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目的:探讨恩替卡韦(ETV)治疗慢性乙型肝炎抗病毒感染的量效关系及安全性。方法:采用随机、双盲、安慰剂对照的临床试验,选择未经抗病毒治疗的慢性乙型肝炎病毒(HBV)感染者,按1:1:1的比例分为3组:ETV0.5mg/d组、ETV0.1mg/d组和安慰剂组,治疗28d,停药观察56d,然后用ETV0.5mg/d开放治疗48周,再次停药观察24周。结果:ETV0.5mg/d的疗效优于0.1mg/d,停药后HBV DNA的反跳也较缓慢。开放治疗期间有81.6%的受试者HBV DNA<0.7mmol/ml,HBeAg/抗HBe的血清转换率为7.9%,但停药后80%的受试者HBV DNA再度升高。给药组和安慰剂组受试者不良事件发生率无统计学差异(P=0.428),开放治疗期间未发现与恩替卡韦相关的严重不良反应。结论:ETV有较强的抗HBV活性,其抗病毒作用与剂量相关。恩替卡韦0.5mg/d治疗慢性乙型肝炎更为有效和安全。
Objective: To investigate the efficacy and safety of entecavir (ETV) in treating chronic hepatitis B antiviral infection. Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted to select patients without HBV infection who were divided into 3 groups according to the ratio of 1: 1: 1: ETV 0.5mg / D group, ETV0.1mg / d group and placebo group. After 28 days of treatment, the drug withdrawal was observed for 56 days. ETV 0.5 mg / d was given for 48 weeks and re-stopped for 24 weeks. Results: The efficacy of ETV 0.5 mg / d was better than 0.1 mg / d, and the rebound of HBV DNA was also slower after drug withdrawal. During the open treatment period, 81.6% of the subjects had HBV DNA <0.7 mmol / ml and the seroconversion rate of HBeAg / anti-HBe was 7.9%. However, HBV DNA was again elevated in 80% of the subjects after withdrawal. There was no significant difference in the incidence of adverse events between the study and placebo groups (P = 0.428). No serious adverse reactions were found to be associated with entecavir during the open treatment. Conclusion: ETV has strong anti-HBV activity, and its anti-virus effect is dose-dependent. Entecavir 0.5mg / d treatment of chronic hepatitis B more effective and safe.