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目的观察拉米夫定(LAM)联合胸腺肽α1(Tα1)治疗慢性乙型肝炎的疗效和安全性。方法选择156例HBV-DNA、HBeAg阳性的慢性乙型肝炎患者分为单一使用拉米夫定组(LAM组)和拉米夫定联合胸腺肽α1组(LAM+Tα1组)。结果治疗52周时LAM+Tα1组HBeAg血清转换率38.5%明显高于LAM组11.5%(P<0.05)。HBV-DNA阴转率LAM+Tα1组82.1%明显高于LAM组51.3%(P<0.05)。ALT复常率LAM+Tα1组91.0%明显高于LAM组67.9%(P<0.05)。综合疗效评价LAM+Tα1组完全应答率38.5%明显高于LAM组11.5%(P<0.05)。治疗过程中无明显不良反应,LAM+Tα1组未发生HBV前C区变异株,LAM组发生YMDD变异19例,LAM+Tα1组仅2例。结论 LAM+Tα1治疗慢性乙型肝炎,不良反应少、安全、疗效确切,优于单一LAM治疗。
Objective To observe the efficacy and safety of lamivudine (LAM) combined with thymosin α1 (Tα1) in the treatment of chronic hepatitis B patients. Methods 156 patients with HBV-DNA were selected and patients with HBeAg-positive chronic hepatitis B were divided into single use lamivudine group (LAM group) and lamivudine combined with thymosin α1 group (LAM + Tα1 group). Results At 52 weeks of treatment, the HBeAg seroconversion rate in LAM + Tα1 group was significantly higher than that in LAM group (38.5% vs 11.5%, P <0.05). The negative rate of HBV-DNA in LAM + Tα1 group was significantly higher than that in LAM group (82.1% vs 51.3%, P <0.05). The ALT normalization rate was 91.0% in LAM + Tα1 group and 67.9% in LAM group (P <0.05). The overall response rate in LAM + Tα1 group was 38.5%, which was significantly higher than that in LAM group (11.5%, P <0.05). There was no obvious adverse reaction in the course of treatment. There was no pre-HBV C mutation in LAM + Tα1 group. There were 19 cases of YMDD mutation in LAM group and 2 cases in LAM + Tα1 group. Conclusion LAM + Tα1 treatment of chronic hepatitis B, less adverse reactions, safety, curative effect is better than single LAM treatment.