丹参注射液联合恩替卡韦治疗慢性乙型肝炎肝纤维化的临床研究

目的探讨丹参注射液联合恩替卡韦片治疗慢性乙肝肝纤维化患者的临床疗效。方法选择2014年10月—2015年10月西宁市第一人民医院收治的慢性乙肝肝纤维化患者共136例作为研究对象,所有患者随机分为对照组和治疗组,每组各68例。对照组口服恩替卡韦片0.5 mg,1次/d。治疗组在对照组治疗的基础上静脉滴注丹参注射液,30 mL加入5%葡萄糖注射液250 mL中,1次/d。两组均连续治疗3个月。观察两组的临床疗效,比较两组治疗前后肝纤维化指标、血清HBV-DNA水平和血清转化生长因子β1(TGF-β1)水平。结果治疗后,对照组、治疗组总有效率分别为82.4%、94.1%,两组总有效率比较差异具有统计学意义(P0.05)。治疗后,两组患者血清透明质酸(HA)、Ⅳ型胶原(CIV)、Ⅲ型前胶原肽(PIIINP)和层黏连蛋白(LN)水平均显著降低,同组治疗前后差异具有统计学意义(P0.05);且治疗组这些观察指标降低程度明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患者血清HBV-DNA、TGF-β1水平均显著降低,同组治疗前后差异具有统计学意义(P0.05),且治疗组血清TGF-β1水平降低程度明显优于对照组,两组比较差异具有统计学意义(P0.05),而治疗组与对照组HBV-DNA水平比较差异无显著性。结论丹参注射液联合恩替卡韦片治疗慢性乙肝肝纤维化具有较好的临床效果,能够改善肝脏纤维化,降低血清TGF-β1水平,具有一定的临床推广应用价值。

Clinical study of Danshen Injection combined with entecavir in treatment of chronic hepatitis B hepatic fibrosis

Objective To investigate clinical efficacy of Danshen Injection combined with Entecavir Tablets in treatment of chronic hepatitis B hepatic fibrosis. Methods The patients (136 cases) with chronic hepatitis B hepatic fibrosis in Xining No. 1 People’s Hospital from October 2014 to October 2015 were randomly divided into control and treatment groups, and each group had 68 cases. The patients in the control group were po administered with Entecavir Tablets 0.5 mg, once daily. The patients in the treatment group were iv administered with Danshen Injection on the basis of the control group, 30 mL added into 5%Glucose Injection 250 mL, once daily. The patients in two groups were treated for 3 months. After treatment, the efficacy was evaluated, and indexes of liver fibrosis, serum levels of HBV-DNA and TGF-β1 in two groups were compared. Results After treatment, the efficacies in the control and treatment groups were 82.4%and 94.1%, respectively, and there were differences between two groups (P<0.05). After treatment, HA, CIV, PIIINP, and LN in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). After treatment, the observational 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, serum levels of HBV-DNA and TGF-β1 in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). After treatment, serum levels of TGF-β1 in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P < 0.05), but there were no difference on serum levels of HBV-DNA between two groups. Conclusions Danshen Injection combined with Entecavir Tablets has clinical curative effect in treatment of chronic hepatitis B hepatic fibrosis, and can improve liver fibrosis, and also decrease the serum levels of TGF-β1, which has a certain clinical application value.