大黄蟅虫胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化的效果观察

Clinical effect of Dahuang Zhechong capsules combined with entecavir in treatment of chronic hepatitis B patients with liver fibrosis

目的观察大黄蟅虫胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床疗效。方法收集2014年10月-2016年1月于北京大学深圳医院门诊和住院治疗的慢性乙型肝炎肝纤维化患者100例。将患者随机分为2组,每组各50例,其中西药组采用恩替卡韦治疗,联合治疗组在西药组的基础上加服大黄蟅虫胶囊治疗,疗程均为48周。观察两组患者肝功能、HBV DNA载量、血清肝纤维化4项、肝脏硬度、天门冬氨酸氨基转移酶-血小板指数(APRI)/肝纤维化指数(Fibro Index)变化情况。计量资料组间比较采用t检验,计数资料组间比较采用χ2检验。结果与同组治疗前相比,治疗48周后两组患者肝功能ALT、AST和HBV DNA载量均下降,差异均有统计学意义(P值均<0.05)。两组患者治疗后肝纤纤维化4项均恢复正常,且两组间血清透明质酸、Ⅲ型前胶原、Ⅳ型胶原水平比较,差异均有统计学意义(P值均<0.05)。治疗后两组间比较,门静脉内径、脾厚度、肝硬度值和APRI/FibroIndex指数。差异均有统计学意义(P值均<0.05)。联合治疗组治疗总有效率(92.0%)高于西药组(72.0%),差异有统计学意义(χ2=6.775,P=0.009)。结论大黄蟅虫胶囊联合恩替卡韦治疗慢性乙型肝炎肝纤维化疗效优于单用恩替卡韦。

Objective To investigate the clinical effect of Dahuang Zhechong capsules combined with entecavir in the treatment of chronic hepatitis B（ CHB） patients with liver fibrosis. Methods A total of 100 CHB patients with liver fibrosis who visited or were hospitalized in Shenzhen Hospital of Peking University from October 2014 to January 2016 were enrolled and randomly divided into Western medicine group and combined treatment group,with 50 patients in each group. The patients in the Western medicine group were given entecavir,and those in the combined treatment group were given Dahuang Zhechong capsules in addition to entecavir. The course of the treatment was 48 weeks.The changes in liver function,HBV DNA load,four serum parameters of liver fibrosis,liver stiffness,and aspartate aminotransferase- to-platelet ratio index（ APRI） / Fibro Index were observed in both groups. The t- test was used for comparison of continuous data between groups,and the chi- square test was used for comparison of categorical data between groups. Results Both groups showed significant reductions in serum levels of aspartate aminotransferase（ AST）,alanine aminotransferase（ ALT）,and HBV DNA load after 48 weeks of treatment（ all P〈0. 05）. After treatment,the four serum parameters of liver fibrosis all returned to normal after treatment,and the serum levels of hyaluronic acid,type Ⅲ precollagen,and type IV collagen showed significant differences between the two groups（ all P〈0. 05）,and the portal vein diameter,thickness of the spleen,liver stiffness and APRI / Fibro Index also showed significant differences between the two groups（ both P〈0. 05）. The combined treatment group had a significantly higher overall response rate than the Western medicine group（ 92. 0%vs 72. 0%,χ2= 6. 775,P = 0. 009）. Conclusion Dahuang Zhechong capsules combined with entecavir have a better effect in the treatment of CHB patients with liver fibrosis compared with entecavir alone.