薬理と治療
Volume 36, Issue 8, 2008
Volumes & issues:
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TOPICS
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- 第14回浜名湖セミナー
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- 高齢者の疾患と薬物治療
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ORIGINAL ARTICLES
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A Large−scale, Long−term, Prospective Post−marketing Surveillance of Pitavastatin(LIVALO Tablet)
36巻8号(2008);View Description Hide DescriptionA large−scale, long−term, prospective post−marketing surveillance study of pitavastatin (LIVALO Tablet), an HMG−CoA reductase inhibitor, was conducted by prospective recruitment of patients by central registration. Of the 20279 patients recruited, 19925 patients were analyzed for drug safety and 18031 patients analyzed for effectiveness. The outcome of the single−arm uncontrolled observational study is summarized below:1 )Adverse drug reactions were observed in 2069 out of the 19925 patients(10.4%), and almost all of the adverse drug reactions were classified as mild. 2 ) Common adverse drug reactions were blood creatine phosphokinase increased(2.74%), alanine aminotransferase increased(1.79%), aspartate aminotransferase increased (1.50%), myalgia(1.08%)and gamma−glutamyltransferase increased(1.00%).3 )Treatment with this drug resulted in significant reductions of serum LDL−cholesterol (LDL−C)(29.1%). The peak serum lipid level reduction occurred within 4 weeks of treatment initiation, and then remained at the same level. In data from patients who had baseline abnormal levels of triglyceride(TG)and HDL−cholesterol(HDL−C), pitavastatin decreased TG(22.7%), and increased the HDL−C(19.9%)from the baseline. 4 )By criteria established in the Japan Atherosclerosis Society(JAS)guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese, 88.2% of the primary prevention low−risk patients achieved a goal of LDL−C level, 82.7% of intermediaterisk patients, 66.5% of high−risk patients and 50.3% of secondary prevention patients. No significant safety or effectiveness issues were observed. These safety and effectiveness results reflect similar findings to the studies performed to support the Japan New Drug Application. Pitavastatin is an effective and safe drug for the indication of hypercholesterolemia.(Jpn Pharmacol Ther 2008;36:709−31)KEY WORDS Pitavastatin, HMG−CoA reductase inhibitor, Post−marketing surveillance,Long−term study, Safety, Effectiveness -
ステビア発酵エキスの抗ヒスタミン作用に関する研究
36巻8号(2008);View Description Hide DescriptionObjectives Stevia rebaudiana Bertoni is grown originally in Paraguay. The extract form the leaves of this medicinal plant is clinically useful for the treatment of IgE related disease, such as atopic dermatitis, or allergic dermatitis. Therefore, we studied the effects of these extracts on histamine−induced contraction using in guinea pig ileum. Methods Contractions are induced by the application of histamine using Magnus method in isolated ileum from guinea pig.Results and Conclusion Fermented Stevia extracts showed antihistaminergic effects at concentrations from 10−5 g/mL, in a dose−dependent and reversible manner. However, these extract did not show anticholinergic and Ca2+ antagonistic effect.(Jpn Pharmacol Ther 2008;36:733−6)KEY WORDS Stevia, Antihistaminergic effects, Allergy -
キトサンの薬物相互作用に関する検討
36巻8号(2008);View Description Hide DescriptionThe interaction of chitosan with drugs, warfarin, pravastatin, trichlormethiazide and allopurinol in the gastrointestinal absorption was examined. The plasma concentrations of the drugs were measured, and compared between single administration of drugs and co−administration with chitosan in male beagles. Chitosan was administered in two doses, 36.6 mg/kg(effective intake)and 183 mg/kg(five times of effective intake). In each chitosan intake, the time courses of plasma concentration and pharmacokinetic parameters(Cmax and AUC)of each drug were not changed compared with single administration of drugs. These results suggested that chitosan showed no significant effect on the absorption of these drugs in dogs. There is a small possibility that chitosan shows significant interactions with the absorption of drugs, when chitosan is taken with medicine. (Jpn Pharmacol Ther 2008;36:737−45)KEY WORDS Chitosan, Food−drug interaction, Beagle dog -
スズメバチの幼虫由来アミノ酸混合物がラットの基礎体温および血中カテコラミンに与える影響
36巻8号(2008);View Description Hide DescriptionAmino acid mixture derived from hornet larva is very important nutrient food for the activity of adult hornet. This study aimed to investigate the effect of amino acid mixture derived from hornet larva on the basal metabolism of conscious rat by measuring the body temperature as an index of basal metabolism. Oral administration of amino acid mixture derived from hornet larva significantly increased the body temperature. However, amino acid mixture derived from casein, reference compound of amino acid mixture derived from hornet larva, did not affect on the body temperature at all. To clarify the mechanism of increased body temperature, the effect of blood catecholamine levels were measured. Oral administration of amino acid mixture derived from hornet larva increased the levels of catecholamine, such as adrenaline, noradrenaline and dopamine. Especially, a significant difference was observed in adrenaline level as compared with control group. On amino acid mixture derived from casein, a significant increase was observed only in dopamine blood level. However, noradlenarine level was lower than that of the control rats. This point was obviously different between amino acid mixture derived from hornet larva and amino acid mixture derived from casein. From above results, it was found that amino acid mixture derived from hornet larva increased the basal metabolism and that this finding might be caused by increasing the catecholamine blood levels. These results suggest that the ingestion of amino acid mixture derived from hornet larva is effective to increase the basic metabolism.(Jpn Pharmacol Ther 2008;36:749−55)KEY WORDS Amino acid, Hornet larva, Body temperature, Catecholamine, Rat -
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 の効果
36巻8号(2008);View Description Hide DescriptionObjectives To examine the effects of single−dose administration of wheat albumin(WA)on postprandial blood glucose control. Method A randomized single−blind, placebo−controlled, crossover trial was conducted in 17 volunteers with slightly higher fasting blood glucose. The volunteers were randomly assigned to WA group or placebo group. The volunteers of each group were orally administered 0.5 g of WA or placebo respectively in hard capsule forms together with the calorie controlled breakfast. We monitored postprandial blood glucose level after they took the breakfast. Results The postprandial blood glucose levels for WA and placebo group peaked at one hour after taking WA and placebo. The peaked values of WA group was significantly lower than that of placebo group. In addition, the increased value of WA group for the peaked blood glucose level was 19% lower than that of placebo group(p<0.01). The AUC of the blood glucose levels up to 3 h after WA intake were 15%(p<0.05)lower than that of the placebo group. For the subjects of the fasting blood glucose were not more than 126 mg/dL, the peaked postprandial blood glucose value were significantly decreased by the intake of WA and increased value was decreased 18%(p<0.05)compared with placebo group. Although the AUC of blood glucose levels up to 3 h after WA intake were 14% lower than that of the placebo group, this was not significant. In the present study, subjective symptoms, objective symptoms, physiological test findings and clinical laboratory test findings did not indicate any undesirable symptoms resulting from consumption of the test food of WA.Conclusion The test foods, 0.5 g of WA, significantly decreased the postprandial blood glucose level for the subjects of the fasting blood glucose were 110−140 mg/dL. In addition, for the subjects of the fasting blood glucose were 110−126 mg/dL, the test food, 0.5 g WA, also decreased the postprandial blood glucose significantly. Therefore WA is considered to be useful, for the people who have higher blood glucose, to control their blood glucose level.(Jpn Pharmacol Ther 2008;36:761−5)KEY WORDS Wheat albumin, α−amylase inhibitor, Postprandial blood glucose -
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茶カテキンを高濃度に含有するノンカフェイン飲料の効果
36巻8号(2008);View Description Hide DescriptionIt has been reported that green tea extract(GTE)reduces body fat accumulation in several clinical trials;however, impacts of decaffeinated GTE on body fat and metabolic disorders in humans are unknown. We investigated whether daily consumption of decaffeinated GTE ameliorates body weight, waist circumference, abdominal body fat, blood lipids and safety parameters in overweight and obese adults. This is a randomized, double−blind, placebo− controlled, and parallel study. After a 2−week run in period, 81 healthy Japanese overweight and obese men(BMI≧25)were randomly assigned to one of two groups, who consumed 1 bottle sports drink/day containing decaffeinated GTE(548 mg tea catechins and 0mg caffeine:catechin group, n=40), or 1 bottle sports drink/day(0 mg of both tea catechins and caffeine:placebo group, n=41)over 12 weeks. At the end of the study, body weight, waist circumference, and body fat including visceral fat area(VFA)were significantly lowered in the catechin group than in the placebo group. In addition, in the present study, cholesterollowering effects were found in the catechin group. In conclusion, daily consumption of a drink enriched with tea catechins, even with no caffeine, may be useful for the primary prevention of metabolic syndrome and atherosclerotic diseases in obese population.(Jpn Pharmacol Ther 2008;36:767−76)KEY WORDS Green tea, Catechins, Caffeine, Obesity, Cholesterol, LDL, Human
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