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The clinical study of foscarnet sodium combined with adefovir dipivoxil for lamivudine-resistant patients with chronic hepatitis B
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摘要: 目的观察膦甲酸钠联合阿德福韦酯治疗拉米夫定耐药的慢性乙型肝炎患者的疗效和安全性。方法选择拉米夫定耐药的慢性乙型肝炎患者70例,随机分为联合组(膦甲酸钠和阿德福韦酯组)36例,对照组(阿德福韦酯组)34例,完成4周和12周治疗时,分别检测血清HBV DNA水平和肝功能变化。结果在治疗4周和12周时,联合组肝功能恢复及病毒应答率,均显著高于对照组。两组均未发生与研究药物相关的严重不良反应。两组不良事件发生率无统计学差异。结论膦甲酸钠联合阿德福韦酯治疗拉米夫定耐药的慢性乙型肝炎,可在生物化学及病毒学方面取得较好疗效,且安全性好。Abstract: Objective To investigate the efficacy and safety of foscarnet sodium combined with adefovir dipivoxil for Chinese chronic hipatitis B patients with lamivudine resistance.Methods 70 chronic hepatitis B patients with lamivudine resistanc were ramdomly put in a foscarnet sodium combined with adefovir dipivoxil group (36 patients) or an adefovir dipivoxil group (34 patients) .After 4 and 12-weeks of treatment, serum HBV DNA levels were measured by quantitative PCR and liver function tests.Results In the foscarnet sodium combined with adefovir dipivoxil group, the virological response and the liver function normalization at 4 and 12 weeks were significantly higher than those in the the adefovir dipivoxil group.There was no adverse event related to the investigational product in this trial.There was no significant difference between the two groups in the incidence of adverse events.Conclusion It was shown that foscarnet sodium combined with adefovir dipivoxil were effective and safe for the treatment of chronic hepatitis B patients with lamivudine resistance.
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Key words:
- chronic hepatitis B /
- clinical trial /
- lamivudine /
- drug resistance /
- foscarnet sodium /
- adefovir dipivoxil
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