each time-point of evaluation from Week 1 onward, these results were no individuals with hypotension. Also, although systolic and diastolic blood pressures at Week 4 recovered at Week 6(the period of observation after intake finished)compared to Week 4, these werenʼt exceed baseline. Any abnormal changes in clinical findings such as laboratory test, physical test, and adverse reactions were not observed. These results demonstrate that powdered green tea containing 150 mg of long pepper extract is safe, even when it is taken at an excess amount, because blood pressures and other tests showed no abnormal changes of clinical importance. -
ポリデキストロース含有粉末紅茶飲料の食後血中中性脂肪値上昇抑制効果―プラセボ対照ランダム化二重盲検クロスオーバー試験―
43巻8号(2015);View Description Hide DescriptionObjectives A randomized, double-blind, placebo-controlled, cross-over study was conducted to evaluate the effects of powdered black tea containing polydextrose on postprandial serum triglyceride. Methods The subjects were 90 healthy volunteers whose fasting serum triglyceride levels were from 120 to 199 mg╱dL. The subjects were randomly divided into two groups and ingested a fat-rich diet and either a test drink containing 5 g(as dietary fiber)of polydextrose or a placebo drink without polydextrose. Serum triglyceride levels were measured before and at2, 3, 4, and 6 hours after ingestion. Results The test drink significantly decreased postprandial serum triglyceride levels at 4 hours and area under the curve after the fat︱rich diet was ingested, compared to placebo drink (P<0.05). During this study period, no abnormal changes attributed to test drink were observed. Conclusions These results indicate that powdered black tea containing polydextrose taken with a diet has an inhibitory effect on the postprandial serum triglyceride elevation. -
ケール青汁粉末食品摂取による食後血糖値上昇抑制効果―無作為化プラセボ対照二重盲検クロスオーバー試験―
43巻8号(2015);View Description Hide DescriptionObjectives Kale(Brassica oleracea var. acephala)is a vegetable in the family Brassicaceae. Previous studies have suggested some beneficial effects of kale on health. To explore further evidence, we studied the effects of intake of kale on postprandial blood glucose and insulin levels in volunteers with relatively higher postprandial blood glucose levels in a randomized, double-blind, placebo-controlled crossover trial. Methods The trial was conducted with 19 Japanese subjects(10 males and 9 females aged from 20 to 64 years)with fasting glucose levels less than 126 mg╱dL and a 30︱min postprandial blood glucose level ranging 140-200 mg╱dL. Subjects consumed either placebo or 14 g of test food containing kale together with a carbohydrate-loading diet, and the levels of blood glucose and insulin were determined after 30-120 min. Results The postprandial blood glucose level at 60 min after the intake of test food(158.5±28.4 mg╱dL)was significantly lower than that of the placebo(171.2±25.9 mg╱dL; P=0.035). The maximum blood glucose level between 0 and 120 min following loading diet intake was also reduced significantly in the kale group(167.9±23.3 mg╱dL compared to 177.8 ±21.2 mg╱dL for the placebo group; P=0.044), and the area under the curve of blood glucose level was 286.1±43.8 mg・h╱dL in the kale group and 301.2±36.8 mg・h╱dL in the placebo group(P=0.051). No significant difference between the groups was observed with blood insulin level. There was no serious adverse event.Conclusions Our findings suggest that the consumption of test food containing kale reduces postprandial blood glucose level in subjects with relatively higher fasting blood glucose levels. The intake of kale as much as 14 g at a single dose was safe in humans. -
ゴマペプチドカプセル(KM—20)の12 週間摂取による血圧降下に及ぼす用量相関性および安全性(第2 報)
43巻8号(2015);View Description Hide DescriptionObjective We examined a dose of sesame peptide(KM-20)on changes of blood pressure (BP)in volunteers with either high normal blood pressure or GradeⅠ hypertension. Methods 55 subjects including 34 males and 21 females, whose averaged year was 52.3, were divided 4 groups: Group A was a control group, subjects with BP at 145.5╱88.0; Group B was 250 mg╱day(low-dose), subjects with BP at 144.4╱87.6; Group C was 500 mg╱day(middle-dose), subjects with BP at 145.4╱87.4; Group D was 1000 mg╱day(high-dose), subjects with BP at 149.0╱89.3. Each group was given 4 capsules by orally once a day for 12 weeks. The BP was monitored every three weeks. Results A result of analysis of systolic blood pressure, the Group D showed significant improvement compared with that in the Group A at week 12(P<0.05). On diastolic pressure, the Group D showed significant improvement compared with that in the Group A at week 6(P<0.05)and the Group C improved significantly comparing with the Group A at week 10(P<0.05). A result of stratified analysis of systolic blood pressure with subjects of GradeⅠ Hypertension, Group D showed significant improvement compared with that in the Group A at week 12(P<0.05); on diastolic pressure, the Group D improved significantly comparing with the Group A at week 6(P<0.05). Discussion These results suggested that Sesame peptide(KM-20)would be useful for controlling BP in subjects with high normal blood pressure or GradeⅠ hypertension. Ile-Val-Tyr (IVY), an ingredient concerning to reduce blood pressure, is contained 300μg╱500 mg in sesame peptide(KM-20). Conclusion The optimum dose of sesame peptide(KM︱20)would be a dose either 500 or 1000 mg╱day from this report. -
ターミナリアベリリカ(R)(Terminalia bellirica) 抽出物による食後血中中性脂肪上昇抑制作用の検討―無作為化二重盲検プラセボ対照クロスオーバー試験―
43巻8号(2015);View Description Hide DescriptionObjectives A double-blind placebo controlled crossover clinical study was conducted on healthy adults volunteers to examine the effects of Terminalia bellirica extract on elevation of postprandial serum triglyceride. Methods The subjects were 34 healthy adult volunteers(mean age of 22.1±2.0 years). The subjects were randomly divided to three groups and took a high fat meal(41.6 g fat)with test supplement containing 200 mg or 300 mg Terminalia bellirica extract (the 200 mg group, the 300 mg group), or a placebo supplement(the control group). Serum triglyceride was measured before and 2, 3, 4, and 6 hours after intake of the high fat meal. Results Compared to the control group, the 200 mg group and the 300 mg group had significantly lower serum triglyceride at 2 hours after the high fat meal and IAUC of postprandial serum triglyceride(each P<0.05).Conclusions These results suggested that the Terminalia bellirica extract had inhibitory effect on the elevation of postprandial serum triglyceride. -
健常者を対象としたオリーブおよびブドウ種子ポリフェノールとビタミンC 含有食品摂取による血管内皮機能改善効果の検証―ランダム化プラセボ対照二重盲検交差比較試験―
43巻8号(2015);View Description Hide DescriptionBackground and aim The Mediterranean diet is reported to be effective in preventing cardiovascular disease(CVD). Olive polyphenols, grape seed oligomeric proanthocyanidins and vitamin C are major components of the Mediterranean diet. We evaluated combination effects of these compounds on vascular endothelial function as a surrogate marker for arteriosclerosis and CVD. Methods A randomized, placebo-controlled, double-blind crossover trial was conducted. Seventy-two healthy subjects were randomly assigned to the test food group(50 mg of olive extract containing 6 mg of hydroxytyrosol, 100 mg of grape seed extract containing 60 mg of oligomeric proanthocyanidins and 100 mg of vitamin C)or the placebo group. The subject ingested each supplement for 4 weeks. After a washout period of 2 weeks, the other supplement was ingested for 4 weeks. Results Flow-mediated vasodilation(FMD)was significantly improved by 4 weeks supplementationof the test food, and the change in FMD from baseline to 4 weeks was also significantly greater in the test food group than in the placebo group. Urinary 8-OHdG, an oxidative stress marker, and plasma high-sensitivity C-reactive protein(hsCRP), an inflammatory marker, were significantly reduced in the test food group compared to the placebo group. No adverse events relating to test food supplementation were observed. Conclusions These results suggest that the supplementation of olive and grape seed polyphenols with vitamin C could improve endothelial function via anti-oxidant and anti-inflamma-tory functions and that might be safe and effective for reducing the risk of arteriosclerosis and CVD.
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INFORMATION
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CONSORT 2010 声明─ランダム化並行群間比較試験報告のための最新版ガイドライン─(薬理と治療2010;38:939-49. より再掲載)
43巻8号(2015);View Description Hide Description
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