薬理と治療
Volume 43, Issue 7, 2015
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扉・目次
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SYMPOSIUM:J-CLEAR発足5周年記念シンポジウム 記録
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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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6.シンポジウム/医療機関の品質管理の仕組みづくりI ―リスクに基づくモニタリング/10.シンポジウム/医療機関の品質管理の仕組みづくりⅡ―ローカルデータマネジメント
43巻7号(2015);View Description Hide Description - 6.シンポジウム/医療機関の品質管理の仕組みづくりI ―リスクに基づくモニタリング
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- 10.シンポジウム/医療機関の品質管理の仕組みづくりⅡ ―ローカルデータマネジメント
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【講演2】 医療機関におけるデータの品質管理への取り組み―CRC ができるデータの品質管理・EDC チェックリストの活用
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COMMENT
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ORIGINAL ARTICLES
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ミコフェノール酸モフェチルにおける先発品と後発品との生物学的同等性
43巻7号(2015);View Description Hide DescriptionA dissolution test was performed using Cellcept(R) Capsules 250 as the reference formulation to evaluate the similarity of dissolution profile of mycophenolate mofetil capsule 250 mg“Pfizer” in various test solutions in accordance with the“Guideline for Bioequivalence Studies of Generic Products”. The test results showed mycophenolate mofetil capsule 250 mg“Pfizer” satisfied the evaluation criteria for similarity of dissolution profile to the reference formulation in all the test conditions. A bioequivalence study in healthy male adult subjects treated with mycophenolate mofetil capsule 250 mg“Pfizer”(test formulation)or Cellcept(R) Capsules 250(reference formulation) showed test formulation satisfied the evaluation criteria for equivalence based on the 90% confidence interval of difference of mean AUCt and Cmax(equivalence parameters).Thus, the clinical efficacy and safety of mycophenolate mofetil capsule 250 mg“Pfizer” and those of the original product Cellcept(R) Capsules 250 are considered comparable. -
Daily Sorghum Tea Reduces Human Body Fat and Plasma Glucose―A Clinical Investigation of the Efficacy and Safety of Long—term Intake―
43巻7号(2015);View Description Hide DescriptionBackground Several health foods are available in the market for their ability to mitigate modern high︱calorie diets. Coffee and many kinds of teas are expected to reduce calories and help control body weight because these beverages contain rich polyphenols(tannins, flavonoids and catechins). Sorghum tea is available in the market as such a beverage, but there is little literature about its health benefits. The aim of this study was to explore the favourable human health effects and to confirm the safety of drinking sorghum tea daily. Methods This study compared indexes about human health before and after a 90-day trial of drinking of 1 L of sorghum tea each day in five women and four men. Results The mean changes after the long-term intake of sorghum tea were -0.2 kg╱m2(P=0.45)for body mass index, -2.0%(P=0.01)for percent body fat and -6.6 mg╱dL(P<0.01) for fasting plasma glucose. No severe adverse events were reported. Conclusions We observed a statistically non-significant reduction in body mass index and statistically significant reductions in percent body fat and fasting plasma glucose levels after a 90-day trial of drinking sorghum tea daily. These results illuminate a new use for sorghum tea as a beverage to control body fat and plasma glucose. -
Sorghum Tea Does Not Alter Postprandial Plasma Triglycerides―A Randomized, Placebo—controlled, Crossover Clinical Trial―
43巻7号(2015);View Description Hide DescriptionBackground Overeating is a common problem for humans in modern life. One option to decrease food intake is to consume plant-derived polyphenols during meals. Because studies have observed impaired digestion and absorption in farm animals fed sorghum, sorghum tea, containing rich polyphenols, may be suitable for this purpose at meals. We performed a randomized controlled trial to explore the utility of sorghum tea in lowering postprandial plasma triglyceride levels. Methods In a crossover manner, 22 participants were provided sorghum tea, water, or oolong tea while eating their breakfast soup. Plasma triglyceride levels were measured every hour at 0-6 h after the meal. Mean triglyceride levels in the sorghum tea group were compared with those in the water and oolong tea groups. Results Mean triglyceride levels among the sorghum tea, water, and oolong tea groups were 75.9 mg╱dL, 70.6 mg╱dL, and 80.1 mg╱dL at 4 h, respectively, and 66.8 mg╱dL, 58.8 mg╱dL, and 58.0 mg╱dL at 6 h after breakfast, respectively. No statistically significant difference in triglyceride levels was observed between drinking sorghum tea and water╱oolong tea at meals. Conclusions Sorghum contains rich polyphenols that prevent triglyceride digestion and absorption in the small intestine; thus, its utility as another functional food to help reduce weight should be further investigated. -
The Relationship between Plasma Levels of l—Arginine and NO after l—Citrulline Supplementation ―A Randomized, Double—blind, Placebo—controlled Trial―
43巻7号(2015);View Description Hide DescriptionBackground L-Citrulline, a potent precursor of L-arginine, is known to be effective in enhancing nitric oxide(NO)production, which is a potent vasodilator and a critical modulator of vascular function. However, there is no direct evidence demonstrating the correlation between plasma L-arginine and NO levels following oral supplementation with L-citrulline. Methods In a double-blind, randomized, placebo-controlled cross-over protocol, 14 healthy females(27.8±6.0 years old)received L-citrulline(3.2 g╱day)or placebo for 5 days. Following supplementation, plasma levels of L-arginine, NOx, and changes in peripheral blood volume were determined sequentially. Results L-Citrulline supplementation significantly increased plasma L-arginine concentrations, as well as NOx levels. A significant correlation was found between the increase in plasma L-arginine and NOx levels following L-citrulline supplementation. Moreover, with L-citrulline intake, the recovery of the skin blood volume after cooling stress was markedly increased. No effects were observed with placebo. Conclusion These results showed for the first time that increased plasma L-arginine concentrations following oral L-citrulline raise the levels of plasma NOx correlatively, leading to enhancement of blood circulation in humans. -
大豆胚芽摂取による頭髪および肌環境の改善
43巻7号(2015);View Description Hide DescriptionObjectives In the present study, the effects of soybean hypocotyls supplementation on conditions of the scalp hair and skin were examined. Methods The subjects were 18 healthy adult volunteers conscious of their thinning hair (mean age: 49.8±1.2 years). Conditions of the scalp hair and skin were evaluated at baseline, and after 6- and 12-week supplementation of 2 g╱day soybean hypocotyls. Results The diameter and density of the scalp hair showed significant improvement after 12 weeks of supplementation. Intake of soybean hypocotyls significantly decreased melanin formation caused by aging. Subjective evaluation by the visual analogue scale also demonstrated improvement of the scalp hair and skin.Conclusions The present study suggests that daily supplementation of soybean hypocotyls could restrain the hair and skin aging phenomenon. -
健常男女成人におけるカキ肉エキス含有飲料「ワタナベオイスタードリンク」の安全性評価
43巻7号(2015);View Description Hide DescriptionObjectives To evaluate the safety of an oyster extract-based, liquid︱form dietary supplement “Watanabe Oyster Drink”. Methods With the use of“Watanabe Oyster Drink”containing 2000 mg of oyster extract per 50 mL in a bottle as the study drink, two clinical studies were performed in a total of 40 healthy male and female adults. In the first study designed as an excessive dosing study(StudyⅠ), 5, 12 and 12 subjects received 1 bottle of oyster extract-free placebo drink, 1 bottle of study drink and 3 bottle of study drink, respectively, daily for 4 weeks with a subsequent 2-week follow-up period. In the second study designed as a long-term dosing study(StudyⅡ), 11 subjects received a bottle of study drink daily for 12 weeks. Medical inspection, physical examinations and laboratory tests were conducted at the end of 4-week intervention and at the end of 2-week follow-up in the StudyⅠ and at weeks 4, 8 and 12 of intervention in the StudyⅡ. Results Two, 2 and 3 subjects in the placebo, regular dose and 3-fold increased dose groups, respectively, in the StudyⅠ and 1 subject in the StudyⅡ reported various types of adverse events, such as gastralgia and diarrhea, which were judged by the medical investigator that their relationship with the intervention was unable to be ruled out. All these adverse events were mild in extent and transient in occurrence and appeared to have no clinical significance. Throughout the two studies, there was no subject who had any intervention-related laboratory test abnormalities. The study group-based analyses of laboratory data showed that there were no clinically abnormal changes of any demographic, physical or laboratory test parameters in the two studies. Conclusion Intakes of the study drink in daily doses up to 3 bottles (6000 mg as oyster extract)for 4 weeks and those in a daily dose of 1 bottle(2000 mg as oyster extract)for 12 weeks were well tolerated and thus considered to be safe in healthy adults. -
Evaluation of the Safety and Efficacy of Kaempferia parviflora Extract(SIRTMAX(R))in Human―A Randomized Double‒blind, Placebo‒controlled Crossover Clinical Study―
43巻7号(2015);View Description Hide DescriptionObjective Kaempferia parviflora is a plant belonging to the family Zingiberaceae. Its rhizome has been used in strength precision drugs and tonics and has been reported to exhibit prevention effect on metabolic diseases in mice. In this study, we examined the safety and efficacy of Kaempferia parviflora extract(SIRTMAX(R))on obesity, glucose and lipid metabolism, and arterial stiffness in human. Methods We performed a randomized double-blind, placebo-controlled crossover clinical study. Twenty-seven healthy volunteers were given either a test product containing 100 mg of SIRTMAX(R) or a placebo by oral administration for 7 weeks.Results Body weight and fasting blood glucose declined significantly(P=0.0033, and P=0.04)in the SIRTMAX(R) group. For the subjects whose HbA1c values (NGSP)were more than 5.4%, improvement trends in the fasting blood glucose (127.9±17.8 mg╱dL before and 120.7±14.9 mg╱dL after ingestion)and the cardio-ankle vascular index(CAVI, 8.0±0.2 before and 7.8 ±0.2 after ingestion) were observed in the SIRTMAX(R) group. Furthermore, only a slight increase in the production of advanced glycation end products(AGEs)was observed in the SIRTMAX(R) group(26.0±3.4μg╱mL before and 27.4±1.8μg╱mL after ingestion, P=0.64), compared with a significant increase in the placebo group (22.4±2.6μg╱mL before and 29.1±2.1μg╱mL after ingestion, P=0.02). No abnormal values were observed during the test. Conclusion SIRTMAX(R) had the ameliorative effects on body weight and blood glucose level for all 27 subjects, and improved the vascular function for the subjects with mild hyperglycemia (HbA1c≳5.4%). No severe adverse effects caused by SIRTMAX(R) were found during the test. -
軽度の職業性ストレスを自覚している就労者におけるニンニク・卵黄配合食品の気分変調および睡眠障害に対する効果―無作為化,二重盲検,プラセボ対照並行群間比較試験―
43巻7号(2015);View Description Hide DescriptionObjective The aim of this study was to investigate the potential of garlic-egg yolk combination die(t GE diet)for improving dysthymic symptoms and sleep difficulty in workers with mild work-stresses. Methods A randomized, double-blind, placebo-controlled parallel-group trial was conducted on 54 adult subjects, who randomly assigned to receive either capsule︱form GE diet or placebo once daily for 8 weeks. The capsular GE diet contained(in a daily dose)376 mg of garlic-egg yolk powder. At day-0(baseline)and at weeks 2, 4, 6 and 8, all subjects were tested for measuring their perceived mood and quality of sleep by the use of the Profile of Mood States Short Form Japanese versionⅡ(POMS-S)and the Ogri-Shirakawa-Azumi sleep inventory MA version(OSA-MA), respectively. In addition, sleep difficulty was also quantified with the use of Athens Insomnia Scale(AIS)at day-0 and at weeks 4 and 8. Results Although the results were not definite, supplementation with the GE diet appeared to be effective in improving various areas of perceived mood, as well as quantity and quality of sleep. Conclusion GE diet may have a benefit for promoting self-estimated mental health in workers with mild work-stresses. -
グルコサミン塩酸塩,コンドロイチン硫酸およびケルセチン配糖体を含む食品の膝関節機能に対する有効性に関する研究―K—L 分類による層別解析―
43巻7号(2015);View Description Hide DescriptionObjectives The objective of this study was to investigate the effect of a dietary supplement containing glucosamine hydrochloride, chondroitin sulfate and quercetin glycosides on knee joint functions in subjects with knee pain in stratified analysis based on Kellgren-Lawrence(K-L)grades. Methods A randomized, placebo-controlled, double blind intervention trial was conducted in 40 subjects with knee pain. They were randomly assigned to two groups and ingested either test supplement containing 1200 mg glucosamine hydrochloride, 60 mg chondroitin sulfate and 45 mg quercetin glycosides(GCQ supplement)per day or placebo for 16 weeks. Stratified analysis for the result about knee joint functions evaluated by Japanese Orthopaedic Association(JOA)criteria and visual analog scales(VAS)for knee pain was conducted in subject with K-L grades≲Ⅰ or K-L grades≳Ⅱ. Results The result based on JOA criteria showed that change of the aggregate scores was significantly improved at week 8, 12, and 16 in the GCQ group compared to the placebo group in subject with K-L grades≲Ⅰ, although that in subject with K-L grades≳Ⅱ was not significantly improved. VAS for knee pain was not significantly improved in subject with K-L grades ≲Ⅰ or K-L grades≳Ⅱ. Conclusions These results suggest that the daily supplementation of GCQ can be effective for improving knee joint functions in subjects with K-L grades≲Ⅰ. -
ギムネマ酸およびキトサン摂取による食後血中中性脂肪上昇抑制効果検証試験―非盲験クロスオーバー比較試験―
43巻7号(2015);View Description Hide DescriptionObjective The study aimed to verify that ingestion of gymnemic acid, chitosan or combination of gymnemic acid and chitosan would reduce the postprandial blood triglyceride level of subject. Methods 10 subjects aged 20 to 59 years with BMI less than thirty kg╱m2 was enrolled in open label, four periods cross over study. They had high fat diet after ingestion of 50 mL water with 9.4 mg gymnemic acid, 100 mg chitosan, mixture of 4.9 mg gymnemic acid and 100 mg chitosan or nothing (control). The blood triglyceride level was measured before intake of high fat diet and 2, 4, 6 and 8 hours after intake of it, and compared. Results Ingestion of mixture of 9.4 mg gymnemic acid and 100 mg chitosan was suppressed the elevation of blood triglyceride level at 4 hours after intake of high fat diet, and the AUC(area under the curve)value of postprandial blood triglyceride level. These results were remarkably shown by analysis date of nine subjects with BMI less than twenty five. Conclusions These results suggest that ingestion of a combination of gymnemic acid and chitosan reduce the postprandial blood triglyceride level. -
難消化性デキストリン配合炭酸飲料の食後血中中性脂肪上昇抑制効果の検証―プラセボ対照二重盲検ランダム化クロスオーバー試験―
43巻7号(2015);View Description Hide DescriptionObjectives We carried out a randomized double-blind crossover study to investigate the effect of carbonated beverage containing resistant maltodextrin (RMD)on the postprandial serum triglyceride. Methods The subjects were 90 healthy volunteers(fasting serum triglyceride: 120-200 mg╱dL)and randomly divided into two groups. They ingested the test beverage containing RMD(5g)or the beverage without RMD(placebo)together with a fat︱rich meal(lipid: 41.0 g). Blood samples were drawn before and 2, 3, 4 and 6 hours after ingestion, and the serum triglyceride was measured. Results In comparison with the placebo beverage, the test beverage significantly lowered the postprandial serum triglyceride at 2, 3, 4 and 6 hours after ingestion of the test beverage(2 and 3 hours: P<0.05, 4 and 6 hours: P<0.01). Postprandial RLP-cholesterol elevation also significantly suppressed at 2, 3, 4 and 6 hours after food ingestion as compared with that of the placebo(2, 3 and 6 hours: P<0.05, 4 hours: P<0.01).Conclusions These results indicated that the carbonated beverage containing RMD has inhibitory effect on the elevation of postprandial serum triglyceride.
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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)
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