甘草酸二胺对阿德福韦酯治疗HBeAg阳性慢性乙型肝炎疗效影响的研究

Diammonium glycyrrhizinate does not affect efficacy of adefovir dipivoxil therapy in patients with HBeAgpositive chronic hepatitis B

目的评价短期应用甘草酸二胺（甘利欣）对阿德福韦酯（ADV）治疗HBeAg（＋）慢性乙型肝炎患者抗病毒疗效的影响。方法采用随机、有限的（24周）双盲、安慰剂（PLB）对照、多中心临床研究。HBeAg阳性的慢乙肝患者按照2：1的比例，随机分为ADV＋ADV组：ADV10mg／d，治疗48周；PLB＋ADV组：PLB10mg／d，24周后改用ADV10mg／d，治疗24周，共48周。评价研究过程中使用甘草酸二胺对病毒学应答、血清学应答及生化应答的影响。结果ADV＋ADV组和PLB＋ADV组应用甘草酸二胺和未用者间的病毒学、血清学和生化学应答方面无明显差异。在治疗0～24周期间短期应用甘草酸二铵的两组患者，治疗前人口学、既往治疗史、HBVDNA和ALT水平间无差别。治疗12、24周后，ADV＋ADV组血清中HBVDNA平均水平明显低于PLB＋ADV组，HBVDNA与基线相比的下降量则明显高于PLB＋ADV组患者，P〈0、05。结论甘草酸二胺单独应用不能替代ADV的抗病毒作用，但与ADV同时应用不影响其抗病毒疗效。

Objective To evaluate the effect of diammonium glycyrrhizinate on the antiviral therapy with adefovir dipivoxil （ADV） in patients with HBeAg-positive chronic hepatitis B. Methods Patients with HBeAgpositive chronic hepatitis B enrolled in this study were randomized to receive either ADV 10 mg/d for 48 weeks or placebo for 24 weeks followed by ADV 10 mg/d for 24 weeks. Antiviral activities of diammonium glycyrrhizinate adminstered during the trial were studied with respect to virological and serologic response, and ALT normalization. Results Twenty-one of 142 patients in ADV group vs. 11 of 68 patients in placebo group were treated with diammonium glycyrrhizinate. There was no significant difference in virological, serological and biochemical responses between patients with or without diammonium glycyrrhizinate in both therapy groups. During double-blind period, virological response was significantly worse in patients only receiving diammonium glycyrrhizinate than those combined with ADV. Conclusion Diammonium glycyrrhizinate had no antiviral activity and exerts no influence on the efficacy of ADV treatment in patients with HBeAg-positive chronic hepatitis B.