Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
Volume 31, Issue 6
Displaying 1-7 of 7 articles from this issue
  • 2000 Volume 31 Issue 6 Pages 146E
    Published: 2000
    Released on J-STAGE: February 25, 2011
    JOURNAL FREE ACCESS
  • [in Japanese]
    2000 Volume 31 Issue 6 Pages 677-684
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
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  • Takanori MIURA, Ryoji KOJIMA, Youji SUGIURA, Masayo YAMASHITA, Eiji YO ...
    2000 Volume 31 Issue 6 Pages 685-691
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
    Our previous study suggested that maintaining the serum digoxin concentration (SDC) in a lower target range (0.5-1.4 ng/ml) than the generally recommended range (0.5-2.0 ng/ml) may be useful to avoid the occurrence of digoxin toxicity in elderly patients (over 71 years old). Thus, the present prospective clinical study was carried out to evaluate the significance of the new target therapeutic SDC range in decreasing the incidence of digoxin toxicity during digoxin maintenance therapy in elderly patients.
    Study subjects who received oral maintenance therapy with digoxin for heart failure and/or atrial fibrillation with tachycardia included 899 patients and 946 patients in 1995 and 1997, respectively at Kosei Hospital. In all study subjects, measurements of SDC, blood chemistry analysis, and 24-hour Holter electrocardiographic recording were performed when the SDC was at a presumed steady state.
    After treatment of patients with a lower SDC range, the incidence (1.8%) of digoxin toxicity in 1997 was significantly less than that (7.3%) in 1995. In addition, the incidence (2.6%) of adverse reactions of patients over 71 years old in 1997 was also markedly lower than that (16.4%) in 1995. In 83 elderly patients, no significant difference in heart rate under conditions of resting and exercise was observed between patients with SDCs over 1.4 ng/ml (mean SDC 1.79 ng/ml) and patients with SDCs less than 1 .4 ng/ml (mean SDC 1.26 ng/ml).
    These results indicate that the treatment of elderly patients with the new therapeutic SDC range reduces the incidence of digoxin toxicity with an equivalent therapeutic efficacy to that obtained with the generally recommended range.
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  • Etsuko UEJIMA, Kyoko TAKAHASHI, Masako OHISHI, Ikuo ARAKAWA, Nobuo KUR ...
    2000 Volume 31 Issue 6 Pages 693-699
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
    In Chinese herbal drugs, different drugs have the same name, causing confusion of drug origin which might cause harmful effects when clinically applied. We examined a 19-year-old female who acquired Chinese herbs syndrome (aristolochia nephropathy) induced by a mixture of crude Chinese drugs. She had imported the Chinese drug (decoction) consisting of approximately 20 natural elements and taken it for atopic dermatitis over a course of approximately 3 years. We identified“Guan Mutong”of Aristolochiaceae as analyzed by means of thin-layer chromatography (TLC) and highperformance liquid chromatography (HPLC). We confirmed aristolochic acid, a known nephrotoxin, from stem slices of“Guan Mutong”in her drug. It is not known if“Guan Mutong”was intentionally included in her imported Chinese drugs or put in by mistake. However, the present study has suggested the possibility that the Chinese herb“Guan Mutong”which is potentially nephrotoxic, might be accidentally delivered in the plant fraction of the Chinese drug. The possible adverse effects of crude Chinese drugs should be emphasized for patients who self-administer them.
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  • Koh-ichi SUGIMOTO, Masami OHMORI, Shuichi TSURUOKA, Kazuhiro HARADA, K ...
    2000 Volume 31 Issue 6 Pages 701-704
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
    This study was performed to determine the influence of dosing time of enalapril, an angiotensin-converting enzyme. inhibitor, on pulmonary function. Enalapril (10 mg) or placebo was given orally at 10: 00 and 22: 00 to eight healthy, nonsmoking, male adults in a randomized, double-blind crossover design. Peak expiratory flow (PEF) was determined at 16: 00 on day 1 and 04: 00 and 16: 00 on day 2. PEF at 04: 00 was significantlylower than that at 16: 00 (p<0.01). Enalapril dosed at 10: 00 or 22: 00 did not signifi cantly influence the daily variations of PEF compared to placebo. The daily variation of pulmonary function might not be influenced by a single dosing of enalapril in the morning or evening.
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  • Akifumi YAFUNE, Masahiro TAKEUCHI, Mamoru NARUKAWA
    2000 Volume 31 Issue 6 Pages 705-713
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
    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.
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  • Akifumi YAFUNE
    2000 Volume 31 Issue 6 Pages 715-718
    Published: November 30, 2000
    Released on J-STAGE: June 28, 2010
    JOURNAL FREE ACCESS
    In the guideline for bioequivalence studies published in 1997, the decision for bio equivalence is basically based on the confidence intervals for AUC and Cmax.This decision is equivalent to rejecting two one-sided hypotheses by the two one-sided tests procedure. For the sample size determination, we must consider the statistical power, i. e., the probability of correctly accepting bioequivalence. This paper describes the sample size determination for bioequivalence studies giving consideration to the statisti cal power.
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