Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics
Online ISSN : 1882-8272
Print ISSN : 0388-1601
ISSN-L : 0388-1601
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Volume 38, Issue 5
Displaying 1-13 of 13 articles from this issue
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Feature Articles : Surrogate Biomarkers for Clinical Trials of Cardiovascular Drugs
Original
  • A Randomized Controlled Study on the Effects of Gargling with Tea Catechin Extracts on the Prevention of Influenza Infection in Healthy Adults
    Hiroshi YAMADA, Takashi DAIMON, Katsuhiko MATSUDA, Masayuki YOSHIDA, N ...
    2007 Volume 38 Issue 5 Pages 323-330
    Published: September 30, 2007
    Released on J-STAGE: October 31, 2008
    DOIhttps://doi.org/10.3999/jscpt.38.323
    JOURNAL FREE ACCESS
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    Experimental studies have revealed that tea catechins prevent influenza virus infection ; however, the clinical effects have been inconclusive. At the onset of the influenza season, a randomized, double-blind, placebo-controlled study was conducted from December 2005 to March 2006 in Japan. A total of 404 healthy volunteers, 20-65 years of age, were enrolled and randomly assigned to two groups : the catechin group gargling with tea catechin extract solution (approximately 400 μg/mL catechins) or the placebo group gargling without tea catechin extracts. In both groups, gargling was performed three times daily for 90 days. All participants were inoculated with the influenza vaccine before participating in the study. The primary outcome measure was the incidence rate of influenza infection during the study identified by a rapid assay for influenza virus antigens. On an intention to treat basis, 195 participants in the catechin group and 200 in the placebo group who started the intervention were included in the analysis. Of the participants, 6 (1.5%) were infected with influenza. The incidence rate of influenza infection in the catechin group (1.0%, 2 participants) was half that in the control group (2.0%, 4 participants), but not significant between the two groups. We could not find significant effects of gargling with tea catechin on prevention of influenza in the healthy adults inoculated with the influenza vaccine of the 2005-2006 season. However, the effects in more susceptible groups, i.e., those not vaccinated against the influenza virus, children, elderly or immunosuppressed people remain inconclusive.
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  • Pharmacokinetic and Pharmacodynamic Properties of Intravenous Darbepoetin Alfa (KRN321) in Japanese Hemodialysis Patients
    Toshihiko UEMATSU, Satoru NAGASHIMA, Mitsutaka KANAMARU, Naro OHASHI, ...
    2007 Volume 38 Issue 5 Pages 331-339
    Published: September 30, 2007
    Released on J-STAGE: October 31, 2008
    DOIhttps://doi.org/10.3999/jscpt.38.331
    JOURNAL FREE ACCESS
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    This article describes the pharmacokinetics, pharmacodynamics of darbepoetin alfa, a novel erythropoietin analogue showing a long-lasting effect. In the single-dose segment of this study, hemodialysis patients were administered darbepoetin alfa intravenously in increasing doses ranging from 90-180 μg/body. In the repeated-dose segment, switching to once-weekly administration of darbepoetin alfa was attempted in 14 patients who had been receiving intravenous rHuEPO two or three times a week. The intravenous dose of darbepoetin alfa to be administered once weekly (10-60 μg/body) was titrated to maintain hemoglobin levels within±1.0 g/dL of the individual mean baseline level as well as in the range of 9-12 g/dL for 28 weeks. When given as a single dose, darbepoetin alfa showed almost linear pharmacokinetics within the dose range of 90-180 μg, and the mean elimination half-life ranged from 45.37 to 48.67 hours and the total body clearance ranged from 52.69 to 64.07 mL/hour/body. When given as repeated doses for up to 28 weeks, almost no changes were observed in the pharmacokinetics of darbepoetin alfa, i.e., the mean elimination half-life and total body clearance rate were 33.14 hours and 76.90 mL/hour/body at Week 1, 39.13 hours and 83.89 mL/hour/body at Week 21, and 42.09 hours and 83.48 mL/hour/body at Week 28. darbepoetin alfa was well tolerated and no antibodies against it were detected. The results suggest that less frequent intravenous administration of darbepoetin alfa can effectively maintain target hemoglobin levels safely in the treatment of renal anemia in hemodialysis patients.
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Forum
  • The Current Situation and Problems in Clinical Trials with Electronic Medical Record System
    Kaoru ISHIYAMA, Machiko SAKURAI, Tomoko KITAGAWA, Yuho NABATA, Kyoko O ...
    2007 Volume 38 Issue 5 Pages 341-348
    Published: September 30, 2007
    Released on J-STAGE: October 31, 2008
    DOIhttps://doi.org/10.3999/jscpt.38.341
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    To clarify the current situation and problems in clinical trials with the electronic medical record system (EMR), a survey of 183 hospitals and 45 sponsors was undertaken. Among them, 133 hospitals replied and 31 are using EMR. More than 60% fulfilled “the check items to secure the reliability of clinical trial data in medical institutions using EMR systems” issued by the Japan Pharmaceutical Manufacturers Association. However, several problems have been revealed. It is necessary to clarify either paper-based data or electric data as source documents and to stipulate it in standard operating procedure since both of them are often used together. The identification and authentication of monitors, partition of patient's information, and controlling the access rights at source document verification (SDV) are not properly conducted in all hospitals. Also 35 replies were obtained from the sponsors, and they are generally favorable to EMR because EMR can improve the reliability of data. In conclusion, currently few hospitals perform clinical trials with EMR, and it is necessary to solve several problems, especially relating SDV with EMR.
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  • Questionnaire to General Citizens on Human Tissue Bank for Research Use
    Takako MAEKAWA, Sachiko NAKAYA, Toshio KUMAI, Masami TANAKA, Naoki MAT ...
    2007 Volume 38 Issue 5 Pages 349-354
    Published: September 30, 2007
    Released on J-STAGE: October 31, 2008
    DOIhttps://doi.org/10.3999/jscpt.38.349
    JOURNAL FREE ACCESS
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    The Human Science Research Resources Bank (HSRRB) was established in 2000. St. Marianna University School of Medicine has been contributing in offering human tissue to HSRRB for six years by introducing a clinical research coordinator (CRC) to our novel system, though HSRRB has not been well recognized yet. We previously carried out a questionnaire surveillance to the patients and their family members who participated in this program, and also to our medical staff. Here, we undertook a similar surveillance to the general citizen.
    As a result of the surveillance, the recognition of HSRRB was found to be low among the general citizens, but many of them agreed to the concept of HSRRB after we explained the necessity for the tissue bank. There was no big difference between patients and their family's recognition and the citizen's.
    We have re-recognized the importance of providing information and education for better understanding of the tissue bank while citizens are healthy and fit. We want to provide information on the human tissue bank and perform education activities from now on, so that use of human tissue for medical research may be better understood and recognized.
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  • Proposals for Improving the Japanese Clinical Trial Environment to Increase International Competitiveness :
    Based on the Results of the EFPIA Survey on the Japanese Clinical Trial Environment
    Akimitsu SANO, Hiroyuki AONO, Shiroh INOUE, Yasuhiko OMIYA, Takayuki K ...
    2007 Volume 38 Issue 5 Pages 355-362
    Published: September 30, 2007
    Released on J-STAGE: October 31, 2008
    DOIhttps://doi.org/10.3999/jscpt.38.355
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    From the perspective of simultaneous drug development, Japan has been rapidly losing its competitiveness in terms of efficiency and cost-effectiveness compared to Western and other Asian countries. There is a need to improve the clinical trial environment in Japan, in line with international standards, in order to bring quality medicines to patients more quickly.
    The EFPIA conducted this survey to determine the current organisation of clinical trials at medical institutions in Japan through the following assessments. 1) procedures for trial application, 2) IRB, 3) support by CRC, 4) management of essential documents, 5) SDV, and 6) handling of safety information. Further, these results were compared with a similar study conducted in March 2003. The results confirmed that improvements have been observed in some aspects, such as markedly improved support by CRC, however many issues remain unsolved, such as the requirements of SDV and how safety information is handled.
    Based on these results, we present proposals for improving the clinical trial environment in Japan to improve competitiveness internationally, focusing on speed and the reduction of cost of clinical trials.
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