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目的III期临床研究结果显示恩替卡韦(ETV)治疗48周,在组织学改善、ALT复常和HBVDNA抑制方面均优于拉米夫定(LMV);肝纤维化的改善在核苷类似物初治患者中2个治疗组相似,在拉米夫定失效患者中,ETV明显优于LMV。对基线时表现为中重度肝纤维化/硬化患者(Ishak评分:4-6)进行亚组分析,评估ETV或LMV治疗48周的疗效。方法纤维化评分是由1位病理学家对基线和48周时标本进行评估,治疗组及标本先后顺序均对他设盲。结果对HBeAg(+)核苷类似物初治的患者,48周时肝纤维化发生改善的患者比例ETV组为57%,LMV组为49%;肝纤维化没变化的患者比例ETV组35%,LMV组为28%;肝纤维化恶化的患者比例ETV组为0,LMV组为6%;对HBeAg(-)核苷类似物初治的患者,48周时肝纤维化发生改善的患者比例ETV组为59%,LMV组为53%;肝纤维化没变化的患者比例ETV组为31%,LMV组为18%;肝纤维化恶化的患者比例ETV组为2%,LMV组为5%;对HBeAg(+)LMV失效的患者,48周时肝纤维化发生改善的患者比例ETV组为43%,LMV组为33%;肝纤维化没变化的患者比例ETV组为35%,LMV组为29%;肝纤维化恶化的患者比例ETV组为0,LMV组为19%。结论接受ETV治疗的中重度肝纤维化/硬化患者比接受LMV治疗更可能获得纤维化改善或不变,这些数据与其他治疗终点(全组人群的病毒学、生化学和Knodell评价的组织学改善情况)结果一致,均为ETV优于LMV。
The purpose of the phase III clinical study showed that entecavir (ETV) for 48 weeks had better histologic improvement, ALT normalization and HBVDNA inhibition than lamivudine (LMV); improvement of hepatic fibrosis was at the initial stage of nucleoside analogue Two of the patients treated were similar, with ETV being significantly better than LMV among patients with lamivudine failure. Subgroup analyzes of patients with moderate-to-severe liver fibrosis / sclerosis (Ishak score 4-6) at baseline were performed to assess the efficacy of ETV or LMV for 48 weeks. Methods Fibrosis score was assessed by a pathologist at baseline and at 48 weeks, with blindness in both the treatment group and the specimen. Results In HBeAg (+) nucleoside analogue-naive patients, the proportion of patients with improvement of hepatic fibrosis at week 48 was 57% in ETV group and 49% in LMV group. The proportion of patients with unchanged hepatic fibrosis in 35% In the LMV group and 28% in the LMV group. The proportion of patients with worsening liver fibrosis was 0 in the ETV group and 6% in the LMV group. The percentage of patients with HBeAg (-) nucleoside analogue-naive patients who had an improvement in liver fibrosis at 48 weeks ETV group was 59%, LMV group was 53%; liver fibrosis patients did not change the proportion of ETV group was 31%, LMV group was 18%; liver fibrosis worsening ratio of ETV group was 2%, LMV group was 5% ; In patients with HBeAg (+) LMV failure, the proportion of patients with improved fibrosis at 48 weeks was 43% in the ETV group and 33% in the LMV group; the proportion of patients with unchanged liver fibrosis was 35% in the ETV group and in the LMV group Was 29%. The proportion of patients with worsening liver fibrosis was 0 in the ETV group and 19% in the LMV group. Conclusions Patients with moderate-to-severe liver fibrosis / sclerosis who received ETV are more likely to have fibrosis improvements or invariance than those who receive LMV. These data are associated with other end points of treatment (virologic, biochemical, and Knodell-assessed histological improvement across the cohort The situation) the same result, are ETV better than LMV.