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恩替卡韦治疗拉米夫定失效的慢性乙型肝炎患者5年的临床疗效 被引量:10

Five years trial of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area
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摘要 目的评价恩替卡韦(ETV)对重庆地区拉米夫定治疗失效的慢性乙型肝炎(CriB)患者5年的疗效和安全性。方法选取拉米夫定治疗失效的CHB患者32例,随机分为ETV组(剂量1.0mg/d)28例和安慰剂组4例,完成12周的双盲治疗后,患者均接受开放的ETV(剂量1.0mg/d)治疗,持续治疗至240周。分别检测治疗2、4、8、12、24、48、96、144、168、240周时患者的血清HBVDNA水平、HBsAg与HBeAg状态和肝功能情况。双盲阶段HBVDNA水平变化情况经Mauchly“球对称”检验后采用重复测量数据方差分析;连续性变量的统计描述用均数±标准差(x±s)表示。结果在接受ETV治疗后,12周时ETV组患者血清HBVDNA水平平均下降4.05log10拷贝/ml,安慰剂组平均下降0.08log10拷贝/ml(P〈0.05)。治疗240周时,ETV组患者HBVDNA水平均值下降至2.58log10拷贝/ml。HBVDNA〈3 log10拷贝/ml患者的百分比在治疗前为0,从第8周开始上升(6.25%),24周时为15.6%,尤其在96周明显上升(50%),到240周末为57.14%。240周末有2例出现HBsAg血清学转换,4例出现HBeAg血清学转换。服用ETV后ALT水平下降较迅速,12周后均数达正常水平,且5年持续低于40U/L。5年治疗期间,患者不良事件发生率为21%,有1例出现严重不良事件。结论ETV(1.0mg/d)治疗拉米夫定失效的CHB患者具有显著的抗病毒和临床疗效,且安全性及耐受性良好。 Objective To evaluate the efficacy and safety of five-year wail of entecavir for chronic hepatitis B patients failed with lamivudine therapy in the Chongqing area. Methods 32 patients failed with lamivudine therapy were enrolled in this study. In the double-blind phase, patients were randomly divided into entecavir 1.0 mg/d group (n = 28) and placebo group(n = 4) for 12 weeks. In the open-lable phase, patients received ETV 1.0 mg/d for 240 weeks. HBV DNA level, liver function, HBV serology were observed. Results The mean reduction in HBV DNA level at week 12 was 4.05 log10 copies/ml in ETV group, and 0.08 log10 copies/ml in placebo group (P 〈 0.05). The mean of HBV DNA level after 240 weeks of ETV treatment was decreased to 2.58 log10 copies/ml. The proportion of patients with HBV DNA〈 3 log10 copies/ml was 0, 6.25%, 15.6%, 50%, and 57.14% at 0, 8, 24, 96 and 240 weeks respectivfely. There were 2 patients with HBsAg seroconversion and 4 patients with HBeAg seroconversion at the end of the study. The ALT level returned to normal at week 12 and remained normal throughout the following 240 weeks. One patient had a severe adverse event during the trail. Condusion Entecavir is effective and safe for the chronic hepatitis B patients failed with lamivudine therapy.
出处 《中华肝脏病杂志》 CAS CSCD 北大核心 2009年第5期338-341,共4页 Chinese Journal of Hepatology
关键词 肝炎 乙型 慢性 临床试验 拉米夫定 恩替卡韦 Hepatitis B, chronic Clinical trials Lamivudine Entecavir
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