聚乙二醇干扰素α-2a治疗对拉米夫定耐药的慢性乙型肝炎的临床观察

Clinical Observation of Polyethylene Glycol Interferon α-2a in the Treatment of Lamivudine-resistant Chronic Hepatitis B

目的:观察聚乙二醇干扰素α-2a治疗对拉米夫定耐药的慢性乙型肝炎的临床效果。方法:采用随机分组法将112例对拉米夫定耐药的慢性乙型肝炎患者分为3组:长效干扰素治疗组(40例)皮下注射聚乙二醇干扰素α-2a注射液,每次180μg,每周1次;阿德福韦酯组(36例)服用阿德福韦酯片,每次10mg,qd;对照组(26例)继续服用拉米夫定片治疗。3组疗程均为6个月,且均积极给予护肝治疗。比较3组治疗前后肝功能、乙肝标志物和乙型肝炎病毒(HBV)DNA、肝纤维化指标以及不良反应。结果:治疗3个月时,长效干扰素治疗组与阿德福韦酯组丙氨酸氨基转移酶(ALT)复常率均显著高于对照组(P<0.05),但2组间无显著性差异(P>0.05);治疗6个月时,长效干扰素治疗组ALT复常率较对照组和阿德福韦酯组均有显著升高(P<0.01或P<0.05)。长效干扰素治疗组较阿德福韦酯组能更好地抑制HBVDNA复制,促进HBeAg/HBeAb转换,2组比较差异有统计学意义(P<0.05)。对照组治疗前、后肝纤维化指标无显著变化,而阿德福韦酯组和长效干扰素治疗组治疗前后玻璃酸(HA)、层粘连蛋白(LN)、Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(Ⅳ-C)均有显著差异(P<0.01),且治疗后长效干扰素治疗组HA、LN、PCⅢ较阿德福韦酯组显著降低(P<0.01)。长效干扰素治疗组虽不良反应发生率较高,但不严重,均未影响治疗。结论:聚乙二醇干扰素α-2a治疗拉米夫定耐药的慢性乙型肝炎疗效确切,不良反应可耐受。

OBJECTIVE:To observe the clinical efficacy of polyethylene glycol interferon α-2a in the treatment of lamivudine-resistant chronic hepatitis B.METHODS:112 patients with lamivudine-resistant chronic hepatitis B were randomly divided into 3 groups.40 patients in long-term interferon group were given polyethylene glycol interferon α-2a 180 μg per time,once a week,subcutaneously for 6 months.36 patients in adefovir dipivoxil group were Adefovir dipivoxil tablets 10 mg per time,once a day for 6 months.26 patients in control group continued to receive lamivudine treatment for 6 months.3 groups were given positive liver treatment.Liver function,HBV markers and HBV DNA,liver fibrosis index were compared among 3 groups before and after treatment.RESULTS:After 3 months of treatment,ALT normalization rates of long-term interferon group and adefovir group were higher than that of control group(P<0.05),but there was no significant difference between 2 groups(P>0.05).After 6 months of treatment,ALT normalization rate of long-term interferon group was increased significantly,compared with control group and adefovir dipivoxil group(P<0.01 or P<0.05).Long-term interferon group was better than adefovir dipivoxil group in inhibiting HBV DNA replication and promoting HBeAg/HBeAb conversion,there was statistical significance in the difference between 2 groups(P<0.05).Control group showed no significant changes in liver fibrosis before and after treatment,and the differences of HA,LN,PC Ⅲ,IV-C were significant between adefovir dipivoxil group and long-term interferon group before and after treatment(P<0.01),and HA,LN and PC Ⅲ of long-term interferon group were decreased significantly,compared with adefovir dipivoxil group(P<0.01).The incidence of ADR in long-term interferon group was higher than other groups,but it was not serious and can not affect therapy.CONCLUSION:Polyethylene glycol interferon α-2a is effective in the treatment of lamivudine-resistant chronic hepatitis B with ADR tolerance.