心肝宝胶囊联合替比夫定治疗活动性代偿期乙型肝炎肝硬化的疗效观察

Clinical observation of Xinganbao Capsules combined with telbivudine in treatment of active compensatory hepatitis B cirrhosis

目的探讨心肝宝胶囊联合替比夫定片治疗活动性代偿期乙型肝炎肝硬化的临床疗效。方法选择2014年5月—2017年5月于洛阳市第一人民医院就诊的活动性代偿期乙型肝炎肝硬化患者94例为研究对象,采用随机数字表法将所有患者分为对照组和治疗组,每组各47例。对照组口服替比夫定片,1片/次,1次/d。治疗组在对照组治疗的基础上口服心肝宝胶囊,5粒/次,3次/d。两组患者均连续治疗6个月。观察两组的临床疗效,比较两组的肝功能指标、抗病毒相关指标、肝纤维化指标、肝脾影像学指标。结果治疗后,对照组和治疗组的总有效率分别为76.6%、89.4%,两组比较差异有统计学意义(P<0.05)。治疗后,两组天门冬氨酸氨基转移酶(AST)、白蛋白(ALB)、丙氨酸氨基转移酶(ALT)、总胆红素(TBIL)水平均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组肝功能指标明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组乙肝病毒的脱氧核糖核酸(HBV-DNA)转阴率、e抗原阳性(Hbe Ag)血清学转换率、ALT复常率、HBeAg转换率均显著高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组Ⅲ型前胶原(PC-Ⅲ)、透明质酸(HA)、Ⅳ型胶原(Ⅳ-C)和层黏连蛋白(LN)水平均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组肝纤维化指标明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组脾静脉内径(D_(sv))、门静脉内径(D_(pv))和脾厚度均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组肝脾影像学指标明显低于对照组,两组比较差异具有统计学意义(P<0.05)。结论心肝宝胶囊联合替比夫定片治疗活动性代偿期乙型肝炎肝硬化具有较好的临床疗效,可改善肝功能和肝纤维化,提高抗病毒疗效,具有一定的临床推广应用价值。

Objective To investigate the clinical effects of Xinganbao Capsules combined with Telbivudine Tablets in treatment of active compensatory hepatitis B cirrhosis. Methods Patients（94 cases） with active compensatory hepatitis B cirrhosis in the First People＇s Hospital of Luoyang from May 2014 to May 2017 were randomly divided into control and treatment groups, and each group had 47 cases. Patients in the control group were po administered with Telbivudine Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Xinganbao Capsules on the basis of the control group, 5 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and liver function indexes, anti-virus related indexes, liver fiber indexes, liver and spleen imaging indexes in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 76.6% and 89.4%, respectively, and there was difference between two groups（P〈0.05）. After treatment, the levels of AST, ALB, ALT, and TBIL in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And liver function indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, HBV-DNA conversion rates, Hbe Ag serological conversion rates, ALT recurrence rates, and HBeAg conversion rates in the treatment group were significantly higher than those in the control group, and there was difference between two groups（P〈0.05）. After treatment, the levels of PC-Ⅲ, HA, Ⅳ-C, and LN in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the liver fiber indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, D_（sv）, D_（pv）, and spleen thickness in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the liver and spleen imaging indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. Conclusion Xinganbao Capsules combined with Telbivudine Tablets has clinical curative effect in treatment of active compensatory hepatitis B cirrhosis, can improve liver function and liver fibrosis, and increase antiviral effect, which has a certain clinical application value.