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)
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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
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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
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