巻号一覧
37 巻, 1 号
選択された号の論文の11件中1～11を表示しています
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第37巻第1号特集/EBM(Evidenced-based Medicine)景山 茂2006 年 37 巻 1 号 p. 1-2
発行日: 2006/01/31
公開日: 2010/06/28
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岡山 雅信2006 年 37 巻 1 号 p. 3-8
発行日: 2006/01/31
公開日: 2010/06/28
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バイアスについて松島 雅人2006 年 37 巻 1 号 p. 9-14
発行日: 2006/01/31
公開日: 2010/06/28
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新保 卓郎2006 年 37 巻 1 号 p. 15-20
発行日: 2006/01/31
公開日: 2010/06/28
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Yukiho TAKIZAWA, Yasuharu MIZUHARA, Toshimi MORITA, Yoshio KASE, Shuic ...2006 年 37 巻 1 号 p. 21-32
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーAims: Unpito, an herbal medicine extracted from a mixture of five crude medicines (Rhei Rhizoma, Glycyrrhizae Radix, Ginseng Radix, Zingiberis Rhizoma and Aconiti Tuber), has been developed as a drug for chronic renal failure. In general, it is difficult to estimate the absorption and excretion of herbal medicines due to the presence of a wide variety of components. The purpose of the current study was to examine the systemic pharmacokinetics and elimination of Unpito in healthy volunteers as part of the clinical study of the medicine.
Methods: Three compounds, (-) epicatechin 3-O-gallate (ECG), glycyrrhetic acid (GA) and rhein (RH) were selected as markers, to examine the clinical pharmacokinetics of Unpito based on their levels in this medicine. The disposition of each compound was evaluated in 32 healthy volunteers receiving single oral doses (2, 4, 8, and 12 capsules).
Results: After a single oral administration, ECG and RH exhibited linear pharmacokinetics in AUC and Cmax, while GA did not exhibit linear pharmacokinetics. A cross-over study was conducted to evaluate the effect of food at a single dose of 4 capsules. The effect of food was observed for the plasma concentrations of ECG and RH, while not for GA. The potential accumulations of δ-(3, 4-dihydroxyphenyl) γ-valerolactone (VL-2), a metabolite of ECG and RH were not observed. GA was not detected in urine.
Conclusions: This is the first study presenting pharmacokinetics of ECG, GA and RH derived from Unpito, an herbal medicine, in healthy volunteers after single dose administration.抄録全体を表示PDF形式でダウンロード (3372K) -
Yukiho TAKIZAWA, Yasuharu MIZUHARA, Toshimi MORITA, Yoshio KASE, Shuic ...2006 年 37 巻 1 号 p. 33-40
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーAims: Unpito, an herbal medicine extracted from a mixture of five crude medicines (Rhei Rhizoma, Glycyrrhizae Radix, Ginseng Radix, Zingiberis Rhizoma and Aconiti Tuber), has been developed as a drug for chronic renal failure. In general, it is difficult to estimate the absorption and excretion of herbal medicines due to the presence of a wide variety of components. The purpose of the current study was to examine the systemic pharmacokinetics and elimination of Unpito in healthy volunteers following repeated administration as part of the clinical study of the medicine.
Methods: Three compounds, (-) epicatechin 3-O-gallate (ECG), glycyrrhetic acid (GA) and rhein (RH) were selected as markers, to examine the clinical pharmacokinetics of Unpito based on their levels in this medicine. The disposition of each compound was evaluated in 24 healthy volunteers receiving multiple oral doses (4, 6, and 8 capsules three times a day).
Results: After repeated administration, plasma ECG and GA concentrations were lower than those simulated. RH plasma concentrations were consistent with the simulation, indicating linear pharmaco kinetics of RH. The potential accumulations of marker compounds were not observed from the roughly constant plasma concentrations of troughs at 72, 120, and 144h after the first administration nor from the urinary excretions.
Conclusions: This is the first study presenting pharmacokinetics of ECG, GA and RH derived from Unpito, an herbal medicine, in healthy volunteers after multiple dose administration.抄録全体を表示PDF形式でダウンロード (2529K) -
二木 芳人, 松島 敏春, 原田 和博2006 年 37 巻 1 号 p. 41-48
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーThe effects of concomitant gastrointestinal drugs on the absorptivity of cefcapene-pivoxil hydrochloride (CFPN-PI) were examined in patients who were hospitalized due to infection and were to be treated with a gastrointestinal drug. CFPN-PI was orally administrated at a dose of 100mg after meals concomitant with a gastrointestinal drug. The urinary recovery rate of CFPN was determined from the urine collected for 12 hours after the first administration of CFPN-PI. In addition, the clinical efficacy and safety of CFPNPI was evaluated. The results were as follows:
1. The mean urinary recovery rate of CFPN in 25 cases evaluable for the absorptivity of CFPN-PI was 24.7% (95% confidence interval: 21.0-28.3%). The mean urinary recovery rate of CFPN was 25 .6% in the famotidine group, 23.9% in the dried alminium hydrooxide gel group, and 25.2% in the teprenone group.Thus, there was no significant difference in the urinary recovery rate of CFPN among the concomitant drug groups (p-value: 0.9239).
2. Clinical efficacy was judged as “excellent” in 4 cases, “good” in 16 cases, and “poor” in 2 cases, generating a clinical efficacy rate of 90.9%.
3. The incidence of adverse drug reactions (ADRs) was 16.7%. All of the ADRs were slight in severity and were resolved without any treatment.
Based on these results, it is suggested that the concomitant administration of the gastrointestinal drugs used in this study does not largely affect the absorptivity of CFPN-PI and the drug shows a sufficient antibacterial effect at the approved dose in such concomitant administration.抄録全体を表示PDF形式でダウンロード (1385K) -
Ikuo TANIGUCHI, Sahachiro NAKAE, Taro DATE, Satoru YOSHIDA, Shingo SEK ...2006 年 37 巻 1 号 p. 49-54
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーAngiotensin II receptor blockers (ARBs) are frequently used to treat the patients with hypertension because of the cardiovascular beneficial effects. ARBs have been reported to cause aldosterone break through in some patients, however, there are no definite reports concerning it. We studied the changes of renin-angiotensin-aldosterone system during ARB treatment and evaluated the additive effects of an aldosterone antagonist, spironolactone (SPRL). Ninety-seven patients with essential hypertension (62 men, 67±10 years) were enrolled in this study. To exclude the complex influence of other antihypertensive drugs, we analyzed 31 patients who had never been treated with any antihypertensive drugs. The patients were randomly divided into two groups; one group was treated with an ARB, candesartan (8mg/day), for one year and the other group was treated with the ARB for the first 6 months and with ARB plus SPRL (25mg/day) for the next 6 months. Sixteen patients were treated with the ARB alone for one year, which tended to reduce systolic blood pressure (BP) and decreased the PAC level from 98.0±49.6pg/mL at baseline to 73.5±38.0pg/mL and 68.8±35.1pg/mL after 3 and 6 months of treatment, respectively, but increased to 84.6±44.3 pg/mL after 9 months of treatment. The addition of SPRL in 15 patients significantly reduced the systolic BP compared with ARB monotherapy. These results indicated that ARB monotherapy reduced the PAC levels for the first 6 months, however, some patients experienced a rise in the PAC levels during the late phase of treatment. The addition of SPRL to ARB monotherapy is useful to treat the patients with essential hypertension.抄録全体を表示PDF形式でダウンロード (1105K) -
Objective Evaluation of the Sedative Effects by Analysis of Saccadic Eye MovementTomoko NAGAI, Naoki UCHIDA, Mariko IWASE, Kuninobu YASUDA, Li HUA, Ken ...2006 年 37 巻 1 号 p. 55-64
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーThe purpose of the present clinical study was to evaluate the sedative effects of Drewell® (50mg of diphenhydramine hydrochloride). The study was conducted with a randomized, placebo-controlled, cross over design in eight healthy male volunteers. Subjects took either a Drewell® or a matched placebo tablet on two occasions with more than a 6-day wash-out period. The sedative effects on central nervous system (CNS) were assessed using both objective evaluation (saccadic eye movement analysis) and subjective evaluation (Visual Analogue Scale: VAS). Statistical analyses for pharmacodynamic parameters were performed by repeated measures-ANOVA. Saccadic peak velocity (SPV), one of the sensitive parameters for sedative effects, showed a significant decline in the Drewell group compared with the placebo group.In the VAS evaluation, a sedative effect was also detected in the Drewell group.Despite some inter-individual differences of SPV values, in both the Drewell and the placebo sessions SPV baseline values within the same subject were quite similar. This suggests that subjects might have their own SPV values and those values might be reproducible. In addition, it was also confirmed that objective and quantitative evaluations of the sedative effects of Drewell® were possible using saccadic eye movement analysis.抄録全体を表示PDF形式でダウンロード (1732K) -
勝俣 範之2006 年 37 巻 1 号 p. 65-69
発行日: 2006/01/31
公開日: 2010/06/28
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齋藤 裕子2006 年 37 巻 1 号 p. 70-74
発行日: 2006/01/31
公開日: 2010/06/28
ジャーナル フリーPDF形式でダウンロード (3014K)
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