恩替卡韦治疗慢性乙型肝炎48周疗效观察

目的以拉米夫定（LAM）为对照,观察恩替卡韦（ETV）治疗慢性乙型肝炎（CHB）的抗病毒疗效。方法84例CHB患者,分为ETV组（0.5mg/d）和LAM组（100mg/d）各42例,用药时间至少48周。于第4、12、24和48周时,分别检测丙氨酸氨基转移酶（ALT）水平及应用PCR定量法检测血清病毒载量。治疗前和治疗48周时分别检测乙型肝炎病毒血清学指标。结果经过48周治疗后ALT的复常率,ETV组为90.5%,LAM组为73.8%（P＆lt;0.05）;HBV DNA＆lt;103拷贝/ml的患者比例,ETV组为92.7%,LAM组为71.4%（P＆lt;0.05）,ETV组均优于LAM组。两组患者HBeAg血清转换率差别无统计学意义,而HBeAg低于检测下限的比率ETV组（39.4%）高于LAM组（17.7%）（P＆lt;0.05）。治疗48周时ETV组无1例患者出现病毒反弹,而LAM组有8例（19.0%）出现病毒反弹,经检测系YMDD变异。结论ETV治疗CHB患者,在改善肝脏生化指标、抑制病毒、HBeAg低于检测下限和减少病毒变异方面均优于LAM。

The efficacy of entecavir in patients with chronic hepatitis B treatment for 48 weeks

Objective To study the antiviral efficacy of entecavir （ETV） compared with lamivudine （LAM） in patients with chronic hepatitis B. Methods Eighty four patients with chronic hepatitis B were divided into ETV group （0.5 mg/d） and LAM group （ 100 mg/d） for at least 48 weeks. After 4, 12, 24, 48 weeks treatment, serum samples of the patients were tested for alanine aminotransferase levels and HBV viral loads according to PCR assay, respectively. HBV serological markers were tested before and after 48 weeks treatment. Results After 48 weeks treatment, the ALT normalization rate in ETV and LAM groups were 90.5% and 73.8%, respectively （P 〈 0.05 ）. The proportion of patients with ttBV DNA undetectable （HBV DNA 〈 103 copies/ml ） was higher in ETV group than in LAM group （92.7% vs 71.4%, P 〈 0.05）. There were no significant difference in proportion of HBeAg seroconversion between two groups, but the HBeAg loss rate in ETV group was higher than LAM group （39.4% vs 17.7%, P 〈0.05 ）. No patient was resistant to ETV, while 8 cases （ 19.0% ） occoured viral rebound and YMDD mutations were confirmed by examination. Conclusions The rates of virologic response, normalization of alanine aminotransferase levels and HBeAg loss in ETV group were significantly higher than LAM group.