著者

矢船 明史 竹内 正弘 成川 衛

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.31, no.6, pp.705-713, 2000-11-30 (Released:2010-06-28)

参考文献数

20

被引用文献数

1

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Since nonlinear mixed effects model is statistically quite complicated, it is not possible to obtain the analytical forms of the marginal mean and its corresponding covariance matrix for observations. To circumvent this issue, a first-order Taylor series expansion is generally employed to approximate a nonlinear model with a linear form additive in inter-subject random effects. This linear approximation is based on the assumption that the parameter variation among subjects is negligible, which is quite hard to satisfy in actual clinical data analyses. Consequently, the linear approximation probably leads to inconsistent estimators. This paper describes the statistical issues regarding the first-order linear approximation in nonlinear mixed effects models.

著者

矢船 明史 津谷 喜一郎

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.27, no.3, pp.635-645, 1996-09-30 (Released:2010-06-28)

参考文献数

55

被引用文献数

4 7 2

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There has been an increasing number of clinical reports in the West to suggest that hepatotoxic reactions can be induced by herbal preparations including skullcap of Scutellaria species. In Japan, the root of Scutellaria baicalensis (Scutellariae Radix) is used under the name of Ogon, which is included in many kinds of Kampo formulations, such as Sho-saiko-to widely used for treating hepatic disorders. Reviewing the Information on Adverse Reactions to Drugs published by the Ministry of Health and Welfare of Japan, we found 22 cases of liver and biliary system reactions caused by Kampo formulations from 1989 through 1993, and in 20 of the cases, six types of Kampo formulations including Ogon were suspected as the cause of the reactions. In two clinical reports of pulmonary damage due to Sho-saiko-to, Lymphocyte Stimulation Test indicated that Ogon was the causative factor for the damage. Although there have been no reports to indicate that Ogon can actually cause liver damage, the results of our review strongly suggest the necessity for surveillance of the possibility of hepatotoxic reactions caused by Ogon.

著者

後藤 伸之 月岡 理絵 八田 壽夫 政田 幹夫 北澤 式文

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.27, no.2, pp.465-468, 1996-06-30 (Released:2010-06-28)

参考文献数

9

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We performed a pharmacoepidemiological study on triazolam dependence with typical doses in out-patients of Fukui Medical School Hospital. We investigated the prescriptions (duration of treatment and total dose prescribed) for patients administered triazolam.The patients were classified according to the prescription pattern of this drug, Group 1: patients who had been prescribed triazolam daily, Group 2: those who had been allowed to take triazolam when they cannot sleep.Approximately 40% of all the patients had been prescribed triazolam for 8 months or longer, and were judged to be normal dose dependence. The prevalence of this dependence was apparently higher in group 1 than in group 2.

著者

守内 匡 高田 加寿代 浅野 聡美 田中 治 金本 郁男

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.34, no.2, pp.43-47, 2003-03-31 (Released:2010-06-28)

参考文献数

26

被引用文献数

1

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A family history of diabetes and genetic predisposition are established as risk factors for diabetes mellitus, lifestyle factors also play an important role in the etiology of diabetes. Alcohol consumption may be related to risk for type 2 diabetes mellitus (type 2 DM) through effects on insulin secretion and sensitivity. Several large-scale epidemiological studies have suggested an inverse association between moderate alcohol consumption and reduced risk for type 2 DM. We assessed whether or not moderate alcohol consumption is associated with DM.Among 2, 338 men, 150 cases of incident DM were newly identified by means of an oral 75 g glucose tolerance test. The newly diagnosed DM percentages of drinking 0 g/day, 1-9.9 g/day, 10-29.9 g/day, 30-49.9 g/day and ≥50 g/day were 8 .3, 6.3, 5 .1, 5.2, 7.2, respectively. The newly diagnosed DM percentage of drinking 1-9.9 g/day had a significantly lower risk than 0 g/day. The frequency of alcohol consumption was significantly inversely associated with diabetes ; a frequency of greater than 6 times per week showed a significantly lower risk than 0 times per week. HbA1c of drinking 10-29.9 g/day, 30-49.9 g/day, and 5≥0g/day were significantly lower than that of 0 g/day.These data suggest that light moderate and frequent alcohol consumption have a decreased subsequent risk of diabetes mellitus.

著者

二木 芳人 松島 敏春 原田 和博

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.37, no.1, pp.41-48, 2006-01-31 (Released:2010-06-28)

参考文献数

15

被引用文献数

1

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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.

著者

Sumio HIRATA Mami MATOBA Satoshi IZUMI Taku FURUKUBO Miyuki OTA Minori FUJITA Senji OKUNO Tomoyuki YAMAKAWA

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.34, no.3, pp.87-90, 2003-05-31 (Released:2010-06-28)

参考文献数

15

被引用文献数

4 7

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We present a 68-year-old male case, hemodialysis patient (body weight 56.8 kg) with Clostridium difficile (C. difficile) induced pseudomembranous colitis. The colitis was treated with orally administered vancomycin (VCM), 2.0 g/day, for 14 days leading to high serum levels. At this time, the VCM treatment was discontinued following negative stool cultures for C. difficile, and the serum VCM concentration was 58.7 μg/ml, the highest level in oral VCM case reports up to the present. Mean bioavailability was estimated as 16.8% during the VCM administration period in this patient, and it was assumed that the intestinal absorption of VCM was increased with severe colitis. As the serum VCM levels continued to decrease gradually, the symptoms of colitis improved. Nevertheless, the patient's colitis relapsed after oral levofloxacin treatment for bronchitis and high fever, although the serum VCM levels were still far greater than the minimum inhibitory concentration of C. difficile infection.This finding suggests that VCM concentrations may remain insufficient in the colon despite the high serum levels. The high and persistent serum VCM concentrations in this patient may be due to the follow-ing: 1. increased absorption of VCM with severe colitis, 2. decreased excretion with renal impairment leading to VCM serum accumulation, and 3. too high a VCM dosage. We conclude that patients with both renal failure and severe intestinal disease may absorb and accumulate significant amounts of orally administered VCM. Therefore, a high dose oral VCM should be avoided in hemodialysis patients with severe pseudomembranous colitis.

著者

田中 利明 吉川 健一 寺嶋 さなえ 折井 義光 谷河 賞彦 加藤 昌功 浦江 明憲 入江 伸 田中 孝典 松木 孝道

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.28, no.1, pp.221-222, 1997-03-31 (Released:2010-06-28)

被引用文献数

1 1

著者

竹内 正弘 矢船 明史 成川 衛

出版者

日本臨床薬理学会

雑誌

臨床薬理 (ISSN:03881601)

巻号頁・発行日

vol.31, no.5, pp.659-665, 2000-09-30 (Released:2010-06-28)

参考文献数

26

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Nonlinear mixed effects models are often used for the analysis of repeated measure ments in clinical trials. A typical example is population pharmacokinetic analysis. Due to the statistical complexity, careful attention must be paid to some statistical issues in order to obtain reliable and robust results. This paper provides a description of the notes on the use of nonlinear mixed effects models for the analysis of repeated measurements in clinical trials. Three main issues are discussed in this paper: 1) a first-order lineariza tion, 2) a missing data, and 3) a measurement error.