A Pilot Study of Thymosin α_1 Therapy for Chronic Hepatitis B Patients

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<i>Objective</i> The efficacy of thymosin alpha 1 (Tα<sub>1</sub>) in patients with chronic hepatitis B still requires confirmation. We, therefore, evaluated the efficacy of therapy in patients with chronic hepatitis B.<br> <i>Methods</i> Sixteen patients were randomly assigned into one of two groups, treated with O.Smg of Tα<sub>1</sub> (low dose group; n=8) or 1.6 mg Tα<sub>1</sub> (high dose group; n=8), administered six times weekly for two weeks, followed by twice weekly for another 22 weeks. Responders were defined as patients having clearance of hepatitis B e antigen by radioimmunoassay and negativity of hepatitis B virus (HBV)-DNA by branched DNA signal amplification and normalization of serum alanine aminotransferase (ALT) 24 months after initiation of Tα<sub>1</sub> therapy. Transient acute exacerbation was defined as an increase of more than 300 IU/l in serum ALT level during Tα<sub>1</sub> therapy.<br> <i>Results</i> The response rate was 37.5% (6/16). Tα<sub>1</sub> therapy had a significant effect when, 1) transient acute exacerbation was present (p=0.0029), 2) the serum HBV-DNA level was <100 Meq/ml prior to the commencement of Tα<sub>1</sub> therapy (p=0.0063). The difference between low and high dose groups was not statistically significant (p=0.608).<br> <i>Conclusion</i> The results of this trial show that: 1) a 24-week course of Tα<sub>1</sub> could be a worthwhile strategy for chronic hepatitis B patients with a serum HBV-DNA level of less than 100 Meq/ml; and 2) patients with a transient acute exacerbation during Tα<sub>1</sub> therapy generally often respond well.<br>(Internal Medicine 42: 941-946, 2003)

収録刊行物

  • Internal medicine

    Internal medicine 42(10), 941-946, 2003-10-01

    The Japanese Society of Internal Medicine

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各種コード

  • NII論文ID(NAID)
    10012456998
  • NII書誌ID(NCID)
    AA10827774
  • 本文言語コード
    ENG
  • 資料種別
    ART
  • ISSN
    09182918
  • NDL 記事登録ID
    6721355
  • NDL 雑誌分類
    ZS21(科学技術--医学--内科学)
  • NDL 請求記号
    Z53-M398
  • データ提供元
    CJP書誌  NDL  J-STAGE 
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