恩替卡韦联合长效干扰素治疗HBeAg阳性慢性乙型肝炎的临床观察

摘要

目的:观察恩替卡韦联合长效干扰素治疗乙型肝炎e抗原(HBeAg)阳性慢性乙型肝炎(以下简称“乙肝”)的临床疗效及安全性.方法:选取2013年5月-2015年5月我院收治的HBeAg阳性慢性乙肝患者140例,按随机数字表法分为观察组和对照组,各70例.两组患者均行常规保肝治疗,对照组患者同时给予聚乙二醇干扰素a-2b注射液80 μg,皮下注射,每周1次;观察组患者在对照组的基础上加用恩替卡韦分散片0.5 mg,po,qd.两组患者均连续治疗50周.观察两组患者的临床疗效、治疗前后肝功能指标、病毒学疗效及不良反应发生情况.结果:两组患者各脱落5例,共130例(观察组和对照组各65例)完成研究.观察组患者的总有效率为90.8％,显著高于对照组的76.9％,差异有统计学意义(P＜0.05).治疗前,两组患者丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、白蛋白(ALB)、总胆红素(TBIL)水平比较,差异均无统计学意义(P＞0.05);治疗后,两组患者ALT、AST和TBIL水平显著降低,ALB水平显著升高,且观察组显著优于对照组,差异均有统计学意义(P＜0.05).治疗50周后,观察组患者乙肝病毒脱氧核糖核酸(HBV-DNA)转阴率、HBeAg血清学转换率和ALT复常率均显著高于对照组,病毒学突破率显著低于对照组,差异均有统计学意义(P＜0.05).两组患者均未见严重的不良反应发生,不良反应发生率比较,差异均无统计学意义(P＞0.05).结论:恩替卡韦联合长效干扰素治疗HBeAg阳性慢性乙肝疗效确切,可抑制HBV的复制,改善患者的肝功能,且安全性较高.%OBJECTIVE:To observe therapeutic efficacy and safety of entecavir combined with long-acting interferon in the treatment of HBeAg positive chronic hepatitis B (CHB).METHODS:A total of 140 patients with HBeAg positive CHB selected from our hospital during May 2013-May 2015 were divided into observation group and control group according to random number table,with 70 cases in each group.Both groups received routine liver-protecting treatment;control group was additionally given Peginterferon α-2b injection 80 μg subcutaneously,once a week;observation group was additionally given Entecavir dispersible tablets 0.5 mg,po,qd,on the basis of control group.Both groups received treatment for consecutive 50 weeks.Clinical efficacies,liver function indexes before and after treatment,virological efficacies and the occurrence of ADR of 2 groups were observed.RESULTS:Each 5 cases withdrew from the study in 2 groups,and 130 cases (65 cases in each group) completed the study.Total response rate of observation group was 90.8％,which was significantly higher than 76.9％ of control group,with statistical significance (P＜0.05).Before treatment,there was no statistical significance in the levels of ALT,AST,ALB or TBIL between 2 groups (P＞0.05).After treatment,the levels of ALT,AST and TBIL in 2 groups were decreased significantly,while ALB level was increased significantly,the observation group was significantly better than the control group,with statistical significance (P＜0.05).After 50 weeks of treatment,the negative conversion rate of HBV-DNA,HBeAg serology conversion rate and ALT normalizing rate of observation group were significantly higher than those of control group,and virologic breakthrough rate was significantly lower than control group,with statistical significance (P＜0.05).No severe ADR was found in 2 groups.There was no statistical significance in the incidence of ADR (P＞0.05).CONCLUSIONS:The entecavir combined with long-acting interferon show defmite therapeutic efficacy for HBeAg positive CHB,inhibit the replication of HBV and improve liver function of patients with good safety.