薬理と治療
Volume 43, Issue 2, 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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- 受賞演題
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ORIGINAL ARTICLES
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Antihypertensive Effect of Quercetin Glycosides in Apocynum venetum L. Leaves
43巻2号(2015);View Description Hide DescriptionObjectives The leaves of Apocynum venetum L(. Apocynaceae), commonly known as Luobuma in China, are a traditional and popular Chinese herb with a long history of use as an antihypertensive tea in China and Japan. Hyperoside[HP]and isoquercitrin[IQ]are contained in A. venetum leaves in ratio of 1:1 as the principle quercetin glycosides. The dose-related decreases in blood pressure of HP, IQ and the equivalent mixture[HP+IQ]were examined in the doses of 10, 20, 40, and 80 mg╱kg, respectively. Methods HP, IQ and[HP+IQ]were given orally to Male SHR╱Izm rats by gavage for 7 weeks, respectively. Systolic blood pressure in each conscious rat was measured by the indirect tail-cuff method with an authomatic sphygmotonograph. Results The only[HP+IQ]in dose of 40 mg╱kg showed a significant reduction in blood pressure in SHR, which showed an inverted U-shaped dose-dependent relationship. Conclusions The content of[HP+IQ]in an adequate and restricted dose might be required in order to produce the antihypertensive effect of A. venetum leaves since the antihypertensive effect of[HP+IQ]showed an inverted U-shaped dose-dependent relationship. -
服用者および調剤者の立場からの既存錠2 錠と倍量大型錠1 錠の比較検討
43巻2号(2015);View Description Hide DescriptionBased on a case in which a high dose or a combination tablet of a prescription drug was released, a comparative examination was conducted with placebo tablets of normal(e. g. 10 mg)and double size(e. g. 20 mg)from the point of view of both recipient and pharmacist. The result showed there was no difference between the ease of taking two tablets of normal size or one tablet of double size in the view of the recipient. Prior to taking, the two tablets of normal size were considered slightly advantageous in comparison to the double sized tablet. In addition, the double sized tablet was preferred for“ease of handling”. On the other hand, the double sized tablet had an advantage over the smaller pair in“ease of dispensing, explaining and identifying(each tablet)from the inside of a single dose package”in the opinion of the pharmacist. Thus, by comparing the different-sized placebo tablets used in this study, the development of the high-dose tablet was considered to be useful for both recipient and pharmacist and to improve medication adherence. -
魚鱗癬におけるリペアクト(R) の臨床効果の検討
43巻2号(2015);View Description Hide DescriptionBackground The patients with ichthyosis are annoyed with large scales and xerosis. Topical moisturizing agent is important for the treatment of ichthyosis. Methods We studied the efficacy of Repairact(R) to 18 patients with ichthyosis, who visited Department of Dermatology in Kurume University between May and December in 2013, in terms of clinical efficacy including erythema, edema╱papule, exudate ╱crust, scratch mark, lichenification, scale, and pruritus, using Propeto(R) as a control ointment. Results We found that Repairact(R) significantly improved scale more than Propeto(R) did. Repairact(R) also tended to improve pruritus than Propeto(R) did. Conclusions These results raised the possibility that Repairact(R) could be effective on other dermatitis associated with xerosis. -
肥満者に対するケルセチン配糖体(酵素処理イソクエルシトリン)配合茶飲料の体脂肪低減作用および安全性の検証
43巻2号(2015);View Description Hide DescriptionObjectives The objective of this study was to evaluate the effect of long-term consumption of tea containing quercetin glucosides on body fat accumulation and the safety in obese subjects. Methods We performed a randomized double-blind, placebo-controlled trial on subjects(111men and 89 women)aged 20-64 years old with 25≲body mass index(BMI)<30 kg╱m2. They were randomly assigned into two groups and consumed the beverages containing 0 mg or 110 mg of quercetin glucosides daily for 12 weeks. Results Both abdominal total fat area and visceral fat area were significantly reduced in test group compared with placebo group. No adverse effect related to the test beverage containing quercetin glucosides was observed in this study. Conclusions The results of this study suggested that the long-term consumption of tea containing quercetin glucosides reduced body fat in safe, and could be useful for prevention and amelioration of obesity and metabolic syndrome. -
正常高値血圧者に対する杜仲葉エキス配合飲料の血管内皮機能改善効果
43巻2号(2015);View Description Hide DescriptionObjectives We examined the beneficial effects of the beverage containing Eucommia leaf extract on vascular endothelial function in subjects with high normal blood pressure. Methods We performed a randomized, double-blind, placebo-controlled, parallel group study. The subjects were 46 adults(28 males and 18 females) with high normal blood pressure, who had not been treated with antihypertensive drugs. Test food containing 85mg geniposidic acid or placebo was given once a day for 12 weeks. We examined the effects of the test food on the vascular endothelial function with flow-mediated dilation(FMD). Results Percentage FMD significantly increased time-dependently in the active group. After 8 and 12 weeks, the changes of %FMD were significantly higher compared with the placebo group. Conclusion The result shows the beverage containing Eucommia leaf extract improved the vascular endothelial function in subjects with high normal blood pressure, suggesting that food containing it may protect vascular walls against events following sclerotic changes. -
ジンチョウゲ科ジンコウ属(Aquilaria 属)植物の葉部エキス含有食品の二重盲検クロスオーバーによる有効性試験ならびに安全性試験
43巻2号(2015);View Description Hide DescriptionObjectives We investigated whether or not intake of an extract of Aquilaria crassna (agarwood)leaves ameliorates constipation︱related symptoms in healthy volunteers with mild constipation, and then we also assessed clinical events produced by subchronic oral administration or an overdose of the agarwood leave extract in healthy volunteers. We prepared a tablet containing a mixed powder of 100 mg agarwood leave extract and 100 mg dextrin for carrying out these clinical experiments. Methods Clinical trial-1. We conducted a double-blinded, placebo-controlled, crossover trial in 64 healthy volunteers(ages 20 to 65 years old)with mild constipation. The subjects ingested placebo or 600 mg of the agarwood leave extract(6 tablets daily)for 2 weeks. The primary endpoints were changes in self-reported stool volume and the number of bowel movements. Clinical trial-2. We conducted an open-label trial with 22 volunteers(age 20 to 65 years old) in which 11 subjects had a mild constipation. The subject ingested 600 mg of the agarwoodleave extract(6 tablets daily), the same dose as in the Clinical trial-1, for 12 weeks and underwent physician interviews, physical examinations, blood tests, laboratory examination, urine tests, and medical examination interviews. Clinical trial-3. We conducted an open-label trial with 22 volunteers(ages 20 to 65 years old)in which 11 subjects had a mild constipation. The subjects ingested 1800 mg(18 tablets daily)of the agarwood leave extract for 4 weeks and underwent the same examinations as in the clinical trial-2. A stool volume, the total number ofbowel movements, and days with defecation were recorded using a constipation diary. Results Clinical trial-1. Daily ingestion of 600 mg of the extract significantly increased the primary endpoints, the stool volume and the total number of bowel movements, as compared with placebo. In addition, any clinically critical adverse events were not found during the study period. Clinical trial-2. Daily ingestion of 600 mg of the agarwood leave extract did not cause clinically critical changes in any parameters in all the examinations. We observed adverse events in 9 out of 22 subjects, and 3 of them dropped out of the study. All the adverse events were thought to be unrelated with ingestion of the test food. Clinical trial-3. Daily ingestion of 1800 mg of the extract did not cause clinically critical changes in any parameters in physical examinations, blood tests, and urine tests. We observed adverse events in 19 out of 22 subjects, and 8 of them dropped out of the study. Almost all the adverse events were thought to be caused by excessive stimulation of gastrointestinal motility due to overdose. Conclusions Present results indicate that the adequate ingestion of the Aquilaria crassna leaves extract possibly serves to relieve constipation without critical adverse reaction.
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REVIEWS
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高齢者糖尿病の治療を考える
43巻2号(2015);View Description Hide Description人口の高齢化に伴い高齢者糖尿病は増加し続けている。こうした状況のなか,高齢者糖尿病の病態を把握し,治療を行う際の留意点を理解することは重要である。高齢者糖尿病は身体的,精神的,社会的に個人差が大きく多様性があることが臨床上の特徴であり,個々人の状況に応じた治療が求められる。各種ガイドラインでの高齢者糖尿病の血糖管理目標は,リスクに応じて患者を分類し,リスクの高い患者では血糖コントロール目標を高めに設定している。薬物治療では,高齢者に腎排泄の低下や低血糖発症リスク上昇,薬剤感受性の上昇などの特徴があることから,各種薬剤の特性を考慮し,副作用,とくに低血糖の抑制に留意した薬剤の選択,減量などを考慮する。副作用のなかでも高齢者における低血糖は重症化しやすく,認知症発症のリスクを高めることからも,症状を見逃さない工夫が必要である。2013 年に発表されたIDF Global Guideline for Managing Older People with Type 2 Diabetes では,Functionally independent╱dependent の高齢者糖尿病それぞれに対する治療指針をDPP︱4 阻害薬も含めて示している。新規にSGLT2 阻害薬も本邦で使用可能となり,これらを含めた高齢者糖尿病に特化した治療戦略が今後必要となってくる。【利益相反】あり:講演料(小野薬品工業㈱,サノフィ㈱,武田薬品工業㈱,日本イーライリリー㈱,日本ベーリンガーインゲルハイム㈱)。 -
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BRIEF COMMUNICATION
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軽費老人ホームの食事に含まれるコラーゲン量の推定
43巻2号(2015);View Description Hide DescriptionObjective The amount of collagen in the diet at low︱cost homes for the elderly were investigated to clarify the amount of supplemental collagen peptide required for elderly individuals. Methods Energy, protein, lipid, carbohydrate and collagen levels in the diet were investigated at six low-cost homes for the elderly in Ibaraki prefecture in Japan over 1 week(September 1-7, 2014). Amount of collagen was calculated using previously reported values. These values were compared with those for adult Japanese women. Results Mean±SD(standard deviation)and coefficient of variation(CV)for energy, protein, lipid, carbohydrate and collagen were 1555.6±59.4 kcal╱day(0.038), 62.3±6.0 g╱day(0.096), 43.4±4.6 g╱day(0.105), 226.0±9.9 g╱day(0.044), and 1.4±0.3 g╱day(0.195), respectively. Amount of collagen(1.4 g╱day)was smaller than that in Japanese adult females(1.9 g╱day).If elderly individuals take 2.5 or 5.0 g╱day of collagen peptide, this level would be 4.0% or 8.0% of protein intake(62.3 g╱day), smaller than the SD of protein intake(6.0 g╱day). Conclusions Ingestion of 5-10 g╱day of collagen peptide reportedly exerts beneficial effects without adverse effects in Japanese adults who take 1.9 g╱day of collagen peptide. The present investigation suggests that ingestion of 2.5-5.0 g╱day of collagen peptide would not result in severe adverse effect among elderly individuals in low-cost homes for the elderly.
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TOPIC
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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2号(2015);View Description Hide Description
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