复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床研究

Clinical effects of Compound Biejia Ruangan Tablet combined with entecavir in patients with chronic hepatitis B with hepatic fibrosis

目的分析复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床疗效。方法以2013年1月—2015年5月陕西省安康市人民医院消化内科诊治慢性乙型肝炎肝纤维化患者92例为研究对象,根据自愿原则分为观察组(n=45)和对照组(n=47),观察组给予复方鳖甲软肝片联合恩替卡韦治疗,对照组仅给予恩替卡韦治疗,两组均治疗48周,比较两组的肝功能、肝纤维化、血清炎症因子以及不良反应。结果治疗后,两组的丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、白蛋白/球蛋白(ALB/GLB)和总胆红素(TBIL)均较治疗前显著降低(P<0.05),但两组间比较,差异均无统计学意义。治疗后,两组的血清乙型肝炎病毒脱氧核糖核苷酸(HBV DNA)转阴率比较差异无统计学意义。治疗前,两组的Ⅲ型前胶原(PCⅢ)、Ⅳ型胶原(Ⅳ-C)、透明质酸(HA)、层黏蛋白(LN)水平比较,差异无统计学意义;治疗后,两组的PCⅢ、Ⅳ-C、HA和LN水平均较治疗前显著降低(P<0.05),且观察组的PCⅢ、Ⅳ-C、HA和LN水平均低于对照组(P<0.05)。治疗后,两组的白介素-6(IL-6)、IL-4、IL-10和肿瘤坏死因子α(TNF-α)水平均较治疗前显著降低(P<0.05),且观察组的IL-6、IL-4、IL-10和TNF-α水平均低于对照组(P<0.05)。两组不良反应发生率比较,差异无统计学意义。结论复方鳖甲软肝片联合恩替卡韦治疗慢性乙型肝炎肝纤维化安全有效,可显著改善肝功能,改善肝纤维化程度,降低患者血清炎症因子水平。

Objective To investigate the clinical effects of Compound Biejia Ruangan Tablet （CBRT） combined with enteeavir in patients with chronic hepatitis B with hepatic fibrosis. Methods Totally 92 cases of patients with hepatic fibrosis of chronic hepatitis B in Ankang people＇s hospital from January 2013 to May 2016 were divided into observation group （n = 45） and control group （n = 47）, patients in observation group were treated with CBRT combined with enteeavir, and patients in the control group were treated with entecavir. Treatment was for 48 weeks. The liver function, liver fibrosis, serum inflammatory factors, and adverse reactions were compared between two groups. Results After treatment, the ALT, AST, TBIL, and ALB/GLB levels of two group were significantly lower than those before treatment （P 〈 0.05）, but there was no significant difference between two groups after treatment. After treatment, the PCIII, IV-C, HA, LN, IL-6, IL-4, IL-10, and TNF-α levels of two group were significantly lower than those before treatment （P 〈 0.05）, and the PCII/, IV-C, HA, LN, IL-6, IL-4, IL-10, and TNF-α levels of observation group were significantly lower than those of control group （P 〈 0.05）; there was no statistically significant difference in the incidence of adverse reactions between two groups （P 〈 0.05）. Conclusion CBRT combined with entecavir is safe and effective to treat liver fbrosis of chronic hepatitis b, and it could significantly improve liver function, improve the degree of liver fibrosis, and reduce the level of serum inflammatory factors.