薬理と治療
Volume 36, Issue 9, 2008
Volumes & issues:
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SERIES
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- 国際的視野からみた先端研究の倫理的諸問題
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[第1回]Ethics, Politics, and Stem Cell Research: An Update from America
36巻9号(2008);View Description Hide Description
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ORIGINAL ARTICLES
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クリニックにおける臨床試験の実態調査および除外・中止症例の検討
36巻9号(2008);View Description Hide DescriptionBackground In Japan number of clinical trials is declining due to tightening the study design, official regulation and introduction of international trials. Recently trial institution is tending to change from hospital to private clinic in Japan. Objectives and Methods To know the recent circumstances of clinical trials in a private clinic in Japan, we examined into the actual conditions in F clinic in Fukuoka. Results Since 1996 to 2004, 28 clinical trials on life style related diseases have been undertaken and completed 85% of total contracted cases of 300. The most common reasons for discontinued cases before medication were deviation from entry criteria. After medication, 12 cases were discontinued mainly due to adverse events.Conclusions Clinic is an adequate to the clinical trial on lifestyle related disease.(Jpn Pharmacol Ther 2008;36:797−803)KEY WORDS Clinical trial, Clinic, Lifestyle related disease -
ラット拘束ストレスおよびマウスセロトニン誘発下痢に対するラモセトロンとポリカルボフィルの併用効果
36巻9号(2008);View Description Hide DescriptionRamosetron, a potent and selective serotonin(5−HT)3 receptor antagonist, is known to possess therapeutic effects on various symptoms in patients suffered from irritable bowel syndrome(IBS)with diarrhea, as well as inhibitory effects on stress−induced abnormal defecation and colonic hyperalgesia in animals. Although existing drugs such as anti−diarrheal agents, spasmolytics, and synthetic polymer, are widely prescribed for IBS patients in present, no study has yet been carried out on the effects of co−administration of ramosetron with such drugs. In the present study, therefore, we examined the effects on ramosetron, polycarbophil, a synthetic polymer, and their concomitant administration on restraint stressand 5−HT−induced diarrhea in rats and mice. Diarrhea was induced by restraint stress for 3 h in rats that had been fasted overnight, or intraperitoneal administration with 5−HT at a dose of 3 mg/kg in mice. Oral administration of ramosetron and polycarbophil inhibited restraint stress− and 5−HT−induced diarrhea in a dose−dependent manner. Co−administration of ramosetron with polycarbophil showed significant synergistic effects in both diarrheal models. These results indicate a possibility that co−administration of ramosetron with polycarbophil possesses useful synergistic effects in clinical practice.(Jpn Pharmacol Ther 2008;36:805−10)KEY WORDS Ramosetron, Polycarbophil, Diarrhea, Co−administration -
高コレステロール血症患者における小腸コレステロールトランスポーター阻害剤ゼチーア のファーストライン投与およびスタチンへの追加投与の効果
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エリンギ抽出物による脂肪摂取後の血清中性脂肪上昇抑制効果
36巻9号(2008);View Description Hide DescriptionObjectives A randomized double−blind placebo−controlled crossover study was conducted on 26 subjects with mild hyperlipidemia to evaluate the suppressive effect of Pleurotus eryngii extract(PEE)on postprandial serum triacylglycerol(TG)elevation. Methods Subjects were Japanese adult male and female whose fasting TG levels were between 110〜275 mg/dL. Subjects were divided into two groups randomly, and ingested a high fat meal(40 g fat)with or without PEE. Serum TG levels were measured at 0, 1, 2, 3, 4, 5 hr after ingestion of the meal. Results Postprandial serum TG elevation of the high fat meal containing PEE was signifi- cantly suppressed at 3 hr and 4 hr after ingestion compared with the placebo fat meal. Rem- nant-like particles cholesterol(RLP-C)concentrations in serum were also significantly decreased at 2 hr and 4 hr. AAUCs(areas under the curves)of both serum TG and RLP-C levels were significantly decreased by 18.1%(p<0.05)and 24.1%(p<0.01), respectively. No significant differences in VLDL-TG and non-esterified fatty acids(NEFA)were observed. No adverse effects were observed. Conclusions PEE has considerable suppressive effect on the postprandial serum TG eleva- tion in the subjects with mild hyperlipidemia, suggesting that PEE may be useful for the risk reduction of obesity and obesity-related diseases. (Jpn Pharmacol Ther 2008;36:817-23) KEY WORDS Pleurotus eryngii, Lipase inhibitor, Postprandial serum triacylglycerol, Obesity -
血圧改善ミルクコーヒーの過剰摂取時の安全性
36巻9号(2008);View Description Hide DescriptionWe have investigated the safety on excess intake of the milk−coffee, which has an antihypertensive effect of chlorogenic acids made by reduced oxidative component, in a randomized, single−blind, placebo−controlled, parallel study. Ordinary commercially available canned coffee was used as a control beverage. The subjects were 37 adult women and men(19 in the test beverage group, 18 in the control beverage group)with blood pressures ranging from optimal to mild hypertension, none of who were taking medication. The subjects in the test beverage group were given three cans of the anti−hypertensive test beverage(570 g)and the subjects in the control beverage group were given the same amount of ordinary canned coffees per day for 4 weeks. The subjects were instructed to consume either the test beverage or the control beverage all at once as often as possible. Although several subjects who drank three cans of test or control beverage all at once complained of abdominal symptoms such as diarrhea and heartburn, there were no significant differences between groups in the number of subjects in each symptom. These symptoms were transitory and not serious. Blood pressure and blood laboratory tests showed no abnormal changes of clinical importance. These results suggest that the anti−hypertensive milk−coffee can be safely consumed similar to ordinary canned coffee.(Jpn Pharmacol Ther 2008;36:825−33)KEY WORDS Anti−hypertensive beverage, Chlorogenic acids, Excess intake, Safety evaluation -
大豆発酵調味液(大豆ペプチド含有)配合減塩しょうゆの正常高値血圧者および軽症高血圧者に対する有効性と安全性
36巻9号(2008);View Description Hide DescriptionObjectives The present clinical study attempted to assess the hypotensive effect and safety of less−sodium soy sauce containing soybean peptides in a double blind, placebo−controlled, parallel group study. Methods The study was conducted on 132 subjects with high−normal(male/female=36/35)blood pressure or mild hypertension(male/female=29/32). These subjects were randomly divided into two groups. The test group ingested 8 mL/day of less−sodium soy sauce containing soybean peptides for 12 weeks. And the placebo group ingested less−sodium soy sauce without soybean peptides. Results The results revealed that the systolic blood pressure and the diastolic blood pressure were significantly lower in the test group compared with placebo group. In addition, any abnormal changes in clinical findings such as blood test, urinalysis and physical examination were not observed. Conclusions These results demonstrated the safety as well as efficacy of the less−sodium soy sauce containing soybean peptides, which reduced the blood pressure in subjects with high−normal blood pressure and mild hypertension.(Jpn Pharmacol Ther 2008;36:837−50)KEY WORDS Soybean peptides, Hypertension, Hypotensive effect, Clinical trial -
大豆発酵調味液(大豆ペプチド含有)の過剰摂取時における安全性
36巻9号(2008);View Description Hide DescriptionBackground/Objective We found that the soybean peptides in Fermented Soybean Seasoning, glycyltyrosine(Gly−Tyr)and seryltyrosine(Ser−Tyr), had an angiotensin−I converting enzyme inhibitory activity and antihypertensive effect. That prompted us to develop Fermented Soybean Seasoning rich in soybean peptides as a promising dietary agent for reducing risk of hypertension or related morbidity in humans. The present clinical study attempted to assess the safety and tolerability of Fermented Soybean Seasoning in Japanese adult male and female subjects. Methods Twenty−two subjects, who had normal or high−normal blood pressure or mild hypertension, each ingested daily 12.7 mL of Fermented Soybean Seasoning containing a total of 1750 mg of soybean peptides(1720μg of Gly−Tyr and 1240μg of Ser−Tyr)for 4 consecutive weeks. During the 4−week intake period and the 2−week follow−up period, all subjects were instructed to record daily general health conditions, every subjective symptom, and compliance with the intake protocol. Subjects were also given medical, physical, and laboratory examinations at 2−week intervals. Results The Fermented Soybean Seasoning was well tolerated and no subject discontinued study agent intake. There were no intake−related adverse events or physical and laboratory abnormalities. Moreover, there were slight but no clinically significant changes from baseline of physical examination and laboratory test findings. Conclusions Based on these results, it is concluded that the Fermented Soybean Seasoning is safe and well tolerated in humans.(Jpn Pharmacol Ther 2008;36:851−60)KEY WORDS Safety, Soybean peptides, Fermented Soybean Seasoning, Clinical trial,Hypertension, Overdose
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