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Development and its application of serum marker for the evaluation of staging in primary biliary cirrhosis

Research Project

Project/Area Number 14570481
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeSingle-year Grants
Section一般
Research Field Gastroenterology
Research InstitutionNagasaki University

Principal Investigator

OMAGARI Katsuhisa  Nagasaki University, Graduate School of Biomedical Sciences, instructor, 大学院・医歯薬学総合研究科, 講師 (90244045)

Project Period (FY) 2002 – 2005
Project Status Completed (Fiscal Year 2005)
Budget Amount *help
¥3,300,000 (Direct Cost: ¥3,300,000)
Fiscal Year 2005: ¥500,000 (Direct Cost: ¥500,000)
Fiscal Year 2004: ¥500,000 (Direct Cost: ¥500,000)
Fiscal Year 2003: ¥500,000 (Direct Cost: ¥500,000)
Fiscal Year 2002: ¥1,800,000 (Direct Cost: ¥1,800,000)
Keywordsprimary biliary cirrhosis / antimitochondrial antibody / ELISA / Western blotting / autoimmune cholangitis / enzyme inhibition assay / epidemiology / Weatern blotting / ELISA法)
Research Abstract

Primary biliary cirrhosis (PBC) is a chronic autoimmune cholestatic liver disease characterized by destruction of small and medium-sized bile ducts and the presence of antimitochondrial antibodies (AMA) in the serum traditionally detected by immunofluorescence. The "gold standard" procedure for the diagnosis of PBC is histopathological examination of liver tissue. However, liver biopsy is not a totally safe procedure, and the characteristic histopathological changes of PBC are not always evident in biopsy specimens. Therefore, serological examination such as AMA is useful for the diagnosis of PBC because this is non-invasive and therefore can be repeated throughout the course of the disease. Unfortunately, however, there is so far no "gold standard" assay (i.e., with 100% sensitivity and 100% specificity) for the detection of AMA in PBC. Our results indicated that the sensitivity of the newly developed enzyme-linked immunosorbent assay (ELISA) using MESACUP-2 Test Mitochondria M2 kit w … More as higher than that of an original ELISA, and comparable with that of immunofluorescence. It can be particularly suitable for monitoring disease activity and treatment outcome of PBC. By using these methods, it can be speculated that there are 330,000 AMA-positive people, 30,000-40,000 patients with PBC in Japan. Of these, 20,000 patients with PBC are diagnosed as having PBC. Our results also suggested that the diagnosis of PBC and so-called "autoimmune cholangitis (AIC)" was dependent on the "phase" of the respective disease in 22% of the patients. This may result in recommending Western blotting analysis before making the diagnosis of AIC. A prospective study without selection bias is needed to develop the definite diagnostic criteria of AIC. The enzyme inhibition assay for the detection of anti- pyruvate dehydrogenase complex (PDC) antibodies offers certain advantages such as objectivity, rapidity, simplicity, and low cost. Since this assay has almost 100% specificity, it may have particular applicability in screening the at-risk segment of the population in developing countries. Thus, we successfully demonstrated the characteristics and utilization of these AMA measurements. More accurate and larger study is requested for the development of a "complete" or "gold standard" diagnostic assay for PBC in the future. Less

Report

(5 results)
  • 2005 Annual Research Report   Final Research Report Summary
  • 2004 Annual Research Report
  • 2003 Annual Research Report
  • 2002 Annual Research Report
  • Research Products

    (21 results)

All 2005 2003 Other

All Journal Article (18 results) Publications (3 results)

  • [Journal Article] Does the diagnosis of primary biliary cirrhosis or autoimmune cholangitis depend on the 'phase' of the disease?2005

    • Author(s)
      Kadokawa Y, et al.
    • Journal Title

      Liver International 25巻2号

      Pages: 317-324

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] 日本人のPBC患者はどれくらいいるのか?2005

    • Author(s)
      大曲勝久・ 他
    • Journal Title

      消化器の臨床 8巻2号

      Pages: 238-244

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] 再考・自己免疫性胆管炎2005

    • Author(s)
      大曲勝久・ 他
    • Journal Title

      消化器の臨床 8巻6号

      Pages: 724-732

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Does the diagnosis of primary biliary cirrhosis or autoimmune cholangitis depend on the 'phase' of the disease?2005

    • Author(s)
      Kadokawa Y, Omagari K, et al.
    • Journal Title

      Liver International, 25-2

      Pages: 317-324

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] How many patients with primary biliary cirrhosis are there in Japan?2005

    • Author(s)
      Omagari K, et al.
    • Journal Title

      Clinics in Gastroenterology, (in Japanese) 8-2

      Pages: 238-244

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Reconsideration of autoimmune cholangitis2005

    • Author(s)
      Omagari K, et al.
    • Journal Title

      Clinics in Gastroenterology, (in Japanese) 8-6

      Pages: 724-732

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] 再考・自己免疫性胆管炎2005

    • Author(s)
      大曲勝久・他
    • Journal Title

      消化器の臨床 8巻6号

      Pages: 724-732

    • Related Report
      2005 Annual Research Report
  • [Journal Article] Does the diagnosis of primary biliary cirrhosis or autoimmune cholangitis depend on the 'phase' of the disease?2005

    • Author(s)
      Yoshiko kadokawa, et al.
    • Journal Title

      Liver International (In press)

    • Related Report
      2004 Annual Research Report
  • [Journal Article] 日本人のPBC患者はどれくらいいいるのか?2005

    • Author(s)
      大曲勝久, 他
    • Journal Title

      消火器の臨床 (In press)

    • Related Report
      2004 Annual Research Report
  • [Journal Article] Evaluation of newly developed ELISA using "MESACUP-2 Test Mitochondrial M2" kit for the diagnosis of primary biliary cirrhosis2003

    • Author(s)
      Kadokawa Y, et al.
    • Journal Title

      Clinical Biochemistry 36巻3号

      Pages: 203-210

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] 原発性胆汁性肝硬変の経過観察における「MESACUP-2 テストミトコンドリアM2」測定の臨床的意義 -蛍光抗体間接法との比較検討-2003

    • Author(s)
      大曲勝久, 他
    • Journal Title

      医学と薬学 50巻4号

      Pages: 543-550

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Correlation between histopathological findings of the liver and IgA class Antibodies to 2-oxo-acid dehydrogenase complex in primary biliary cirrhosis2003

    • Author(s)
      Masuda J, et al.
    • Journal Title

      Digestive Diseases and Sciences 48巻5号

      Pages: 932-938

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Evaluation of newly developed ELISA using "MESACUP-2 Test Mitochondrial M2" kit for the diagnosis of primary biliary cirrhosis2003

    • Author(s)
      Kadokawa Y, Omagari K, et al.
    • Journal Title

      Clinical Biochemistry, 36-3

      Pages: 203-210

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Clinical significance of antimitochondrial antibody by ELISA using "MESACUP-2 Test Mitochondrial M2" kit for the diagnosis of primary biliary cirrhosis2003

    • Author(s)
      Omagari K, et al.
    • Journal Title

      Japanese Journal of Medicine and Pharmaceutical Science, (in Japanese) 50-4

      Pages: 543-550

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Correlation between histopathological findings of the liver and IgA class Antibodies to 2-oxo-acid dehydrogenase complex in primary biliary cirrhosis2003

    • Author(s)
      Masuda J, Omagari K, et al.
    • Journal Title

      Digestive Diseases and Sciences, 48-5

      Pages: 932-938

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Enzyme inhibition assay for pyruvate dehydrogenase complex : Clinical utility for the diagnosis of primary biliary cirrhosis

    • Author(s)
      Omagari K, et al.
    • Journal Title

      World Journal of Gastroenterology (in press)

    • Description
      「研究成果報告書概要(和文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Enzyme inhibition assay for pyruvate dehydrogenase complex : Clinical utility for the diagnosis of primary biliary cirrhosis

    • Author(s)
      Omagari K, et al.
    • Journal Title

      World Journal of Gastroenterology, (in press)

    • Description
      「研究成果報告書概要(欧文)」より
    • Related Report
      2005 Final Research Report Summary
  • [Journal Article] Enzyme inhibition assay for pyruvate dehydrogenase complex : Clinical utility for the diagnosis of primary biliary cirrhosis

    • Author(s)
      Omagari K, et al.
    • Journal Title

      World Journal of Gastroenterology (in press)

    • Related Report
      2005 Annual Research Report
  • [Publications] 大曲勝久, 角川淑子, 石原 康, 河野 茂: "原発性胆汁性肝硬変の経過観察における「MESACUP-2テストミトコンドリアM2」測定の臨床的意義-蛍光抗体間接法との比較検討-"医学と薬学. 50巻・4号. 543-550 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Masuda J, Omagari K, et al.: "Correlation between histopathological findings of the liver and IgA class Antibodies to 2-oxo-acid dehydrogenase complex in primary biliary cirrhosis"Digestive Diseases and Sciences. 48巻・5号. 932-938 (2003)

    • Related Report
      2003 Annual Research Report
  • [Publications] Kadokawa Y, Omagari K, et al.: "Evaluation of newly developed ELISA using "MESACUP-2 Test Mitochondrial M2" kit for the diagnosis of primary biliary cirrhosis"Clinical Biochemistry. 36巻(in press). (2003)

    • Related Report
      2002 Annual Research Report

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Published: 2002-04-01   Modified: 2016-04-21  

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