单磷酸阿糖腺苷治疗慢性乙型肝炎临床研究

THE THERAPEUTIC EFFECT OF ARA-AMP WITH THYMO-PEPTIDE OR HBV VACCINE ON PATIENTS WITH CHRONIC HEPATITIS B

为进一步验证国产单磷酸阿糖腺苷(Ara-AMP)单独应用和联合乙肝疫苗或胸腺肽治疗慢性乙型肝炎的疗效,进行了全国多中心验证,共1977例慢性乙型肝炎病人分为3组,分别应用上述三种疗法进行治疗。治疗结束时乙型肝炎e抗原(闭HBeAg)和乙型肝炎病毒(HBV)DNA的阴转率分别为:Ara-AMP单独应用组为43.5％和41.5％。Ara-AMP联合乙肝疫苗组为50.7％和58.7％,Ara-AMP联合胸腺肽组为56.3％和59.7％。部分病例进行了随访12个月,单独应用Ara-AMP组HBeAg和HBV DNA阴转率分别为30.8％和32.7％,合用乙肝疫苗组分别为40.0％和42.1％,合用胸腺肽30天组分别为51.9％和42.3％,合用胸腺肽90天组分别为62.1％和72.4％。各组皆未见严重毒副作用。研究结果揭示单独应用Ara-AMP或联合乙肝疫苗或胸腺肽皆有一定的抗HBV疗效,而联合疗法可进一步提高疗效,特别是联合长疗程胸腺肽组远期疗效更好。

To study the therapeutic effects of Ara-AMP with thymo-peptide or HBV vaccine on chronic hepatitis B, 1997 cases of chronic hepatitis B were divided into 3 groups . In group 1,382 patients were treated with Ara-AMP alone ,in group Ⅱ ,710 patients with Ara-AMP combined with hepatitis B vaccine and in group Ⅲ,885 patients with Ara-AMP plus thymo-peptide. Before treatment,serum HBsAg@HBeAg and HBV-DNA were positive,and ALT elevated in all patients. At the end of the treatment,the HBeAg and/or HBV-DNA clearence rates were 43. 5% and 41.5% ,50.7% and 58.7% ,56. 3% and 59.7% in the 3 groups,respectively. At one year follow up, the HBeAg and HBV-DNA clearence rates were 30.8% and 32. 7 % , 40. 0 % and 42. 1 % , 51. 9 %- 62. 1 % and 42. 3 % - 72. 4 % , respectively. According to these data ,it is concluded that the therapeutic effect of Ara-AMP combined with thynio-peptide is the best regimen without severe side effects in treating chronic hepatitis B.