恩替卡韦治疗慢性重型乙型肝炎的病例对照研究

Case-controlled study of entecavir treatment for chronic severe hepatitis B

目的评估恩替卡韦（ETV）治疗慢性重型乙型肝炎的疗效及安全性。方法选择78例HBVDNA阳性慢性重型乙型肝炎分为ETv治疗组、对照组各39例。ETV组采用与对照组相同的内科综合治疗，并予ETV抗病毒治疗。检测两组肝功能、PTA、HBVDNA载量变化，记录不良事件。于第12周比较两组治疗有效率，并对ETV，组有效与无效病例的基线情况进行比较分析。结果ETV组、对照组的基线特征相似。12周时ETV组治疗有效率56．41％，对照组33．33％（P=0．0405）。重肝早期患者中，ETV组治疗有效率明显高于对照组（P=0．0275），而中、晚期无明显差异（P=0．4687）。ETV治疗有效与无效病例的基线比较结果显示：两组间年龄、胆红素、HBVDNA载量以及病情分期、肝硬化比例差异有统计学意义（P〈0．05）；而胆碱酯酶、甲胎蛋白水平及性别、腹水、HBeAg阳性比例差异无统计学意义（P〉0．05）。ETV治疗期间，无明显不良反应发生。结论ETV在慢性重型乙型肝炎早期应用可以提高疗效，但对中期和晚期的疗效可能没有影响。其疗效可能与年龄、重肝分期、胆红索水平、HBVDNA载量、是否合并肝硬化有关。ETV治疗慢性重型乙型肝炎有较好的安全性。

Objective To evaluate the efficacy and safety of entecavir（ETV）treatment for chronic severe hepatitis B. Methods 78 patients with chronic severe hepatitis B and positive HBV DNA were divided into ETV group and control group, each group had 39 patients. ETV group was given the same conventional therapy as control group,and was treated with ETV. The change of liver function, PTA, HBV DNA level were observed, and adverse events were recorded. The effective rate of treatment between ETV group and control group, the baseline characteristics between the effective cases and non-responsive cases after ETV treatment were compared at week 12. Results The baseline characteristics were well balanced between ETV group and control group. The effective rate of ETV group was 56.41% versus 33.33% of control group at week 12（ P = 0.0405） .The effective rate of ETV group was higher than that of control group, in the early stage of chronic severe hepatitis B（ P = 0.0275）, but there was no statistically significant in the middle or late stage （P = 0.4687 ）. The comparison result of baseline characteristics between the effective and non-responsive cases after ETV treatment showed： there were statistically different in age, hilirubin level, HBV DNA level and stage of the severe hepatitis, proportion of cirrhosis, but no statistically different in cholinesterase level, a- fetoprotein level and sex ratio, the proportion of ascites, positive HBeAg （ P 〉 0.05 ）. No serious adverse events occurred. Conclusions ETV improves the curative effect when used in the early stage of chronic severe hepatitis B, and may not in the middle and late stage. The curative effect of ETV may be affected by age, hilirubin level, HBV DNA level and stage of the severe hepatitis, cirrhosis. ETV has good security in the treatment for chronic severe hepatitis B.