【作者】 杨桂生； 王海涛； 常爱娜；

【Author】 Yang Gui-sheng Wang Hai-tao CHANG Ai-na Department of Infectious Diseases,Shandong wei-hai Wendeng hospitai 264400,China

【机构】 威海市文登中心医院感染性疾病科；

【摘要】 目的:评价恩替卡韦治疗慢性乙型肝炎(CHB)的疗效和安全性。方法:72例 CHB 患者随机分配到治疗组和对照组。治疗组(30例)予恩替卡韦0.5mg,每日1次口服,疗程48周。对照组(42例) 予拉米夫定100mg,每日1次口服,疗程48周。完成24周、48周时,检测血清 HBV-DNA 水平、乙型肝炎病毒血清学标志物及肝功能变化。结果:恩替卡韦组和拉米夫定组:在治疗24周,48周时,血清 HBV-DNA 水平比基线值(log10copies/ml)平均下降分别为-5.48,-6.87和-2.84,-5.38;病毒应答率分别为53%, 67%,和21%,43%,均 P<0.001;两组均有显著差异。丙氨酸氨基转移酶(ALT)复常率分别为为67%,77 %和60%,67%:及治疗后血清 HbeAg 阴转率、HbeAg 血清转换率、HBsAg 消失率、不良事件发生率,均 P>0.05, 差异无统计学意义.未发生一种与研究药物相关的严重不良反应。结论:恩替卡韦治疗慢性乙型肝炎,可在病毒学及生物化学方面取得显著疗效,且安全性良好,无耐药发生(需要长时间观测验证)。更多还原

【Abstract】 objective To investigate the efficacy and safety of Entecavir in the treatment of chronic hepatiti B. Methods Seventy-two patients with chronic hepatitis B were assigned to a Entecovir(expermental)group(n=30) and LAM(control)group(n=42)randomly.Each patient in the experimental group received 0.5rag every day.Each patient in the control gracp received 100rag every day.All the patients were treated for 48 weeks.After 24 and 48-weeks of treatment,serum HBV DNA levels were measured and liver function tests.HBV serology and safety assessments were also conducted.Results The mean reduction of HBV DNA from baseline at 24 and 48 weeks was significantly greater in the Entecovir group compared with that in the LAM group(-5.48,-6.87log10 copies/ml and-2.84,-5.34log10copies/ml p<0.001).In the Entecovir group,the virological response and and ALT normalization at 24 and 48-weeks were significantly greater in the Entecovir group than those t in the LAM group.There was no significant difference between the two groupsin the portion of HbeAg reduction,HbeAg seroconversion and incidence of adverse events.There was no severe adverse event related to the investigational product,Entecovir,in this trial.Conclusion Entecovir is effective and safe for the treatment of chronic hepatitis B patients.更多还原