二十五味松石丸联合恩替卡韦治疗慢性乙型肝炎的临床研究

Clinical study on Ershiwuwei Songshi Pills combined with entecavir in treatment of chronic hepatitis B

目的探究二十五味松石丸联合恩替卡韦治疗慢性乙型肝炎的有效性。方法选取邯郸市第一医院2010年9月—2017年9月收治慢性乙型肝炎患者的84例,随机分成对照组和治疗组,每组各42例。对照组口服恩替卡韦片,1片/次,1次/d;治疗组患者在对照组基础上开水泡服二十五味松石丸,1丸/次,1次/d。两组患者均连续治疗3个月。观察两组患者临床疗效,同时比较治疗前后两组患者HBV-DNA转阴率、谷丙转氨酶(ALT)复常率和持续应答率及血清生化指标和不良反应情况。结果治疗后,对照组临床有效率为78.57%,显著低于治疗组的95.24%,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组患者HBV-DNA转阴率、ALT复常率及持续应答率均要显著高于对照组患者,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者转化生长因子β1(TGF-β1)、透明质酸(HA)和Ⅳ型胶原(Ⅳ-C)血清水平均显著降低(P<0.05),且治疗组患者这些血清生化指标明显低于对照组(P<0.05)。治疗期间,治疗组药物不良反应发生率为4.76%,显著低于对照组的11.90%,两组比较差异具有统计学意义(P<0.05)。结论二十五味松石丸联合恩替卡韦治疗慢性乙型肝炎临床效果好,安全性高,同时可减慢肝纤维化进程,具有一定的临床推广应用价值。

Objective To explore the clinical efficacy of Ershiwuwei Songshi Pills combined with entecavir in treatment of chronic hepatitis B. Methods Patients(84 cases) with chronic hepatitis B in Handan First Hospital from September 2010 to September 2017 were randomly divided into control and treatment groups, and each group had 42 cases. Patients in the control group were po administered with Entecavir Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Ershiwuwei Songshi Pills on the basis of the control group, 1 pill/time, once daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the HBV-DNA negative rate, ALT recurrence rate and sustained response rate, serum biochemical indexes and adverse reaction in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 78.57%, which was significantly lower than 95.24% in the treatment group, and there were differences between two groups(P < 0.05). After treatment, the HBV-DNA negative rate, ALT recurrence rate, and sustained response rate in the treatment group was significantly higher than that in the control group, with significant difference between two groups(P < 0.05). After treatment, the serum TGF-β1, HA, and Ⅳ-C levels in two groups were significantly decreased(P < 0.05), and the serum biochemical indexes levels in the treatment group were significantly lower than that in the control group(P < 0.05). During the treatment, the adverse reactions rate in the treatment group was 4.76%, which was significantly lower than 11.90% in the control group, with significant difference between two groups(P < 0.05). Conclusion Ershiwuwei Songshi Pills combined with entecavir has good clinical efficacy in treatment of chronic hepatitis B with high safety, and can slow down the process of liver fibrosis, which has a certain clinical application value.